Utility of real-world evidence in biosimilar development.

Biosimilar development refers to the process of creating a biologic drug that is similar to an existing approved biologic drug, also known as a reference drug. Due to the complex nature of biologics drugs and the inherent variability in their manufacturing process biosimilars are not identical but highly similar to the reference drug in terms of quality, safety, and efficacy. Efficacy and safety trials for biosimilars involve large numbers of patients to confirm comparable clinical performance of the biosimilar and the reference product in appropriately sensitive clinical indications and for appropriate sensitive endpoints. The objective of a biosimilar clinical data is to address slight differences observed at previous steps and to confirm comparable clinical performance of the biosimilar and the reference product. In recent years with advances in big data computing, there has been increasing interest to incorporate the totality of information from different data sources (e.g. Real World data and published literature) in design and conduct of clinical trial to support regulatory objectives. The biosimilar development is an ideal framework for utilization of Real-World Evidence in design of trials as potentially large amount of data are available for the reference dug. Hence there may be an opportunity to use RWD in establishing, improving or validating equivalence margins (EQM) for biosimilar designs, specifically in the case there is no historical published data in the intended sensitive population. In this article, we propose a variation of matching method that seems promising to identify the matched set from a real-world data for which the effect size of targeted endpoint would be comparable to historical data. We believe this is a reasonable approach because in design stage, we can view covariates and secondary endpoints as data feature that can be used in a matching method. This approach was illustrated through a case study which indicated the estimate of the primary endpoint is within 1% of published results and thus RWD may be used to justify or estimate the equivalence margin. To ensure consistent results we recommend using this approach in different indications and endpoint scenarios. Thus utilization of RWD/RWE can provide an important opportunity to increase access to biologic therapies, reducing cost by repurposing existing data.

Insulin Infusion Protocols for Blood Glucose Management in Critically Ill Patients: A Scoping Review.

BACKGROUND: Continuous insulin infusion is a method for maintaining blood glucose stability in critically ill patients with hyperglycemia. Many insulin infusion protocols have been applied in intensive care units. Understanding the content of these protocols can help clinical staff choose the most appropriate and convenient protocol and promote best practices in managing glucose levels in critically ill adult patients. OBJECTIVE: To examine the types of insulin infusion therapies performed for blood glucose management in critically ill patients. METHODS: For this scoping review, 3 Chinese-language and 8 English-language databases were searched for articles published from May 25, 2016, to October 25, 2022. RESULTS: Twenty-one articles met the inclusion criteria. Twenty-one insulin infusion protocols were examined. Most of the insulin infusion protocols were paper protocols. Fourteen glucose management indicators were included in the 21 protocols. The glucose target range for all 21 protocols ranged from 70 to 180 mg/dL (3.9-10.0 mmol/L). Nurses were primarily responsible for protocol implementation in most protocol development processes. The roles of nurses differed in nurse-led insulin infusion protocols and non-nurse-led insulin infusion protocols. DISCUSSION: This scoping review indicates an urgent need for more comprehensive glycemic control guidelines for patients receiving critical care. Because insulin infusion protocols are core aspects of blood glucose management guidelines, different population subgroups should also be considered. CONCLUSIONS: Nurse-led guidelines must be based on the best available evidence and should include other variables related to glucose management (eg, patient disease type, medication, and nutrition) in addition to insulin infusion.

Nurses' preparedness, opinions, barriers, and facilitators in responding to intimate partner violence: A mixed-methods study.

INTRODUCTION: Intimate partner violence (IPV) is associated with multiple adverse health consequences. Nurses (including midwives) are well positioned to identify patients subjected to IPV, and provide care, support, and referrals. However, studies about nursing response to IPV are limited especially in low- and middle-income countries (LMICs). The study aimed to examine nurses' perceived preparedness and opinions toward IPV and to identify barriers and facilitators in responding to IPV. DESIGN: An explanatory sequential mixed-methods study was conducted by collecting quantitative data first and explaining the quantitative findings with qualitative data. METHODS: The study was conducted in two tertiary general hospitals in northeastern (Shenyang city) and southwestern (Chengdu city) China with 1500 and 1800 beds, respectively. A total of 1071 survey respondents (1039 female [97.0%]) and 43 interview participants (34 female [79.1%]) were included in the study. An online survey was administered from September 3 to 23, 2020, using two validated scales from the Physician Readiness to Manage Intimate Partner Violence Survey. In-depth, semistructured interviews were conducted from September 15 to December 23, 2020, guided by the Consolidated Framework for Implementation Research. RESULTS: The survey respondents largely agreed with feeling prepared to manage IPV, e.g., respond to discourses (544 [50.8%] of 1071) and report to police (704 [65.7%] of 1071). The findings of surveyed opinions (i.e., Response competencies; Routine practice; Actual activities; Professionals; Victims; Alcohol/drugs) were mixed and intertwined with social desirability bias. The quantitative and qualitative data were consistent, contradicted, and supplemented. Key qualitative findings were revealed that may explain the quantitative results, including lack of actual preparedness, absence of IPV-related education, training, or practice, and socially desirable responses (especially those pertaining to China's Anti-domestic Violence Law). Commonly reported barriers (e.g., patients' reluctance to disclose; time constraints) and facilitators (e.g., patients' strong need for help; female nurses' gender advantage), as well as previously unreported barriers (e.g., IPV may become a workplace taboo if there are healthcare professionals known as victims/perpetrators of IPV) and facilitators (e.g., nurses' responses can largely meet the first-line support requirements even without formal education or training on IPV) were identified. CONCLUSIONS: Nurses may play a unique and important role in responding to IPV in LMICs where recognition is limited, education and training are absent, policies are lacking, and resources are scarce. Our findings support World Health Organization recommendations for selective screening. CLINICAL RELEVANCE: The study highlights the great potential of nurses for IPV prevention and intervention especially in LMICs. The identified barriers and facilitators are important evidence for developing multifaceted interventions to address IPV in the health sector.

Effect of overall lifestyle on the all-cause mortality and cardiovascular disease death in dyslipidemia patients with or without lipid-lowering therapy: a cohort study.

BACKGROUND: Lifestyle adjustment has been reported as one of the interventions for dyslipidemia. This study aimed to explore the effect of overall lifestyle on the risk of all-cause mortality and cardiovascular disease (CVD) death in dyslipidemia patients with or without lipid-lowering therapy. METHODS: This was a retrospective cohort study, and data were extracted from the National Health and Nutrition Examination Survey (NHANES). Overall lifestyle was assessed based on Mediterranean diet score, physical activity, smoking status, sleep duration, and body mass index (BMI). Multivariate Cox regression model was used to explore the effect of overall lifestyle score on the risk of all-cause mortality and CVD death. Results were shown as hazard ratio (HR), with 95% confidence interval (CI). RESULTS: A total of 11,549 dyslipidemia patients were finally included in this study. The results showed that optimal overall lifestyle was associated with the decreased risk of all-cause mortality (HR = 0.47, 95%CI: 0.34-0.64) and CVD death (HR = 0.45, 95%CI: 0.22-0.94) in patients without lipid-lowering therapy. The similar results were found in patients with lipid-lowering therapy (all-cause mortality: HR = 0.45, 95%CI: 0.33-0.62; CVD death: HR = 0.38, 95%CI: 0.23-0.63). CONCLUSIONS: A favorable overall lifestyle may have great benefits to improve the prognosis of dyslipidemia, highlighting the importance of overall lifestyle adjustment for dyslipidemia patients.

Experiences of breast cancer survivors with lymphedema self-management: a systematic review of qualitative studies.

PURPOSE: This study systematically identified, evaluated, and synthesized qualitative literature on the experiences of breast cancer survivors with lymphedema self-management. METHODS: This systematic review followed the Joanna Briggs Institute meta-aggregation approach and was guided by the ENTREQ, graded according to the ConQual approach, and evaluated using the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI). Qualitative studies related to the experiences in lymphedema self-management among breast cancer survivors conducted until March 9, 2022, were searched. The selected studies were reviewed independently, and the data were synthesized collaboratively into core themes. RESULTS: A total of 24 studies were included, and 85 findings resulted in three synthesis findings: (a) breast cancer survivors face challenges in lymphedema self-management, (b) breast cancer survivors are entangled in rebuilding a new balance between different roles, and (c) breast cancer survivors seek internal and external resources to regulate negative emotions. CONCLUSIONS: Lymphedema self-management is a lifetime commitment and a challenge for breast cancer survivors, who find it difficult to adhere to self-management and cope with their problems. They require timely and continuous effective self-management education, and instrumental and emotional support from others, particularly healthcare providers and family members. IMPLICATIONS FOR CANCER SURVIVORS: Timely self-management education and access to lymphedema treatment and related resources are important for survivors to prevent and manage lymphedema. Breast cancer survivors should develop coping skills, and family members should participate in survivors' lymphedema self-management.

The Effectiveness of a Self-management Program of Bowel Dysfunction in Patients With Mid and Low Rectal Cancer After Sphincter-Preserving Surgery: A Pilot Randomized Controlled Trial.

BACKGROUND: Most patients with mid and low rectal cancer passively react to bowel symptoms after sphincter-preserving surgery (SPS), and their self-management behaviors are scarce in the Chinese patient population. OBJECTIVE: The aim of this study was to evaluate the effect of a self-management program for bowel symptoms in patients with mid and low rectal cancer after SPS. METHODS: A convenient sampling method was used to recruit patients with mid and low rectal cancer after SPS in gastric wards from 2 tertiary hospitals in Beijing, China. Ninety-five patients (intervention, n = 47; control, n = 48) were recruited. The intervention group received a predetermined self-management program plus routine postoperative care; the control group received only routine care in the ward. Data on patients' bowel symptoms, quality of life, and bowel symptom self-management behaviors were collected at baseline and at 3 and 6 months postoperatively using questionnaires. A generalized estimating equation was adopted to examine group effect and time effect. RESULTS: Bowel symptoms and quality of life in both the intervention and control groups of patients improved significantly 6 months after SPS compared with baseline (time effect, P < .001). The total score of patients' bowel symptom self-management behaviors and the score of the therapeutic domain increased significantly in the intervention group compared with those in the control group (group effect, P = .009). CONCLUSIONS: Self-management programs could help prompt patients' self-management behaviors, but the extent to which they impact patients' bowel symptoms requires further investigation. IMPLICATIONS FOR PRACTICE: The bowel dysfunction self-management program could alter the behavior of patients. It also effectively improves self-management strategies for bowel symptoms.

Surviving rectal cancer at the cost of a colostomy: global survey of long-term health-related quality of life in 10 countries.

BACKGROUND: Colorectal cancer management may require an ostomy formation; however, a stoma may negatively impact health-related quality of life (HRQoL). This study aimed to compare generic and stoma-specific HRQoL in patients with a permanent colostomy after rectal cancer across different countries. METHOD: A cross-sectional cohorts of patients with a colostomy after rectal cancer in Denmark, Sweden, Spain, the Netherlands, China, Portugal, Australia, Lithuania, Egypt, and Israel were invited to complete questionnaires regarding demographic and socioeconomic factors along with the Colostomy Impact (CI) score, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and five anchor questions assessing colostomy impact on HRQoL. The background characteristics of the cohorts from each country were compared and generic HRQoL was measured with the EORTC QLQ-C30 presented for the total cohort. Results were compared with normative data of reference European populations. The predictors of reduced HRQoL were investigated by multivariable logistic regression, including demographic and socioeconomic factors and stoma-related problems. RESULTS: A total of 2557 patients were included. Response rates varied between 51-93 per cent. Mean time from stoma creation was 2.5-6.2 (range 1.1-39.2) years. A total of 25.8 per cent of patients reported that their colostomy impairs their HRQoL 'some'/'a lot'. This group had significantly unfavourable scores across all EORTC subscales compared with patients reporting 'no'/'a little' impaired HRQoL. Generic HRQoL differed significantly between countries, but resembled the HRQoL of reference populations. Multivariable logistic regression showed that stoma dysfunction, including high CI score (OR 3.32), financial burden from the stoma (OR 1.98), unemployment (OR 2.74), being single/widowed (OR 1.35) and young age (OR 1.01 per year) predicted reduced stoma-related HRQoL. CONCLUSION: Overall HRQoL is preserved in patients with a colostomy after rectal cancer, but a quarter of the patients interviewed reported impaired HRQoL. Differences among several countries were reported and socioeconomic factors correlated with reduced quality of life.

Risk factors of unilateral breast cancer-related lymphedema: an updated systematic review and meta-analysis of 84 cohort studies.

PURPOSE: To review and update the incidence and risk factors for breast cancer-related lymphedema based on cohort studies. METHODS: The study was guided by the Joanna Briggs Institute methodology and the Cochrane handbook for systematic reviews. PubMed, EMBASE, CINAHL, Scopus, Web of Science, The Cochrane Library, CNKI, SinoMed, and Wan Fang Database were searched from inception to November 15, 2021. Cohort studies reported adjusted risk factors were selected. PRISMA guideline was followed. Study quality were evaluated using the Newcastle-Ottawa scale. Random-effects models were adopted. The robustness of pooled estimates was validated by meta-regression and subgroup analysis. Lymphedema incidence and adjusted risk factors in the multivariable analyses with hazard / odds ratios and 95% CIs were recorded. RESULTS: Eighty-four cohort studies involving 58,358 breast cancer patients were included. The pooled incidence of lymphedema was 21.9% (95% CI, 19.8-24.0%). Fourteen factors were identified including ethnicity (black vs. white), higher body mass index, higher weight increase, hypertension, higher cancer stage (III vs. I-II), larger tumor size, mastectomy (vs. breast conservation surgery), axillary lymph nodes dissection, more lymph nodes dissected, higher level of lymph nodes dissection, chemotherapy, radiotherapy, surgery complications, and higher relative volume increase postoperatively. Additionally, breast reconstruction surgery, and adequate finance were found to play a protective role. However, other variables such as age, number of positive lymph nodes, and exercise were not correlated with risk of lymphedema. CONCLUSION: Treatment-related factors still leading the development of breast cancer-related lymphedema. Other factors such as postoperative weight increase and finance status also play a part. Our findings suggest the need to shift the focus from treatment-related factors to modifiable psycho-social-behavioral factors.

Experiences of bowel symptoms in patients with rectal cancer after sphincter-preserving surgery: a qualitative meta-synthesis.

PURPOSE: This study is to identify and synthesize the available evidence of bowel symptom experiences of patients with rectal cancer after sphincter-preserving surgery (SPS). METHODS: This qualitative meta-synthesis was conducted following the Joanna Briggs Institute (JBI) qualitative systematic review methodology and reported following the Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) guidelines. Seven databases were searched on 22 December 2021. The selected studies were reviewed by two independent reviewers, and disagreements were resolved by discussion or with a third reviewer. RESULTS: Seven qualitative articles were included in the meta-synthesis with 192 total rectal cancer patients. The review summarized 53 qualitative findings into three synthesized findings: (a) Patients experienced bowel symptoms and triggered additional physiological problems, and they underestimated bowel symptoms; (b) patients had many negative emotions, and their daily life and social interaction were disturbed; and (c) patients adopted strategies to adapt or control their bowel symptoms. According to the ConQual evidence grading approach, the confidence of the synthesized findings was rated as moderate to low. CONCLUSIONS: The bowel symptoms of patients with rectal cancer after SPS have troubled their lives. Timely acquisition of symptom-related knowledge and enhancement of their coping abilities are important for the control and management of bowel symptoms. Healthcare professionals should clearly understand the bowel symptoms that patients may experience after SPS and provide supportive care for patients to improve patients' self-management abilities and quality of life. TRIAL REGISTRATION: PROSPERO: CRD42021242610.

Efficacy and safety of percutaneous nephrolithotripsy in elderly patients: a retrospective study.

BACKGROUND: Percutaneous nephrolithotripsy (PCNL) is difficult to perform for elderly patients; thus, this study aimed to assess its efficacy and safety in elderly patients aged > 70 years, note any associations between outcomes and patient characteristics, and summarize relevant themes and observations. METHODS: Data from patients older than 70 years who had undergone PCNL for upper urinary tract calculi between January 2016 and January 2021 was retrospectively analyzed. Risk factors for postoperative complications and residual stones were analyzed using multivariate logistic regression. RESULTS: A total of 116 elderly patients underwent 122 PCNL operations, of which six underwent secondary PCNL operations, and all of which were successfully completed. The average age was 74.6 ± 4.3 years; the average stone size and operation time were 3.5 ± 1.8 (1.2-11 cm), and 71.8 ± 34.1 min, respectively. Of the participants, 16 or 13.8% had postoperative complications and 29 (25%) had residual stones after operation. The stone free rate was 75%. Multivariate analysis revealed that an American Score of Anesthesiology III was an independent risk factor for postoperative complications (odds ratio [OR] = 4.453, p = 0.031), and staghorn calculi were independent risk factors for postoperative residual calculi (OR = 31.393, p = 0.001). CONCLUSION: PCNL was shown to be safe and effective for elderly patients aged > 70 years. Further, ASA III was an independent risk factor for postoperative complications, and staghorn calculi were independent risk factors for postoperative residual calculi in elderly patients.

LFT: Neural Ordinary Differential Equations With Learnable Final-Time.

Since the last decade, deep neural networks have shown remarkable capability in learning representations. The recently proposed neural ordinary differential equations (NODEs) can be viewed as the continuous-time equivalence of residual neural networks. It has been shown that NODEs have a tremendous advantage over the conventional counterparts in terms of spatial complexity for modeling continuous-time processes. However, existing NODEs methods entail their final time to be specified in advance, precluding the models from choosing a desirable final time and limiting their expressive capabilities. In this article, we propose learnable final-time (LFT) NODEs to overcome this limitation. LFT rebuilds the NODEs learning process as a final-time-free optimal control problem and employs the calculus of variations to derive the learning algorithm of NODEs. In contrast to existing NODEs methods, the new approach empowers the NODEs models to choose their suitable final time, thus being more flexible in adjusting the model depth for given tasks. Additionally, we analyze the gradient estimation errors caused by numerical ordinary differential equations (ODEs) solvers and employ checkpoint-based methods to obtain accurate gradients. We demonstrate the effectiveness of the proposed method with experimental results on continuous normalizing flows (CNFs) and feedforward models.

The Quality and Clinical Applicability of Recommendations in Ostomy Guidelines: A Systematic Review.

Aim: To systematically search ostomy clinical practice guidelines, critically assess their quality and clinical applicability of recommendations, and summarize the recommendations. Design: Systematic review. Data Sources: The PubMed, ProQuest and CINAHL databases, eight guideline databases, and three ostomy institution websites were searched on September 3, 2021. Review Methods: Appraisal of Guidelines for Research and Evaluation II (AGREE II) and AGREE Recommendation EXcellence (AGREE-REX) were used to assess the guideline. Results: The initial search identified 1475 documents. Of these, 27 full-text documents were reviewed. Finally, 10 guidelines were included. Among these, the 2019 Registered Nurses' Association of Ontario (RNAO) guidelines had the highest total scores using AGREE II and AGREE-REX. The 2019 National Institute for Health and Care Excellence (NICE) and 2018 European Hernia Society (EHS) were also ranked as high-quality and evaluated as "recommended." The median of the "applicability" domain was the lowest (45%) among the six AGREE II domains. The median of the "values and preferences" domain was the lowest (38%) among the three AGREE-REX domains. In total, 172 recommendations were summarized and parastomal hernia received the most attention among the recommendations. Conclusion: The quality of the 10 clinical practice guidelines varied widely. The three identified high-quality guidelines might be appropriate first choices in daily ostomy care and management practice and can be tailored to the local context. Ostomy guidelines require further improvement in the "applicability" and "values and preferences" domains. No Patient or Public Contribution: This review only searched and evaluated relevant documents, so such details do not apply to this review.

An investigation of knowledge, attitude and practice towards simulation among clinical nursing teachers in China: A cross-sectional study.

AIM: This study aimed to investigate the knowledge, attitude and practice towards simulation among CNTs in China and analyze the influencing factors. BACKGROUND: In China, simulation is now increasingly used by Clinical Nursing Teachers (CNTs) who are mainly responsible for nurses' continuing education, novice nurses training and nursing students practice in clinical settings. Over the past 20 years, enrolment scale of nursing education was expanded greatly, and the number of registered nurses increased from 1.22 to 4.10 million in China. To contribute to nurses' or nursing students' professional development and successful transition to competent practitioners, CNTs are now being challenged to use simulation to develop more learner-centered educational programs, which could better facilitate learner engagement. As faculty preparation is a prerequisite for conducting quality simulation, it is critical that CNTs have the requisite knowledge and skills to use simulation to its full potential. However, data on CNTs' knowledge, attitude and practice towards simulation is limited. DESIGN: A cross-sectional study. METHODS: A total of 342 CNTs from six tertiary affiliated teaching hospitals of a medical university in Beijing, China, participated in the study. Electronic questionnaire of Nurse Educators' Knowledge, Attitude and Practice towards Simulation (NEKAPS) was delivered to CNTs. Analysis of variance, t-test were used to analyze data. RESULTS: The mean score of knowledge and attitude for all participants was 60.01 ± 13.42 and 81.40 ± 19.99, respectively. The mean practice score was 70.65 ± 22.05 for 162 participants (47.4 %) who had conducted simulation in their hospitals. Participants with higher educational level (F=3.476, p = 0.032) and nursing career length≤ 15 years (t = 2.676, p = 0.008) had higher knowledge scores. However, there were no significant differences among different groups for attitudes. Participants with age ≤ 35 years old (t = 3.355, p = 0.001), nursing teaching length ≤ 10 years (t = 2.073, p = 0.041) and advanced beginner nurses (t = 3.212, p = 0.002) presented higher practice scores. CONCLUSIONS: CNTs had a low level of knowledge on simulation. Their attitudes towards simulation were positive, whereas their practices were still lacking. It is highlighted an urgent need for standardized training of CNTs to improve their knowledge and practice towards simulation, so that they can optimize the simulation programs they provide for nurses or nursing students.

Influence of Surface Roughness on Biodegradability and Cytocompatibility of High-Purity Magnesium.

High-purity magnesium (Mg) is a promising biodegradable metal for oral and maxillofacial implants. Appropriate surface roughness plays a critical role in the degradation behavior and the related cellular processes of biodegradable Mg-based metals. Nevertheless, the most optimized surface roughness has been questionable, especially for Mg-based oral and maxillofacial implants. Three representative scales of surface roughness were investigated in this study, including smooth (Sa < 0.5 µm), moderately rough (Sa between 1.0−2.0 µm), and rough (Sa > 2.0 µm). The results indicated that the degradation rate of the Mg specimen in the cell culture medium was significantly accelerated with increased surface roughness. Furthermore, an extract test revealed that Mg with different roughness did not induce an evident cytotoxic effect. Nonetheless, the smooth Mg surface had an adversely affected cell attachment. Therefore, the high-purity Mg with a moderately rough surface exhibited the most optimized balance between biodegradability and overall cytocompatibility.

Life-Course Influence of Adolescent Behaviour Problems on Type 2 Diabetes in Midlife: Results from 1958 British Birth Cohort Study.

Purpose: To assess whether there is a long-term relationship between childhood behaviour problems and type 2 diabetes in midlife. The study will also investigate whether any of such relationship is independent of other factors which may be associated with type 2 diabetes. Design: Cohort study. Participants: A total of 9377 members of the 1958 British birth cohort participated in the biomedical survey at age 45 years. The cohort has been followed up at regular intervals in childhood (age 7, 11 and 16 years) and adulthood (23, 33, 42 and 45 years). Predictor Variables: Information regarding childhood behaviour collected during follow-ups at ages 7, 11 and 16 years. Main Outcome Variables: Type 2 diabetes assessed using HbA1c at age 45 years. Results: Unadjusted estimates show that teachers reported adolescent behaviour problems at age of 16 are associated with increased risk of type 2 diabetes in midlife. After adjustment for potential confounders and mediators in childhood and adulthood, a relationship was observed between the severity of adolescent behaviour problems and type 2 diabetes risk in midlife (mild behaviour problems: OR 2.17, 95% CI 1.11-4.23; severe behaviour problems: OR 4.40, 95% CI 1.14-16.99). However, no such relationship was observed between behaviour problems at 7 and 11 years and type 2 diabetes in midlife. Conclusion: There is an association between adolescent behaviour problems and an increased risk of type 2 diabetes in midlife. Further molecular/genetic studies are required to understand the biological basis for this observed association.

Development and Validation of a Simple Risk Model for Predicting Metabolic Syndrome (MetS) in Midlife: A Cohort Study.

Purpose: To develop and validate a simple risk model for predicting metabolic syndrome in midlife using a prospective cohort data. Design: Prospective cohort study. Participants: A total of 7626 members of the 1958 British birth cohort (individuals born in the first week of March 1958) participated in the biomedical survey at age 45 and have completed information on metabolic syndrome. Methods: Variables utilised were obtained prospectively at birth, 7, 16, 23 and 45 years. Multivariable logistic regression was used to develop a total of ten (10) MetS risk prediction models taking the life course approach. Measures of discrimination and calibration were used to evaluate the performance of the models. A pragmatic criteria developed was used to select one model with the most potential to be useful. The internal validity (overfitting) of the selected model was assessed using bootstrap technique of Stata. Main Outcome Measure: Metabolic syndrome was defined based on the NCEP-ATP III clinical criteria. Results: There is high prevalence of MetS among the cohort members (19.6%), with males having higher risk as compared to females (22.8% vs 16.4%, P < 0.001). Individuals with MetS are more likely to have higher levels of HbA1c and low HDL-cholesterol. Similarly, regarding the individual components of MetS, male cohort members are more likely to have higher levels of glycaemia (HbA1c), BP and serum triglycerides. In contrast, female cohort members have lower levels of HDL-cholesterol and higher levels of waist circumference. Furthermore, a total of ten (10) MetS risk prediction models were developed taking the life course approach. Of these, one model with the most potential to be applied in practical setting was selected. The model has good accuracy (AUROC 0.91 (0.90, 0.92)), is well calibrated (Hosmer-Lemeshow 6.47 (0.595)) and has good internal validity. Conclusion: Early life factors could be included in a risk model to predict MetS in midlife. The developed model has been shown to be accurate and has good internal validity. Therefore, interventions targeting socioeconomic inequality could help in the wider prevention of MetS. However, the validity of the developed model needs to be further established in an external population.

Factors influencing bedtime procrastination in junior college nursing students: a cross-sectional study.

BACKGROUND: Sleep quality is related to physical and mental health. Though bedtime procrastination has been identified as a potentially key source of poor sleep quality, related research is scarce. The goal of our study was to determine bedtime procrastination among nursing students and identify its influencing factors. METHODS: This cross-sectional study comprised 1827 junior college nursing students. The data were collected from November to December 2021 using a mobile app-based survey. We evaluated demographic factors, Big Five personality traits, self-regulatory fatigue, future time perspective, and problematic mobile phone use. Multiple linear regression analysis was used to identify independent characteristics that influence bedtime procrastination among junior college nursing students. RESULTS: The mean bedtime procrastination score in junior college nursing students was 25.11 ± 6.88. Family monthly income of 3000-6000 RMB (ß = 0.740; p = 0.015), as well as that of > 6000 RMB (ß = 1.708; p = 0.001), and an extroverted personality (ß = 0.225; p = 0.001), self-regulatory fatigue (ß = 0.135; p < 0.001), and problematic mobile phone use (ß = 0.078; p < 0.001) had significant positive effects on bedtime procrastination. Conscientious personality (ß = - 0.284; p = 0.003), neurotic personality (ß = - 0.203; p = 0.031), and future time perspective (ß = - 0.141; p < 0.001) had significant negative effects on bedtime procrastination. CONCLUSION: The nursing students who participated in this study had moderate levels of bedtime procrastination. Bedtime procrastination was predicted by higher monthly household income; personality traits of extroversion, conscientiousness, and neuroticism; self-regulatory fatigue; future time perspective; and problematic mobile phone use. PRACTICAL IMPLICATIONS: We recommend that effective measures are needed to help alleviate bedtime procrastination and improve the health and well-being of nursing students.

Rapid reviews and the methodological rigor of evidence synthesis: a JBI position statement.

ABSTRACT: The demand for rapid reviews has exploded in recent years. A rapid review is an approach to evidence synthesis that provides timely information to decision-makers (eg, health care planners, providers, policymakers, patients) by simplifying the evidence synthesis process. A rapid review is particularly appealing for urgent decisions. JBI is a world-renowned international collaboration for evidence synthesis and implementation methodologies. The principles for JBI evidence synthesis include comprehensiveness, rigor, transparency, and a focus on applicability to clinical practice. As such, JBI has not yet endorsed a specific approach for rapid reviews. In this paper, we compare rapid reviews versus other types of evidence synthesis, provide a range of rapid evidence products, outline how to appraise the quality of rapid reviews, and present the JBI position on rapid reviews. JBI Collaborating Centers conduct rapid reviews for decision-makers in specific circumstances, such as limited time or funding constraints. A standardized approach is not used for these cases;instead, the evidence synthesis methods are tailored to the needs of the decision-maker. The urgent need to deliver timely evidence to decision-makers poses challenges to JBI's mission to produce high-quality, trustworthy evidence. However, JBI recognizes the value of rapid reviews as part of the evidence synthesis ecosystem. As such, it is recommended that rapid reviews be conducted with the same methodological rigor and transparency expected of JBI reviews. Most importantly, transparency is essential, and the rapid review should clearly report where any simplification in the steps of the evidence synthesis process has been taken.

Validation of the Chinese version of the colostomy impact score in rectal cancer patients with permanent colostomy.

OBJECTIVE: To test the reliability and validity of the Chinese version of the colostomy impact score (CIS) among patients with a permanent colostomy in China. METHODS: A total of 218 patients completed the survey either in the clinic or remotely and mailed their responses. Reliability was estimated based on test-retest reliability. Validity was evaluated based on content validity, construct validity, and discriminative validity. The sensitivity and specificity of the score were analysed. The area under the curve was analysed by drawing the receiver-operating characteristic (ROC) curve; the optimal cutoff point was calculated to assess the impact of a stoma on domestic patients. RESULTS: The test-retest reliability of the CIS was 0.967. The content validity was 0.98, and the construct and discriminative validities were good; sensitivity, specificity, and area under the ROC curve were 100, 48.53, and 0.806%, respectively. The optimal cutoff point for the Chinese version of the Colostomy Impact Score was 11.5. CONCLUSIONS: The Chinese version of the CIS indicated good reliability and validity, making it suitable for the evaluation of the impact of a permanent colostomy.

Core competencies of the midwifery workforce in China: A scoping review.

AIM: This review aims to demonstrate the current core competencies of the Chinese midwifery workforce and to summarize the influencing factors of core competencies. BACKGROUND: Midwifery core competencies are crucial to providing high-quality maternal and newborn health care, but little is known about the overall status of the core competencies of the Chinese midwifery workforce. EVALUATION: A scoping review was conducted following the latest Joanna Briggs Institute (JBI) scoping review methodology and Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. KEY ISSUES: Forty-one studies were included in this review. Regarding core competency assessment tools, the Midwife Core Competency Scale was used most frequently among 16 identified tools. Generally, the core competencies of the Chinese midwifery workforce were at a moderate or high level, but the competencies in pre-pregnancy, public health care and integrative competence were relatively inadequate. The main factors influencing the core competencies of the midwifery workforce were their working years, educational level and training experience. CONCLUSION: This review provides a comprehensive overview of the core competencies of the Chinese midwifery workforce at the national level. Future studies are encouraged to use objective instruments to reflect core competencies and explore the intervenable influencing factors of core competencies. IMPLICATIONS FOR NURSING MANAGEMENT: Core competency assessment tools can be used to select the qualified midwifery workforce. Targeted core competency enhancement programmes should be formulated based on the current core competencies level and the factors influencing core competencies.