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.

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.

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.

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.

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.

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.

Translation and international validation of the Colostomy Impact score.

AIM: Optimal oncological resection in cancers of the lower rectum often requires a permanent colostomy. However, in some patients a colostomy may have a negative impact on health-related quality of life (HRQoL). The Colostomy Impact (CI) score is a simple questionnaire that identifies patients with stoma dysfunction that impairs HRQoL by dividing patients into 'minor' and 'major' CI groups. This aim of this study is to evaluate construct and discriminative validity, sensitivity, specificity and reliability of the CI score internationally, making it applicable for screening and identification of patients with stoma-related impaired HRQoL. METHOD: The CI score was translated in agreement with WHO recommendations. Cross-sectional cohorts of rectal cancer survivors with a colostomy in Australia, China, Denmark, the Netherlands, Portugal, Spain and Sweden were asked to complete the CI score, the European Organization for Research and Treatment of Cancer (EORTC) quality of life 30-item core questionnaire, the stoma-specific items of the EORTC quality of life 29-item colorectal-specific questionnaire and five anchor questions assessing the impact of colostomy on HRQoL. RESULTS: A total of 2470 patients participated (response rate 51%-93%). CI scores were significantly higher in patients reporting reduced HRQoL due to their colostomy than in patients reporting no reduction. Differences in EORTC scale scores between patients with minor and major CI were significant and clinically relevant. Sensitivity was high regarding dissatisfaction with a colostomy. Regarding evaluation of discriminative validity, the CI score relevantly identified groups with differences in HRQoL. The CI score proved reliable, with equal CI scores between test and retest and an intraclass correlation coefficient in the moderate to excellent range. CONCLUSION: The CI score is internationally valid and reliable. We encourage its use in clinical practice to identify patients with stoma dysfunction who require further attention.

Preoperative physical exercise strategies for patients undergoing major abdominal cancer surgery: a scoping review.

BACKGROUND: Although preoperative physical exercise has been demonstrated to be associated with clinical improvements among abdominal cancer patients, there remains heterogeneity in exercise strategies and uncertainty of what the optimal strategies should be. PURPOSE: This scoping review aimed to review and summarize the existing knowledge about preoperative exercise strategies for abdominal cancer patients. METHODS: The Joanna Briggs Institute (JBI) framework for conducting scoping reviews was adopted to investigate preoperative physical exercise strategies for patients undergoing major abdominal cancer surgery. RESULTS: A total of 1563 studies were identified and 24 were included in this review. Most of the study populations were colorectal cancer (n = 14). The most common type of exercise was a combination of aerobic and resistance exercises (n = 19). The most common form of aerobic exercise was walking (n = 13) or cycling (n = 12). Most resistance exercises were targeting at major muscle groups (n = 12). Most of the studies were performed at moderate intensity (n = 14) with frequency of 2 ~ 3 times/week (n = 14). The time of a training session was 30 ~ 60 min in half studies (n = 12). The intervention duration for most studies was less than 4 weeks (n = 11). Exercise locations included home (n = 10), facility (n = 7), and a combination of home and facility (n = 5). Phone calls were utilized by nearly half of the home-based exercise studies to supervise the exercise adherence (n = 7). CONCLUSIONS: This review provides a comprehensive summary of preoperative physical exercise strategies. It has the potential to inform clinical practice and future studies.

Foot Care Education Among Patients With Diabetes Mellitus in China: A Cross-sectional Study.

PURPOSE: To investigate the foot care knowledge and behavior of patients with diabetes to determine effect and current challenges of foot care education, as a basis to improve education and reduce diabetic foot complications. DESIGN: Quantitative, cross-sectional study. METHODS: A convenience sampling method was used to recruit 200 patients with diabetes from the endocrinology clinic of a tertiary general hospital in Beijing between September 2014 and January 2015. Demographic and disease-related data, foot care education, foot risk stratification status, and knowledge and behavior (K&B) scores were collected using investigator-designed questionnaires. RESULTS: Of the 200 patients, 128 (64.0%) patients received routine diabetes education, and 73 (36.5%) received foot care education. The mean ± standard deviation (SD) for K&B scores were 63.76 ± 14.85, and 59.78 ± 11.17, respectively. The K&B scores of patients who received foot care education (69.54 ± 14.32 and 65.27 ± 11.90) were significantly higher than those who received diabetic education only (60.75 ± 15.27 and 57.54 ± 10.25) and those with no diabetic education (60.21 ± 13.37 and 55.94 ± 8.74) (P < .01). The K&B scores did not differ for patients based on diabetic foot risk strata (P > .05). CONCLUSION: The foot care K&B scores of patients with diabetes were low to moderate levels, particularly on items that pertained to self-foot examination, prompt treatment of foot problems, and regular foot inspection by professionals. Individuals with high risk of developing foot complications did not score higher on the K&B questionnaire. These data suggest there is need for improvement in instruction and patient uptake and application of knowledge. We recommend further study on the effectiveness of the delivery of foot care education based on foot risk stratification, and the implications of foot ulcer prevention in community settings.

Validation of the Chinese version of the Head and Neck Patient Symptom Checklist for measuring nutrition impact symptoms during radiotherapy in patients with head and neck cancer.

PURPOSE: The Head and Neck Patient Symptom Checklist (HNSC) is a valid tool for measuring nutrition impact symptoms (NIS) specific to head and neck cancer (HNC) patients. This study aimed to translate the HNSC into Chinese and to evaluate its psychometric properties in Chinese HNC patients treated with radiotherapy. METHODS: The HNSC was translated into Chinese following standard forward- and back-translation procedures. Three instruments, the Chinese version of HNSC, the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, and Patient-Generated Subjective Global Assessment (PG-SGA), were answered by 116 HNC patients, of whom 11 were submitted to the test-retest in 3-7 days. The criterion and convergent validities were confirmed by measuring the relations of the HNSC score with the PG-SGA and EORTC QLQ-C30, respectively. The discriminant validity was evaluated through known group analysis. Reliability was evaluated by means of Cronbach's alpha and test-retest using the correlation coefficient. RESULTS: Criterion validity was 0.767 for intensity dimension and 0.795 for interference dimension, respectively. Convergent validity was confirmed by the significant correlations between the HHSC score and most domains of QLQ-C30. The comparison among the groups demonstrated good discriminant validity. The Cronbach's alpha was 0.787 for intensity dimension and 0.797 for interference dimension, respectively. The test-retest reliability was 0.845 for intensity dimension and 0.883 for interference dimension, respectively. CONCLUSIONS: The Chinese version of HNSC demonstrated favorable validity and reliability. It can be used in identification of NIS and development of symptom management program in HNC patients in China.

Effect of family education program on cognitive impairment, anxiety, and depression in persons who have had a stroke: A randomized, controlled study.

People who have had a stroke face high risks of cognitive impairment, anxiety, and depression. Health education for family members contributes to better outcomes in various diseases, but the effects of health education on family members of people who have had a stroke are unclear. The aim of the present study was to evaluate the effects of the family member education program (FMEP) on cognitive impairment, anxiety, and depression in persons who have had a stroke. In total, 144 persons who experienced a stroke were randomly allocated to the FMEP group or control group (1:1 ratio). In the FMEP group, the FMEP and conventional treatment were provided, while in control group only conventional treatment was provided. The increase in the Montreal Cognitive Assessment (MOCA) score from baseline to 12 months (M12 - baseline) in the FMEP group was higher compared with the control group, and the FMEP led to a decreased cognitive impairment rate (MOCA score ≤26) after 12 months compared to the control group. Changes in the Hospital Anxiety and Depression Scale anxiety and depression score (M12 - baseline) decreased in the FMEP group compared with the control group. Fewer participants with depression and a lower depression grade were observed in the FMEP group compared with the control group. The FMEP could reduce cognitive impairment, anxiety, and depression in persons who have had a stroke.

MicroRNA-134 modulates glioma cell U251 proliferation and invasion by targeting KRAS and suppressing the ERK pathway.

Dysregulated microRNA-134 (miR-134) has been observed in glioma carcinogenesis, and studies suggested that the ERK pathway plays vital roles in glioma cell growth and proliferation. However, the fundamental relationship between miR-134 and the ERK pathway in glioma has not been fully explained. As a result, this study was aimed to explore the underlying functions of miR-134 in human glioma. Intentionally overexpressed or inhibited miR-134 expression resulted from the transfection of miR-134 mimics, or miR-134 inhibitor within glioma cell line U251 was detected using RT-PCR. Both cell counting kit-8 (CCK-8) assays and Transwell assays were carried out to clarify the proliferation and invasion of U251 cells transfected with miR-134 mimics or miR-134 inhibitors. Our findings showed that miR-134 was significantly downexpressed in glioma tissues, and low miR-134 expression was significantly related to high histopathological grades. However, upregulated miR-134 expression restrained the proliferation and invasion of U251 cells in vitro. Kirsten rat sarcoma viral oncogene (KRAS), a vital factor for the ERK pathway, was directly targeted by miR-134 through its binding with the 3'-UTR of KRAS in glioma. Furthermore, KRAS expression exhibited a positive correlation with the activity of the ERK pathway. Overexpression of KRAS without 3'-UTR partly offsets the suppressive effect of miR-134 on glioma progression. Our data also indicated that miR-134 negatively modulated glioma progression and upregulated miR-134 triggered aberrant activation of the ERK pathway by targeting KRAS. Therefore, miR-134 might be considered as a benign therapeutic target of glioma.

Who uses NHS Direct? Investigating the impact of ethnicity on the uptake of telephone based healthcare.

INTRODUCTION: NHS Direct, a leading telephone healthcare provider worldwide, provided 24/7 health care advice and information to the public in England and Wales (1998-2014). The fundamental aim of this service was to increase accessibility, however, research has suggested a disparity in the utilisation of this service related to ethnicity. This research presents the first national study to determine how the diverse population in England have engaged with this service. METHODS: NHS Direct call data from the combined months of July, 2010 October, 2010, January 2011 and April, 2011 was analysed (N = 1,342, 245) for all 0845 4647 NHS Direct core service calls in England. Expected usage of NHS Direct was determined for each ethnic group of the population by age and gender and compared by actual usage using Chi-square analysis. A one-way analysis of variance (ANOVA) was used to determine variations of uptake by ethnic group and Index for Multiple Deprivation (IMD) 2010 rank. RESULTS: Results confirmed that all mixed ethnic groups (White and Black Caribbean, White and Black African, White and Asian) had a higher than expected uptake of NHS Direct which held consistent across all age groups. Lower than expected uptake was found for Black (African/Caribbean) and Asian (Bangladeshi/Indian/Chinese) ethnic group which held consistent by age and gender. For the Pakistani ethnic group usage was higher than expected in adults aged 40 years and older although was lower than expected in younger age groups (0-39). CONCLUSION: Findings support previous research suggesting a variation in usage of NHS Direct influenced by ethnicity, which is evidenced on a national level. Further research is now required to examine the underlying barriers that contribute to the ethnic variation in uptake of this service.

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.

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.

Accelerometry-assessed sedentary behaviour and physical activity levels during the segmented school day in 10-14-year-old children: the HAPPY study.

UNLABELLED: The school day offers several different time periods that provide varying opportunities for sedentary time (SED) and engagement in physical activity (PA), yet little is known about the PA and sedentary behaviour patterns of boys and girls during these times. The volume, intensity and temporal distributions of SED and PA undertaken by 135 schoolchildren aged 10-14 years, during different segments of the school day: (a) school transport, (b) morning recess, (c) lunch break, (d) class time and (e) after school, were explored using triaxial accelerometry. PA was categorised into SED, light PA (LPA), moderate PA (MPA) and vigorous PA (VPA). Girls engaged in significantly more SED and LPA than boys during recess and lunch break (p < 0.05), while boys engaged in significantly higher levels of VPA during recess (p < 0.001) and MPA and VPA during lunch break (p < 0.001). PA engagement was similar between sexes during other segments of the day. CONCLUSION: PA patterns appear more beneficial for health in boys during less structured school-based time periods and interventions may therefore target opportunities for girls to be physically active during these times to overcome this observed sex deficit.