A feasibility study on re-establishing the Bioavailability/Bioequivalence unit of the Department of Pharmacology and Toxicology, College of Medicine-University of the Philippines Manila

Objectives@#The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center. @*Methods@#The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members. @*Results@#The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers. @*Conclusion@#Based on the SWOT analysis and market, technical, financial, and organizational considerations, reestablishing the BA/BE Unit as a bioequivalence testing center is feasible.

Feasibility of a novel type of complex anterior cervical fixation by using Mimics software / 中国骨伤

OBJECTIVE@#To investigate the feasibility of mimics software in analyzing a new type of complex anterior cervical fixation -- anterior transpedicular screw fixation+zero notch internal fixation.@*METHODS@#From January 2021 to September 2022, 50 normal pedestrians who underwent cervical spine CT scanning were selected for C1-C7 segment scanning, including 27 males and 23 females, aged from 25 to 65 years old with an average of (46.0 ± 9.0) years old. The dicom format is exported and engraved into the CD, and use the mimics software to perform 3D reconstruction of each segment. A simulated screw is placed on the image according to the critical value of zero notch screw (head and tail angle 44°, internal angle 29°). The position of zero notch screw in each segment is observed to determine the feasibility of anterior transpedicular screw fixation plus zero notch internal fixation.@*RESULTS@#For the upper zero notch screws the three-dimensional images of the cervical spine across all 50 subjects within the C3-C7 segments demonstrated safe position, with no instances of intersection with ATPS. For the lower zero notch screw, in C3-C4 and C4-C5, 4 out of 50 subjects are in the safe position in the three-dimensional images of cervical vertebrae, and 46 cases could achieve secure screw placement when the maximum caudal angle is(32.3±1.9) ° and (36.1±2.2) °, respectively. In C5-C6 and C6-C7 segments, no lower zero notch screws intersected with ATPS, and all screws are in safe positions.@*CONCLUSION@#Lower cervical anterior pedicle screw fixation plus zero notch internal fixation can achieve successful nail placement through the selected entry point and position.

Older people's perceptions and experiences of older people with the Sit-to-stand activity: An ethnographic pre-feasibility study / Percepções e experiências de idosos com a atividade Sit-to-stand: Um estudo etnográfico de pré-viabilidade / Percepciones y experiencias de los adultos mayores con respecto a la actividad Sit-to-stand: Un estudio etnográfico de viabilidad previa

Abstract Objective: the purpose of this pre-feasibility study was to examine perceptions and experiences of a Sit-to-stand activity with urban Brazilian community-dwelling older people in their homes. Method: the exploration method was focused ethnography. Purposive sampling was used to recruit 20 older people. Five means of data generation were used, namely: socio-demographic surveys, participant observations, informal interviews, formal semi-structured interviews, and field notes. Data analysis was qualitative content analysis. Results: the experience of mobility-challenged older people with the Sit-to-stand activity was dependent on their mobility expectations involving many factors that worked together to influence their beliefs and attitudes towards the activity, preferences, behaviors, and cultural perceptions. The participants of this study seemed to find the activity enjoyable; however, the most noticeable shortcomings for their engagement in the Sit-to-stand activity emerged as gaps in their personal and intrapersonal needs. Conclusion: the recommendations generated from the study findings call for the design of implementation strategies for the Sit-to-stand intervention that are tailored to this particular population's needs.

Resumo Objetivo: o objetivo deste estudo de pré-viabilidade foi examinar percepções e experiências da atividade de Sit-to-stand com idosos brasileiros residentes em suas casas, no meio urbano. Método: o método exploratório foi etnografia focada. Foi utilizada a amostragem intencional para recrutar 20 idosos. Foram utilizados cinco meios de geração de dados: inquéritos sociodemográficos, observações participantes, entrevistas informais, entrevistas formais semiestruturadas e notas de campo. Os dados foram analisados mediante análise de conteúdo qualitativo. Resultados: a experiência dos idosos com problemas de mobilidade na realização da atividade Sit-to-stand dependia de suas expectativas de mobilidade envolvendo muitos fatores coordenados que, de forma conjunta, influenciaram suas crenças e atitudes em relação à atividade, suas preferências, seus comportamentos e percepções culturais. Os participantes deste estudo pareciam considerar a atividade aprazível; no entanto, as deficiências mais perceptíveis para o engajamento dos participantes na atividade Sit-to-stand surgiram de falhas em suas necessidades pessoais e intrapessoais. Conclusão: as recomendações geradas a partir dos achados do estudo convocam a concepção de estratégias de implementação da intervenção Sit-to-stand adaptadas às necessidades dessa população em particular.

Resumen Objetivo: el propósito de este estudio de viabilidad previa fue examinar percepciones y experiencias con respecto a la actividad Sit-to-stand entre los adultos mayores de Brasil que viven en sus hogares en comunidades urbanas. Método: el método de exploración se enfocó en la etnografía. Se utilizó muestreo intencional para reclutar 20 adultos mayores. Se emplearon cinco medios para generar datos, a saber: encuestas sociodemográficas, observaciones participantes, entrevistas informales, entrevistas formales semiestructuradas y notas de campo. Para el análisis de los datos se recurrió a análisis de contenido cualitativo. Resultados: la experiencia de los adultos mayores con problemas de movilidad en relación con la actividad Sit-to-stand dependió de sus expectativas en torno a la movilidad, las cuales implicaron muchos factores que actuaron en conjunto para influenciar sus creencias y actitudes con respecto a la actividad, al igual que preferencias, conductas y percepciones culturales. Aparentemente, a los participantes de este estudio la actividad les resultó amena; sin embargo, los inconvenientes más notorios para adoptar la actividad Sit-to-stand surgió en la forma de déficits en sus necesidades personales e intrapersonales. Conclusión: las recomendaciones resultantes de los hallazgos del estudio indican la necesidad de diseñar estrategias de implementación para la intervención Sit-to-stand a la medida de las necesidades de este grupo poblacional específico.

Automanejo de la diabetes en personas socioeconómicamente vulnerables: estudio de factibilidad / Diabetes self-management in socioeconomically vulnerable people: A feasibility study

Introducción: La diabetes mellitus tipo 2 es una de las principales causas de morbimortalidad en el mundo, su prevalencia es aún mayor en países de medianos y bajos ingresos. El automanejo es una estrategia que ha demostrado controlar las enfermedades crónicas. Objetivo: Determinar la factibilidad y eficacia preliminar de la intervención educativa AMAS + Vida enfocada en el automanejo de la salud dirigida a personas adultas con diabetes tipo 2 en una Institución de salud de primer nivel en Neiva, Colombia. Materiales y Métodos: Estudio de factibilidad, pre test ­ post test con un solo grupo, para establecer la eficacia preliminar de la intervención. Muestra intencional de 36 adultos con diabetes tipo 2. Los instrumentos empleados fueron ficha de caracterización y escala Partners in Health para medir automanejo. Resultados: 31 adultos con diabetes completaron el seguimiento de 3 meses, mayoría eran mujeres, con bajo nivel socioeconómico y educativo, hubo buena factibilidad de la intervención. Los participantes mejoraron significativamente los conocimientos de la enfermedad (p < 0,001); además hábitos alimenticios (p = 0,001), comportamientos de automanejo de la salud (p < 0,001) y disminución del índice de masa corporal (p = 0,01). No hubo cambios significativos en la actividad física (p = 0,125). Discusión: Las intervenciones basadas en el automanejo estructuradas bajo la teoría de adaptación a las enfermedades crónicas logran cambios en la promoción de la salud en personas con diabetes. Conclusiones: La intervención tuvo eficacia preliminar en el grupo estudiado con buena factibilidad. Se recomienda continuar desarrollando estudios de tipo experimental.

Introduction: Type 2 diabetes mellitus is a leading cause of morbidity and mortality worldwide, and its prevalence is even higher in middle- and low-income countries. Self-management is a strategy that has been shown to control chronic diseases. Objective: To determine the feasibility and preliminary efficacy of the AMAS + Vida educational intervention focused on health self-management in adults with type 2 diabetes in a primary health care facility in Neiva, Colombia. Materials and Methods: Feasibility study using a one-group pretest-posttest design to determine the preliminary efficacy of the intervention. Purposive sample of 36 adults with type 2 diabetes. The instruments used were a characterization form and the Partners in Health scale to measure self-management. Results: Thirty-one adults with diabetes completed the 3-month follow-up, most of whom were women with low socioeconomic and educational levels. The feasibility of the intervention was good. Participants significantly improved disease knowledge (p < 0.001), eating habits (p = 0.001), health self-management behaviors (p < 0.001), and decreased body mass index (p = 0.01). There were no significant changes in physical activity (p = 0.125). Discussion: Self-management-based interventions, structured according to the theory of adaptation to chronic illness, achieve health-promoting changes in people with diabetes. Conclusions: The intervention showed preliminary efficacy in the study group with good feasibility. Further experimental studies are recommended.

Introdução: O diabetes mellitus tipo 2 é uma das principais causas de morbidade e mortalidade no mundo; sua prevalência é ainda maior em países de baixa e média renda. A autogestão é uma estratégia que comprovadamente controla doenças crônicas. Objetivo: Determinar a viabilidade e eficácia preliminar da intervenção educativa AMAS + Vida focada na autogestão da saúde dirigida a adultos com diabetes tipo 2 em uma instituição de saúde de primeiro nível em Neiva, Colômbia. Materiais e Métodos: Estudo de viabilidade, pré-teste ­ pós-teste com grupo único, para estabelecer a eficácia preliminar da intervenção. Amostra intencional de 36 adultos com diabetes tipo 2. Os instrumentos utilizados foram uma ficha de caracterização e a escala Partners in Health para medir a autogestão. Resultados: 31 adultos com diabetes completaram o acompanhamento de 3 meses, a maioria eram mulheres, com baixo nível socioeconômico e educacional, houve boa viabilidade da intervenção. Os participantes melhoraram significativamente o conhecimento sobre a doença (p < 0,001); também hábitos alimentares (p = 0,001), comportamentos de autogestão da saúde (p < 0,001) e diminuição do índice de massa corporal (p = 0,01). Não houve alterações significativas na atividade física (p = 0,125). Discussão: Intervenções baseadas na autogestão estruturadas sob a teoria da adaptação às doenças crônicas alcançam mudanças na promoção da saúde das pessoas com diabetes. Conclusões: A intervenção teve eficácia preliminar no grupo estudado com boa viabilidade. Recomenda-se continuar desenvolvendo estudos experimentais.

Feasibility and safety of one-stage bilateral video-assisted thoracic surgery for resection of bilateral multiple pulmonary nodules / 南方医科大学学报

OBJECTIVE@#To evaluate the feasibility and safety of one- stage bilateral video-assisted thoracic surgery (VATS) for resection of bilateral multiple pulmonary nodules (BMPNs).@*METHODS@#We analyzed the clinical characteristics, pathological features, perioperative outcomes and follow-up data of 41 patients with BMPNs undergoing one-stage bilateral VATS from July, 2011 to August, 2021.@*RESULTS@#One-stage bilateral VATS was performed uneventfully in 40 of the patients, and conversion to open surgery occurred in 1 case. The surgical approaches included bilateral lobectomy (4.9%), lobar-sublobar resection (36.6%) and sublobar-sublobar resection (58.5%) with a mean operative time of 196.3±54.5 min, a mean blood loss of 224.6±139.5 mL, a mean thoracic drainage duration of 4.7±1.1 days and a mean hospital stay of 14±3.8 days. Pathological examination revealed bilateral primary lung cancer in 15 cases, unilateral primary lung cancer in 21 cases and bilateral benign lesions in 5 cases. A total of 112 pulmonary nodules were resected, including 67 malignant and 45 benign lesions. Postoperative complications included pulmonary infection (5 cases), respiratory failure (2 cases), asthma attack (2 cases), atrial fibrillation (2 cases), and drug-induced liver injury (1 case). No perioperative death occurred in these patients, who had a 1-year survival rate of 97.6%.@*CONCLUSION@#With appropriate preoperative screening and perioperative management, one-stage bilateral VATS is feasible and safe for resection of BMPNs.

A Novel Three-minute Game-based Cognitive Risk Screening Tool-WeChat Mini-program-based Design and Large-sample Feasibility Studies / 中国医疗器械杂志

OBJECTIVE@#To develop a novel cognitive screening tool for older adults in China.@*METHODS@#"Game-based Cognitive Assessment-3 Minute Version"(G3) was designed and developed based on WeChat mini-program. And its feasibility was analyzed.@*RESULTS@#G3 mini-program contains three one-minute mini digital games and supports users' self-assessment of cognitive functions with instant access to reports. G3 had a good correlation with Montreal Cognitive Assessment Basic (MoCA-B) with Pearson's r =0.611 (P<0.001). Among natural users aged 50 and older (71 179), the G3 initiation and completion rates were 99.55% and 92.28%, respectively. The average time to complete G3 assessments was (278.5±73.73) seconds.@*CONCLUSIONS@#The novel G3 mini-program has good feasibility and usability for older Chinese adults, and can be used for cognitive screening and home self-assessment.

Exploring the Feasibility of Machine Learning to Predict Risk Stratification Within 3 Months in Chest Pain Patients with Suspected NSTE-ACS / 生物医学与环境科学（英文）

OBJECTIVE@#We aimed to assess the feasibility and superiority of machine learning (ML) methods to predict the risk of Major Adverse Cardiovascular Events (MACEs) in chest pain patients with NSTE-ACS.@*METHODS@#Enrolled chest pain patients were from two centers, Beijing Anzhen Emergency Chest Pain Center Beijing Bo'ai Hospital, China Rehabilitation Research Center. Five classifiers were used to develop ML models. Accuracy, Precision, Recall, F-Measure and AUC were used to assess the model performance and prediction effect compared with HEART risk scoring system. Ultimately, ML model constructed by Naïve Bayes was employed to predict the occurrence of MACEs.@*RESULTS@#According to learning metrics, ML models constructed by different classifiers were superior over HEART (History, ECG, Age, Risk factors, & Troponin) scoring system when predicting acute myocardial infarction (AMI) and all-cause death. However, according to ROC curves and AUC, ML model constructed by different classifiers performed better than HEART scoring system only in prediction for AMI. Among the five ML algorithms, Linear support vector machine (SVC), Naïve Bayes and Logistic regression classifiers stood out with all Accuracy, Precision, Recall and F-Measure from 0.8 to 1.0 for predicting any event, AMI, revascularization and all-cause death ( vs. HEART ≤ 0.78), with AUC from 0.88 to 0.98 for predicting any event, AMI and revascularization ( vs. HEART ≤ 0.85). ML model developed by Naïve Bayes predicted that suspected acute coronary syndrome (ACS), abnormal electrocardiogram (ECG), elevated hs-cTn I, sex and smoking were risk factors of MACEs.@*CONCLUSION@#Compared with HEART risk scoring system, the superiority of ML method was demonstrated when employing Linear SVC classifier, Naïve Bayes and Logistic. ML method could be a promising method to predict MACEs in chest pain patients with NSTE-ACS.

Feasibility analysis of puncture robot technology for the application of acupuncture robot / 中国针灸

The difficulties such as how to accurately locate acupoints and safely insert needles are presented in acupuncture robot. The puncture robot with high technological similarity to acupuncture robot is getting mature, and a large number of human trials and animal experiments have been conducted for the development of puncture robot. Through comparing the similarities and differences between puncture robot and acupuncture robot in the aspects of through-skin puncture, needle insertion and needle removal, the valuable technology of puncture robot is analyzed for the development of acupuncture robot, and the crucial direction of technology migration is determined. ①Integrating the mechanical feedback and medical imaging technology and utilizing the multi-modal perception to achieve the safety of acupuncture operation. ②Emphasizing the integration of the existing designs of chest puncture robot to realize the acupuncture operation with inhalation and exhalation involved. ③Focusing on the development of relevant technology of automatic needle removal through conducting the actual scenario of treatment with acupuncture robot in patients under non-anaesthetic condition.

Analysis of the feasibility and prognostic value of circulating tumor DNA monitoring in detecting gene mutations in patients with diffuse large B-cell lymphoma receiving chimeric antigen receptor T-cell therapy / 中华血液学杂志

Objective: To explore the prognostic value of circulating tumor DNA (ctDNA) testing in patients with refractory/relapsed diffuse large B-cell lymphoma (R/R DLBCL) undergoing chimeric antigen receptor T-cell (CAR-T) therapy, and to guide the prevention and subsequent treatment of CAR-T-cell therapy failure. Methods: In this study, 48 patients with R/R DLBCL who received CAR-T-cell therapy at the First Affiliated Hospital of Zhejiang University School of Medicine between December 2017 and March 2022 were included. Furthermore, ctDNA testing of 187 lymphoma-related gene sets was performed on peripheral blood samples obtained before treatment. The patients were divided into complete remission and noncomplete remission groups. The chi-square test and t-test were used to compare group differences, and the Log-rank test was used to compare the differences in survival. Results: Among the patients who did not achieve complete remission after CAR-T-cell therapy for R/R DLBCL, the top ten genes with the highest mutation frequencies were TP53 (41%), TTN (36%), BCR (27%), KMT2D (27%), IGLL5 (23%), KMT2C (23%), MYD88 (23%), BTG2 (18%), MUC16 (18%), and SGK1 (18%). Kaplan-Meier survival analysis revealed that patients with ctDNA mutation genes >10 had poorer overall survival (OS) rate (1-year OS rate: 0 vs 73.8%, P<0.001) and progression-free survival (PFS) rate (1-year PFS rate: 0 vs 51.8%, P=0.011) compared with patients with ctDNA mutation genes ≤10. Moreover, patients with MUC16 mutation positivity before treatment had better OS (2-year OS rate: 56.8% vs 26.7%, P=0.046), whereas patients with BTG2 mutation positivity had poorer OS (1-year OS rate: 0 vs 72.5%, P=0.005) . Conclusion: ctDNA detection can serve as a tool for evaluating the efficacy of CAR-T-cell therapy in patients with R/R DLBCL. The pretreatment gene mutation burden, mutations in MUC16 and BTG2 have potential prognostic value.

Feasibility study of arterial pressure measurement by snuff pot artery puncture / 中华危重病急救医学

OBJECTIVE@#To explore the feasibility of snuff pot arterial pressure measurement for patients undergoing routine elective surgery during anesthesia.@*METHODS@#A prospective randomized controlled trial was conducted. Patients undergoing elective surgery admitted to the Handan Hospital of Traditional Chinese Medicine from June 1, 2020 to June 1, 2022 were enrolled. Patients who needed arterial pressure measurement for hemodynamic monitoring were randomly divided into routine radial artery puncture group and snuff pot artery puncture group with their informed consent. The patients in the routine radial artery puncture group were placed a catheter at the styloid process of the patient's radius to measure pressure. In the snuff pot artery puncture group, the snuff pot artery, that was, the radial fossa on the back of the hand (snuff box), was selected to conduct the snuff pot artery puncture and tube placement for pressure measurement. The indwelling time of arterial puncture catheter, arterial blood pressure, and complications of puncture catheterization of patients in the two groups were observed. Multivariate Logistic regression analysis was used to screen the relevant factors that affect the outcome of arterial catheterization.@*RESULTS@#Finally, a total of 252 patients were enrolled, of which 130 patients received routine radial artery puncture and 122 patients received snuff pot artery puncture. There was no statistically significant difference in general information such as gender, age, body mass index (BMI), and surgical type of patients between the two groups. There was no significant difference in the indwelling time of artery puncture catheter between the routine radial artery puncture group and the snuff pot artery puncture group (minutes: 3.4±0.3 vs. 3.6±0.3, P > 0.05). The systolic blood pressure (SBP) and the diastolic blood pressure (DBP) measured in the snuff pot artery puncture group were significantly higher than those in the conventional radial artery puncture group [SBP (mmHg, 1 mmHg ≈ 0.133 kPa): 162.3±14.3 vs. 156.6±12.5, DBP (mmHg): 85.3±12.6 vs. 82.9±11.3, both P < 0.05]. There was no statistically significant difference in the incidence of complications such as arterial spasm, arterial occlusion, and pseudoaneurysm formation between the two groups. However, the incidence of hematoma formation in the snuff pot artery puncture group was significantly lower than that in the conventional radial artery puncture group (2.5% vs. 4.6%, P < 0.05). Based on the difficulty of arterial puncture, multivariate Logistic regression analysis showed that gender [odds ratio (OR) = 0.643, 95% confidence interval (95%CI) was 0.525-0.967], age (OR = 2.481, 95%CI was 1.442-4.268) and BMI (OR = 0.786, 95%CI was 0.570-0.825) were related factors that affect the outcome of arterial catheterization during anesthesia in patients undergoing elective surgery (all P < 0.05).@*CONCLUSIONS@#Catheterization through the snuff pot artery can be a new and feasible alternative to conventional arterial pressure measurement.

Feasibility analysis of digital method for measuring supracrestal tissue height crest around implant / 华西口腔医学杂志

OBJECTIVES@#This study aimed to investigate the feasibility of measuring the soft tissue height of bone cristae around implant by digital method.@*METHODS@#A total of 36 patients with dental implants were selected from the Dental Medicine Center of the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) from August 2022 to December 2022. A total of 43 dental implants were enrolled. All postoperative cone beam CT (CBCT) imaging data and intraoral digital impressions obtained before surgery were immediately obtained by the patients on the day of completion of oral implant surgery and they were imported into oral implant surgery planning software for image fitting. Then, virtual implants of the same specification were placed in the planting area, and the implant position was adjusted to overlap with the implant shadow in the CBCT image. Supracrestal tissue height (STH) was measured at the implant view interface (digital group). During the operation, implant holes were prepared step by step in accordance with the standard preparation method, and implants were implanted. The upper edge of the implant was flushed with the crest of the alveolar ridge. STH was measured by perio-dontal probing (periodontal probe group). Paired t-test was used to compare the STH differences between the digital and periodontal probe groups. Bland-Altman test was used to analyze the consistency of the two methods. Intra-group correlation coefficient (ICC) was used to verify the reliability of the results measured by different surveyors using di-gital methods.@*RESULTS@#No statistical significance was observed in the STH difference between the two methods (P>0.05). Bland-Altman test showed good consistency between the two methods, but the measurement of mandibular posterior teeth showed that the results of periodontal probe were greater than those of digital method. The ICC and 95%CI of the STH results measured digitally by different surveyors are 0.992 (0.986-0.996).@*CONCLUSIONS@#The digital me-thod is in good agreement with the periodontal probe method in measuring the soft tissue height of the bone cristae around the implant.

Muscle energy technique for chronic obstructive pulmonary disease: A feasibility study / 中西医结合学报

OBJECTIVE@#This study aimed to investigate the feasibility of implementing a manual therapy technique (muscle energy technique, MET) protocol in a hospital pulmonary rehabilitation (PR) program for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Please cite this article as: Baxter DA, Coyle ME, Hill CJ, Worsnop C, Shergis JL. Muscle energy technique for chronic obstructive pulmonary disease: A feasibility study. J Integr Med. 2023; 21(3): 245-253.@*METHODS@#Participants aged 40 years and over, with moderate to severe COPD, were recruited into this 12-week study. The primary outcome measures were feasibility (acceptability of the intervention and attendance/adherence to the trial) and safety (adverse events, AEs). All participants received the MET and PR therapies. Participants and assessors were unblinded. Semi-standardized MET was delivered on 6 occasions (a maximum of once per week) at the hospital directly before a PR session. Participants undertook PR sessions as per the hospital program at a frequency of two days per week for 8 weeks. Participants were contacted 4 weeks after their final MET treatment via a telephone call to assess acceptability of the intervention.@*RESULTS@#Thirty-three participants were enrolled, with a median age of 74 years (range 45-89 years). The median number of MET sessions that participants attended was 5 (range 0-6) out of a possible 6 sessions (83% attendance). At follow-up, participants overwhelmingly enjoyed the MET treatment with some subjectively reporting improved breathing. There were no major AEs related to the intervention, with the majority of AEs classified as expected events related to COPD exacerbations.@*CONCLUSION@#It is feasible to implement a manual therapy protocol using MET as an adjunct to PR in a hospital setting. Recruitment rates were satisfactory and there were no AEs related to the MET component of the intervention.

Safety and feasibility of right colectomy via a transvaginal approach: early experience from a single center / 中华胃肠外科杂志

Objective: To investigate the safety and feasibility of performing right colectomy via a transvaginal approach. Methods: This was a retrospeltive cohort study. Data of 30 patients who had undergone transvaginal laparoscopic right colectomy (transvaginal group) and 23 women who had undergone laparoscopic right colectomy (laparoscopic group) from January 2019 to March 2022 in the Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital were collected retrospectively. The inclusion criteria for the transvaginal group were as follows: (1) post-menopausal woman; (2) transverse diameter of the tumor < 6 cm; and (3) diagnosis of benign polyps that were unresectable by endoscopy, mucinous tumors of the appendix, or confirmed right colon cancer not requiring D3 lymphadenectomy. The inclusion criteria for the laparoscopic group were as follows: (1) pathologically confirmed adenocarcinoma or high-grade intraepithelial neoplasia; (2) lesion located from the cecum to the right third of the transverse colon; and (3) clinically stage T1-4NanyM0. The exclusion criteria for the laparoscopic group were as follows: (1) distant metastasis discovered during surgical exploration; (2) multiple organ resection required or R0 resection not possible; or (3) conversion to open surgery required. Safety was evaluated on the basis of intra- and post-operative complications. Feasibility was assessed by postoperative recovery and quality of operative specimen. The body mass index was lower in the transvaginal than the laparoscopic group (22.0±3.1 kg/m2 vs. 24.1±2.6 kg/m2, t=2.617, P=0.012). Results: Among the 30 transvaginal laparoscopic right colectomies, 26 were pure transvaginal surgeries, three required laparoscopic assistance because of difficulties with anastomosis (n=2) or abdominal adhesions (n=1), and one required conversion to laparoscopic surgery because of vascular injury. Compared with the laparoscopic group, the transvaginal group had a longer surgery time (175.0 [147.5, 216.3] minutes vs. 120.0 [100.0, 120.0] minutes, U=63.000, P<0.001) and more blood loss (30.0 [10.0, 50.0] ml vs. 23.0 [10.0, 20.0] ml, U=208.000, P=0.011). The incidence of intraoperative complications (16.7% [5/30) vs. 0, P=0.061] was comparable between the two groups. In the transvaginal group, the sites of intraoperative injuries were bladder (n=3), ileocecal artery (n=1), and right uterine artery (n=1). The incidence of postoperative complications (20.0% [6/30] vs. 17.4% [4/23], χ2<0.001,P>0.999) was also comparable between the two groups. Clavien-Dindo grade III postoperative complications occurred in two patients in the transvaginal group (one patient had a pelvic hematoma that required embolization; the other had a vesico-vaginal fistula that required surgery). Postoperative visual analogue scale scores were significantly lower (P<0.001) in the transvaginal group. Times to first flatus, ambulation, and first intake and duration of postoperative hospital stay were comparable between the two groups (P>0.05). The proportion of specimens of moderate quality was 83.3% (25/30) in the transvaginal group and 100% (23/23) in the laparoscopic group; this difference is not significant (P=0.061). Among patients who underwent D2 lymph node dissection, the number of lymph nodes examined was comparable between the transvaginal (n=23) and laparoscopic groups (n=7) (18 [15, 27] vs. 20 [16, 29], U=69.500, P=0.589). Conclusion: Transvaginal right colon surgery is associated with less postoperative pain than laparoscopic surgery, but is not yet the preferred alternative because of the incidence of surgical complications.

Feasibility of a single-port thoracoscopy-assisted five-step laparoscopic procedure via transabdominal diaphragmatic approach for No.111 lymphadenectomy in patients with Siewert type II esophageal gastric junction adenocarcinoma / 中华胃肠外科杂志

Objective: We aimed to explore the feasibility of a single-port thoracoscopy- assisted five-step laparoscopic procedure via transabdominal diaphragmatic(TD) approach(abbreviated as five-step maneuver) for No.111 lymphadenectomy in patients with Siewert type II esophageal gastric junction adenocarcinoma (AEG). Methods: This was a descriptive case series study. The inclusion criteria were as follows: (1) age 18-80 years; (2) diagnosis of Siewert type II AEG; (3) clinical tumor stage cT2-4aNanyM0; (4) meeting indications of the transthoracic single-port assisted laparoscopic five-step procedure incorporating lower mediastinal lymph node dissection via a TD approach; (5) Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1; and (6) American Society of Anesthesiologists classification I, II, or III. The exclusion criteria included previous esophageal or gastric surgery, other cancers within the previous 5 years, pregnancy or lactation, and serious medical conditions. We retrospectively collected and analyzed the clinical data of 17 patients (age [mean ± SD], [63.6±11.9] years; and 12 men) who met the inclusion criteria in the Guangdong Provincial Hospital of Chinese Medicine from January 2022 to September 2022. No.111 lymphadenectomy was performed using five-step maneuver as follows: superior to the diaphragm, starting caudad to the pericardium, along the direction of the cardio-phrenic angle and ending at the upper part of the cardio-phrenic angle, right to the right pleura and left to the fibrous pericardium , completely exposing the cardio-phrenic angle. The primary outcome includes the numbers of harvested and of positive No.111 lymph nodes. Results: Seventeen patients (3 proximal gastrectomy and 14 total gastrectomy) had undergone the five-step maneuver including lower mediastinal lymphadenectomy without conversion to laparotomy or thoracotomy and all had achieved R0 resection with no perioperative deaths. The total operative time was (268.2±32.9) minutes, and the lower mediastinal lymph node dissection time was (34.0±6.0) minutes. The median estimated blood loss was 50 (20-350) ml. A median of 7 (2-17) mediastinal lymph nodes and 2(0-6) No. 111 lymph nodes were harvested. No. 111 lymph node metastasis was identified in 1 patient. The time to first flatus occurred 3 (2-4) days postoperatively and thoracic drainage was used for 7 (4-15) days. The median postoperative hospital stay was 9 (6-16) days. One patient had a chylous fistula that resolved with conservative treatment. No serious complications occurred in any patient. Conclusion: The single-port thoracoscopy-assisted five-step laparoscopic procedure via a TD approach can facilitate No. 111 lymphadenectomy with few complications.

Feasibility study of immediate breast reconstruction with fusion fascia combined with implants / 中华肿瘤杂志

Objective: To investigate the oncologic and surgical safety of the fused fascia method for immediate breast reconstruction with implants. Methods: The clinical data of 343 patients with immediate breast reconstruction with implants in Tianjin Medical University Cancer Hospital from 2014-2017 were retrospectively analyzed to compare the 5-year local recurrence-free survival, 5-year disease-free survival and 5-year overall survival of patients with breast reconstruction by fusion fascia and other methods, and to analyze the complication incidences of implant removal between different implant groups. Results: Of the 343 patients with breast reconstruction, 95 were in the fused fascia group (fascia group) and 248 were in the non-fascia group (25 in the bovine pericardial patch group and 223 in the muscle flap group). At a median follow-up of 49 months, the differences in 5-year local recurrence-free survival (90.1% and 94.9%, respectively), 5-year disease-free survival (89.2% and 87.6%, respectively), and 5-year overall survival (95.2% and 95.1%, respectively) between patients in the fascial and non-fascial groups were not statistically significant (P>0.05). The complication incidence of implant removal was 24.0% (6/25) in the patch group and 2.1% (2/95) and 2.2% (5/223) in the fascia and muscle flap groups, respectively. Conclusion: Immediate breast reconstruction with fused fascial combined with implant is safe and feasible, less invasive than muscle flaps, more economical and with fewer complications than patches.

Feasibility study of using bridging temporary permanent pacemaker in patients with high-degree atrioventricular block after TAVR / 中华心血管病杂志

Objective: To determine the feasibility of using temporary permanent pacemaker (TPPM) in patients with high-degree atrioventricular block (AVB) after transcatheter aortic valve replacement (TAVR) as bridging strategy to reduce avoidable permanent pacemaker implantation. Methods: This is a prospective observational study. Consecutive patients undergoing TAVR at Beijing Anzhen Hospital and the First Affiliated Hospital of Zhengzhou University from August 2021 to February 2022 were screened. Patients with high-degree AVB and TPPM were included. Patients were followed up for 4 weeks with pacemaker interrogation at every week. The endpoint was the success rate of TPPM removal and free from permanent pacemaker at 1 month after TPPM. The criteria of removing TPPM was no indication of permanent pacing and no pacing signal in 12 lead electrocardiogram (EGG) and 24 hours dynamic EGG, meanwhile the last pacemaker interrogation indicated that ventricular pacing rate was 0. Routinely follow-up ECG was extended to 6 months after removal of TPPM. Results: Ten patients met the inclusion criteria for TPPM, aged (77.0±11.1) years, wirh 7 females. There were 7 patients with third-degree AVB, 1 patient with second-degree AVB, 2 patients with first degree AVB with PR interval>240 ms and LBBB with QRS duration>150 ms. TPPM were applied on the 10 patients for (35±7) days. Among 8 patients with high-degree AVB, 3 recovered to sinus rhythm, and 3 recovered to sinus rhythm with bundle branch block. The other 2 patients with persistent third-degree AVB received permanent pacemaker implantation. For the 2 patients with first-degree AVB and LBBB, PR interval shortened to within 200 ms. TPPM was successfully removed in 8 patients (8/10) at 1 month without permanent pacemaker implantation, of which 2 patients recovered within 24 hours after TAVR and 6 patients recovered 24 hours later after TAVR. No aggravation of conduction block or permanent pacemaker indication were observed in 8 patients during follow-up at 6 months. No procedure-related adverse events occurred in all patients. Conclusion: TPPM is reliable and safe to provide certain buffer time to distinguish whether a permanent pacemaker is necessary in patients with high-degree conduction block after TAVR.

Feasibility analysis and nail planning ofS2 iliac crest screw placement in children / 中国骨伤

OBJECTIVE@#To evaluate the feasibility of S2 alar iliac screw insertion in Chinese children using computerized three-dimension reconstruction and simulated screw placement technique, and to optimize the measurement of screw parameters.@*METHODS@#A total of 83 pelvic CT data of children who underwent pelvic CT scan December 2018 to December 2020 were retrospectively analyzed, excluding fractures, deformities, and tumors. There were 44 boys and 39 girls, with an average age of (10.66±3.52) years, and were divided into 4 groups based on age (group A:5 to 7 years old;group B:8 to 10 years old;group C:11-13 years old;group D:14 to 16 years old). The original CT data obtained were imported into Mimics software, and the bony structure of the pelvis was reconstructed, and the maximum and minimum cranial angles of the screws were simulated in the three-dimensional view with the placement of 6.5 mm diameter S2 alar iliac screws. Subsequently, the coronal angle, sagittal angle, transverse angle, total length of the screw, length of the screw in the sacrum, width of the iliac, and distance of the entry point from the skin were measured in 3-Matic software at the maximum and minimum head tilt angles, respectively. The differences among the screw parameters of S2 alar iliac screws in children of different ages and the differences between gender and side were compared and analyzed.@*RESULTS@#In all 83 children, 6.5 mm diameter S2 iliac screws could be placed. There was no significant difference between the side of each screw placement parameter. The 5 to 7 years old children had a significantly smaller screw coronal angle than other age groups, but in the screw sagittal angle, the difference was more mixed. The 5 to 7 years old children could obtain a larger angle at the maximum head tilt angle of the screw, but at the minimum cranial angle, the larger angle was obtained in the age group of 11 to 13 years old. There were no significant differences among the age groups. The coronal angle and sagittal angle under maximum cephalic angle and minimum cranial angle of 5 to 7 years old male were (40.91±2.91)° and (51.85±3.75)° respectively, which were significantly greater than in female. The coronal angle under minimum cranial angle was significantly greater in girls aged 8-10 years old than in boys. For the remaining screw placement angle parameters, there were no significant differences between gender. The differences in the minimum iliac width, the screw length, and the length of the sacral screws showed an increasing trend with age in all age groups. The distance from the screw entry point to the skin in boys were significantly smaller than that of girls. The minimum width of the iliac in boys at 14 to 16 years of age were significantly wider than that in girls at the same stage. In contrast, in girls aged 5 to 7 years and 11 to 13 years, the screw length was significantly longer than that of boys at the same stage.@*CONCLUSION@#The pelvis of children aged 5 to 16 years can safely accommodate the placement of 6.5 mm diameter S2 alar iliac screws, but the bony structures of the pelvis are developing and growing in children, precise assessment is needed to plan a reasonable screw trajectory and select the appropriate screw length.

Feasibility Study of Beam Angle Optimization Based on Scripts in Automated-planning for Liver Cancer / 中国医疗器械杂志

OBJECTIVE@#To study the feasibility and potential benefits of beam angle optimization (BAO) to automated planning in liver cancer.@*METHODS@#An approach of beam angle sampling is proposed to implement BAO along with the module Auto-planning in treatment planning system (TPS) Pinnacle. An in-house developed plan quality metric (PQM) is taken as the preferred evaluating method during the sampling. The process is driven automatically by in-house made Pinnacle scripts both in sampling and scoring. In addition, dosimetry analysis and physician's opinion are also performed as the supplementary and compared with the result of PQM.@*RESULTS@#It is revealed by the numerical analysis of PQM scores that only 15% patients whose superior trials evaluated by PQM are also the initial trials. Gantry optimization can bring benefit to plan quality along with auto-planning in liver cancer. Similar results are provided by both dose comparison and physician's opinion.@*CONCLUSIONS@#It is possible to introduce a full automated approach of beam angle optimization to automated planning process. The advantages of this procedure can be observed both in numerical analysis and physician's opinion.

Feasibility and safety of bipolar-plasmakinetic transurethral enucleation and resection of the prostate in day surgery mode / 浙江大学学报·医学版

OBJECTIVES@#To evaluate the feasibility and safety of bipolar-plasmakinetic transurethral enucleation and resection of the prostate (B-TUERP) in day surgery.@*METHODS@#From January 2021 to August 2022, 34 patients with benign prostatic hyperplasia (BPH) underwent B-TUERP in day surgery in the First Affiliated Hospital of Anhui Medical University. Patients completed the screening and anesthesia evaluation before admission and received the standard surgery which implements "anatomical enucleation of the prostate" and "absolute bleeding control" on the same day of admission, and by the same doctor. Bladder irrigation was stopped, catheter was removed and the discharge evaluation was performed on the first day after operation. The baseline data, perioperative conditions, time of recovery, treatment outcomes, hospitalization costs, and postoperative complications were analyzed.@*RESULTS@#All operations were successfully conducted. The average age of the patients was (62.2±7.8) years, average prostate volume was (50.2±29.3) mL. The average operation time was (36.5±19.1) min, the average hemoglobin and blood sodium were decreased by (16.2±7.1) g/L and (2.2±2.0) mmol/L, respectively. The average postoperative length of hospital stay, and total length of hospital stay were (17.7±2.2) and (20.8±2.1) h, respectively, and the average hospitalization cost was (13 558±2320) CNY. All patients were discharged on the day after surgery except for one patient who was transferred to a general ward. Three patients received indwelling catheterization after catheter removal. The 3-month follow-up results showed a substantial improvement in the International Prostate Symptom Score, quality of life score and maximum urinary flow rate (all P<0.01). Three patients experienced temporary urinary incontinence, 1 patient experienced urinary tract infection, 4 patients were diagnosed with urethral stricture and 2 patients experienced bladder neck contracture. No complications above Clavien grade Ⅱ occurred.@*CONCLUSIONS@#The preliminary results showed that B-TUERP ambulatory surgery is a safe, feasible, economical and effective treatment for appropriately selected patients with BPH.

Feasibility of enlarging the ventral space by using a drill under spinal endoscopy in the treatment of severe free lumbar disc herniation / 中国骨伤

OBJECTIVE@#To evaluate the clinical efficacy of spinal endoscopy in the treatment of severe free lumbar disc herniation and explore the feasibility and application of microscopic drills to expand ventral space.@*METHODS@#Thirty patients with severe free lumbar intervertebral disc herniation treated by spinal endoscopic technique from April 2019 to March 2021 were collected, including 19 males and 11 females;aged from 19 to 76 years with an average of (44.03±16.92) years old. All patients had a single segmental lesion with prolapse of the nucleus pulposus. Among them, there were 3 cases on L2,3, 3 cases on L3,4, 15 cases on L4,5, and 9 cases on L5S1. During operation, posterior bone of vertebral body and pedicle notch were removed by a drill under the endoscope to enlarge the ventral space. And the free nucleus pulposus was exposed and completely removed. The intraoperative blood loss, operation time, hospital stay and postoperative neurological complications were recorded, and Japanese Orthopaedic Association (JOA) score, Oswestry Disability Index (ODI) and visual analogue scale (VAS) were compared before operation, 2 days, 3 months and 1 year after operation, and Macnab standard was used to evaluate clinical efficacy.@*RESULTS@#All operations were successful and the free nucleus pulposus was completely removed. Pain in the lower back and legs was significantly relieved on the day after operation. Two patients experienced transient pain and numbness in lower limbs after operation, and no serious nerve injury complications occurred. ODI and VAS at each time point after surgery were significantly lower than those before surgery (P<0.01), and JOA score was significantly higher than before surgery (P<0.01). The excellent and good rates of Macnab were 66.67% (20/30), 83.33% (25/30) and 90.00% (27/30) on 2 days, 3 months and 1 year after operation, respectively.@*CONCLUSION@#For severe free lumbar intervertebral disc herniation, using of a drill under endoscope to expand the ventral space can smoothly remove the free nucleus pulposus and avoid nerve damage.