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Use of external control arms in immune-mediated inflammatory diseases: a systematic review

Por: Zayadi · A. · Edge · R. · Parker · C. E. · Macdonald · J. K. · Neustifter · B. · Chang · J. · Zhong · G. · Singh · S. · Feagan · B. G. · Ma · C. · Jairath · V.
Objectives

External control arms (ECAs) provide useful comparisons in clinical trials when randomised control arms are limited or not feasible. We conducted a systematic review to summarise applications of ECAs in trials of immune-mediated inflammatory diseases (IMIDs).

Design

Systematic review with an appraisal of ECA source quality rated across five domains (data collection, study populations, outcome definitions, reliability and comprehensiveness of the dataset, and other potential limitations) as high, low or unclear quality.

Data sources

Embase, Medline and Cochrane Central Register of Controlled Trial were searched through to 12 September 2023.

Eligibility criteria

Eligible studies were single-arm or randomised controlled trials (RCTs) of inflammatory bowel disease, pouchitis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and atopic dermatitis in which an ECA was used as the comparator.

Data extraction and synthesis

Two authors independently screened the search results in duplicate. The characteristics of included studies, external data source(s), outcomes and statistical methods were recorded, and the quality of the ECA data source was assessed by two independent authors.

Results

Forty-three studies met the inclusion criteria (inflammatory bowel disease: 16, pouchitis: 1, rheumatoid arthritis: 12, juvenile idiopathic arthritis: 1, ankylosing spondylitis: 5, psoriasis: 3, multiple indications: 4). The majority of these trials were single-arm (33/43) and enrolled adult patients (34/43). All included studies used a historical control rather than a contemporaneous ECA. In RCTs, ECAs were most often derived from the placebo arm of another RCT (6/10). In single-arm trials, historical case series were the most common ECA source (19/33). Most studies (31/43) did not employ a statistical approach to generate the ECA from historical data.

Conclusions

Standardised ECA methodology and reporting conventions are lacking for IMIDs trials. The establishment of ECA reporting guidelines may enhance the rigour and transparency of future research.

ARCHERY: a prospective observational study of artificial intelligence-based radiotherapy treatment planning for cervical, head and neck and prostate cancer - study protocol

Por: Aggarwal · A. · Court · L. E. · Hoskin · P. · Jacques · I. · Kroiss · M. · Laskar · S. · Lievens · Y. · Mallick · I. · Abdul Malik · R. · Miles · E. · Mohamad · I. · Murphy · C. · Nankivell · M. · Parkes · J. · Parmar · M. · Roach · C. · Simonds · H. · Torode · J. · Vanderstraeten · B. · Lan
Introduction

Fifty per cent of patients with cancer require radiotherapy during their disease course, however, only 10%–40% of patients in low-income and middle-income countries (LMICs) have access to it. A shortfall in specialised workforce has been identified as the most significant barrier to expanding radiotherapy capacity. Artificial intelligence (AI)-based software has been developed to automate both the delineation of anatomical target structures and the definition of the position, size and shape of the radiation beams. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy.

Methods

ARCHERY is a non-randomised prospective study to evaluate the quality and economic impact of AI-based automated radiotherapy treatment planning for cervical, head and neck, and prostate cancers, which are endemic in LMICs, and for which radiotherapy is the primary curative treatment modality. The sample size of 990 patients (330 for each cancer type) has been calculated based on an estimated 95% treatment plan acceptability rate. Time and cost savings will be analysed as secondary outcome measures using the time-driven activity-based costing model. The 48-month study will take place in six public sector cancer hospitals in India (n=2), Jordan (n=1), Malaysia (n=1) and South Africa (n=2) to support implementation of the software in LMICs.

Ethics and dissemination

The study has received ethical approval from University College London (UCL) and each of the six study sites. If the study objectives are met, the AI-based software will be offered as a not-for-profit web service to public sector state hospitals in LMICs to support expansion of high quality radiotherapy capacity, improving access to and affordability of this key modality of cancer cure and control. Public and policy engagement plans will involve patients as key partners.

Evaluation of immunogenicity-induced DNA vaccines against different SARS-CoV-2 variants

by Se Eun Kim, So Hee Park, Woo-Jung Park, Gayeong Kim, Seo Yeon Kim, Hyeran Won, Yun-Ho Hwang, Heeji Lim, Hyeon Guk Kim, You-Jin Kim, Dokeun Kim, Jung-Ah Lee

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in 2019 and caused the coronavirus disease 2019 (COVID-19) pandemic worldwide. As of September 2023, the number of confirmed coronavirus cases has reached over 770 million and caused nearly 7 million deaths. The World Health Organization assigned and informed the characterization of variants of concern (VOCs) to help control the COVID-19 pandemic through global monitoring of circulating viruses. Although many vaccines have been proposed, developing an effective vaccine against variants is still essential to reach the endemic stage of COVID-19. We designed five DNA vaccine candidates composed of the first isolated genotype and major SARS-CoV-2 strains from isolated Korean patients classified as VOCs, such as Alpha, Beta, Gamma, and Delta. To evaluate the immunogenicity of each genotype via homologous and heterologous vaccination, mice were immunized twice within a 3-week interval, and the blood and spleen were collected 1 week after the final vaccination to analyze the immune responses. The group vaccinated with DNA vaccine candidates based on the S genotype and the Alpha and Beta variants elicited both humoral and cellular immune responses, with higher total IgG levels and neutralizing antibody responses than the other groups. In particular, the vaccine candidate based on the Alpha variant induced a highly diverse cytokine response. Additionally, we found that the group subjected to homologous vaccination with the S genotype and heterologous vaccination with S/Alpha induced high total IgG levels and a neutralization antibody response. Homologous vaccination with the S genotype and heterologous vaccination with S/Alpha and S/Beta significantly induced IFN-γ immune responses. The immunogenicity after homologous vaccination with S and Alpha and heterologous vaccination with the S/Alpha candidate was better than that of the other groups, indicating the potential for developing novel DNA vaccines against different SARS-CoV-2 variants.

Trends in the treatment of fibromyalgia in South Korea between 2011 and 2018: a retrospective analysis of cross-sectional health insurance data

Por: Yu · J.-S. · Kim · E.-S. · Park · K. S. · Lee · Y. J. · Park · Y. C. · Nam · D. · Kim · E.-J. · Ha · I.-H.
Objectives

Fibromyalgia treatment trends vary globally; however, the trend in South Korea has not been investigated yet. This study aimed to analyse the fibromyalgia treatment trends in South Korea.

Design

Retrospective, observational study using serial cross-sectional data.

Setting

The National Patient Samples of the Korean Health Insurance Review & Assessment Service from 2011 to 2018 were used.

Participants

A total of 31 059 patients with fibromyalgia were included in this study. The basic characteristics of the patients were stratified by sex, age and comorbidity. A patient was considered to have a condition if it was recorded as a principal diagnosis at least once in a year.

Primary and secondary outcome measures

Trends in the types of medical visits and prescribed treatments were investigated and the values are presented as rates per 100 patients. The types of pharmacological treatment were presented according to the existing clinical guidelines. Additionally, combination prescription trends and associated characteristics were investigated.

Results

Of the patients, 66.2% were female. Visits to internal medicine departments showed the most significant increase (2011: 11.34; 2018: 21.99; p

Conclusions

Our findings provide basic reference data for the development and application of national guidelines for fibromyalgia.

Menopausal hormone therapy increases the risk of gallstones: Health Insurance Database in South Korea (HISK)-based cohort study

by Jin-Sung Yuk, Ji Young Park

Objective

To determine whether menopausal hormone therapy (MHT) increases the risk of gallstones and gallbladder cancer.

Design

A retrospective cohort study.

Patients or other participants

Data from the Korea National Health Insurance Corporation was obtained between January 1, 2002, and December 31, 2019.

Interventions

Participants were divided into MHT and non-MHT groups; the MHT group was analyzed in detail by dividing participants into tibolone, combined estrogen plus progestin by the manufacturer (CEPM) or physician (CEPP), oral estrogen alone, and topical estrogen subgroups.

Main outcome measures

The incidence of gallstones and gallbladder cancer was compared between the two groups.

Results

This study enrolled 1,004,034 and 381,711 patients in the non-MHT and the MHT groups, respectively. The incidence of gallstones was 2.6% in the non-MHT group and 3.4%, 2.6%, 3.4%, 3.2%, and 4.4% in the tibolone, CEPM, oral estrogen alone, CEPP, and topical estrogen groups, respectively. Cox proportional hazard analysis revealed that all hormones increased the risk of gallstones ([tibolone] hazard ratio [HR]: 1.347, 95% confidence interval [CI]: 1.309–1.387, [CEPM] HR: 1.146, 95% CI: 1.1–1.19, [oral estrogen alone] HR: 1.241, 95% CI: 1.18–1.305, [CEPP] HR: 1.164, 95% CI: 1.01–1.341, [topical estrogen] HR: 1.602, 95% CI: 1.295–1.983). However, the risk of gallbladder cancer did not change with any hormone therapy.

Conclusions

All types of MHT including tibolone, increased the risk of gallstones. This risk was the highest with topical estrogen, which may be a result of selection bias due to concerns regarding the adverse effects of CEE and MPA.

A genome-wide and candidate gene association study of preterm birth in Korean pregnant women

by Young Min Hur, Jae Young Yoo, Young Ah You, Sunwha Park, Soo Min Kim, Gain Lee, Young Ju Kim

Preterm birth (PTB) refers to delivery before 37 weeks of gestation. Premature neonates exhibit higher neonatal morbidity and mortality rates than term neonates; therefore, it is crucial to predict and prevent PTB. Advancements enable the prediction and prevention of PTB using genetic approaches, especially by investigating its correlation with single nucleotide polymorphisms (SNPs). We aimed to identify impactive and relevant SNPs for the prediction of PTB via whole–genome sequencing analyses of the blood of 31 pregnant women with PTB (n = 13) and term birth (n = 18) who visited the Ewha Womans University Mokdong Hospital from November 1, 2018 to February 29, 2020. A genome-wide association study was performed using PLINK 1.9 software and 256 SNPs were selected and traced through protein-protein interactions. Moreover, a validation study by genotyping was performed on 60 other participants (preterm birth, n = 30; term birth, n = 30) for 25 SNPs related to ion channel binding and receptor complex pathways. Odds ratios were calculated using additive, dominant, and recessive genetic models. The risk of PTB in women with the AG allele of rs2485579 (gene name: RYR2) was significantly 4.82-fold increase, and the risk of PTB in women with the AG allele of rs7903957 (gene name: TBX5) was significantly 0.25-fold reduce. Our results suggest that rs2485579 (in RYR2) can be a genetic marker of PTB, which is considered through the association with abnormal cytoplasmic Ca2+ concentration and dysfunctional uterine contraction due to differences of RYR2 in the sarcoplasmic reticulum.

Comprehensive lifestyle modification interventions for metabolic syndrome: A systematic review and meta‐analysis

Abstract

Introduction

Previous systematic reviews and meta-analyses have mainly focused on improvements in the number of metabolic syndrome risk factors and individual changes in each risk factor, making it challenging to examine the impact of comprehensive lifestyle modification interventions on adherence to recommended health behaviors. To address this gap, we conducted a systematic and meta-analysis aimed at identifying clinical parameter levels associated with lifestyle modification outcomes and adherence to recommended health behaviors for individuals with metabolic syndrome.

Methods

A total of seven studies retrieved from four databases (CINAHL, Medline via PubMed, American Psychological Association PsycINFO, and Embase) were included in the review. The selected studies, which demonstrated improvements in health behaviors, all included diet and exercise as main factors of comprehensive lifestyle modification in home settings.

Results

Our findings suggest that a 6-month comprehensive intervention including diet and exercise can be effective in decreasing glucose levels and systolic blood pressure. However, given the limited available data, further studies investigating the efficacy of interventions of varying durations are needed.

Discussion

Although our review included a small number of studies, comprehensive lifestyle modifications consisting of at least two components (primarily diet and exercise) can improve health behaviors and some clinical parameters among individuals with metabolic syndrome. Future studies are needed to investigate the long-term effects of lifestyle modifications on health behavior adherence and explore effective interventions to address certain clinical parameters, such as high-density lipoprotein levels. Also, we recommend using objective and quantifiable measure to compare adherence to recommended lifestyle modifications across studies.

Clinical Relevance

This research provides empirical evidence of the effectiveness of comprehensive lifestyle modification and emphasizes the need to develop long-term nursing strategies in public health that can be used to effectively manage metabolic syndrome.

Association between hypoglycemic agent use and the risk of occurrence of nonalcoholic fatty liver disease in patients with type 2 diabetes mellitus

by Choungwon Jung, Soyoung Park, Hyunah Kim

Nonalcoholic fatty liver disease (NAFLD) is a growing health concern with increasing prevalence and associated health impacts. Although no approved drugs are available for the NAFLD treatment, several hypoglycemic agents have been investigated as promising therapeutic agents. We aimed to compare the risk of occurrence of NAFLD with respect to the use of different hypoglycemic agents in patients with type 2 diabetes. This retrospective cohort study used data from the National Health Insurance Service–National Sample Cohort of South Korea. Participants newly diagnosed with type 2 diabetes (2003–2019) were included in this study. Two new user-active comparator cohorts were assembled: Cohort 1, new users of thiazolidinediones (TZD) and dipeptidyl peptidase-4 inhibitors (DPP-4i), and Cohort 2, new users of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and DPP-4i. The occurrence of NAFLD was defined based claims that include diagnostic codes. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox proportional hazard models in 1:3 propensity score (PS)-matched cohorts. For 65,224 patients newly diagnosed with type 2 diabetes, the overall prevalence of NAFLD was 42.6%. The PS-matched Cohort 1 included 6,351 and 2,117 new users of DPP-4i and TZD, respectively. Compared to DPP-4i, TZD use was associated with the decreased risk of NAFLD (HR, 0.66; 95% CI: 0.55–0.78). Cohort 2 consisted of 6,783 and 2,261 new users of DPP-4i and SGLT-2i, respectively; SGLT-2i use was associated with a decreased risk of NAFLD (HR, 0.93; 95% CI: 0.80–1.08). This population-based cohort study supports the clinical implications of prioritizing TZD and SGLT-2i over DPP-4i in reducing the risk of occurrence of NAFLD in patients with type 2 diabetes. However, the findings lacked statistical significance, highlighting the need for further verification studies.

Development and validation of an updated PICC length prediction formula based on anteroposterior chest radiographs for the ultrasound-guided bedside placement

by Hyoung Nam Lee, Sangjoon Lee, Sung-Joon Park, Youngjong Cho, Hwan Hoon Chung

Bedside peripherally inserted central catheter (PICC) placement is sometimes required when the patient’s intrahospital transport is restricted, and the ideal catheter length prediction is needed. This study aimed to develop an updated formula that predicts the optimal length of a PICC based on anteroposterior chest radiographs (AP-CXRs). This retrospective study collected PICC procedure data as the training and validation sets in three hospitals, including cubital crease-puncture point distance (CP), the actual PICC length (aCL), and the approach side. Horizontal and vertical measurement variables were set on the AP-CXRs. Two dependent variables were ipsilateral upper arm length (AL) and ideal truncal catheter length (iTCL). Simple and multiple regression analyses were used for formula development, and it was applied to the test set to evaluate the length prediction performance. The study included 309 patients in the training and validation sets and 91 intensive care patients in the test set. The final derived formula was: (AL + iTCL = CP + estimated PICC length, cm) = 19.831 − 0.062 × (contralateral clavicle length, cm) + 0.255 × (2nd ribs horizontal distance, cm) + 0.720 × (humero-vertebral distance, cm) + 0.761 × (thoraco-carinal distance, cm) + 1.024 × (the vertical distance of two vertebral body units, cm). (If approaching from the left, add 2.843cm, and if female, subtract 0.821cm.) In the test set, there was no case of length prediction failure. Moreover, the catheter tip position was evaluated as optimal in 82 cases (90.1%). This study’s results suggest an updated formula to predict the ideal PICC length using only AP-CXRs for bedside placement.

Talking numbers: how women and providers use risk scores during and after risk counseling - a qualitative investigation from the NRG Oncology/NSABP DMP-1 study

Por: Blakeslee · S. B. · Gunn · C. M. · Parker · P. A. · Fagerlin · A. · Battaglia · T. · Bevers · T. B. · Bandos · H. · McCaskill-Stevens · W. · Kennedy · J. W. · Holmberg · C.
Objectives

Little research exists on how risk scores are used in counselling. We examined (a) how Breast Cancer Risk Assessment Tool (BCRAT) scores are presented during counselling; (b) how women react and (c) discuss them afterwards.

Design

Consultations were video-recorded and participants were interviewed after the consultation as part of the NRG Oncology/National Surgical Adjuvant Breast and Bowel Project Decision-Making Project 1 (NSABP DMP-1).

Setting

Two NSABP DMP-1 breast cancer care centres in the USA: one large comprehensive cancer centre serving a high-risk population and an academic safety-net medical centre in an urban setting.

Participants

Thirty women evaluated for breast cancer risk and their counselling providers were included.

Methods

Participants who were identified as at increased risk of breast cancer were recruited to participate in qualitative study with a video-recorded consultation and subsequent semi-structured interview that included giving feedback and input after viewing their own consultation. Consultation videos were summarised jointly and inductively as a team.tThe interview material was searched deductively for text segments that contained the inductively derived themes related to risk assessment. Subgroup analysis according to demographic variables such as age and Gail score were conducted, investigating reactions to risk scores and contrasting and comparing them with the pertinent video analysis data. From this, four descriptive categories of reactions to risk scores emerged. The descriptive categories were clearly defined after 19 interviews; all 30 interviews fit principally into one of the four descriptive categories.

Results

Risk scores were individualised and given meaning by providers through: (a) presenting thresholds, (b) making comparisons and (c) emphasising or minimising the calculated risk. The risk score information elicited little reaction from participants during consultations, though some added to, agreed with or qualified the provider’s information. During interviews, participants reacted to the numbers in four primary ways: (a) engaging easily with numbers; (b) expressing greater anxiety after discussing the risk score; (c) accepting the risk score and (d) not talking about the risk score.

Conclusions

Our study highlights the necessity that patients’ experiences must be understood and put into relation to risk assessment information to become a meaningful treatment decision-making tool, for instance by categorising patients’ information engagement into types.

Trial registration number

NCT01399359.

Association between physical activity and health-related quality of life in middle-aged and elderly individuals with musculoskeletal disorders: Findings from a national cross-sectional study in Korea

by Jung Hyun Lee, Il Yun, Chung-Mo Nam, Suk-Yong Jang, Eun-Cheol Park

Purpose

This study aimed to identify the association between physical activity and health-related quality of life (HRQoL) in middle-aged and elderly individuals with musculoskeletal disorders.

Methods

This study used data from the 2016–2020 Korea National Health and Nutrition Examination Survey (KNHANES). We included only those over 40 years of age diagnosed with one or more of the following: osteoarthritis, rheumatism, and osteoporosis. In total, 4,731 participants (783 men and 3,948 women) were included as the study population. Multiple logistic regression analysis was performed to examine the association between physical activity and HRQoL.

Results

In the case of middle-aged and elderly individuals with musculoskeletal disorders, the likelihood of HRQoL worsening was significantly lower for those who regularly engaged in physical activity compared with that of those who did not engage in physical activity at all (men: OR 0.58, 95% CI 0.37–0.90; women: OR 0.64, 95% CI 0.53–0.79). Stratified analysis by the type and intensity of physical activity revealed that the possibility of poor HRQoL was lowest when leisure-related moderate-intensity physical activities were performed (men: OR 0.44, 95% CI 0.22–0.89; Women: OR 0.50, 95% CI 0.36–0.69).

Conclusions

Our findings suggest that engaging in regular physical activity contributes to preventing exacerbation of HRQoL, even if the individual suffers from musculoskeletal disorders. It is necessary to provide an appropriate type and intensity of physical activity in consideration of the patients’ pain and severity.

Digital health intervention on patient safety for children and parents: A scoping review

Abstract

Aim

To explore digital health interventions on patient safety for children and their parents.

Design

A scoping review.

Methods

The PCC ‘Participants, Concepts, and Contexts’ guided the selection of studies that focused on children under 19 years of age or their parents, patient safety interventions for children, and digital health technology for patient safety interventions. This study was conducted using the Arksey and O'Malley framework's five steps. We reported the review according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews Checklist.

Data Sources

PubMed, CINAHL, Embase, Web of Science, and Cochrane were searched for articles published up to November 2022.

Results

A total of 13 articles were included and categorized according to the following criteria to describe the results: intervention characteristics, type of digital technology, and outcome characteristics. Regarding intervention characteristics, we identified two categories, prevention and risk management. Additionally, we identified four types of digital technology, mobile applications, web-based technologies, computer kiosks and electronic health records. Finally, in studies focussing on child safety, parental safety behaviours were used to assess injury risk or detect changes related to prevention.

Conclusion

Patient safety interventions provided through appropriate digital technologies should be developed to enhance continuum of care for children from hospitalization to home after discharge.

Implications for the Profession and/or Patient Care

Digital health interventions can bolster the role of healthcare providers in patient safety in and out of hospitals, thus improving children's safety and quality of care.

Impact

What problem did the study address? Although the various advantages of digital health technology have been demonstrated, the potential role of digital technology in patient safety interventions for children has not been explored. What were the main finding? Preventive patient safety interventions and risk management for children have been developed. Where and on whom will the research have an impact? Digital health interventions on patient safety can improve children's safety and quality of care by promoting non-face-to-face engagement of children and parents after discharge and expanding healthcare providers' roles.

Trial and Protocol Registration

Registered on the Open Science Framework (https://osf.io/dkvst).

Patient or Public Contribution

No patient or public contribution.

Effects of COVID-19 outbreak on Korean adolescents: Impact of altered economic perception on physical activity, sedentary behavior, and stress levels in an age-, gender-, and BMI-matched study

by Jisu Kim, In-Whi Hwang, Jeong-Hui Park, Youngdeok Kim, Jung-Min Lee

The current study is to examine the disparities in physical activity (PA), sedentary behavior (SB), and stress levels in Korean adolescents concerning changes in their perception of family economic status (ES) during COVID-19. Among a total of 6144 Korean adolescents aged 12 to 18, the participants were categorized into two groups based on their responses regarding changes in their family ES due to COVID-19: Declined ES (n = 3072) and Non-changed ES (n = 3072), with matching in terms of age, gender, and BMI. All variables were assessed using the 16th year (2020) of the Korean Youth Risk Behavior Survey. Statistical analyses were conducted using the SPSS 26.0 version, employing independent t-tests to examine anthropometrics’ differences and multinominal logistic regression to predict the impact of perception of family ES on PA, SB, and stress while comparing the two groups. The significance level was set at α = 0.05. Adolescents in the Declined ES group were 1.2 times more likely to engage in MVPA for less than 420 mins/wk (OR = 1.16, p = 0.039), 1.7 times more likely to meet recommended muscular strength activities (i.e., ≥ 3 days/wk) (OR = 1.70, p p p

Randomized clinical trial to compare the efficacy of self-expanding bare metal nitinol stent and balloon angioplasty alone for below-the-knee lesions following successful balloon angioplasty: 1-year clinical outcomes

by Jihun Ahn, HyeYon Yu, Seung-Woon Rha, Byoung Geol Choi, Dong Oh Kang, Cheol Ung Choi, Sangho Park, Jon Seo, Kichang Kim, Minung Kim, Yong Hoon Kim, Yong Seong Seo

This prospective, multicenter, randomized study aimed to compare the 1-year clinical outcomes after primary stenting with self-expanding bare metal nitinol stent (SENS) and plain old balloon angioplasty (POBA) in patients with critical limb ischemia (CLI) and below-the-knee (BTK) lesions. Overall, 119 patients with CLI and BTK lesions were randomized to POBA alone (POBA group, 61 patients) or primary stenting with SENS (stenting group, 58 patients) after achieving acceptable POBA results in target BTK lesions. Clinical outcomes including amputation and revascularization rates were prospectively compared for 1 year. After 1 year, similar incidence rates of individual clinical endpoints, including cardiac death (6.5% vs. 5.1%, p > 0.999), myocardial infarction (1.6% vs. 0.0%, p > 0.999), repeat revascularization (19.6% vs. 18.9%, p = 0.922), target lesion revascularization (13.1% vs. 17.2%, p = 0.530), and amputation (4.9% vs. 0.0%, p = 0.244), were observed. POBA appeared to have acceptable treatment outcomes compared with primary stenting with SENS after 1 year in CLI patients with BTK lesions undergoing percutaneous transluminal angioplasty (PTA).

The global prevalence of overweight and obesity among nurses: A systematic review and meta‐analyses

Abstract

Background

Several studies have reported the prevalence of overweight and obesity in various countries but the global prevalence of nurses with overweight and obesity remains unclear. A consolidation of figures globally can help stakeholders worldwide improve workforce development and healthcare service delivery.

Objective

To investigate the global prevalence of overweight and obesity among nurses.

Design

Systematic review with meta-analysis.

Setting

29 different countries across the WHO-classified geographical region.

Participants

Nurses.

Methods

Eight electronic databases were searched for articles published from inception to January 2023. Two independent reviewers performed the article screening, methodological appraisal and data extraction. Methodological appraisal was conducted using Newcastle-Ottawa Scale (NOS). Inter-rater agreement was measured using Cohen's Kappa. Meta-analyses were conducted to pool the effect sizes on overweight, obesity and waist circumference using random effects model and adjusted using generalised linear mixed models and Hartung–Knapp method. Logit transformation was employed to stabilise the prevalence variance. Subgroup analyses were performed based on methodological quality and geographical regions. Heterogeneity was assessed using the I 2 statistic.

Results

Among 10,587 studies, 83 studies representing 158,775 nurses across 29 countries were included. Based on BMI, the global prevalence of overweight and obesity were 31.2% (n = 55, 95% CI: 29%–33.5%; p < .01) and 16.3% (n = 76, 95% CI: 13.7%–19.3%, p < .01), respectively. Subgroup analyses indicated that the highest prevalence of overweight was in Eastern Mediterranean (n = 9, 37.2%, 95% CI: 33.1%–41.4%) and that of obesity was in South-East Asia (n = 5, 26.4%, 95% CI: 5.3%–69.9%). NOS classification, NOS scores, sample size and the year of data collected were not significant moderators.

Conclusions

This review indicated the global prevalence of overweight and obesity among nurses along with the differences between regions. Healthcare organisations and policymakers should appreciate this increased risk and improve working conditions and environments for nurses to better maintain their metabolic health.

Patient or Public Contribution

Not applicable as this is a systematic review.

Registration

PROSPERO (ref: CRD42023403785) https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=403785.

Tweetable Abstract

High prevalence of overweight and obesity among nurses worldwide.

The correlation between transcutaneous oxygen pressure (TcPO2) and forward‐looking infrared (FLIR) thermography in the evaluation of lower extremity perfusion according to angiosome

Abstract

The increased peripheral arterial disease (PAD) incidence associated with aging and increased incidence of cardiovascular conditions underscores the significance of assessing lower limb perfusion. This study aims to report on the correlation and utility of two novel non-invasive instruments: transcutaneous oxygen pressure (TcPO2) and forward-looking infrared (FLIR) thermography. A total of 68 patients diagnosed with diabetic foot ulcer and PAD who underwent vascular studies at a single institution between March 2022 and March 2023 were included. Cases with revascularization indications were treated by a cardiologist. Following the procedure, ambient TcPO2 and FLIR thermography were recorded on postoperative days 1, 7, 14, 21 and 28. In impaired limbs, TcPO2 was 12.3 ± 2 mmHg and FLIR thermography was 28.7 ± 0.9°C. TcPO2 (p = 0.002), FLIR thermography (p = 0.015) and ankle–brachial index (p = 0.047) values significantly reduced with greater vascular obstruction severity. Revascularization (n = 39) significantly improved TcPO2 (12.5 ± 1.7 to 19.1 ± 2.2 mmHg, p = 0.011) and FLIR (28.8 ± 1.8 to 32.6 ± 1.6°C; p = 0.018), especially in severe impaired angiosomes. TcPO2 significantly increased immediately post-procedure, then gradually, whereas the FLIR thermography values plateaued from day 1 to 28 post-procedure. In conclusion, FLIR thermography is a viable non-invasive tool for evaluating lower limb perfusion based on angiosomes, comparable with TcPO2.

Software‐based interventions for low back pain management: A systematic review and meta‐analysis

Abstract

Introduction

Using software for self-management interventions can improve health outcomes for individuals with low back pain, but there is a dearth of research to confirm its effectiveness. Additionally, no known research has evaluated the effective elements of software-based interventions for low back pain self-management components. This study aimed to synthesize the effectiveness of software-based interventions to promote self-management health outcomes among individuals with low back pain.

Design

A systematic review and meta-analysis was conducted.

Methods

Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement, relevant studies up to July 2022 were searched via four electronic databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and Web of Science.

Results

4908 adults with low back pain who participated in 23 studies were included. Software-based interventions were effective in reducing fear avoidance (mean difference [MD] = −0.95, 95% CI: −1.45 to −0.44), pain catastrophizing (MD = −1.31, 95% CI: −1.84 to −0.78), disability (MD = −8.21, 95% CI: −13.02 to −3.39), and pain intensity (MD = −0.86, 95% CI: −1.17 to −0.55). Specifically, interventions that included an exercise component were more effective in reducing pain and disability. Additionally, cognitive behavioral therapy (CBT) intervention significantly reduced fear avoidance and pain catastrophizing but had no noticeable impact on disability and pain compared to standard treatment. The certainty of the evidence in this review varied from very low to high across outcomes. The heterogeneity of the study results was significant, suggesting that future studies in this area could optimize the design, time points, measures, and outcomes to strengthen the evidence.

Conclusions

Low back pain self-management interventions delivered through software-based programs effectively reduce pain intensity, disability, fear avoidance, and pain catastrophizing.

Clinical Relevance

Low back pain is among the most common reasons for seeking healthcare visits. Combining exercise and counseling through soft-based programs may effectively address this issue and its associated suffering and disability.

Revisiting metformin therapy for the mitigation of diabetic foot ulcer in patients with diabetic kidney disease from real‐world evidence

Abstract

Diabetic foot ulcer and diabetic kidney disease are diabetes-related chronic vascular complications that strongly correlate with high morbidity and mortality. Although metformin potentially confers a wound-healing advantage, no well-established clinical evidence supports the benefit of metformin for diabetic foot ulcer. Thus, this study investigated the effect of metformin on diabetic foot ulcer from a large diabetic kidney disease cohort for the first time. This retrospective cohort study enrolled 10 832 patients who visited the nephrology department more than twice at two South Korean tertiary-referral centers between 2001 and 2016. The primary outcome was diabetic foot ulcer events; secondary outcomes included hospitalization, amputation, a composite of amputation or vascular intervention, and Wagner Grade ≥ 3. Multivariate Cox analysis and propensity score matching (PSM) were used to balance baseline intergroup differences between metformin users and non-users. In total, 4748 patients were metformin users, and 6084 patients were metformin non-users. Over a follow-up period of 117.5 ± 66.9 months, the diabetic foot ulcer incidence was 5.2%. After PSM, metformin users showed a lower incidence of diabetic foot ulcer events than metformin non-users (adjusted hazard ratio 0.41; p < 0.001). In a sensitivity analysis of 563 patients with diabetic foot ulcer, metformin usage was associated with lower severity in all four secondary outcomes: hospitalization (adjusted hazard ratio 0.33; p < 0.001); amputation (adjusted hazard ratio 0.44; p = 0.001); composite of amputation or vascular intervention (adjusted hazard ratio 0.47; p < 0.001); and Wagner Grade ≥ 3 (adjusted hazard ratio 0.39; p < 0.001). In conclusion, metformin therapy in patients with diabetic kidney disease can lower diabetic foot ulcer incidence and progression.

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