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2. Material and Methods | PMC10125751 | |||
2.1. Study Population | bleeding, seizure, cancer, vaginal atrophy, diabetes | BLEEDING, CANCER, LIVER DISEASE, VAGINAL ATROPHY, AUTOIMMUNE DISEASE, DIABETES | In the present randomized clinical trial, postmenopausal women with vaginal atrophy who complained of menopausal symptoms were recruited at Shahid Beheshti Hospital, Kashan, Iran, from February to December 2021. The study was approved by the Ethics Committee of the Kashan University of Medical Sciences (IR.KAUMS.MEDNT.REC.1399.206), and the trial was registered at IRCT20210405050859N1. All participants were informed of the protocol and purpose of the study. Informed consent was obtained from participants before they took part in the study.A total of 63 postmenopausal women were enrolled in this study. The inclusion criteria were as follows: women aged >40 years old who had natural menopause and last menstrual bleeding at least 12 months before. The exclusion criteria were as follows: sensitivity to hormonal therapy, cancer, autoimmune disease, smoking or alcohol consumption, liver disease, diabetes, and seizure. | PMC10125751 |
2.2. Study Design | MALE SEXUAL DYSFUNCTION | Women were randomized according to a permuted block randomization scheme with a block size of 4. Patients were categorized into the two study groups (hop and estradiol). In the hop group, all women (Female sexual dysfunction was explained by a gynecologist. A questionnaire was used to evaluate the Female Sexual Function Index (FSFI), as previously described [ | PMC10125751 | |
2.3. Statistical Analysis | The statistical analysis was performed using the independent | PMC10125751 | ||
3. Results | sexual pain | A total of 63 women participated in this study and were randomly assigned to the two groups (hop group (Before starting treatment, the hop and estradiol groups did not indicate any differences in sexual desire, sexual arousal, vaginal lubrication, and satisfaction scores (Two studied groups showed no statistically significant differences in FSFI scores (sexual desire, sexual arousal, vaginal lubrication, satisfaction, orgasm, sexual pain, and total FSFI) after treatment ( | PMC10125751 | |
4. Discussion | sexual dysfunction, hormone-dependent cancers | CARDIOVASCULAR DISORDERS | To date, there is no approved treatment for postmenopausal women suffering from sexual dysfunction. Although hormone therapy with estradiol seems to be an effective treatment for these women, it may have some side effects, such as the risk of developing hormone-dependent cancers and cardiovascular disorders [ | PMC10125751 |
5. Conclusion | sexual dysfunction | ADVERSE EVENTS | The results of this study for the first time show that the administration of vaginal hop was as effective as estradiol in eliminating and reducing sexual dysfunction among postmenopausal women with no adverse events. Therefore, given the possible consequences of hormone therapy, the vaginal use of the hop extract can be recommended as a safe herbal alternative to estradiol for postmenopausal women to improve sexual dysfunction and enhance the quality of life among these women. Although this observation suggests that the vaginal use of the hop extract can be effective in reducing sexual dysfunction in postmenopausal women, the limitations of the study were the lack of case groups treated with different doses of the hop extract and the evaluation of hop effects on sexual function of spouses of postmenopausal women. Furthermore, further studies with a larger sample size are needed to confirm the results of the current study [ | PMC10125751 |
Acknowledgments | infertility | The authors thank the personnel of the infertility center of Shahid Beheshti Hospital for valuable assistance. This study was financially supported by the Kashan University of Medical Sciences (Grant no. 3231). | PMC10125751 | |
Data Availability | All data generated or analyzed during this study are included in this manuscript. | PMC10125751 | ||
Ethical Approval | The study was approved by the Ethics Committee of the Kashan University of Medical Sciences (IR.KAUMS.MEDNT.REC.1399.206), and the trial was registered at | PMC10125751 | ||
Consent | Informed consent was obtained from participants before they took part in the study. | PMC10125751 | ||
Disclosure | This manuscript was previously preprinted [ | PMC10125751 | ||
Conflicts of Interest | The authors declare that they have no conflicts of interest. | PMC10125751 | ||
Authors' Contributions | Zahra Vahedpoorfard and Samira Ferdosi carried out some experiments and obtained funding for the work. Habibollah Rahimi participated in the design of the experiments and preformed statistical analysis. Hossein Motedayyen participated in the study design and drafted the manuscript. All authors read and approved the final manuscript. | PMC10125751 | ||
Supplementary Materials | SD | APPENDIX | FSFI scoring Appendix 1 was used to evaluate the Female Sexual Function Index (FSFI).Click here for additional data file.Demographic characteristics of the participants.Data are presented as the mean ± SD or frequency (percentage).FSFI scores of the women in the hop and estradiol groups before treatment.Data are presented as the mean ± SD. FSFI scores of the women in the hop and estradiol groups after treatment.Data are presented as the mean ± SD. | PMC10125751 |
1. Introduction | deaths, birth companions, anxiety, stillbirths | The study aimed to assess the effect of midwife-provided orientation of birth companions on maternal anxiety and coping during labor. A stepped wedge cluster randomized trial design was conducted among 475 participants (control Improving the quality of care around the time of birth has been acknowledged as the most impactful strategy for reducing stillbirths and maternal and newborn deaths [Labor companionship, like other non-clinical interventions, has not been regarded as a priority in many settings, yet it is an essential component of the experience of care [Presently, women in Uganda are allowed to have a companion of choice during labor. These companions, however, neither receive an orientation nor have defined roles and responsibilities. It is acknowledged that actively involving family members in the process of labor ensures ownership and engagement [There is low-quality evidence on the effect of continuous labor support in low-income settings. Additionally, it is still unknown whether training impacts the effectiveness of continuous labor support [ | PMC9866548 | |
2. Materials and Methods | mental illness, Anxiety, anxiety, birth companions, VAS-A, humor | SECONDARY | A cross-sectional stepped wedge cluster randomized trial was used. In this design, different individuals in the control and intervention are used with a single observation of outcomes [The study was carried out in the Bugisu sub-region located in the eastern part of Uganda. The Bugisu sub-region consists of six districts, including Manafwa, Mbale, Bududa, Sironko, Namisindwa, and Bulambuli. According to the Uganda National Bureau of Statistics, the sub-region is home mainly to the Gisu people with an average household size of 4.8 and a literacy rate of 51.5% [Cluster sampling: Each health facility in this context was considered a cluster. The inclusion criteria were the functionality of an operating theatre. Hospitals and HCIVs with a functional operating theatre were included. It was assumed that the presence of a functional theatre meant that the chances of referring women for cesarean sections to other facilities were small, enabling us to monitor more deliveries. Four clusters were selected for this trial. These were Mbale Regional Referral Hospital, Bududa, district hospital, Muyembe HCIV, and Busiu (Manafwa) HCIV.Individual specific criteria. Women who had a birth companion, in spontaneously established labor and, expecting a vaginal delivery. Exclusion criteria were women with multiple pregnancies, previous cesarean section, and mental illness, or deaf or mute women. We excluded women who had previous cesarean sections because they had a higher chance of having another cesarean section.Intervention: The intervention was “midwife-provided orientation of birth companions”. The admitting midwife provided an orientation session for the birth companion on supportive labor techniques. We assumed that providing an orientation session was likely to boost birth companion confidence, hence increasing the effectiveness of continuous support. The content for the orientation session consisted of providing emotional and physical support. Emotional support included being present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, and praise, and encouraging and acknowledging efforts. Physical support included supporting her to change positions favoring upright positions, walking with her, giving her drinks and food, massaging, reminding her to go and pass urine, helping her find a comfortable position for pushing, and wiping her face with a cool cloth. The content was developed based on the literature on labor companionship techniques [Control (usual care): Women are escorted to the health facilities by one or more family members or friends. One person is allowed, besides her, to provide support. The support persons do not receive any orientation sessions and have no designated roles. Routine analgesia is not given. Midwives, medical officers, and obstetricians provide skilled care. Typically, two to three midwives are allocated per 8-h shift managing about six laboring women at a given time.Outcomes: This article is a part of a larger study assessing the effectiveness of midwife-provided orientation of birth companions on several outcomes. These were the incidence of having a spontaneous vaginal delivery, length of labor, Apgar score, coping, anxiety, and maternal satisfaction. The primary outcome was the chance of having a spontaneous vaginal delivery. This article is a reporting on two of the secondary outcomes of the actual trial. The rationale for reporting maternal anxiety and coping separately was to give more attention to the psychological aspects of childbirth. Psychological research on childbirth is scarce [Sample size and randomization: Stepped wedge trials are designed to study the effect of an intervention [Randomization for stepped wedge trials is not performed individually but rather involves the crossover of clusters from control to intervention until all clusters are exposed [Women’s self-reported anxiety levels were measured within 6 h after birth using the 10 cm Visual Analogue Scale for Anxiety (VAS-A). It ranges from 0 to 10, with a higher score representing high levels of anxiety. The VAS-A has demonstrated validity and reliability for measuring anxiety and has been used in several studies to assess anxiety in similar low-resource settings [Analysis: In this study design, the distribution of results across control periods is compared with that across the intervention periods [ | PMC9866548 |
3. Results | PMC9866548 | |||
3.2. Maternal Anxiety | Anxiety, birth companions, anxiety | Maternal anxiety for women who received continuous labor support from birth companions who had a midwife-provided orientation (intervention) was compared to those who received usual care (control).The overall mean anxiety score was 5.4 (SD = 2.0). Anxiety was higher in the pre-intervention period (5.7, SD = 1.9) compared to the post-intervention period (5.1, SD = 2.0). There was a statistically significant difference in the mean anxiety score between the pre-and post-intervention period (Subgroup analysis to evaluate treatment effects for specific endpoint groups showed that although not statistically significant, there was a notable reduction in the mean anxiety score at the regional referral hospital (from (6.3-SD 2.3) to (3.4-SD2.2)). Additionally, high differences were noted among women who were younger, first-time mothers, with a low education status, and those who were married. Additionally, anxiety levels were much lower when sisters (siblings) (6.2(2.0) vs. 4.8(2.3)) offered support compared to the parents, spouses, friends, or other relatives. See A multivariable analysis was performed to assess the relative contributions of different factors that could affect maternal anxiety. We found a statistically significant difference in the anxiety scores by study period ( | PMC9866548 | |
3.3. Coping with Labor | active labor | The proportion of those able to cope was highest during the early active labor (89.7%) and lowest during the second stage (53.4%). A significant difference (Further assessment of coping at 4–7 cm within the clusters and other variables was performed to evaluate treatment effects for specific baseline characteristics. We found a statistically significant difference in the proportion of women coping by study period (A multivariable analysis was performed to assess the relative contributions of different factors that could affect coping. Confounding baseline characteristics adjusted for were age, parity, cervical dilatation on admission, and relation of support person. Women in the intervention period had 80% higher odds of coping at 4–7 cm (Unadj.1.8; 95%CI 1.1–3.1) than those in the control period. The same results (Adj.1.8; CI 1.0–3.2) were found after adjusting. Furthermore, women having their second or more children and those who were supported by siblings had higher odds of coping. See | PMC9866548 | |
4. Discussion | post-traumatic stress disorder, birth companions, anxiety, Birth companions | EVENTS | In this study, we assessed the effect of midwife-provided orientation for birth companions on maternal anxiety and coping with labor. Results from our study showed that maternal anxiety score was reduced and the proportion of women coping was higher in the intervention period. Similar findings are also reported in other related studies where the presence of trained husbands during delivery decreased maternal anxiety [The current study further found that the intervention was more effective among first-time mothers. A study conducted in Malawi to determine the efficacy of a companion-integrated package for primigravid women showed that birth companions enhanced childbirth self-efficacy [Coping during childbirth is a significant predictor of the development of post-traumatic stress disorder symptoms after birth [It is also imperative to note that the current study found non-significant findings on coping during the later stages of labor. A related study found that the anxiety levels of women were high during the last stage of labor, irrespective of the intervention [Following WHO implementation, labor companionship has been implemented in Uganda to a certain extent. Birth companions, however, are not oriented nor the midwives trained on how to integrate the birth companion in the woman’s care. This study highlights the effectiveness of midwife-provided orientation on maternal anxiety and coping during labor. Findings could inform the feasibility of implementing the presence of birth companions. We would like to acknowledge that having 20 min for orientation of each birth companion in low-resource settings may perhaps be a challenge. This intervention can be modified by considering these options: group orientation sessions, conducting sessions during the antenatal period, and video recordings of supportive techniques playing on TV screens in the admission and waiting areas in busy facilities.To our knowledge, this is the first study to assess the effect of continuous labor support on the events of labor and outcomes in Uganda. The selected study design enabled all the facilities to receive the intervention. The facilities were their controls, thereby buffering the effects of heterogeneity. Nonetheless, caution should be taken in generalizing the findings, given the following limitations: randomization was performed to determine the order of introduction of the intervention to clusters and not by individual participants. The ratings of the anxiety were recalled retrospectively and could have been affected by the arrival of the baby. Additionally, coping in labor was midwife assessed, which could have led to potential bias. The numbers within the subgroup analysis were small and this may perhaps have generated a spurious correlation. However, it is beneficial to note that subgroup analysis of treatment effects in subgroups of participants may provide useful information for the specific care of women and for future research. | PMC9866548 |
5. Conclusions | active labor, birth companions, anxiety, pain | Our results suggest that midwives providing an orientation on continuous labor support lowers women’s anxiety and enhances their ability to cope with pain during early active labor. Findings from this study may be of benefit in informing the development of protocols for the implementation of the presence of birth companions in similar low-resource settings. Future evaluation of the intervention is necessary to assess the effect of additional orientation during the antenatal period. An evaluation of the acceptability and perceptions of midwives regarding guiding or orienting birth companions is essential for implementation. Women’s experience of care during childbirth is key, and organized involvement of birth companions could improve women’s experience of care and consequently their health and future reproductive decisions. | PMC9866548 | |
Author Contributions | Conceptualization, E.W.W.; data curation, E.W.W. and G.K.N.; formal analysis, E.W.W., N.M.T., G.K.N. and J.K.B.; funding acquisition, E.W.W.; investigation, E.W.W., N.M.T., G.K.N. and J.K.B.; methodology, E.W.W., N.M.T. and G.K.N.; project administration, E.W.W., P.A.M. and G.K.N.; resources, E.W.W.; supervision, G.K.N. and N.M.T.; validation, P.A.M.; visualization, P.A.M., G.K.N. and N.M.T.; writing—original draft, E.W.W.; writing—review and editing, P.A.M., G.K.N., N.M.T. and J.K.B. All authors have read and agreed to the published version of the manuscript. | PMC9866548 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board of Makerere School of Health Sciences Research Ethics Committee (SHSREC REF: 2017−54) and the Uganda National Council for Science and Technology (HS377ES). | PMC9866548 | ||
Informed Consent Statement | Written informed consent was sought from participants before enrollment in the study. Participation was voluntary and the women were informed that there were no negative repercussions for non-involvement. All methods were carried out under relevant guidelines and regulations. | PMC9866548 | ||
Data Availability Statement | Data are available on request from the corresponding author. | PMC9866548 | ||
Conflicts of Interest | All authors report no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC9866548 | ||
1. Introduction | Gastric cancer, tumor, cancer, deaths, AJCC, gastric cancer | GASTRIC CANCER, TUMOR, METASTASIS, LUNG METASTASIS, CANCER, BRAIN METASTASES, BONE METASTASIS, REGRESSIONS, REGRESSION, METASTATIC GASTRIC ADENOCARCINOMA, LIVER METASTASIS, GASTRIC CANCER | The aim of this study was to investigate the prognostic factors affecting overall survival in patients with metastatic gastric adenocarcinoma and to establish a nomogram prediction model for comprehensive clinical application. Data from 2370 patients with metastatic gastric adenocarcinoma between 2010 and 2017 were retrieved from the surveillance, epidemiology, and end results database. They were randomly divided into a training set (70%) and a validation set (30%), univariate and multivariate Cox proportional hazards regressions were used to screen important variables that may affect overall survival and to establish the nomogram. The nomogram model was evaluated using a receiver operating characteristic curve, calibration plot, and decision curve analysis. Internal validation was performed to test the accuracy and validity of the nomogram. Univariate and multivariate Cox regression analyses revealed that, age, primary site, grade, and American joint committee on cancer. T, bone metastasis, liver metastasis, lung metastasis, tumor Size, and chemotherapy were identified as independent prognostic factors for overall survival and were included in the prognostic model to construct a nomogram. The prognostic nomogram showed good overall survival risk stratification ability for the area under the curve, calibration plots, and decision curve analysis in both the training and validation sets. Kaplan–Meier curves further showed that patients in the low-risk group had better overall survival. This study synthesizes the clinical, pathological, therapeutic characteristics of patients with metastatic gastric adenocarcinoma, establishes a clinically effective prognostic model, and that can help clinicians to better evaluate the patient’s condition and provide accurate treatment.Gastric cancer remains an important cancer worldwide, and according to global cancer statistics in 2020, there have been more than 1 million new cases of gastric cancer and nearly 769,000 deaths. Gastric cancer has become the cancer with the fifth incidence and fourth mortality. Among these, East Asia had the highest incidence of gastric cancer.Although gastric cancer screening has become more common in recent years with advances in endoscopic screening techniques and increased risk awareness, most patients still present with distant metastasis. Among them, 16.92%, 5.92%, 5.08%, and 0.79% developed liver, lung, bone and brain metastases, respectively.Currently, the prognosis of gastric cancer is based on the TNM stage system issued by the union for international cancer control and the American joint committee on cancer (AJCC). | PMC9981423 |
2. Methods | PMC9981423 | |||
2.1. Patient | cancer, Cancer | CANCER, CANCER | Patients in the development and validation cohorts in this study were recruited from the SEER database supported by the National Cancer Institute, which collects information on the clinical characteristics and survival of approximately 1-third of cancer patients in the United States. SEER Stat software (version 8.4.0) (The inclusion criteria flowchart of recruited patients in SEER database. SEER = surveillance, epidemiology, and end results database. | PMC9981423 |
2.2. Data collection and endpoint definition | tumor | BRAIN METASTASIS, TUMOR, LUNG METASTASIS, BONE METASTASIS, PRIMARY TUMOR, LIVER METASTASIS | The following data were collected for all eligible patients, age, sex, marital status, primary tumor site, histological type, differentiation, TNM stage, clinical stage, tumor size, bone metastasis, brain metastasis, liver metastasis, lung metastasis, and treatment information and survival outcome. In this study, 2 variables, age and tumor size, were grouped and visualized using the X-tile software to determine the optimal cutoff value (Fig. The X-tile analysis of best-cutoff points of age and tumor size variables. (A) X-tile plot of training sets in age; (B) the cutoff point was highlighted using a histogram of the entire cohort; (C) the distinct prognosis determined by the cutoff point was shown using a Kaplan–Meier plot (low subset = blue, middle subset = gray, high subset = magenta); (D) X-tile plot of training sets in tumor size; (E) the cutoff point was highlighted using a histogram; (F) Kaplan–Meier plot of prognosis determined by the cutoff point (low subset = blue, middle subset = gray, high subset = magenta). | PMC9981423 |
2.3. Statistical analysis | REGRESSION | Categorical variables are presented as frequencies and rates and were tested using the chi-square test. Univariate and multivariate Cox proportional hazards models were used to select independent prognostic factors for OS, and nomogram models were constructed to predict the OS at 6, 12, and 24 months. The prognostic models were internally validated using a cohort of 711 patients from the SEER database. Parameters for Cox proportional hazards regression analysis included hazard ratios and the corresponding 95% confidence intervals. The receiver operating characteristic curve (ROC) was used to hire the discrimination power of the current prediction model, and a larger area under the curve (AUC) ROC indicated a better model. Calibration plots were used for visual comparison of the nomogram-predicted prognosis with the actual prognosis. Decision curve analysis (DCA) was performed to assess the clinical validity of the predictive model. Statistical significance was set at 2-sided | PMC9981423 | |
3. Results | PMC9981423 | |||
3.1. Patient characteristics | cancer, tumor | BRAIN METASTASIS, TUMOR, LUNG METASTASIS, CANCER, BONE METASTASIS, LIVER METASTASIS | We extracted data from 2370 patients from the SEER database and randomly divided them into a training set (1659 patients) and validation set (711 patients) in a 7:3ratio. The median follow-up durations were 13 months and 10 months for the training and validation sets, respectively. Table Patients’ demographics and clinicopathological characteristics.AJCC = American joint committee on cancer.The characteristics of patients in the training set were similar to those in the validation set. Among them, 67.4% were males, 32.6% were females, and 50.7% were < = 60 years of age. 61 to 70 years old accounted for 26.5%, > = 71 years old accounted for 22.8%; bone metastasis accounted for 10.1%, brain metastasis accounted for 1.4%, liver metastasis accounted for 39.4%, lung metastasis accounted for 11.2%. Patients with tumor size < = 2.8 cm, 2.9 to 4.7 cm and > = 4.8 cm accounted for 15.9%,27.7%, and 56.4% of the included patients, respectively. With regard to treatment modality, radiotherapy was performed in 26.1% of patients and chemotherapy in 77.7% of patients. No significant differences were found between the training and validation sets for any variable included in this study. | PMC9981423 |
3.2. Determining the predictors | cancer | CANCER | Univariate analysis of OS in this study is shown in Table Univariate analysis of patients with metastatic gastric adenocarcinoma.AJCC = American joint committee on cancer, CI = confidence interval, HR = hazard ratio.Multivariate analysis of patients with metastatic gastric adenocarcinoma.AJCC = American joint committee on cancer, CI = confidence interval, HR = hazard ratio. | PMC9981423 |
3.3. Developing and validating the nomogram | REGRESSION | A nomogram was constructed based on independent prognostic factors derived from multivariate Cox regression analysis to predict the OS at 6, 12, and 24 months in patients with metastatic gastric adenocarcinoma. As shown in Figure Nomogram for predicting 6-, 12-, and 24-month OS of patients with metastatic gastric adenocarcinoma. For each patient, 9 lines are drawn up to determine the points received from the predictors in the line plot. The sum of these points is on the Total Points axis. In addition, 3 lines are drawn down to determine the possibility of 6, 12, and 24 months. OS = overall survival.ROC curves of the nomogram in the prediction of prognosis. 6-month OS (A) and 12-month OS (B) and 24-month OS (C) in the training set; 6-month OS (D) and 12-month OS (E) and 24-month OS (F) in validation set. ROC = receiver operating characteristic curve, AUC = areas under the curve, OS = overall survival.Calibration plots of OS nomogram model. 6-month calibration plot of OS using training set (A); 12-month calibration plot of OS using training set (B); 24-month calibration plot of OS using training set (C);6-month calibration plot of OS using validation set (D);12-month calibration plot of OS using validation set (E);24-month calibration plot of OS using validation set (F). OS = overall survival.Decision curve analysis for the nomogram in the prediction of prognosis of patients with metastatic gastric adenocarcinoma. The Decision curve analysis of the training set (A) and validation set (B). The x-axis shows the threshold probabilities, and the y-axis measures the net benefit calculated by adding the true positives and subtracting the false positives.Kaplan–Meier curves of overall survival (OS) for patients in different risk levels. The survival of the low- and high-risk groups in the training set (A), validation set(B). | PMC9981423 | |
4. Discussion | tumor, Tumor, cancer, Adenocarcinoma, heterogeneous disease | TUMOR, METASTASIS, TUMOR, LIVER METASTASIS, CANCER, ADENOCARCINOMA, PRIMARY TUMOR, METASTATIC GASTRIC ADENOCARCINOMA, METASTASES, GASTRIC CANCER | Adenocarcinoma remains the most common pathological type of gastric malignancy, and metastatic gastric adenocarcinoma remains a serious threat to human health as a heterogeneous disease.As a visualization of multivariate prognostic models, nomograms integrate multiple prognostic factors and can be used to accurately assess the probability of survival of patients at a specific time and to predict the long-term survival of cancer patients.Previous studies have shown that age is a risk factor affecting the prognosis of gastric cancer, the risk ratio of elderly patients is significantly increased, and the survival time is significantly shortened compared with young patients.The primary tumor site has been shown to be one of the factors affecting the survival outcome of patients.Tumor size is another factor that has been shown to influence the survival outcome of patients, and we usually refer to the maximum diameter of the tumor that can be measured as its size.As the tumor burden increases, the tumor develops distant metastases. Liver metastasis is the most common site of distant metastasis in gastric cancer, and the prognosis of this type of patient is poor, with a median OS of only 2 to 3 months.This study has several limitations. First, the SEER database does not contain specific information about chemotherapy, radiotherapy, etc, such as the dose of chemotherapy drugs and target volumes, which are also important for the prognosis of patients with metastatic gastric adenocarcinoma. Second, missing data could have led to selection bias. Third, we did not perform an external validation to further evaluate the nomogram. Next, this can be verified by including a large number of patients from different regions to prove that the prediction models have better applicability. Our study also had certain advantages. First, to our knowledge, this study is the first to use a nomogram model to predict overall survival in patients with metastatic gastric adenocarcinoma. Second, this study developed a nomogram based on a large population and conducted internal validation, making the model relatively reliable and helping clinicians provide individualized treatment for patients with metastatic gastric adenocarcinoma. | PMC9981423 |
Acknowledgment | All authors would like to thank SEER for the open access to the database. | PMC9981423 | ||
Abbreviations: | METASTATIC GASTRIC ADENOCARCINOMA | American joint committee on cancerthe area under the curvedecision curve analysisoverall survivalreceiver operating characteristic curvesurveillance, epidemiology, and end results databaseThe authors have no conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.This work was supported by the Scientific Research Program of the Administration of Traditional Chinese Medicine of Hebei Province, China (2018075,2019155) and the Medical Science Research Project of Hebei Provincial Health Commission, China (20200782).SEER database belongs to public databases. The patients involved in the database have obtained ethical approval. Users can download relevant data for free for research and publish relevant articles. Our study is based on open source data, so there are no ethical issues.XL and YR contributed equally to this work.How to cite this article: Liu X, Ren Y, Wang F, Bu Y, Peng L, Liang J, Kang X, Zhang H. Development and validation of prognostic nomogram for patients with metastatic gastric adenocarcinoma based on the SEER database. | PMC9981423 | |
References | PMC9981423 | |||
Methods | We conducted a non-randomized controlled prospective pilot study that included all medical students from the last year of the pre-clinical cycle of the Université Paris-Cité Medical School, France, in 2021. The intervention group received the formative OSCE program, which consisted of four OSCE sessions, followed by debriefing and feedback, whereas the control group received the standard teaching program. The main objective of this formative OSCE program was to develop skills in taking a structured medical history and communication. All participants took a final summative OSCE. The primary endpoint was the summative OSCE mark in each group. A questionnaire was also administered to the intervention-group students to collect their feedback. A qualitative analysis, using a convenience sample, was conducted by gathering data pertaining to the process through on-site participative observation of the formative OSCE program. | PMC10703252 | ||
Results | Twenty students were included in the intervention group; 776 in the control group. We observed a significant improvement with each successive formative OSCE session in communication skills and in taking a structured medical history (p<0.0001 for both skills). Students from the intervention group performed better in a summative OSCE that assessed the structuring of a medical history (median mark 16/20, IQR [15; 17] versus 14/20, [13; 16], respectively, p = 0.012). Adjusted analyses gave similar results. The students from the intervention group reported a feeling of improved competence and a reduced level of stress at the time of the evaluation, supported by the qualitative data showing the benefits of the formative sessions. | PMC10703252 | ||
Conclusion | Our findings suggest that an early formative OSCE program is suitable for the pre-clinical years of medical education and is associated with improved student performance in domains targeted by the program. | PMC10703252 | ||
Data Availability | The data that support the findings are owned by a third-party organization (the Paris University OSCE group) which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request to | PMC10703252 | ||
Background | The objective structured clinical examination (OSCE) [In France, as in many other countries, the first years of medical education are mainly dedicated to pre-clinical learning, without significative clinical or hospital exposure. Thus, OSCEs have initially been reserved for the clinical years of medical education that follow. However, such a pre-clinical/clinical dichotomy has recently been revised by several universities, paving the way for earlier implementation of OSCEs in the medical curriculum [We conducted a literature review on the use of formative OSCEs in pre-clinical years of the medical formation. A recent study conducted in the United Kingdom suggested that early OSCEs integrated in the 2We aimed to assess the effectiveness of an early formative OSCE program dedicated to pre-clinical medical students on subsequent performance compared to students following a standard teaching program. | PMC10703252 | ||
Methods | PMC10703252 | |||
Study design | We conducted a non-randomized controlled prospective study within the Université Paris-Cité Medical School to evaluate the effectiveness of an early formative OSCE program for students in the preclinical years of their medical education on summative OSCE performance at the end of the last year of the pre-clinical cycle (i.e., third year of medical school in France) compared to students following the standard teaching program of the medical school without an OSCE. In addition, student feedback on the early formative OSCE program was also evaluated. | PMC10703252 | ||
Study population | All students in the last year of the preclinical cycle of medical studies of the Université Paris-Cité Medical School in 2020–2021 (1,002 students) were eligible for the study. The entire 2020–2021 class was divided into several groups by the medical school by alphabetical order to further distribute the students to different traineeships. The intervention group was one of such pre-established groups (20 students) and the rest constituted the control group. No student refused to participate in the study. | PMC10703252 | ||
Intervention | MAY | The formative OSCE program consisted of four sessions that were administered once every two weeks between April 1 and May 31, 2021. This program followed the key objectives of preclinical medical education in France, which focuses on taking an extensive structured medical history, as well as on developing good communication skills.The 20 students from the intervention group were divided into four subgroups. For each, the OSCE sessions were organized as follows:- Two teachers, both medical doctors, managed an OSCE station for a simulation lasting approximately 7 min, during which one teacher simulated the patient and the other was the examiner.- Before each OSCE session, a short briefing was performed by one of the teachers detailing the objectives of the station.- Following the OSCE, individual and collective debriefing sessions were conducted to collect students’ feedback on positive points and difficulties.The subject of each formative OSCE is detailed in In both intervention and control groups, each student received the standard teaching program of semiology courses of the faculty, with a specific focus on medical history and had a daily 3-h observational traineeship in a hospital department for the last 12 weeks of the year. | PMC10703252 | |
Primary endpoint and final evaluation | pelvic pain | MAY, FACIAL PALSY | For all included students, a summative OSCE was performed at the end of the school year on May 2021, organized by the faculty. None of the teachers participating in the formative OSCE program were involved in the organization of the summative OSCE and were blinded to the summative OSCE subjects when conducting the formative program. The summative OSCE consisted of three stations (St1, 2, and 3), including one focusing on medical history, structuring of a medical history, and communication skills (St1, investigating the medical history of pelvic pain), and two others targeting technical skills or physical examination (St2 and St3, performing and analyzing an electrocardiogram and conducting the physical examination of a case of facial palsy, respectively).The primary endpoint was the mark for the summative OSCE of the station targeting medical history (St1) in the intervention group compared to the control group. St2 and St3 served as the control outcome to explore the possibility of an extended benefit of formative OSCE to skills not specifically targeted by the program.Secondary endpoints were the progression curve of the intervention group during the four OSCE training sessions, assessing communication skills and the ability to take an extensive structured medical history.Finally, a standardized anonymized questionnaire was administered to the students of the intervention group to collect feedback concerning both the formative and summative OCSEs, including the level of induced stress, their personal feeling about the formative and summative OCSEs, self-confidence, and performance evaluated using a Likert scale for each item ( | PMC10703252 |
Qualitative study | EVENTS | In addition, to complete the evaluation of this early OSCE training program, a qualitative study was conducted via the observation of five of the formative OSCE sessions (the four sessions of one subgroup and one session of another, convenience sampling). Marshall and Rossman define observation as "the systematic description of events, behaviors, and artifacts in the social setting chosen for study" [ | PMC10703252 | |
Statistical analysis | REGRESSION | The primary endpoint was analyzed using a two-tailed non-parametric Mann-Whitney test, as well as a univariate linear regression model. The same tests were used to analyze the progression curve during the four formative OSCEs.Assuming a median mark of 12/20 in the control group for the summative OSCE, an improvement of 2 points in the intervention group and a standard deviation of 2, with a total of 16 students per group, the study was estimated to have 80% power to detect such a difference, assuming two-sided tests.Multivariate linear regression models were then performed adjusted for age, repetition of the past year, and the number of students retaking exams to account for potential selection bias.To deal with the difference in sample size between the intervention and the control group, we also conducted sub-group analyses by randomly selecting 80 students among the control group, thus providing a 1:4 ratio between the intervention and control groups respectively to reanalyze the main outcome. This process was performed 5 times, to explore whether the difference in sample size between the two groups could have influenced our findings.The analyses were performed using R software (version 3.6.1), with a p value < 0.05 considered significant. | PMC10703252 | |
Qualitative analysis | Inductive thematic analysis was used for qualitative analysis. Thus, we coded the data without trying to fit it into a preexisting coding frame, the analysis was data-driven [ | PMC10703252 | ||
Results | PMC10703252 | |||
Implementation of the formative OSCE program | The preparation of the training program required 16 h to develop the exercise scenarios and evaluation grids and 4 h to organize the logistics carried out by four senior doctors (one senior per sub-group). Completion of the training program required the involvement of two senior doctors for 20 min per student, per session (for conducting a short briefing, the OSCE station, and individual debriefing) plus 15 min of collective debriefing per session. No expenditure was associated with implementation of the program. | PMC10703252 | ||
Student population and the formative OSCE program | Among the 1,002 medical students in the final year of the pre-clinical cycle in 2021 at the Université Paris-Cité Medical School, 206 did not take the final summative OSCE of the study and were not included. Thus, 796 students were included in the study, of whom 20 were in the intervention group and 776 in the control group (flow chart, | PMC10703252 | ||
Flow chart. | OSCE: objective structured clinical examination.Among the 20 students in the intervention group, 17 participated in the four formative OSCE sessions and three participated in only three.The progression curve during the formative OSCE program is presented in | PMC10703252 | ||
Progression curve of students during the formative OSCE program (N = 20). | A) General communication skills. B) Structuring of a medical history. OSCE: objective structured clinical examination. | PMC10703252 | ||
Performance in the subsequent summative OSCE | The median mark obtained for the early summative OSCE focusing on taking a structured medical history and communication skills was significantly higher for the intervention group than for the control group (median 16/20, IQR [15; 17] versus 14/20, [13; 16], respectively, p = 0.012, | PMC10703252 | ||
Performance of the intervention and control groups on a summative OSCE focusing on skills covered during the formative OSCE program (OSCE N°1, structured medical history of a pelvic pain and communication skills), N = 796. | REGRESSION | *Linear regression adjusted for age, repetition of the past year, and the number of students retaking exams. OSCE: objective structured clinical examinationHowever, the performance of the two groups did not significantly differ for the summative OSCE assessing skills not targeted by the formative OSCE program (physical examination or technical skill, without communication skills or medical history evaluation ( | PMC10703252 | |
Performance of the intervention and control groups on a summative OSCE focusing on skills not covered during the formative OSCE program (physical examination and technical skills), N = 796. | REGRESSION | *: Linear regression adjusted for age, repetition of the past year, and the number of students retaking exams. OSCE: objective structured clinical examination | PMC10703252 | |
Student feedback following the summative OSCE | Among the 20 students from the intervention group, 17 (85%) completed the final anonymized questionnaire to evaluate their experience. Regarding the structure of the program, 13/17 (76%) found that four formative OSCEs were sufficient, 2 (12%) suggested to reduce the number of formative OSCEs and 2 (12%) suggested to increase the number of sessions. The individual and collective debriefing were well perceived by 16/17 (94%) and 14/17 (82%) students, respectively. Regarding the usefulness of the program, 12/17 (71%) reported that the early formative OSCE program improved their performance. Regarding their personal experience, although 5/17 (29%) reported that the early OSCE program was stressful, 16/17 (94%) reported that it reduced their stress during the subsequent summative OSCE ( | PMC10703252 | ||
Qualitative analysis | The main themes that emerged from the observation analysis were related to stress, the ease and difficulties of the students to act as expected during the exercise, and the reported and observed benefits.The qualitative data allowed interpretation of the quantitative results on the major results. First, concerning the improved performance of the intervention group during the exam, the observation data showed an improvement in performance from one formative session to another during the training, including increased fluidity of the student and higher satisfaction expressed by the evaluator during the end-of-session debriefing. A plateau effect in the acquisition of knowledge and skills was reported by several students and trainers after the fourth session. The students were not only trained by the exercise, i.e., how to properly conduct the exchange with the patient, but also by the feedback during the individual debriefing (what are the points to be addressed according to the scoring grid, how to ensure points, memory aid tips), which constituted a favorable context to pass the exam. On the other hand, qualitative data allowed the interpretation of non-positive results as well. One of the formative sessions (n°3/4) was dedicated to an exercise concerning the announcement of a diagnosis. This particularly unsettled the students. The ease, knowledge, and skills accumulated in previous sessions declined, the stress increased, and the evaluations were weak. Finally, concerning stress during the formative sessions, several students informally reported being stressed by being alone for the first time (for the majority) in front of a patient (even simulated) and by being evaluated during the exercise, particularly by a referent teacher. "Score" and "validation" were major aspects in all debriefings. However, the repetition of the exercise, the better knowledge of assessment processes, and the debriefings were perceived as benefits. Debriefings were times of benevolent reassurance for the student and involved (no standardization) anchoring of the exercise in the professional future, a systematic review of the evaluation grid, and discussion with the evaluator. Overall, we observed good acceptability by the students, as well as by the doctors involved in the exercise, which created a favorable atmosphere for learning. | PMC10703252 | ||
Discussion | In this study, early formative OSCE dedicated to pre-clinical medical students was associated with improved subsequent performance compared to the standard teaching program. Our results highlight the positive impact of early formative OSCE on performance, as there was improvement only for the topics covered by the formative stations in the summative OSCE. Although the positive effect of formative OSCEs on summative outcomes is well described [In our study, we found that the positive impact of early formative OSCEs did not extend to areas not covered by the formative OSCE program. It is possible that a summative OSCE assessing skills not covered by the training may have a destabilizing effect, in which the student trained on a specific aspect and facing an unknown exercise does not know how to use his/her knowledge and skills better than an untrained student. This is corroborated by our qualitative study, showing that the formative session unexpectedly requiring new skills from students was particularly disrupting. This may require diversification of the formative sessions, with the limitation of having to increase committed human resources.The number of formative OSCE sessions appears to be an important consideration for the optimization of resource allocation to such a program. In our study, we found a positive effect of four formative sessions on the summative OSCE. A recent study assessing the impact of a single formative OSCE did not find any effect on subsequent performance [Indeed, we confirmed that students positively accepted early formative OSCE with a feeling of increased competence and decreased stress. We believe that these results are partially related to the design of our study. Before each session, a short briefing was given to explain the skills assessed during the session and it has been previously shown that formative OSCEs are most effective when students understand the end goal and perceive the outcome as being aligned with the stated expectations of the summative OSCE [We show this program to be feasible and acceptable to all parties. It was carried out with existing resources as an integral part of the activity of university physicians. For its transferability to be ensured in other contexts, a balance must be found between the available time of university physicians, available resources, the number of involved students, and the optimal number of sessions to be planned.This study had several limitations. First, our intervention group could be considered as being small (20 students). However, it was calculated In conclusion, this study suggests that an early formative OSCE program dedicated to the pre-clinical years of medical education may be associated with improved subsequent performance. These findings favor the early implementation of formative OSCEs to develop essential pre-clinical skills, such as learning to communicate with the patient, conducting a structured medical interview, and learning the basics of semiology. Further studies are needed to replicate these results and explore the value of early formative OSCE assessments in other core competency areas in medical studies. | PMC10703252 | ||
Supporting information | PMC10703252 | |||
Details of the four formative OSCE stations. | (DOCX)Click here for additional data file. | PMC10703252 | ||
Questionnaire administered to students from the intervention group. | (DOCX)Click here for additional data file. | PMC10703252 | ||
Results of the questionnaire administered to intervention group students, N = 17. | (DOCX)Click here for additional data file.We thank Victoire de Lastours for her help and comments. We thank Damien Livoreil and the Paris Univerisity administrative team for their logistical support. | PMC10703252 | ||
Background | ESPB, pain | Severe pain after lumbar spine surgery can delay recovery in elderly patients. We explored the efficacy of T12 erector spinal plane block (ESPB) in elderly patients who underwent lumbar spine surgery. | PMC10701994 | |
Methods | postoperative delirium, ESPB | COMPLICATIONS | A total of 230 patients undergoing lumbar spine surgery were divided and randomly allocated to ultrasound-guided ESPB (n = 115) and control (n = 115) groups. The ESPB group received 20 mL of 0.4% ropivacaine bilaterally at the T12 level after intubation, whereas the control group did not receive a block. The primary outcome was the numeric rating scale (NRS) score at 12 h after surgery. Secondary outcomes included the NRS score and tramadol use within 72 h postoperatively, intraoperative remifentanil use, incidence of postoperative delirium (POD), complications of ESPB, ambulation time, and length of hospitalization after surgery. | PMC10701994 |
Results | ESPB, NRS | COMPLICATIONS | The12-hour NRS (median (IQR)) score was remarkably lower in the ESPB group than in the control group (2 (1–3) vs. 3 (2–4), p = 0.004), as well as NRS score within 48 h (P < 0.01). The ESPB group had less intraoperative remifentanil use (P < 0.001), and less tramadol use within 72 h postoperatively (P < 0.001). Seven patients (6.7%) developed POD in the ESPB group and ten patients (9.3%) in the control group, without any statistically significant difference (P > 0.05). The ambulation time and length of hospitalization after surgery were shorter in the ESPB group than in the control group (P < 0.05). No ESPB-related complications were observed. | PMC10701994 |
Conclusions | ESPB | Bilateral T12 ESPB lowered the NRS score within 48 h after lumbar spine surgery, decreased perioperative opioid use and resulted in faster recovery in elderly patients but did not significantly reduce the incidence of POD. | PMC10701994 | |
Trial registration | The study was retrospectively registered at | PMC10701994 | ||
Keywords | PMC10701994 | |||
Introduction | postoperative pain, ESPB, pain, paraspinal muscle, truncal block | ADVERSE EFFECTS, RESPIRATORY DEPRESSION, POSTERIOR, LOCAL ANESTHETICS | As the population ages, more older people are undergoing lumbar spine surgery. Posterior lumbar spine surgery is usually an open procedure that results in considerable postoperative pain due to paraspinal muscle dissection and disc removal. In a comprehensive analysis of 179 postoperative pain types, spinal surgery pain ranked second after open calcaneal surgery [Opioids are the main analgesic drugs used after spinal surgery. Due to reduced organ function, elderly patients are less tolerant of opioids and are more susceptible to respiratory depression, excessive sedation, and other adverse effects. Additionally, neuraxial blocks are rarely utilized because they block the anterior branches of the spinal nerves and interfere with intraoperative monitoring of lower limb motor function. With the development of ultrasound visualization techniques, regional block techniques play an increasingly important role in multimode analgesia. An erector spinae plane block (ESPB) is a truncal block in which a local anesthetic is injected between the transverse process and the erector spinae muscle (ESM) under ultrasound guidance. Local anesthetics are widely diffused between the transverse process and the ESM, thus blocking the dorsal branches of spinal nerves at multiple levels [A single-blind randomized controlled trial was designed to principally evaluate the impact of T12 ESPB on postoperative pain scores in elderly patients who underwent lumbar spine surgery. Second, the effects of T12 ESPB on intraoperative hemodynamics, perioperative opioid use, and recovery outcomes were also investigated. | PMC10701994 |
Methods | This prospective, randomized, single-blinded trial protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Harbin Medical University on November 10, 2020 (KY2020-222), and it was registered at | PMC10701994 | ||
Randomization and blinding | ESPB | The anesthesiologist in charge of intraoperative management evaluated the patients on the day before the operation and allocated them to the ESPB or control group based on a 1:1 random number (SPSS Statistics 26.0, IBM, USA). Standard general anesthesia was conducted in the two groups. The ESPB group received T12 ESPB after intubation, whereas the control group did not receive the intervention. T12 ESPB was performed by a specialist who was experienced in nerve blocks. Patients, postoperative physicians and postoperative investigators were unaware of the group assignments throughout the trial. | PMC10701994 | |
Perioperative management | PONV | The electrocardiogram (ECG), pulse oxygen saturation, and bispectral index (BIS) were monitored once the patient entered the operating room. Depending on the patient’s condition, invasive or noninvasive arterial blood pressure monitoring was performed. Intravenous (IV) sufentanil (0.3 µg/kg), etomidate (0.2–0.3 mg/kg), and atracurium (0.6 mg/kg) were used to induce general anesthesia. Following intubation, sevoflurane (1.5-3%) was inhaled to maintain BIS values between 40 and 60. Intermittent atracurium injections kept muscles relaxed, and the continuous infusion volume of remifentanil (0.1–0.2 µg/(kg·min)) was adjusted to maintain the heart rate (HR) and the mean arterial blood pressure (MAP) within 80–120% of baseline. When the MAP was less than 80% of the baseline value, IV ephedrine or IV phenylephrine was administered, and IV atropine was administered when the HR was less than 40 bpm. IV 5 mg dexamethasone were administered for PONV prevention. Flurbiprofen (100 mg) was injected intravenously 30 min before the end of the operation to ensure postoperative analgesia was achieved. When the patient was awake and the tidal volume was sufficient, the tracheal tube was removed. The anesthesiologist then transferred the patient to the postanesthesia care unit (PACU). | PMC10701994 | |
Ultrasound-guided bilateral block | ESPB | STERILE | After induction, the patient was changed to a prone position. The skin was disinfected with iodophor, and the high-frequency linear ultrasound probe (6–13 Mhz, SonoSite S Series, USA) was placed in a sterile sleeve. The probe was placed longitudinally at the 12th rib of the midscapular line and moved inward along the 12th rib until the tip of the transverse process was reached. Using an in-plane method, the needle (0.71 × 120 mm, 22 G, B Braun, Germany) was inserted into the skin at the head of the probe until it reached the transverse process. Two milliliters of normal saline (NaCl 0.9%) were injected to identify the needle tip position. If the needle tip was located between the transverse process and the ESM and was not in the muscle, 20 mL 0.4% ropivacaine (AstraZeneca AB, Sweden) was injected immediately (Fig.
Ultrasound images of ESPB with the in-plane technique. Arrows, needle shaft. Abbreviations: ESM, erector spinae muscle; TP, transverse process | PMC10701994 |
Postoperative pain management | Both groups were administered intravenously guttae flurbiprofen 100 mg twice a day to maintain postoperative analgesia. When the numeric rating scale (NRS) score was ≥ 4, an intramuscular injection of 100 mg tramadol was administered. | PMC10701994 | ||
Data collection | blood loss | BLOOD LOSS | Intraoperative data were collected, including the duration of surgery, remifentanil use, total blood loss, hemodynamic parameters, and vasoactive medication dosage. Postoperative data included extubation time, Sedation-Agitation Scale (SAS) score [Intraoperative data were collected by the anesthesiologists and postoperative data were obtained by the trained investigators. | PMC10701994 |
Outcomes | PONV, NRS pain, pain | COMPLICATIONS | The primary outcome was the NRS pain score (0–10; 0, no pain; 1–3, mild pain; 4–6, moderate pain; 7–10, severe pain) at 12 h after surgery. Secondary outcomes included the NRS pain score and tramadol use within 72 h postoperatively, intraoperative remifentanil use, hemodynamic parameters, extubation time, SAS score after extubation, incidence of POD, incidence of PONV, ESPB-related complications, ambulation time, and length of hospitalization after surgery. | PMC10701994 |
Statistical analysis | ESPB, NRS | The sample size was estimated with the MedSci Application (V.6.2.2, MedSci, China). We performed sample size calculations, in which a 1-point reduction in the NRS score at 12 h was considered clinically relevant. Eight patients in each group were included in our pilot study. The NRS score was 2 (1) (mean (SD)) in the ESPB group and 2.5 (1.4) in the control group at 12 h. According to a two-sided unpaired t test, 90 patients were required in each group to achieve 80% response and an α threshold of 0.05. Due to the nonparametric estimation parameter data, the sample size was increased by 15%, resulting in 104 patients per group. Considering loss to follow-up, we selected 115 patients per group. Statistical tests were conducted with IBM SPSS Statistics 26.0 (IBM, USA). The Shapiro―Wilk test was employed to test for normal distribution; the Student’s t test and the Mann―Whitney U test were used for continuous variables (normal and nonnormal distribution);and the Fisher’s exact or χ2 tests were used for categorical variables and proportions. A two-tailed, | PMC10701994 | |
Results | CEREBROSPINAL FLUID LEAKAGE, MAY | From November 10, 2020, to May 30, 2021, 230 patients met the requirements after being screened. Three patients requested removal from the study after surgery; two patients self-administered analgesics; seven patients experienced cerebrospinal fluid leakage during the operation and the postoperative ambulation time was prolonged; and five patients were discharged early. Finally, the data of 213 patients were analyzed. Figure
Flow chart of included patient numbers | PMC10701994 | |
Pre- and intraoperative data | The demographic and clinical variables were comparable between the two groups (Table
Demographic and intraoperative dataStudent’s t test or Mann―Whitney U test for continuous variables; Fisher’s exact or χ2 tests for categorical variables and proportionsASA, American Society of Anesthesiologist; BMI, body mass index; MMSE, Mini-mental state examination; n, number; SD, standard deviation
Hemodynamic parametersUpon entry into theoperating room (T1)Upon entry into theoperating room (T1)Student’s t test for continuous variables; HR: heart rate; MAP, mean arterial pressure; n, number; SD, standard deviation | PMC10701994 | ||
Postoperative data | delirium, ESPB, postoperative nausea or vomiting, pain, NRS pain, PONV, NRS | Patients in the ESPB group had lower NRS scores at 12 h postoperatively than the control patients (2 (1, 3) vs. 3 (2–4), p < 0.01). Similar differences were observed in the pain scores at 0, 0.5, 4, 24, 36, and 48 h. In contrast, the two groups had similar NRS pain scores at 60 and 72 h postoperatively (Fig.
NRS pain scores (median (IQR)) within 72 h after surgery. MannWhitney U Test. ** p < 0.01, *** p < 0.001. NRS, numeric rating scales
Postoperative recovery outcomesLength of hospitalization aftersurgery (d; mean (SD))Student’s t test or Mann―Whitney U test for continuous variables; Fisher’s exact or χ2 tests for categorical variables and proportionsn, number; PONV: postoperative nausea or vomiting; POD: postoperative delirium; SAS, Sedation-Agitation Scale; SD, standard deviation | PMC10701994 | |
Discussion | nerve injury, thoracolumbar, ESPB, nerve block, cutaneous sensory block, thoracic neuropathic pain, hemorrhage, truncal block, T12 ESPB, NRS, lumbar plexus block | HEMORRHAGE, COMPLICATIONS, COMPLICATION, PUNCTURE SITE INFECTION | The findings of this randomized, single-blind study showed that T12 ESPB could reduce NRS scores within 48 h postoperatively and perioperative opioid use. Compared with no block, T12 ESPB significantly shortened ambulation time and hospital stay.ESPB was proposed for the treatment of thoracic neuropathic pain in 2016 [Singh et al. [The concentration and volume of local anesthetics affect the blocking effect of ESPB, but there is no consensus on the optimal concentration and volume of local anesthetics. In two randomized controlled trials, 25 mL of 0.3% ropivacaine [An ultrasound-guided thoracolumbar interfascial plane (TLIP) block is aimed at the fascia between the lumbar multifidus and longissimus muscles, and local anesthetics are injected to block the medial branch of the posterior branch of the spinal nerve [As a brain complication, POD seriously affects postoperative recovery in older patients, and its occurrence has obvious timing characteristics, generally occurring from 24 to 72 h after surgery [The impact of the regional block on POD is controversial. The meta-analysis performed by Abou-setta et al. [ESPB is a simple truncal block. Because the transverse process is easy to identify with ultrasound, young physicians with no expertise with ultrasound-guided nerve block can quickly learn the technique for ESPB. Furthermore, serious complications are less likely to occur because the puncture site is far from vital structures such as nerves, blood arteries, and viscera. In this study, there were no complications in the ESPB group, such as puncture site infection, hemorrhage, lumbar plexus block, or nerve injury. Therefore, we recommend promoting the use of T12 ESPB in lumbar spine surgery.This trial has several limitations. First, ESPB was performed after anesthesia induction and we did not detect the range of the cutaneous sensory block; therefore, patients for who the block failed cannot be excluded. Moreover, the range of nerve block that might be achieved with 20 mL of local anesthetics injected at the T12 vertebral level was not identified. Second, because ESPB is performed without intraoperative blinding of the anesthesiologist, the intraoperative data he collects are likely to be biased. Last, the small sample size of the two groups may be inadequate in detecting differences in the incidence of POD. | PMC10701994 |
Acknowledgements | RECRUITMENT | We thank the Department of Spinal Surgery and Department of Anesthesia of the Second Affiliated Hospital of Harbin Medical University for their cooperation. We are grateful for Nan Wang for assistance on patient recruitment. | PMC10701994 | |
Authors’ contributions | WD | AZ and JC helped with study design, study procedures, and manuscript writing and editing. XZ, TJ and DL helped with study design, statistical analysis, data interpretation, and manuscript editing. XC and HW helped with data collection, statistical analysis, and manuscript writing. WD is responsible for the overall content as a guarantor. | PMC10701994 | |
Funding | No funding was received to assist with the preparation of this manuscript. | PMC10701994 | ||
Data Availability | All data generated or analyzed during this study are included in this published article. | PMC10701994 | ||
Declarations | PMC10701994 | |||
Ethics approval and consent to participate | This prospective, randomized, single-blinded trial protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Harbin Medical University on November 10, 2020 (KY2020-222), and it was retrospectively registered at | PMC10701994 | ||
Consent for publication | Not applicable. | PMC10701994 | ||
Competing interests | The authors declare no competing interests. | PMC10701994 | ||
Abbreviations | nausea, confusion | The confusion assessment methodErector spinae plane blockMini-mental state examinationNumeric rating scalesPostoperative deliriumPostoperative nausea and vomitingSedation-Agitation ScaleThoracolumbar interfascial plane | PMC10701994 | |
References | PMC10701994 | |||
SUMMARY | 2C06; A.C. provided BG505 DS-SOSIP | MUTANTS | AUTHOR CONTRIBUTIONSS.W. determined cryo-EM structures, analyzed the data, and wrote the manuscript; F.M. performed B cell sorting; B.Z. and T.L. expressed and purified antibodies and performed BLI assays; C.-H.S. analyzed antibody sequences and binding motifs; T.B. calculated Shannon entropyfromthe208-strain panel and analyzed fusion-peptide-directed antibodiesforepitope overlaps; T.J., A.R.H., and J.R.-T. carried out RATP-Ig for the sorted B cells; I.-T.T. and D.W. produced trimer probes; P.T. performed AlphaLISA and Carterra assays; J.E.B. and N.C.M. collected cryo-EM data for 2C06; A.C. provided BG505 DS-SOSIP and ConC trimers; R.C. and A.S.O. prepared BG505 DS-SOSIP mutants and analyzed for antibody binding by BLI; C.C. and D.K.P. performed ELISA; M.G. and L.N. provided serum samples from VRC 018 trial; J.G., R.R., and A.S.O. designed glycan-base BG505; D.R.H. and A.S.O. produced trimersfor binding analysis; M.L. modeled glycan241 conformation and calculated energies for epitope residue mutations; S.O. and N.A.D.-R. performed neutralization assays; T.S. and Y.T. collected cryo-EM data for 2C09; D.J.V.W. and T.Z. performed SPR assays; R.A.K. oversaw neutralization and ELISA experiments; L.S. supervised data collection for 2C06; D.C.D. supervised RATP-Ig experiments; A.B.M. supervised B cell sorting; P.D.K. oversaw the project and–with S.W.–wrote the manuscript, with all authors providing revisions and comments.Elicitation of antibodies that neutralize the tier-2 neutralization-resistant isolates that typify HIV-1 transmission has been a long-sought goal. Success with prefusion-stabilized envelope trimers eliciting autologous neutralizing antibodies has been reported in multiple vaccine-test species, though not in humans. To investigate elicitation of HIV-1 neutralizing antibodies in humans, here, we analyze B cells from a phase I clinical trial of the “DS-SOSIP”-stabilized envelope trimer from strain BG505, identifying two antibodies, N751-2C06.01 and N751-2C09.01 (named for donor-lineage.clone), that neutralize the autologous tier-2 strain, BG505. Though derived from distinct lineages, these antibodies form a reproducible antibody class that targets the HIV-1 fusion peptide. Both antibodies are highly strain specific, which we attribute to their partial recognition of a BG505-specific glycan hole and to their binding requirements for a few BG505-specific residues. Prefusion-stabilized envelope trimers can thus elicit autologous tier-2 neutralizing antibodies in humans, with initially identified neutralizing antibodies recognizing the fusion-peptide site of vulnerability. | PMC10491024 |
Graphical Abstract | PMC10491024 | |||
In brief | Vaccine elicitation of tier-2 HIV-1 neutralizing antibodies in humans has been a long-sought goal. Wang et al. isolate and determine structures of two antibodies from a clinical trial of a prefusion-closed HIV-1 envelope trimer. These antibodies target the fusion-peptide site of vulnerability, form a reproducible class, and neutralize the tier-2 HIV-1 strain BG505. | PMC10491024 |
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