Pregnancy outcomes of fetal reduction in patients with intrauterine haematoma following double embryo transfer.

RESEARCH QUESTION: Is there an association between intrauterine haematoma (IUH) and pregnancy outcomes in patients who undergo fetal reduction after double embryo transfer (DET), and if so, what is the relationship between IUH-related characteristics and pregnancy outcomes? DESIGN: Clinical information and pregnancy outcomes of women who underwent fetal reduction after DET were analysed. Patients with other systematic diseases, ectopic pregnancy or heterotopic pregnancy, monochorionic twin pregnancies and incomplete data were excluded. Stratification of IUH pregnancies was undertaken based on IUH-related characteristics. The main outcome was incidence of fetal demise (<24 weeks), with other adverse pregnancy outcomes considered as secondary outcomes. RESULTS: Thirty-four IUH patients and 136 non-IUH patients who underwent fetal reduction after DET were included based on a 1:4 match for age, cycle type and fertilization method. IUH patients had a higher incidence of early fetal demise (20.6% versus 7.4%, P = 0.048), threatened abortion (48.1% versus 10.3%, P<0.001) and postpartum haemorrhage (PPH; 14.8% versus 4.0%, P = 0.043) compared with non-IUH patients. IUH was an independent risk factor for early fetal demise [adjusted OR (aOR) 3.34, 95% CI 1.14-9.77] and threatened abortion (aOR 8.61, 95% CI 3.28-22.61) after adjusting for potential confounders. IUH pregnancies undergoing fetal reduction that resulted in miscarriage had larger IUH volumes and earlier diagnosis (both P < 0.03). However, IUH characteristics (i.e. volume, changing pattern, presence or absence of cardiac activity) were not associated with threatened abortion or PPH. CONCLUSIONS: Fetal reduction should be performed with caution in IUH pregnancies after DET as the risk of fetal demise is relatively high. Particular attention should be given to IUH patients with early signs of threatened abortion and inevitable fetal demise.

Preoperative predictive model of early urinary continence recovery after laparoscopic radical prostatectomy.

PURPOSE: To develop and validate a predictive model include magnetic resonance imaging (MRI) parameters preoperatively which can assess the risk of incontinence after laparoscopic radical prostatectomy (LRP) accurately. METHODS: We retrospectively reviewed and included 170 patients with prostate cancer who underwent LRP between July 2015 and June 2018 in our institution. All 170 patients were randomly resampled and divided into training set (n = 124) and verification set (n = 46) according to the ratio of 7:3. The Nomogram prediction model of the risk of incontinence after LRP was established through the training set and verified by the verification set. Baseline patient characteristics were obtained, including age, body mass index, and prostate volume. Perioperative characteristics such as pre-biopsy prostate specific antigen, biopsy Gleason score, clinical staging, and NVB sparing status were also collected. MRI parameters preoperatively including membranous urethral length (MUL), prostate apex depth ratio (PADR), and intravesical prostatic protrusion length (IPPL) were obtained. The C index and visual inspection of calibration curve were used to evaluate the discrimination and calibration of the model. RESULTS: According to the urinary incontinence (UI) at 3 months postoperatively, the patients were divided into 104 cases (61.2%) in the group with no incontinence and 66 patients (38.8%) in the group with incontinence. Multivariate logistic regression analysis of training set showed that cT3a (OR = 0.427, 95% CI 0.142-1.281, P = 0.1288), MUL (OR = 0.237, 95% CI 0.102-0.551, P < 0.01), PADR (OR = 0.276, 95% CI 0.116-0.655, P < 0.01), and IPPL (OR = 0.073, 95% CI 0.030-0.179, P < 0.01) were independent predictors of urinary incontinence at 3 months postoperatively. The model showed good discrimination with an area under the receiver operating characteristic (ROC) curve of 0.880, with the sensitivity and specificity 0.800 and 0.816, respectively, and good calibration (Hosmer-Lemeshow test result of 5.57, P = 0.695). Decision curve analysis demonstrated that the model was clinically useful. CONCLUSION: This study developed and validated a preoperative model in the form of a nomogram to predict the risk of UI after LRP at 3 months. MUL, PADR, and IPPL were significant independent predictive factors of the postoperative early urinary continence.

Predicting post-laminoplasty kyphosis in cervical spondylotic myelopathy patients without preoperative kyphosis: a retrospective study.

BACKGROUND: This study aimed to determine potential risk factors for post-laminoplasty kyphosis and the effect of postoperative kyphosis on neurologic function recovery. METHODS: A total of 266 patients with cervical spondylotic myelopathy (CSM) underwent traditional cervical laminoplasty with a minimum of a 12-month follow-up period. The patients were divided into non-kyphosis (NK group) and kyphosis (K group) groups based on the postoperative C2-7 Cobb angle. Clinical and radiological measurements were collected preoperatively and at the final follow-up. RESULTS: Of the 266 patients, 26 (9.77%) developed postoperative kyphosis at the final follow-up. The postoperative Japanese Orthopedic Association score did not differ significantly between the NK and K groups (P > 0.05). The postoperative numeric rating scale (NRS) also showed no significant difference between the NK and K groups; however, postoperative NRS improved better than the preoperative values in the NK group (P < 0.001). Multivariate analysis revealed that the preoperative C2-7 extension Cobb angle and C2-7 Cobb angle were independent predictors of post-laminoplasty kyphosis. Cut-off values for predicting postoperative kyphosis were a C2-7 extension Cobb angle of 18.00° and a C2-7 Cobb angle of 9.30°. CONCLUSIONS: Low preoperative C2-7 extension Cobb angle and C2-7 Cobb angle may be associated with post-laminoplasty kyphosis in CSM patients without preoperative kyphosis. The cut-off value of the C2-7 extension Cobb angle and C2-7 Cobb angle were 18.00° and 9.30°, respectively.

Improving the resident assessment process: application of App-based e-training platform and lean thinking.

BACKGROUND: The assessment system for standardized resident training is crucial for developing competent doctors. However, it is complex, making it difficult to manage. The COVID-19 pandemic has also aggravated the difficulty of assessment. We, therefore, integrated lean thinking with App-based e-training platform to improve the assessment process through Define-Measure-Analyze-Improve-Control (DMAIC) cycles. This was designed to avoid unnecessary activities that generate waste. METHODS: Panels and online surveys were conducted in 2021-2022 to find the main issues that affect resident assessment and the root causes under the frame of waste. An online app was developed. Activities within the process were improved by brainstorming. Online surveys were used to improve the issues, satisfaction, and time spent on assessment using the app. RESULTS: A total of 290 clinical educators in 36 departments responded to the survey, and 153 clinical educators used the online app for assessment. Unplanned delay or cancellation was defined as the main issue. Eleven leading causes accounted for 87.5% of the issues. These were examiner time conflict, student time conflict, insufficient examiners, supervisor time conflict, grade statistics, insufficient exam assistants, reporting results, material archiving, unfamiliarity with the process, uncooperative patients, and feedback. The median rate of unplanned delay or cancellation was lower with use of the app (5% vs 0%, P < 0.001), and satisfaction increased (P < 0.001). The median time saved by the app across the whole assessment process was 60 (interquartile range 60-120) minutes. CONCLUSIONS: Lean thinking integrated with an App-based e-training platform could optimize the process of resident assessment. This could reduce waste and promote teaching and learning in medical education.

Incidence and risk factors of postoperative symptomatic spinal epidural hematoma in cervical spine surgery: a single center, retrospective study of 18,220 patients.

PURPOSE: The goal of this research is to explore the incidence and risk factors of symptomatic spinal epidural hematoma (SSEH) following cervical spine surgery. METHODS: Patients with SSEH from January 2009 to February 2019 were identified as hematoma group. Two control subjects without SSEH were randomly selected for each patient in SSEH group as control group. We collected gender, age, body mass index (BMI), ossification of the posterior ligament (OPLL), comorbidities, anti-platelet or anti-coagulate treatment, coagulation function, segments, instrumental fixation, surgical approach, surgical procedure, duration of surgery and estimated blood loss, which might affect the occurrence of symptomatic epidural hematoma. T-test and Chi-square test were used to univariable test. Multifactor logistic regression analysis was used to investigate the correlation with symptomatic epidural hematoma, furthermore its causes were explored. RESULTS: Among 18,220 patients, 43 subjects developed SSEH, the incidence was 0.24%. The median time from the end of index surgery to SSEH was 150  min (25 and 75 percentile: 85  min to 290  min). The neurologic function before evacuation by modified Frankel scale is grade B in 5 patients, C in 32 patients, grade D in 6 patients. All patients' symptoms relieved partially or completely after evacuation. All patients with neurologic deficit worse than grade C pre-evacuation had at least one-grade improvement except for one patient. Multifactor logistic regression revealed OPLL involved segments are significantly correlated to the incidence of postoperative symptomatic epidural hematoma (P < 0.05), with a cut-off value of 1.5 levels. CONCLUSION: OPLL involved segments are significantly correlated to the incidence of postoperative symptomatic epidural hematoma.

The effectiveness of percutaneous endoscopic decompression compared with open decompression and fusion for lumbar spinal stenosis: protocol for a multicenter, prospective, cohort study.

BACKGROUND: Lumbar spinal stenosis (LSS) is one of the most frequent indications for spine surgery. Open decompression and fusion surgery was the most common treatment and used to be regarded as the golden standard treatment for LSS. In recent years, percutaneous endoscopic decompression surgery was also used for LSS. However, the effectiveness and safety of percutaneous endoscopic decompression in the treatment of LSS have not been supported by high-level evidence. Our aim is to 1) compare the effectiveness of percutaneous endoscopic decompression surgery and open decompression and fusion for the treatment of LSS. 2) Investigate the prognosis risk factors for LSS. 3) Evaluate the influence of percutaneous endoscopic decompression for the stability of operative level, and degeneration of adjacent level. METHODS: It's a prospective, multicenter cohort study. The study is performed at 4 centers in Beijing. This study plans to enroll 600 LSS patients (300 patients in the percutaneous endoscopic decompression group, and 300 patients in the open decompression and fusion group). The demographic variables, healthcare variables, symptom related variables, clinical assessment (Visual analogue score (VAS), Oswestry disability index (ODI), Japanese Orthopaedic Association score (JOA)), and radiological assessment (dynamic X-ray, CT, MRI) will be collected at baseline visit. Patients will follow up at 3, 6, 12 months. The primary outcome is the difference of improvement of ODI between baseline and 12-month follow-up between the two groups. The secondary outcome is the score changes of preoperative and postoperative VAS, the recovery rate of JOA, MacNab criteria, patient satisfaction, degeneration grade of adjacent level, ROM of operative level and adjacent level, complication rate. DISCUSSION: In this study, we propose to conduct a prospective registry study to address the major controversies of LSS decompression under percutaneous spinal endoscopy, and investigate the clinical efficacy and safety of percutaneous endoscopic decompression and open decompression in the treatment of LSS. TRIAL REGISTRATION: This study has been registered on clinicaltrials.gov in January 15, 2020 ( NCT04254757 ). (SPIRIT 2a).

[A survey on the application of diagnostic and evaluation tools for chronic obstructive pulmonary disease among respiratory physicians].

Objective: To investigate the current status of the application of diagnostic and assessment tools for chronic obstructive pulmonary disease(COPD) by respiratory physicians in China. Method: An on-line questionnaire was designed to address the common questions in COPD diagnosis and evaluation, and this survey was conducted through Wechat. Result: A total of 3 204 valid questionnaires were collected. 71.7% of the physicians were from tertiary hospitals. 75.4% of the physicians diagnosed COPD strictly on the basis of lung function results after inhaled bronchodilators, and this percentage was higher in tertiary hospitals than in secondary hospitals(78.71% vs. 66.92%, P<0.01). 99.3% of the physicians evaluated symptoms of dyspnea, but 26.8% of physicians did not use a scoring system(CAT or mMRC) for quantitative assessment. Although 83.8% of physicians would use the guideline-recommended comprehensive assessment(ABCD classification), only 45.1% of them chose initial therapy exactly according to the classification. In addition, 28.3% of physicians did not routinely order blood eosinophil counts and 20.1% did not inquire the history of tuberculosis. Conclusions: Although most respiratory physicians followed the guidelines in the diagnosis and evaluation of COPD, the use of assessment tools was inadequate, which should be addressed in educational programs for COPD management.

A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

BACKGROUND: Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health. DESIGN: This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24-hour urine. TRIAL STATUS: The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups. DISCUSSION: The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide.

Association between Health-Related Quality of Life and Access to Chronic Disease Management by Primary Care Facilities in Mainland China: A Cross-Sectional Study.

The integration of chronic disease management (CDM) services into the essential public health services offered by primary care facilities has been a major strategy in China's healthcare reform since 2009. We aimed to measure the percentage of patients with chronic diseases in China who believed that they could easily obtain CDM services at a nearby primary care facility in mainland China and determine its association with the EQ visual analog scale (EQ-VAS) score and the utility index of the 5-level EQ-5D version (EQ-5D-5L). A cross-sectional survey was conducted nationwide between 20 June 2022 and 31 August 2022, involving 5525 patients with chronic diseases from 32 provincial-level administrative divisions, of which 48.1% (n = 2659) were female with a median age of 55.0 years. The median EQ-VAS score was 73.0 and the utility index of the EQ-5D-5L was 0.942. A majority of patients reported definite (24.3%) or mostly (45.9%) easy access to CDM services from nearby primary care facilities. Multivariable logistic regression analysis revealed that easy access to CDM services in primary care facilities was positively associated with higher HRQoL. Our findings indicate that, as of 2022, approximately 70% of patients with chronic diseases in mainland China had easy access to CDM services provided by primary care facilities, which was significantly and positively associated with their health status.

The Outcomes of Surgical and Nonsurgical Treatment in Patients With Spinal Metastases of Lung Cancer: Protocol for a Prospective Cohort Study.

BACKGROUND: Spinal metastases of lung cancer (SMLC) usually have a high degree of malignancy and require multimodality treatment. Patients with SMLC who experience clinical symptoms (eg, local pain, emerging or potential spinal instability, and progressive neurological dysfunction) require surgical treatment. However, there are discrepancies in the comparison of outcomes between surgical treatment and nonsurgical treatment. OBJECTIVE: This paper presents the protocol for a study that aims to compare the clinical outcomes of surgical treatment and nonsurgical treatment for SMLC, explore the prognostic factors of SMLC, and establish a survival prediction model based on these prognostic factors. METHODS: This is a prospective cohort study, with an anticipated sample size of 240 patients (120 patients in the surgical group and 120 patients in the nonsurgical group). We will collect baseline data, including demographic, clinical, and radiological information, as well as data from patient-reported questionnaires. Patients will be followed up at 3, 6, 12, and 24 months after treatment, and survival status will be assessed every 3 months. The primary outcome is the overall survival period. Prognostic factors associated with overall survival will be analyzed by univariate and multivariate Cox proportional hazards regression. Odds ratios with 95% CIs will be presented. Statistical significance is set at P<.05. RESULTS: This study has been approved by our institute's Medical Science Research Ethics Committee (IRB00006761-M2021085) after a careful audit of the design and content. Patient enrollment began in June 2022 at our hospital. Data collection is expected to be completed by early 2026, and the study results will be published by mid-2027. CONCLUSIONS: In this study, we propose to set up a prospective cohort of patients with SMLC to investigate the outcomes between surgical treatment and nonsurgical treatment. We will explore the role of surgical treatment in SMLC and provide guidance to peer surgeons. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2100048151; http://www.chictr.org.cn/showproj.aspx?proj=129450. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38273.

Prediction models for the risk of total knee replacement: development and validation using data from multicentre cohort studies.

Background: Few prognostic prediction models for total knee replacement are available, and the role of radiographic findings in predicting its use remains unclear. We aimed to develop and validate predictive models for total knee replacement and to assess whether adding radiographic findings improves predictive performance. Methods: We identified participants with recent knee pain (in the past 3 months) in the Multicenter Osteoarthritis Study (MOST) and the Osteoarthritis Initiative (OAI). The baseline visits of MOST were initiated in 2003 and of OAI were initiated in 2004. We developed two predictive models for the risk of total knee replacement within 60 months of follow-up by fitting Cox proportional hazard models among participants in MOST. The first model included sociodemographic and anthropometric factors, medical history, and clinical measures (referred to as the clinical model). The second model added radiographic findings into the predictive model (the radiographic model). We evaluated each model's discrimination and calibration performance and assessed the incremental value of radiographic findings using both category-free net reclassification improvement (NRI) and integrated discrimination improvement (IDI). We tuned the models and externally validated them among participants in OAI. Findings: We included 2658 participants from MOST (mean age 62·4 years [SD 8·1], 1646 [61·9%] women) in the training dataset and 4060 participants from OAI (mean age 60·9 years [9·1], 2379 [58·6%] women) in the validation dataset. 290 (10·9%) participants in the training dataset and 174 (4·3%) in the validation dataset had total knee replacement. The retained predictive variables included in the clinical model were age, sex, race, history of knee arthroscopy, frequent knee pain, current use of analgesics, current use of glucosamine, body-mass index, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, and the most predictive factors were age, race, and WOMAC pain score. The retained predictive variables in the radiographic model were age, sex, race, frequent knee pain, current use of analgesics, WOMAC pain score, and Kellgren-Lawrence grade, and the most predictive factors were Kellgren-Lawrence grade, race, and age. The C-statistic was 0·79 (95% CI 0·76-0·81) for the clinical model and 0·87 (0·85-0·99) for the radiographic model in the training dataset. The calibration slope was 0·95 (95% CI 0·86-1·05) and 0·96 (0·87-1·04), respectively. Adding radiograph findings significantly improved predictive performance with an NRI of 0·43 (95% CI 0·38-0·50) and IDI of 0·14 (95% CI: 0·10-0·18). Both models, with tuned coefficients, showed a good predictive performance among participants in the validation dataset. Interpretation: The risk of total knee replacement can be predicted based on common risk factors with good discrimination and calibration. Additionally, adding radiographic findings of knee osteoarthritis into the model substantially improves its predictive performance. Funding: National Natural Science Foundation of China, National Key Research and Development Program, and Beijing Municipal Science & Technology Commission.

Clinical features and prognosis of patients with COVID-19 after lung surgery: A retrospective clinical study.

AIM: To evaluate whether the history of lung surgery in patients was associated with poor prognosis of coronavirus disease 2019 (COVID-19). METHODS: Clinical data of patients with COVID-19 in a single-center were retrospectively analyzed. Patients with and without lung surgery were matched in 1:4 ratio to compare the differences in clinical characteristics, laboratory results, computed tomography findings, treatment regimens, and prognosis between them. RESULTS: Four patients had a history of lung surgery. The time from surgery to COVID-19 onset ranged from 3 to 10 days, with a median of 6.75 days. The mortality rate in the surgical group was higher than that in the nonsurgical group (25.0% vs. 6.3%). CONCLUSION: Patients contracting COVID-19 after lung surgery presented a higher death rate; hence, it is necessary to omit lung surgery in patients with active COVID-19 infection.

Prognostic value of different N1 lymph node zones in pN1M0 non-small cell lung cancer: a systematic review and meta-analysis.

The IASLC lymph node map grouped the lymph node stations into "zones" for prognostic analyses. In the N1 lymph nodes group, N1 nodes are divided into the Hilar/Interlobar zone (N1h) and Peripheral zone (N1p). There is no consensus on the different prognostic values of N1 lymph nodes in N1h and N1p. Therefore, we conducted a systematic review and meta-analysis to assess the survival difference between N1h and N1p in patients of pN1M0 NSCLC. Medline, the Cochrane Library, Embase, and the Web of science were systematically searched to identify relevant studies published up to April 4th, 2020. A retrospective and prospective cohort study comparing N1h versus N1p to the pN1M0 NSCLC was included. Hazard ratios (HRs) for OS were aggregated according to a fixed or random-effect model. Ten publications for 1946 patients of pN1M0 NSCLC were included for the meta-analysis.The 5-year OS was lower for patients with N1h (HR: 1.67, 95% CI 1.44-1.94; P < 0.001). The pooled 5-year OS in N1h and N1p were 40% and 56%, respectively. The patients in pN1M0 NSCLC have different survival according to different N1 lymph node zones involvement: patients with N1p metastasis have a better prognosis than those with N1h metastasis.

A Randomized Controlled Trial of Psychological Intervention to Improve Satisfaction for Patients with Depression Undergoing TKA: A 2-Year Follow-up.

BACKGROUND: The overall satisfaction of patients after total knee arthroplasty (TKA) is approximately 80%, and current studies have demonstrated that patients with depression may have lower patient satisfaction. The purpose of this study was to determine whether perioperative psychological intervention in patients with depression improves the clinical outcomes and patient satisfaction in patients undergoing TKA. METHODS: Six hundred patients who underwent primary TKA from May 2016 to January 2018 were prospectively screened for eligibility. A preoperative psychological evaluation was conducted by a psychiatrist to evaluate each patient's psychological status. Patients who were diagnosed with depression were randomly divided into 2 groups: the intervention group (patients received psychological interventions that were administered by a psychiatrist at the first visit before surgery and from then on) and the control group (patients received routine TKA care without psychological interventions). The primary outcome was patient satisfaction at 6 months postoperatively. The secondary outcomes were patient satisfaction at 2 years postoperatively as well as the Hospital for Special Surgery (HSS) scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, and range of motion at 6 months and 2 years postoperatively. RESULTS: Fifty-three patients with depression were identified. Fifty-one patients were enrolled in the randomized controlled trial. Two patients were lost to follow-up at 6 months after surgery. Therefore, 49 patients (25 in the intervention group and 24 in the control group) remained in the final analysis. At 6 months postoperatively, statistical differences in patient satisfaction were identified between the 2 groups (88.0% in the intervention group compared with 62.5% in the control group; odds ratio = 4.40; 95% confidence interval, 1.02 to 18.99). There was a significant improvement in the Self-Rating Depression Scale (SDS) score (the reduction rate was 51.97% in the intervention group compared with 17.35% in the control group) and the Symptom Checklist 90 Revised (SCL-90-R) subscore for depression (the reduction rate was 44.66% in the intervention group compared with 15.73% in the control group). The clinical outcomes, including the WOMAC scores, the HSS scores, and maximal range of motion, in the intervention group had improved significantly more compared with those in the control group. CONCLUSIONS: Psychological interventions during the perioperative period can improve patient satisfaction in patients with depression who undergo TKA. Therefore, psychological intervention and management may be beneficial for patients with depression who are planning to undergo TKA. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

The role of EGFR-TKIs as adjuvant therapy in EGFR mutation-positive early-stage NSCLC: A meta-analysis.

BACKGROUND: The role of adjuvant epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) is not clear in early-stage nonsmall-cell lung cancer (NSCLC) patients. This meta-analysis aims to compare the efficacy and safety of EGFR-TKIs as adjuvant therapy with chemotherapy or placebo in NSCLC patients harboring EGFR mutations. PATIENTS AND METHODS: Pubmed, Embase, and Cochrane databases were searched for randomized controlled trials. The hazard ratio (HR) of disease-free survival (DFS) and overall survival (OS) as well as the risk ratio (RR) of severe adverse events were merged. RESULTS: Seven articles from five studies from 1843 records, a total of 1227 patients, were included in the analysis. The HR for DFS was 0.38 (95% confidence interval [CI] 0.22-0.63), in favor of EGFR-TKIs. However, no significant benefit of OS was seen (HR = 0.61, 95% CI 0.31-1.22). Treatment benefit was more pronounced in patients with advanced disease stage and longer duration of medication, EGFR exon 19 deletion mutation, and treatment with third-generation EGFR-TKIs. Adjuvant targeted therapy may cause few adverse events compared with chemotherapy (RR = 0.28, 95% CI 0.09-0.94). The possibility of severe adverse events for the first-generation drugs was significantly lower than for third-generation drugs. CONCLUSION: In EGFR mutation-positive patients with stage IB-IIIA NSCLC, compared with adjuvant chemotherapy or placebo, adjuvant EGFR-TKIs should effectively improve the patient's DFS, but not effectively improve OS. Disease stage, treatment duration, mutation types, and therapeutic drugs could affect the degree of benefit. Adjuvant EGFR-TKIs had more favorable tolerability than chemotherapy, especially with the usage of first-generation drugs.

A Mixed Methods Process Evaluation of a Clustered-Randomized Controlled Trial to Determine the Effects of Community-Based Dietary Sodium Reduction in Rural China.

Purpose: A clustered-randomized controlled trial was conducted to determine the effects of a sodium reduction program in 120 rural villages in Northern China. This mixed-methods process evaluation was used to investigate the implementation and to evaluate the feasibility of the complex intervention to translate the findings from clinical study to the real world. Methods: A convergent mixed-methods process evaluation design was used in this study. Quantitative data were collected from activity logs and routine study records. Qualitative data were collected from 53 project stakeholders and 45 villagers from 10 intervention villages. Thematic analysis of qualitative interviews facilitated integration with the descriptive quantitative data analysis based on theory-informed domains of fidelity, delivery, reach, receipt, and contextual factors of intervention from a process evaluation framework. Results: The intervention was implemented with high fidelity, delivery, reach, and receipt. A total of 5,450 sheets of posters, 31,400 calendars, and 78,000 sheets of stickers were delivered as planned, and 11 promotion activities were conducted in each village. Contextual factors hindering full uptake of the intervention included preference for salty taste, higher cost of low-sodium salt, and low education levels of villagers. Other contextual factors, positive policy support, administrative support, and staff enthusiasm were the facilitators for implementation. Conclusions: This multifaceted intervention was implemented well and effectively in rural China. This process evaluation has indicated that conducting health education interventions in rural areas requires policy and administrative support, enthusiastic staff, easy-to-understand health education materials and activities, and key persons, but tempered expectations as behavior change requires time. This project demonstrates the feasibility and benefits of using mixed-methods process evaluation in large-scale studies.

Perspectives of research ethics committee members on human challenge studies in the development of vaccines against COVID-19: a mixed methods study.

BACKGROUND: Vaccines are considered the most effective protection against the coronavirus disease 2019 (COVID-19). Human Challenge Studies can help to shorten the development process of vaccines. The reviewers' opinions from research ethics committees (REC) play an essential gate-keeping role in determining whether a clinical trial can be conducted or not. METHODS: A convergent mixed-methods study was conducted in a leading general hospital in China. A total of 58 REC members from the institution were invited to participate in an online questionnaire survey. According to the result of the quantitative survey, 15 of these REC members were purposefully selected to participate in qualitative interviews further. Quantitative data were analyzed using descriptive statistical techniques, and thematic analysis was used to analyze the qualitative data. Findings from the quantitative and qualitative analyses were synthesized to deeply illustrate the attitudes, views, and suggestions of REC members on human challenge studies to develop COVID-19 vaccination. RESULTS: The response rate of the online questionnaire was 62% (36/58), and 15 of the respondents were interviewed. All participants deemed that the human challenge study should provide compensation to its participants and that sufficiently informed consent is necessary. The human challenge study was disagreed with by 38.9% of participants. The key points of concern raised were representativeness and fairness of participant selection, benefit, and risk, vulnerable groups, compensation to participants, informed consent, and general view on human challenge studies. CONCLUSIONS: Human challenge studies helped accelerate the development of vaccines for disease control to a certain extent, but the bottom line of medical ethics should not have been broken. At any time, the rights and interests of research participants should come first.

Exploring the barriers of patients with diabetic foot complications in China: a qualitative interview study.

BACKGROUND: Patients with diabetic foot complications are associated with high rates of morbidity, disability, and mortality. Through findings of qualitative interviews with patients with this disease, we aimed to explore the barriers they encountered, provide evidence to improve the efficacy of medical services, discuss prevention and treatment strategies for future policymakers, and attract widespread attention from the Chinese society. METHODS: Patients with diabetic foot complications were recruited from three tertiary hospitals in China between July to September 2020. Patients were included who had a clinical diagnosis of diabetic foot complications, were 18 years or older, spoke Chinese as their first language, and were willing to share treatment experiences. An interview guide was used during the in-person semi-structured interviews that lasted 20 to 50 minutes and were audio-recorded. Transcripts were analyzed for qualitative themes. RESULTS: Forty-one patients (range, 38-79 years; 12 men, 29 women) were recruited. Data analysis indicated five thematic dimensions on barriers encountered by patients with diabetic foot complications: hospital visits, doctor-patient communication, mental burden, economic burden, and social support. CONCLUSIONS: Patients with diabetic foot complications face serious financial, mental, and social burdens in China. Future studies can use the five dimensions to help solve the existing problems and improve treatment outcomes of this patient population.

Barriers and Facilitators to Implementing Reduced-Sodium Salts as a Population-Level Intervention: A Qualitative Study.

Widespread use of reduced-sodium salts can potentially lower excessive population-level dietary sodium intake. This study aimed to identify key barriers and facilitators to implementing reduced-sodium salt as a population level intervention. Semi-structured interviews were conducted with key informants from academia, the salt manufacturing industry, and government. We used the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to inform our interview guides and data analysis. Eighteen key informants from nine countries across five World Health Organization regions participated in the study from January 2020 to July 2020. Participants were concerned about the lack of robust evidence on safety for specific populations such as those with renal impairment. Taste and price compared to regular salt and an understanding of the potential health benefits of reduced-sodium salt were identified as critical factors influencing the adoption of reduced-sodium salts. Higher production costs, low profit return, and reduced market demand for reduced-sodium salts were key barriers for industry in implementation. Participants provided recommendations as potential strategies to enhance the uptake. There are presently substantial barriers to the widespread use of reduced-sodium salt but there are also clear opportunities to take actions that would increase uptake.

Factors Associated With the Use of a Salt Substitute in Rural China.

Importance: Lowering sodium intake reduces blood pressure and may reduce the risk of cardiovascular diseases. The use of reduced-sodium salt (a salt substitute) may achieve sodium reduction, but its effectiveness may be associated with the context of its use. Objective: To identify factors associated with the use of salt substitutes in rural populations in China within the Salt Substitute and Stroke Study, a large-scale cluster randomized trial. Design, Setting, and Participants: This sequential mixed-methods qualitative evaluation, conducted from July 2 to August 28, 2018, in rural communities across 3 provinces in China, included a quantitative survey, collection of 24-hour urine samples, and face-to-face interviews. A random subsample of trial participants, selected from the 3 provinces, completed the quantitative survey (n = 1170) and provided urine samples (n = 1025). Interview respondents were purposively selected from the intervention group based on their different ranges of urinary sodium excretion levels. Statistical analysis was performed from September 18, 2018, to February 22, 2019. Exposures: The intervention group of the Salt Substitute and Stroke Study was provided with the free salt substitute while the control group continued to use regular salt. Main Outcomes and Measures: Knowledge, attitudes, and behaviors regarding the use of the salt substitute were measured using quantitative surveys, and urinary sodium levels were measured using 24-hour urine samples. Contextual factors were explored through semistructured interviews and integrated findings from surveys and interviews. Results: A total of 1170 individuals participated in the quantitative survey. Among the 1025 participants with successful urine samples, the mean (SD) age was 67.4 (7.5) years, and 502 (49.0%) were female. The estimated salt intake of participants who believed that high salt intake was good for health was higher; however, it was not significantly different (0.84 g/d [95% CI, -0.04 to 1.72 g/d]) from those who believed that high salt intake was bad for health. Thirty individuals participated in the qualitative interviews (18 women [60.0%]; mean [SD] age, 70.3 [6.0] years). Quantitative and qualitative data indicated high acceptability of and adherence to the salt substitute. Contextual factors negatively associated with the use of the salt substitute included a lack of knowledge about the benefits associated with salt reduction and consumption of high-sodium pickled foods. In addition, reduced antihypertensive medication was reported by a few participants using the salt substitute. Conclusions and Relevance: This study suggests that lack of comprehensive understanding of sodium reduction and salt substitutes and habitual consumption of high-sodium foods (such as pickled foods) were the main barriers to the use of salt substitutes to reduce sodium intake. These factors should be considered in future population-based, sodium-reduction interventions.