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Survival outcomes following complete mediastinal lymphadenectomy or selective mediastinal lymphadenectomy in patients with stage I-IIIA non-small cell lung cancer: protocol for a systematic review and meta-analysis

Por: Xu · J. · Lai · J. · Huang · X. · Ren · Y. · Chen · Q. · Li · W.
Introduction

Lung cancer remains the largest cause of cancer-related deaths worldwide. Surgical removal of non-small cell lung cancer (NSCLC) has the potential to achieve a cure, although there is ongoing debate regarding the significance of removing mediastinal nodes and the optimal extent of lymph node excision. The purpose of this research is to assess the survival outcomes in patients diagnosed with stage I–IIIA NSCLC who received either complete mediastinal lymphadenectomy (CML) or selective mediastinal lymphadenectomy (SML).

Methods and analysis

The protocol follows the guidelines recommended in Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols, and this meta-analysis will be conducted in accordance with the standard methodology recommended by the Cochrane Collaboration and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidance. We will conduct a comprehensive search for randomised controlled trials and non-randomised studies examining the effectiveness of CML compared with SML in patients with stage I–IIIA NSCLC. Two authors will perform a comprehensive search of the MEDLINE/PubMed, Embase, the Cochrane Library, CNKI, WanFang, Sinomed, VIP and Web of Science databases. There will be no restrictions on language or publication date, and the search will be conducted on 10 April 2024, with ongoing searches for new research. Reference lists will also be checked and pertinent journals will be hand searched. The primary outcomes include overall survival (OS) and disease-free survival (DFS), while the secondary outcomes consist of 1-year, 3-year and 5-year OS rates and 1-year, 3-year and 5-year DFS rates. Two independent reviewers will screen, extract data, assess quality and evaluate the potential for bias in the selected research, with a third acting as arbitrator. Subgroup analyses and sensitivity analyses are planned. The quality of the evidence will be evaluated using Grading of Recommendations Assessment, Development and Evaluation. Review Manager V.5.4 will be used for the analysis and synthesis process.

Ethics and dissemination

Ethical review and approval are not necessary for this study because it is based on a secondary analysis of the literature. The results will be submitted for reporting in a peer-reviewed publication.

Study registration

Open Science Framework (https://doi.org/10.17605/OSF.IO/PN7UQ).

Developing blood-brain barrier arterial spin labelling as a non-invasive early biomarker of Alzheimers disease (DEBBIE-AD): a prospective observational multicohort study protocol

Por: Padrela · B. · Mahroo · A. · Tee · M. · Sneve · M. H. · Moyaert · P. · Geier · O. · Kuijer · J. P. A. · Beun · S. · Nordhoy · W. · Zhu · Y. D. · Buck · M. A. · Hoinkiss · D. C. · Konstandin · S. · Huber · J. · Wiersinga · J. · Rikken · R. · de Leeuw · D. · Grydeland · H. · Tippett · L. · Caw
Introduction

Loss of blood-brain barrier (BBB) integrity is hypothesised to be one of the earliest microvascular signs of Alzheimer’s disease (AD). Existing BBB integrity imaging methods involve contrast agents or ionising radiation, and pose limitations in terms of cost and logistics. Arterial spin labelling (ASL) perfusion MRI has been recently adapted to map the BBB permeability non-invasively. The DEveloping BBB-ASL as a non-Invasive Early biomarker (DEBBIE) consortium aims to develop this modified ASL-MRI technique for patient-specific and robust BBB permeability assessments. This article outlines the study design of the DEBBIE cohorts focused on investigating the potential of BBB-ASL as an early biomarker for AD (DEBBIE-AD).

Methods and analysis

DEBBIE-AD consists of a multicohort study enrolling participants with subjective cognitive decline, mild cognitive impairment and AD, as well as age-matched healthy controls, from 13 cohorts. The precision and accuracy of BBB-ASL will be evaluated in healthy participants. The clinical value of BBB-ASL will be evaluated by comparing results with both established and novel AD biomarkers. The DEBBIE-AD study aims to provide evidence of the ability of BBB-ASL to measure BBB permeability and demonstrate its utility in AD and AD-related pathologies.

Ethics and dissemination

Ethics approval was obtained for 10 cohorts, and is pending for 3 cohorts. The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study)

Por: Kong · Y. · Chen · R. · Xu · M. · Zhang · J. · Chen · G. · Hong · Z. · Zhang · H. · Dai · X. · Ma · Y. · Zhao · X. · Peng · Y. · Zhang · C. · Xing · P. · Zhang · L.
Introduction

The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.

Objective

The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.

Methods and analysis

The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.

Trial registration number

NCT05790447.

Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial

Por: Li · X. · Lin · J. · Hu · C. · Liu · B. · Li · F. · Li · J. · Zeng · X. · Li · S. · Mi · Y. · Yin · X. · Xu · S.
Introduction

Obesity has been identified as a significant risk factor for several chronic conditions, including diabetes, tumours and cardiovascular disease, and has been associated with increased mortality rates. Despite the well-established clinical practice of electroacupuncture (EA) as a potential treatment option for obesity, its efficacy remains questionable, primarily due to the paucity of empirical evidence supporting its therapeutic benefits.

Methods and analysis

The present study aims to investigate the efficacy and safety of EA for weight loss in obese individuals with pre-diabetes, using a randomised, placebo-controlled clinical trial design. A total of 256 eligible patients will be randomly assigned to one of two groups: EA (comprising EA treatment with health education) or superficial acupuncture (SA) (comprising SA treatment with health education). The intervention will be administered three times per week for the initial 12 weeks, two times per week for the subsequent 8 weeks and one time per week for the final 4 weeks, with a 24-week follow-up period. The primary outcome measure will be the percentage of patients who achieve a reduction of 10% or more in their body weight at week 24. Secondary outcome measures will include changes in body weight and body mass index, blood test results, data collected by the body composition analyser, size of adipose tissue scanned by MRI of the abdomen and the Impact of Weight on Quality of Life, the 21-item Three-Factor Eating Questionnaire-Revised and the Food Craving Questionnaire-Trait. The Treatment Emergent Symptom Scale will be employed to monitor every adverse reaction from baseline to follow-up.

Ethics and dissemination

This trial has received ethical clearance from the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine under the registration number 2021SHL-KY-74. All participants will provide their written informed consent prior to their enrolment. The findings of this investigation will be disseminated through peer-reviewed publications and scholarly conferences.

Trial registration number

NCT05237089.

Development of a prognostic model for long-term survival of young patients with bladder cancer: a retrospective analysis of the SEER Database

Por: Guo · L. · Liu · L. · Liu · Y. · Yang · T. · Wang · G. · Liu · J. · Li · S. · Cai · J.
Objectives

This study aims to present the clinical characteristics of young patients with bladder cancer (YBCa), evaluate related risk factors and construct a nomogram based on data acquired from the Surveillance, Epidemiology, and End Results (SEER) Database.

Design

Retrospective analysis of the SEER Database (2004–2015) for primary YBCa.

Setting and participants

Data for YBCa (defined as those aged 40 years or younger) were extracted from the SEER Database, which covers approximately 28% of the US population, using the SEER*Stat software (V.8.4.0.1). A total of 1233 YBCa were identified. Patients were randomly assigned to the training and validation sets. The database included clinicopathological features, demographic information and survival outcomes, such as age, gender, race, year of diagnosis, marital status at diagnosis, primary tumour site, histological type, tumour grade, tumour, node, metastases (TNM) staging, treatment regimen for the primary tumour, cause of death and survival time. A nomogram model was developed using univariate and multivariate analyses. The prediction model was validated using the consistency index (C-index), calibration curve and receiver operating characteristic curve.

Primary outcome measures

3-year, 5-year and 10-year overall survival (OS).

Results

1233 YBCa from 2004 to 2015 were randomly assigned to the training set (n=865) and validation set (n=368). Age, marital status, tumour grade, histological type and TNM staging were included in the nomogram. The C-index of the model was 0.876. The 3-year, 5-year and 10-year OS area under the curve values for the training and validation sets were 0.949, 0.923 and 0.856, and 0.919, 0.890 and 0.904, respectively. Calibration plots showed that the nomogram had a robust predictive accuracy.

Conclusions

To our knowledge, this is the first study to establish a precise nomogram predicting the 3-year, 5-year and 10-year OS in YBCa based on multivariate analyses. Our nomogram may serve as a valuable reference for future diagnostics and individualised treatments for YBCa. However, external validation is warranted to assess the accuracy and generalisability of our prognostic model.

Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol

Por: Vahid · F. · Dessenne · C. · Tur · J. A. · Bouzas · C. · Devaux · Y. · Malisoux · L. · Monserrat-Mesquida · M. · Sureda · A. · Desai · M. S. · Turner · J. D. · Lamy · E. · Perez-Jimenez · M. · Ravn-Haren · G. · Andersen · R. · Forberger · S. · Nagrani · R. · Ouzzahra · Y. · Fontefrancesc
Introduction

Despite international efforts, the number of individuals struggling with obesity is still increasing. An important aspect of obesity prevention relates to identifying individuals at risk at early stage, allowing for timely risk stratification and initiation of countermeasures. However, obesity is complex and multifactorial by nature, and one isolated (bio)marker is unlikely to enable an optimal risk stratification and prognosis for the individual; rather, a combined set is required. Such a multicomponent interpretation would integrate biomarkers from various domains, such as classical markers (eg, anthropometrics, blood lipids), multiomics (eg, genetics, proteomics, metabolomics), lifestyle and behavioural attributes (eg, diet, physical activity, sleep patterns), psychological traits (mental health status such as depression) and additional host factors (eg, gut microbiota diversity), also by means of advanced interpretation tools such as machine learning. In this paper, we will present a protocol that will be employed for a scoping review that attempts to summarise and map the state-of-the-art in the area of multicomponent (bio)markers related to obesity, focusing on the usability and effectiveness of such biomarkers.

Methods and analysis

PubMed, Scopus, CINAHL and Embase databases will be searched using predefined key terms to identify peer-reviewed articles published in English until January 2024. Once downloaded into EndNote for deduplication, CADIMA will be employed to review and select abstracts and full-text articles in a two-step procedure, by two independent reviewers. Data extraction will then be carried out by several independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Peer Review of Electronic Search Strategies guidelines will be followed. Combinations employing at least two biomarkers from different domains will be mapped and discussed.

Ethics and dissemination

Ethical approval is not required; data will rely on published articles. Findings will be published open access in an international peer-reviewed journal. This review will allow guiding future directions for research and public health strategies on obesity prevention, paving the way towards multicomponent interventions.

Artificial intelligence driven malnutrition diagnostic model for patients with acute abdomen based on GLIM criteria: a cross-sectional research protocol

Por: Ma · W. · Cai · B. · Wang · Y. · Wang · L. · Sun · M.-W. · Lu · C. D. · Jiang · H.
Background

Patients with acute abdomen often experience reduced voluntary intake and a hypermetabolic process, leading to a high occurrence of malnutrition. The Global Leadership Initiative on Malnutrition (GLIM) criteria have rapidly developed into a principal methodological tool for nutritional diagnosis. Additionally, machine learning is emerging to establish artificial intelligent-enabled diagnostic models, but the accuracy and robustness need to be verified. We aimed to establish an intelligence-enabled malnutrition diagnosis model based on GLIM for patients with acute abdomen.

Method

This study is a single-centre, cross-sectional observational investigation into the prevalence of malnutrition in patients with acute abdomen using the GLIM criteria. Data collection occurs on the day of admission, at 3 and 7 days post-admission, including biochemical analysis, body composition indicators, disease severity scoring, nutritional risk screening, malnutrition diagnosis and nutritional support information. The occurrence rate of malnutrition in patients with acute abdomen is analysed with the GLIM criteria based on the Nutritional Risk Screening 2002 and the Mini Nutritional Assessment Short-Form to investigate the sensitivity and accuracy of the GLIM criteria. After data cleansing and preprocessing, a machine learning approach is employed to establish a predictive model for malnutrition diagnosis in patients with acute abdomen based on the GLIM criteria.

Ethics and dissemination

This study has obtained ethical approval from the Ethics Committee of the Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital on 28 November 2022 (Yan-2022–442). The results of this study will be disseminated in peer-reviewed journals, at scientific conferences and directly to study participants.

Trial registration number

ChiCTR2200067044.

Physician awareness and understanding of chronic inflammatory demyelinating polyradiculoneuropathy in Japan: a web-based study

Por: Takeshita · Y. · Imajo · Y. · Oh · A. · Kikutani · M. · Okamatsu · N.
Objectives

To investigate potential knowledge gaps between neurologists and non-specialists and identify challenges in the current management of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), with a focus on ‘early diagnosis’ and ‘appropriate treatment’ for CIDP.

Design

A non-interventional, cross-sectional, web-based quantitative survey of physicians working in healthcare clinics or hospitals in Japan.

Setting

Participants were recruited from the Nikkei Business Publications panel from 18 August to 14 September 2022.

Participants

Responses from 360 physicians (120 each of internists, orthopaedists and neurologists) were collected.

Outcome measures

Responses relating to a CIDP hypothetical case and current understanding were assessed to determine awareness, collaboration preferences and diagnosis and treatment decisions.

Results

Understanding of CIDP was 90.8% among neurologists, 10.8% among orthopaedists and 13.3% among internists; >80% of orthopaedists and internists answered that neurologists are preferable for treatment. Diagnostic assessment using a hypothetical case showed 95.0% of neurologists, 74.2% of orthopaedists and 72.5% of internists suspected CIDP. Among orthopaedists and internists suspecting CIDP, >70% considered referring to neurology, while ~10% considered continuing treatment without a referral. Among neurologists, 69.4% chose intravenous immunoglobulin (IVIg) as first-line treatment and determined effectiveness to be ≤3 months.

Conclusions

Orthopaedists and internists had lower CIDP awareness compared with neurologists, which may lead to inadequate referrals to neurology. Evaluation of IVIg effectiveness for maintenance therapy occurred earlier than the guideline recommendations (6–12 months), risking premature discontinuation. Improving CIDP knowledge among orthopaedists and internists is critical for better diagnosis and collaboration with neurologists. Neurologists should consider slow and careful evaluation of IVIg maintenance therapy.

Trial registration number

UMIN000048516.

Examining the impact of COVID-19 on Maori:non-Maori health inequities in Aotearoa, New Zealand: an observational study protocol

Por: Curtis · E. · Jaung · R. · Paine · S.-J. · McLeod · M. · Tamatea · J. · Atkinson · J. · Jiang · Y. · Robson · B. · Reid · P. · Harris · R. B.
Introduction

The COVID-19 pandemic has had both direct and indirect impacts on the health of populations worldwide. While racial/ethnic health inequities in COVID-19 infection are now well known (and ongoing), knowledge about the impact of COVID-19 pandemic management on non-COVID-19-related outcomes for Indigenous peoples is less well understood. This article presents the study protocol for the Health Research Council of New Zealand funded project ‘Mā te Mōhio ka Mārama: Impact of COVID-19 on Māori:non-Māori inequities’. The study aims to explore changes in access to healthcare, quality of healthcare and health outcomes for Māori, the Indigenous peoples of Aotearoa New Zealand (NZ) and non-Māori during the COVID-19 outbreak period across NZ.

Methods and analysis

This observational study is framed within a Kaupapa Māori research positioning that includes Kaupapa Māori epidemiology. National datasets will be used to report on access to healthcare, quality of healthcare and health outcomes between Māori and non-Māori during the COVID-19 pandemic in NZ. Study periods are defined as (a) prepandemic period (2015–2019), (b) first pandemic year without COVID-19 vaccines (2020) and (c) pandemic period with COVID-19 vaccines (2021 onwards). Regional and national differences between Māori and non-Māori will be explored in two phases focused on identified health priority areas for NZ including (1) mortality, cancer, long-term conditions, first 1000 days, mental health and (2) rheumatic fever.

Ethics and dissemination

This study has ethical approval from the Auckland Health Research Ethics Committee (AHREC AH26253). An advisory group will work with the project team to disseminate the findings of this project via project-specific meetings, peer-reviewed publications and a project-specific website. The overall intention of the project is to highlight areas requiring health policy and practice interventions to address Indigenous inequities in health resulting from COVID-19 pandemic management (both historical and in the future).

Impacts of income inequality and the mediation role of reporting delays on COVID-19 deaths during 2020 and 2021 in Hong Kong: an observational study

Por: Yuan · H.-Y. · Wong · W. H. · Khairunnasa · F. · Ho · H. C. · Chung · G. K.-K.
Objective

To estimate the impacts of demographic factors and income disparities on the case fatality rate (CFR) of COVID-19 in Hong Kong, taking into account the influence of reporting delays (ie, the duration between symptom onset and case confirmation).

Design

Retrospective observational longitudinal study.

Participants

A total of 7406 symptomatic patients with residence information reported between 23 January 2020 and 2 October 2021.

Main outcome measures

The study examined the disparity in COVID-19 deaths associated with the factors such as age (≥65 vs 0–64 years old groups), gender and the income level of districts (low income vs non-low income). The severe reporting delay (>10 days) was considered as the mediator for mediation analysis. A Cox proportional hazards regression model was constructed.

Results

We found that CFR was 3.07% in the low-income region, twofold higher than 1.34% in the other regions. Although the severe reporting delay was associated with a hazard ratio (HR) of about 1.9, its mediation effect was only weakly present for age, but not for gender or income level. Hence, high CFR in Hong Kong was largely attributed to the direct effects of the elderly (HR 25.967; 95% CI 14.254 to 47.306) and low income (HR 1.558; 95% CI 1.122 to 2.164).

Conclusion

The disparity in COVID-19 deaths between income regions is not due to reporting delays, but rather to health inequities in Hong Kong. These risks may persist after the discontinuation of test-and-trace measures and extend to other high-threat respiratory pathogens. Urgent actions are required to identify vulnerable groups in low-income regions and understand the underlying causes of health inequities.

Determinants of iron-rich food deficiency among children under 5 years in sub-Saharan Africa: a comprehensive analysis of Demographic and Health Surveys

Por: Osei Bonsu · E. · Addo · I. Y. · Boadi · C. · Boadu · E. F. · Okeke · S. R.
Background

Iron deficiency is a major public health problem that affects the physical and cognitive development of children under 5 years of age (under-5 children) in sub-Saharan Africa (SSA). However, the factors associated with the limited consumption of iron-rich foods in the region are poorly understood.

Objective

This study examined the prevalence and determinants of iron-rich food deficiency among under-5 children in 26 SSA countries.

Design

This nationally representative quantitative study employed pooled data from Demographic and Health Surveys conducted between 2010 and 2019.

Methods

Representative samples comprising 296 850 under-5 children from the various countries were used. Bivariate and multivariate logistic regression models were used to determine the associations between the lack of iron-rich food uptake and various sociodemographic factors.

Result

The overall prevalence of iron-rich food deficiency among the children in the entire sample was 56.75%. The prevalence of iron-rich food deficiency varied widely across the 26 countries, ranging from 42.76% in Congo Democratic Republic to 77.50% in Guinea. Maternal education, particularly primary education (OR 0.62, 95% CI 0.57 to 0.68) and higher education (OR 0.58, 95% CI 0.52 to 0.64), demonstrated a reduced likelihood of iron-rich food deficiency in the sample. Likewise, paternal education, with both primary education (OR 0.69, 95% CI 0.63 to 0.75) and higher education (OR 0.66, 95% CI 0.60 to 0.73) showed decreased odds of iron-rich food deficiency. Postnatal visits contributed significantly to reducing the odds of iron-rich food deficiency (OR 0.90, 95% CI 0.83 to 0.95), along with antenatal visits, which also had a positive impact (OR 0.84, 95% CI 0.74 to 0.95). Finally, residents in rural areas showed slightly higher odds of iron-rich food deficiency (OR 1.12, 95% CI 1.10 to 1.28).

Conclusion

Based on the findings, interventions targeting iron-food deficiency in the SSA region should take into strong consideration the key determinants highlighted in this study.

Effectiveness of shared medical appointments delivered in primary care for improving health outcomes in patients with long-term conditions: a systematic review of randomised controlled trials

Por: Tang · M. Y. · Graham · F. · O'Donnell · A. · Beyer · F. · Richmond · C. · Dhami · R. · Sniehotta · F. F. · Kaner · E. F. S.
Objectives

To examine the effectiveness of shared medical appointments (SMAs) compared with one-to-one appointments in primary care for improving health outcomes and reducing demand on healthcare services by people with one or more long-term conditions (LTCs).

Design

A systematic review of the published literature.

Data sources

Six databases, including MEDLINE and Web of Science, were searched 2013–2023. Relevant pre-2013 trials identified by forward and backward citation searches of the included trials were included.

Eligibility criteria

Randomised controlled trials of SMAs delivered in a primary care setting involving adults over 18 years with one or more LTCs. Studies were excluded if the SMA did not include one-to-one patient-clinician time. All countries were eligible for inclusion.

Data extraction and synthesis

Data were extracted and outcomes narratively synthesised, meta-analysis was undertaken where possible.

Results

Twenty-nine unique trials were included. SMA models varied in terms of components, mode of delivery and target population. Most trials recruited patients with a single LTC, most commonly diabetes (n=16). There was substantial heterogeneity in outcome measures. Meta-analysis showed that participants in SMA groups had lower diastolic blood pressure than those in usual care (d=–0.086, 95% CI=–0.16 to –0.02, n=10) (p=0.014). No statistically significant differences were found across other outcomes. Compared with usual care, SMAs had no significant effect on healthcare service use. For example, no difference between SMAs and usual care was found for admissions to emergency departments at follow-up (d=–0.094, 95% CI=–0.27 to 0.08, n=6, p=0.289).

Conclusions

There was a little difference in the effectiveness of SMAs compared with usual care in terms of health outcomes or healthcare service use in the short-term (range 12 weeks to 24 months). To strengthen the evidence base, future studies should include a wider array of LTCs, standardised outcome measures and more details on SMA components to help inform economic evaluation.

PROSPERO registration number

CRD42020173084.

Home-based mobile-guided exercise-based cardiac rehabilitation among patients undergoing transcatheter aortic valve replacement (REHAB-TAVR): protocol for a randomised clinical trial

Por: Shen · Z. · Mi · S. · Huang · C. · Zhou · D. · Pan · W. · Xu · X. · Lin · Y. · Zhang · Y.
Introduction

Transcatheter aortic valve replacement (TAVR) is a standard treatment for aortic stenosis, particularly in older adults. Reduced exercise capacity and frailty significantly impact outcomes in TAVR patients, yet current management lacks strategies to address these issues. This study aims to assess the effectiveness of home-based mobile-guided exercise-based cardiac rehabilitation in TAVR patients, led by a multidisciplinary team with clear progression milestones.

Methods and analysis

The study involves 90 patients aged 60–89 in a single centre who will be randomised to a 3-month novel multidomain exercise intervention or routine care. Outcome assessors will be blinded towards group allocation. The primary outcome is the 6-min walk distance at month 3. The secondary outcomes include the 6-min walk distance at month 6, physical function measured by total Short Physical Performance Battery score and exercise adherence measured by the Exercise Adherence Rating Scale at months 3 and 6. Additional outcome measures, including rehospitalisations, death, handgrip strength, frailty (Fried Criteria and Essential Toolset), cognitive function (Mini-Mental State Examination), quality of life (EuroQol 5-Dimension 5-Level), nutritional status (Mini-Nutritional Assessment), anxiety (General Anxiety Disorder-7), depression (Geriatric Depression Scale), sleep (Pittsburgh Sleep Quality Index), functional capacity (Duke Activity Status Index), clinical indices (body mass index, symptoms, signs, left ventricular ejection fraction (LVEF), N-Terminal Pro-Brain Natriuretic Peptide, etc) and social support (Lubben Social Network Scale-6), along with comprehensive cost analysis, enhance the study’s significance. The study’s findings hold crucial implications for crafting an effective exercise-focused cardiac rehabilitation strategy for TAVR patients. Community implementation not only deepens understanding but also fosters the potential integration of exercise-based cardiac rehabilitation into self-care, promising enhanced patient adherence and overall cardiovascular health management.

Ethics and dissemination

Ethical approval was obtained from the Zhongshan Hospital, Fudan University Ethics Committee (B2022-062R). Results will be disseminated to local stakeholders and the research community through publications and conferences.

Trial registration number

NCT05989594

Prevalence of metabolic syndrome in patients with inflammatory bowel disease: a systematic review and meta-analysis

Por: Shen · Z. · Zhang · M. · Liu · Y. · Ge · C. · Lu · Y. · Shen · H. · Zhu · L.
Objectives

Patients with inflammatory bowel disease (IBD) may experience comorbidities involving metabolic syndrome (MetS). However, this association remains controversial. Our objective was to estimate the prevalence of MetS in patients with IBD and assess whether MetS is more strongly associated with ulcerative colitis (UC) or Crohn’s disease (CD).

Design

Systematic review and meta-analysis.

Data sources

PubMed, Cochrane Library, Web of Science, EMBASE and MEDLINE were searched from their inception to July 2022.

Eligibility criteria

Observational studies reporting data regarding the rate of comorbid MetS among patients with IBD and published in English.

Data extraction and synthesis

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses and the Meta-analysis of Observational Studies in Epidemiology reporting guidelines were followed. Pooled prevalence, ORs and 95% CIs were calculated using random-effects models. The Newcastle-Ottawa Scale and the Agency for Healthcare Research and Quality checklist were used. Heterogeneity, sensitivity and stratified analyses were performed using R (V.4.2.1).

Results

11 eligible studies involving 2501 patients were included. Of these studies, four reported MetS prevalence separately by IBD phenotype, and only one contained a non-IBD comparison group. Overall, the methodological quality of the included studies was moderate. The pooled prevalence of MetS in IBD was 19.4% (95% CI 15.1% to 23.8%), with a moderate heterogeneity (I2=51.8%, Cochrane Q statistic=12.4, p=0.053). Stratified analyses demonstrated that the aggregate estimate of comorbid MetS was significantly higher in UC than in CD (38.2% vs 13.6%, 2=4.88, p=0.03). We found a positive association between MetS and UC compared with CD (OR=2.11, 95% CI 1.19 to 3.74, p=0.01). Additionally, four studies identified that higher age was a risk factor associated with the development of MetS.

Conclusions

MetS is not rare in IBD, especially in UC. However, longitudinal studies are needed to further clarify the relationship between IBD and MetS.

PROSPERO registration number

CRD42022346340.

Effectiveness of Yijinjing exercise in the treatment of early-stage knee osteoarthritis: a randomized controlled trial protocol

Por: Guo · G. · Wang · Y. · Xu · X. · Lu · K. · Zhu · X. · Gu · Y. · Yang · G. · Yao · F. · Fang · M.
Introduction

Knee osteoarthritis (KOA) is still a challenging degenerative joint disease with high morbidity and disease burden. Early-stage KOA, the focus of this study, could present a Window of Opportunity to arrest the disease process and reduce the disease burden. Yijinjing exercise is an important part of physical and psychological therapies in Traditional Chinese Exercise and may be an effective treatment. However, there is no clinical efficacy assessment of Yijinjing exercise for patients with early-stage KOA. Therefore, we designed a randomised controlled trial to evaluate the effectiveness of Yijinjing exercise on patients with early-stage KOA.

Methods and analysis

This is a parallel-design, two-arm, analyst assessor-blinded, randomised controlled trial. In total, 60 patients with early-stage KOA will be recruited and randomly assigned to the Yijinjing exercise group (n=30) and health education group (n=30) at a ratio of 1:1, receiving 12 weeks of Yijinjing exercise or health education accordingly. The primary outcome will be measured with the Western Ontario and McMaster Universities Osteoarthritis Index, and the secondary outcomes will include the Visual Analogue Scale, Short-Form 36 Item Health Survey Questionnaire, Beck Depression Inventory, Perceived Stress Scale, Berg Balance Scale, and Gait Analysis for a comprehensive assessment. Outcome measures are collected at baseline, at 12 week ending intervention and at the 12 week, 24 week and 48 week ending follow-up. The primay time point will be 12 weeks postintervention. Adverse events will be recorded for safety assessment.

Ethics and dissemination

This study has been approved by the ethical application of the Shanghai Municipal Hospital of Traditional Chinese Medicine Ethics Committee (2021SHL-KY-78).

Trial registration number

ChiCTR2200065178

Coutilisation of oral rehydration solution and zinc for treating diarrhoea and its associated factors among under-five children in East Africa: a multilevel robust Poisson regression

Por: Legesse · B. T. · Wondie · W. T. · Gedefaw · G. D. · Workineh · Y. T. · Seifu · B. L.
Objective

This study aimed to assess the coutilisation of oral rehydration solution (ORS) and zinc for treating diarrhoea and its associated factors among under-5 children in East Africa.

Design

Cross-sectional study design. Multilevel Poisson regression analysis with robust variance was fitted to identify predictors of zinc and ORS coutilisation. An adjusted prevalence ratio (aPR) with a 95% CI was reported to declare the statistical significance.

Setting

Twelve East African countries.

Participants

16 850 under-5 children who had diarrhoea were included in the study.

Result

In East African nations, the coutilisation of ORS and zinc for the treatment of diarrhoea in children under 5 was 53.27% with a 95% CI (52.54% to 54.01%). Children of mothers with primary education (aPR 1.15, 95% CI 1.09 to 1.20), secondary education (aPR 1.08, 95% CI 1.02 to 1.14), higer education (aPR 1.19, 95% CI 1.10 to 1.29), those from maternal age category of 20–24 (aPR 1.14, 95% CI 1.07 to 1.21), age category of 25–29 (aPR 1.13, 95% CI 1.06 to 1.21), age category of 30–34 (aPR 1.09, 95% CI 1.02 to 1.16), those from wealthy households (aPR 1.04, 95% CI 1.01 to 1.09) and those who have a media exposure (aPR 1.04, 95% CI 1.01 to 1.08) were more likely to receive combination.

Conclusion

Only half of the under-5 children with diarrhoea in East Africa were treated with a combination of ORS and zinc. To increase the use of the suggested combination therapy of ORS with zinc, it is important to empower women through education and prevent teen pregnancy.

Impacts of armed conflicts on tuberculosis burden and treatment outcomes: a systematic review

Por: Gebreyohannes · E. A. · Wolde · H. F. · Akalu · T. Y. · Clements · A. C. A. · Alene · K. A.
Objectives

This systematic review aimed to summarise existing literature on the impacts of armed conflicts on tuberculosis burden and treatment outcomes.

Design

A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature Plus, Scopus, ScienceDirect, Embase and medRxiv.

Data extraction and synthesis

Three reviewers independently screened, selected eligible studies and extracted data. A narrative review was undertaken to summarise the findings qualitatively.

Results

Eleven studies were included in this review, reporting on tuberculosis incidence rates, prevalence and treatment outcomes, including mortality. Overall, the impact of armed conflicts on case notifications was variable. Six studies reported overall increases in tuberculosis case notifications following the onset of conflicts, while three studies reported overall decreases in tuberculosis case notifications. Factors, including limited access to healthcare services, challenges in surveillance and laboratory confirmation, the destruction of health systems and incapacitating the healthcare workforce, contributed to a decrease in the number of notified cases. The higher tuberculosis notification in some of the studies could be attributed to the disruption of tuberculosis prevention and control programmes as well as increased socioeconomic deprivation, including malnutrition, mass migration, poor living conditions and overcrowding that are worsened during conflicts. Armed conflicts without effective interventions were associated with worse tuberculosis treatment outcomes, including lower proportions of people with treatment success and higher proportions of people with loss to follow-up, mortality and treatment failure. However, implementing various interventions in conflict settings (such as establishing a National Tuberculosis Control Programme) led to higher tuberculosis notification rates and treatment success.

Conclusion

The impact of armed conflicts on tuberculosis notification is complex and is influenced by multiple factors. The findings of this review underscore the importance of concerted efforts to control tuberculosis in conflict settings using available resources.

Results from a cross-specialty consensus on optimal management of patients with chronic kidney disease (CKD): from screening to complications

Por: Arici · M. · Assaad-Khalil · S. H. · Bertoluci · M. C. · Choo · J. · Lee · Y.-J. · Madero · M. · Rosa Diez · G. J. · Sanchez Polo · V. · Chung · S. · Thanachayanont · T. · Pollock · C.
Background

Chronic kidney disease (CKD) affects around 10% of the global population and has been estimated to affect around 50% of individuals with type 2 diabetes and 50% of those with heart failure. The guideline-recommended approach is to manage with disease-modifying therapies, but real-world data suggest that prescribing rates do not reflect this in practice.

Objective

To develop a cross-specialty consensus on optimal management of the patient with CKD using a modified Delphi method.

Design

An international steering group of experts specialising in internal medicine, endocrinology/diabetology, nephrology and primary care medicine developed 42 statements on aspects of CKD management including identification and screening, risk factors, holistic management, guidelines, cross-specialty alignment and education. Consensus was determined by agreement using an online survey.

Participants

The survey was distributed to cardiologists, nephrologists, endocrinologists and primary care physicians across 11 countries.

Main outcomes and measures

The threshold for consensus agreement was established a priori by the steering group at 75%. Stopping criteria were defined as a target of 25 responses from each country (N=275), and a 4-week survey period.

Results

274 responses were received in December 2022, 25 responses from Argentina, Australia, Brazil, Guatemala, Mexico, Singapore, South Korea, Taiwan, Thailand, Turkey and 24 responses from Egypt. 53 responses were received from cardiologists, 52 from nephrologists, 55 from endocrinologists and 114 from primary care physicians. 37 statements attained very high agreement (≥90%) and 5 attained high agreement (≥75% and

Conclusions

There is a high degree of consensus regarding aspects of CKD management among healthcare professionals from 11 countries. Based on these strong levels of agreement, the steering group derived 12 key recommendations focused on diagnosis and management of CKD.

Sarcopenia in systemic sclerosis: prevalence and impact--a systematic review and meta-analysis

Por: Tu · X. · Lin · T. · Ju · Y. · Shu · X. · Jiang · T. · Ge · N. · Yue · J.
Objective

This review aims to provide an estimate of sarcopenia prevalence and its impact on clinical characteristics in patients with systemic sclerosis (SSc).

Design

Systematic review and meta-analysis.

Data sources

Embase, Medline, Web of Science and the Cochrane Central Register of Controlled Trials were systemically searched from inception to 24 May 2023.

Eligibility criteria for selecting studies

We included observational studies that reported the prevalence of sarcopenia in patients with SSc.

Data extraction and synthesis

Two reviewers independently performed study selection and data extraction using standardised methods. Risk of bias was assessed using the Agency for Healthcare Research and Quality Scale and the Newcastle–Ottawa Scale. Meta-analysis was conducted using random effects models.

Results

A total of 4583 articles were screened and 9 studies with data from 815 patients were included in the analysis (8 cross-sectional studies and 1 retrospective cohort study). The overall prevalence of sarcopenia in patients with SSc was 22% (95% CI 17% to 28%). Patients with SSc with sarcopenia had a poorer quality of life (mean difference –12.02; 95% CI –19.11 to –4.93) and higher C reactive protein (CRP) levels (standardised mean difference 0.67; 95% CI 0.35 to 1.00).

Conclusions

Sarcopenia is common in patients with SSc. Patients with SSc with sarcopenia had a worse quality of life and higher CRP levels, based on our findings. Given the detrimental impact of sarcopenia on quality of life, future efforts aimed at early identification of sarcopenia in the clinical assessment of patients with SSc may have significance.

PROSPERO registration number

CRD42022368326.

Scoping review protocol of post-traumatic growth (PTG) in Korean cancer survivors

Por: Park · Y.-J. · Lee · K. S.
Introduction

Cancer, a life-threatening chronic disease, is the leading cause of death in Korea, accounting for 27% of all deaths in 2020. Due to advancements in medical technology and early detection of cancer in Korea, the 5-year relative survival rate reached 70.7% (2015–2019), highlighting remarkable progress over the past decades. Although cancer has been seen as a traumatic event, cancer survivors also go through a subjective process of self-maturation, which is called post-traumatic growth (PTG). Because research on PTG among Korean cancer survivors has not been systematically synthesised, a scoping review on this topic will provide a better understanding of the positive psychological changes that occur as a patient moves through the illness trajectory of cancer from a Korean cultural perspective. The purpose of this study was to describe the protocol of a scoping review regarding PTG in Korean cancer survivors.

Methods and analysis

The scoping review framework suggested by Arksey and O’Malley and the manual refined by the Joanna Briggs Institute for scoping reviews will be used with the six framework guidelines developed by Levac et al. Searched databases will include Ovid-MEDLINE, PubMed, Embase, CINAHL, Cochrane Library and PsycInfo, as well as Korean databases, examining all articles published between 2012 and 2023 in Korean or English on PTG in Korean cancer survivors. Extracted data will be collated, charted and summarised.

Ethics and dissemination

Because the scoping review methodology undertakes a secondary analysis of collected data from previous research studies, this study does not require ethical approval. The results of this scoping review will be disseminated through presentations at conferences and publication in a scientific journal.

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