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AnteayerBMJ Open

Risk factors for cognitive impairment in middle-aged type 2 diabetic patients: a cross-sectional study

Por: Li · Y.-S. · Li · J.-B. · Wang · J.-J. · Wang · X.-H. · Jiang · W.-R. · Qiu · H.-N. · Xia · L.-F. · Wu · F. · Lin · C.-Y. · Liu · Y.-L. · Lin · J.-N.
Objective

The aim of this study was to investigate risk factors for cognitive impairment (CI) and explore the relationship between obesity and cognition in hospitalised middle-aged patients with type 2 diabetes (T2DM).

Methods

Subjects were divided into normal cognitive function (NCF) (n=320) and CI (n=204) groups based on the results of the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE). The risk factors for CI were determined by logistic regression analysis and generalised linear modelling. The associations between obesity parameters (body mass index (BMI) and waist circumference (WC)) and cognitive ability were studied with the use of linear regression analysis, piecewise regression modelling and interaction analysis. The receiver operating characteristic curve analysis was used to examine the diagnostic value of influencing factors for cc

Results

The prevalence of CI was 38.9% in hospitalised middle-aged T2DM patients (median age, 58 years). Age, WC, hypoglycaemic episode within past 3 months and cerebrovascular disease (CVD) were identified as independent risk factors for CI, while the independent protective factors were education, diabetic dietary pattern, overweight and obesity. BMI was a protective factor for the MoCA score within a certain range, whereas WC was a risk factor for the MMSE and MoCA scores. The area under the curve for the combination of BMI and WC was 0.754 (p

Conclusion

Age, education, diabetic dietary pattern, WC, overweight, obesity, hypoglycaemic episode in 3 months and CVD may be potential influencing factors for the occurrence of CI in hospitalised middle-aged population with T2DM. The combination of BMI and WC may represent a good predictor for early screening of CI in this population. Nevertheless, more relevant prospective studies are still needed.

Comparative efficacy of acupuncture-related therapy for postmenopausal osteoporosis: protocol for Bayesian network meta-analysis

Por: Xu · T. · Deng · B. · Lin · S. · Wang · H. · Xu · Y. · Chen · G.
Introduction

The review aims to conduct the first network meta-analysis to comprehensively evaluate the application of multiple acupuncture techniques in patients with postmenopausal osteoporosis, ranking the best acupuncture treatment and providing a reference for clinical treatment extensively.

Methods and analysis

Randomised controlled trials of different acupuncture-related therapies for postmenopausal osteoporosis will be searched in the following databases from 1 January 2002 to 31 December 2022, including PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, VIP Database, Wanfang Database and China Biomedical Literature Database. Overall, clinical efficacy rate, bone mineral density and a Visual Analogue Scale score are used as the primary outcome indicators. In addition, the secondary outcome indicator is adverse reactions. The entire screening process will be conducted by two independent investigators; meanwhile, Stata (V.14.0) and RevMan (V.5.4) will be used to conduct the network meta-analysis. If the data are permissible and feasible, we will also perform meta-regression and subgroup analyses to address the underlying causes of data inconsistency and heterogeneity in the statistical analyses. Besides, to improve the credibility of this network meta-analysis, we will evaluate the quality of evidence in this research according to the GRADE assessment.

Ethics and dissemination

Ethics approval is not required for network meta-analyses, which do not involve animals’ or people’s welfare. The results of this network meta-analysis will be submitted to a recognised journal for publication.

PROSPERO registration number

CRD42023401003.

Human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis (MSC-DLC-1): a dose-escalation, phase I trial protocol

Por: Wang · Z. · Li · T. · Zhang · Z. · Yuan · M. · Shi · M. · Wang · F.-S. · Linghu · E.-Q. · Shi · L.
Introduction

There are limited therapeutic options to efficiently treat patients with decompensated liver cirrhosis. This trial aims to explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) for the treatment of patients with decompensated liver cirrhosis.

Methods and analysis

This study is an open-label, dose-escalation, one-armed phase I trial. A single injection of UC-MSCs will be administered in a predetermined dose in each cohort (5.0x107, 1.0x108, 1.5x108 or 2.0x108 cells) according to the ‘3+3’ rule. The primary evaluation measures will include the incidence of adverse events and the change in the Model for End-stage Liver Disease (MELD) score from baseline to the 28th day. Secondary evaluation measures will be evaluated at baseline and at each follow-up point. These measures will include the change in the MELD score from baseline to each follow-up point, the incidence of each complication associated with decompensated cirrhosis, liver transplant-free survival and the incidence of liver failure, among other relevant measures. All patients will be followed up for 24 months. This study will evaluate whether the use of UC-MSCs to treat patients with decompensated liver cirrhosis is safe and tolerable.

Ethics and dissemination

The study has been approved by the Chinese People’s Liberation Army General Hospital (Approval#: 2018-107-D-4). Once conducted, the results from the study will be published in a peer-reviewed journal.

Trial registration number

NCT05227846.

Medical students impacted by discrimination: a qualitative study into their experiences of belonging and support systems at medical schools in the UK

Por: Ikhlaq · H. · Agarwal · S. · Kwok · C. · Golamgouse · H. · Derby · S. · McRae · N. · Brown · M. E. L. · Collin · V. · Parekh · R. · Kumar · S.
Objective

To better understand the broader experience of medical students impacted by discrimination and the support systems they engage with.

Design

Qualitative study using semi-structured interviews.

Setting

Four medical schools based in the UK.

Participants

17 medical students were recruited using volunteer and snowball sampling: all students self-identified as being impacted by discrimination.

Results

5 themes were identified: feelings of isolation, imposter syndrome and exclusion; a lack of representation and positive role modelling; the importance of peer support; issues relating to the accessibility of support; building support networks through shared experiences and attempts to foster a sense of inclusion through peer and institutionally led initiatives.

Conclusions

The findings of this study suggest medical schools could do more to recognise the importance of acknowledging the multiple identities at risk of discrimination held by students, perpetuating feelings of isolation and exclusion. Our research highlights the need for practical systemic initiatives to improve the sense of belonging of medical students who are impacted by discrimination. Medical educators and institutions should consider formal and informal provisions, such as creating time and space for students to meet and share experiences, access support and reporting networks, to foster a greater sense of belonging.

Analysis of cardiovascular risk factors for the viability of cornea donors: a case-control study

Objective

The main objective of the study was to evaluate the influence of arterial hypertension, diabetes, dyslipidaemia, smoking, alcoholism and COPD (chronic obstructive pulmonary disease) on the viability of the extracted tissue as well as the donor.

Design

Observational case–control study.

Setting

Regional hospital in Northern Spain.

Participants

1517 corneas were registered.

Interventions

Patients’ medical history was reviewed after corneal donation and evaluation. Previous medical information (age, sex and cardiovascular risk factors (CVRFs)) and data related to the donor (type of donor), the corneal tissue and its evaluation, and the viability of the implant were collected.

Results

A total of 1517 corneas were registered and 81.5% of the donors presented at least one CVRF. In relation to the viability of the donor, it was observed that having suffered from COPD reduced the viability of the donor (no COPD: 93.8% vs COPD: 88%; OR=0.49; 95% CI: 0.28 to 0.84) while alcohol consumption increased it (drinker or ex-drinker: 95.8% vs non-drinker: 92.5%; OR=1.84; 95% CI: 1.01 to 3.33). Regarding tissue viability, decreased viability was observed in the presence of COPD (no COPD: 72.5% vs COPD: 64; OR=0.67; 95% CI: 0.47 to 0.96) and diabetes mellitus (no diabetes: 72.9% vs diabetes: 67.2%; OR=0.76; 95% CI: 0.58 to 0.99). As regards the viability of the implant, a total of 1039 corneas (68.9%) were suitable, observing decreased viability when suffering from COPD (no COPD: 69.8% vs COPD: 60.7%; OR=0.67; 95% CI: 0.47 to 0.94) and increased when having an active smoking habit (no habit: 65.3% vs habit: 74.1%; OR=1.52; 95% CI: 1.21 to 1.91).

Conclusions

Through this study, it can be concluded that in the absence of absolute exclusion criteria for donors, the assessment of how CVRF, alcoholism and COPD may affect the donor provides details about the quality of the tissue to be obtained.

Non-ischaemic preservation of the donor heart in heart transplantation: protocol design and rationale for a randomised, controlled, multicentre clinical trial across eight European countries

Por: Brouckaert · J. · Dellgren · G. · Wallinder · A. · Rega · F.
Introduction

Ischaemic cold static storage (ICSS) is the gold standard in donor heart preservation. This ischaemic time frame renders a time constraint and risk for primary graft dysfunction. Cold oxygenated heart perfusion, known as non-ischaemic heart preservation (NIHP), theoretically limits the ischaemic time, while holding on to the known advantage of hypothermia and cardioplegia, a low metabolic rate.

Methods and analysis

The NIHP 2019 study is an international, randomised, controlled, open, multicentre clinical trial in 15 heart transplantation centres in 8 European countries and includes 202 patients undergoing heart transplantation, allocated 1:1 to NIHP or ICSS. Enrolment is estimated to be 30 months after study initiation. The patients are followed for 12 months after transplantation.

The primary objective is to evaluate the effect of NIHP on survival, allograft function and rejection episodes within the first 30 days after transplantation. The secondary objectives are to compare treatment groups with respect to survival, allograft function, cardiac biomarkers, rejection episodes, allograft vasculopathy, adverse events and adverse device effects within 12 months.

Ethics and dissemination

This protocol was approved by the Ethics Committee (EC) for Research UZ/KU Leuven, Belgium, the coordinating EC in Germany (Bei Der LMU München), the coordinating EC in the UK (West Midlands—South Birmingham Research), the EC of Hospital Puerta de Hierro, Madrid, Spain, the EC of Göteborg, Sweden, the coordinating EC in France, the EC of Padova, Italy and the EC of the University of Vienna, Austria. This study will be conducted in accordance with current local regulations and international applicable regulatory requirements according to the principles of the Declaration of Helsinki and ISO14155:2020. Main primary and secondary outcomes will be published on modified intention-to-treat population and per-protocol population.

Trial registration number

NCT03991923.

Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol

Por: Hanssen · H. M. · Fjellstad · M. S. · Skjevling · L. · Johnsen · P. H. · Kulseng · B. · Goll · R. · Alma · K. H. · Valle · P.-C.
Introduction

Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as lifestyle changes, bariatric surgery or medications. Conservative treatment has a low success rate, and bariatric surgery is typically not reversible, with the risk of complications and recurrences. Treatment of obesity with medications has in recent years shown great promise, but the side effects are many, and the long-term effect is unknown. There is also a need for an option for patients where surgery has contraindications and conservative follow-up does not succeed.

The research on obesity and gut microbiota has yielded promising results regarding weight reduction and metabolic health, but more research is needed to better understand the relationship between gut microbiota and severe obesity. This study could show proof of concept that gut microbiota from a lean donor could, in addition to lifestyle intervention, contribute to weight reduction in people suffering from severe obesity.

Method and analysis

This study aims to investigate if a fecal microbiota transplantation (FMT) from a lean donor leads to weight reduction in participants suffering from severe obesity. The study is a single-centre, double-blinded, placebo-controlled, parallel-group study with 60 participants. Participants will be randomised 1:1 for FMT from a lean donor or placebo. FMT or placebo will be delivered once by enema.

We will include participants from the outpatient clinic for severe obesity, at the Medical Department, University Hospital of North Norway, Harstad, by invitation only. The study has a follow-up period of 12 months, with study visits of 3, 6 and 12 months post FMT. The primary endpoint is a weight reduction of ≥10%, 12 months after intervention.

The results of the study will be published in open access journals. At the end of the study, the participants will receive information on which treatment group they belong to.

Ethics and dissemination

The Regional Ethical Committee in North Norway (REK) approved the study protocol (2017/1655/REK Nord). We plan to present the results from the study at (inter)national conferences and publish in open-access general peer-reviewed journals. The enema method for FMT administration used in this study was developed by our study team.

Trial registration number

NCT03273855.

External validation of the QCovid 2 and 3 risk prediction algorithms for risk of COVID-19 hospitalisation and mortality in adults: a national cohort study in Scotland

Por: Kerr · S. · Millington · T. · Rudan · I. · McCowan · C. · Tibble · H. · Jeffrey · K. · Fagbamigbe · A. F. · Simpson · C. R. · Robertson · C. · Hippisley-Cox · J. · Sheikh · A.
Objective

The QCovid 2 and 3 algorithms are risk prediction tools developed during the second wave of the COVID-19 pandemic that can be used to predict the risk of COVID-19 hospitalisation and mortality, taking vaccination status into account. In this study, we assess their performance in Scotland.

Methods

We used the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 national data platform consisting of individual-level data for the population of Scotland (5.4 million residents). Primary care data were linked to reverse-transcription PCR virology testing, hospitalisation and mortality data. We assessed the discrimination and calibration of the QCovid 2 and 3 algorithms in predicting COVID-19 hospitalisations and deaths between 8 December 2020 and 15 June 2021.

Results

Our validation dataset comprised 465 058 individuals, aged 19–100. We found the following performance metrics (95% CIs) for QCovid 2 and 3: Harrell’s C 0.84 (0.82 to 0.86) for hospitalisation, and 0.92 (0.90 to 0.94) for death, observed-expected ratio of 0.24 for hospitalisation and 0.26 for death (ie, both the number of hospitalisations and the number of deaths were overestimated), and a Brier score of 0.0009 (0.00084 to 0.00096) for hospitalisation and 0.00036 (0.00032 to 0.0004) for death.

Conclusions

We found good discrimination of the QCovid 2 and 3 algorithms in Scotland, although performance was worse in higher age groups. Both the number of hospitalisations and the number of deaths were overestimated.

Exploration of pain assessment and management processes in oncology outpatient services with healthcare professionals: a qualitative study

Por: Robinson · O. C. · Pini · S. · Flemming · K. · Campling · N. · Fallon · M. · Richards · S. H. · Mayland · C. R. · Boland · E. · Swinson · D. · Hurlow · A. · Hartup · S. · Mulvey · M. R.
Objectives

This study explored cancer pain management practices and clinical care pathways used by healthcare professionals (HCPs) to understand the barriers and facilitators for standardised pain management in oncology outpatient services (OS).

Design

Data were collected using semistructured interviews that were audio-recorded and transcribed. The data were analysed using thematic analysis.

Setting

Three NHS trusts with oncology OS in Northern England.

Participants

Twenty HCPs with varied roles (eg, oncologist and nurse) and experiences (eg, registrar and consultant) from different cancer site clinics (eg, breast and lung). Data were analysed using thematic analysis.

Results

HCPs discussed cancer pain management practices during consultation and supporting continuity of care beyond consultation. Key findings included : (1) HCPs’ level of clinical experience influenced pain assessments; (2) remote consulting impeded experienced HCPs to do detailed pain assessments; (3) diffusion of HCP responsibility to manage cancer pain; (4) nurses facilitated pain management support with patients and (5) continuity of care for pain management was constrained by the integration of multidisciplinary teams.

Conclusions

These data demonstrate HCP cancer pain management practices varied and were unstructured. Recommendations are made for a standardised cancer pain management intervention: (1) detailed evaluation of pain with a tailored self-management strategy; (2) implementation of a structured pain assessment that supports remote consultations, (3) pain assessment tool that can support both experienced and less experienced clinicians. These findings will inform the development of a cancer pain management tool to integrate within routine oncology OS.

Randomised controlled trial combining vitamin E-functionalised chocolate with physical exercise to reduce the risk of protein-energy malnutrition in predementia aged people: study protocol for Choko-Age

Por: Pedrinolla · A. · Isanejad · M. · Antognelli · C. · Bartolini · D. · Borras · C. · Cavedon · V. · Di Sante · G. · Migni · A. · Mas-Bargues · C. · Milanese · C. · Baschirotto · C. · Modena · R. · Pistilli · A. · Rende · M. · Schena · F. · Stabile · A. M. · Telesa · N. V. · Tortorella · S.
Objective

Protein–energy malnutrition and the subsequent muscle wasting (sarcopenia) are common ageing complications. It is knowing to be also associated with dementia. Our programme will test the cytoprotective functions of vitamin E combined with the cortisol-lowering effect of chocolate polyphenols (PP), in combination with muscle anabolic effect of adequate dietary protein intake and physical exercise to prevent the age-dependent decline of muscle mass and its key underpinning mechanisms including mitochondrial function, and nutrient metabolism in muscle in the elderly.

Methods and analysis

In 2020, a 6-month double-blind randomised controlled trial in 75 predementia older people was launched to prevent muscle mass loss, in respond to the ‘Joint Programming Initiative A healthy diet for a healthy life’. In the run-in phase, participants will be stabilised on a protein-rich diet (0.9–1.0 g protein/kg ideal body weight/day) and physical exercise programme (high-intensity interval training specifically developed for these subjects). Subsequently, they will be randomised into three groups (1:1:1). The study arms will have a similar isocaloric diet and follow a similar physical exercise programme. Control group (n=25) will maintain the baseline diet; intervention groups will consume either 30 g/day of dark chocolate containing 500 mg total PP (corresponding to 60 mg epicatechin) and 100 mg vitamin E (as RRR-alpha-tocopherol) (n=25); or the high polyphenol chocolate without additional vitamin E (n=25). Muscle mass will be the primary endpoint. Other outcomes are neurocognitive status and previously identified biomolecular indices of frailty in predementia patients. Muscle biopsies will be collected to assess myocyte contraction and mitochondrial metabolism. Blood and plasma samples will be analysed for laboratory endpoints including nutrition metabolism and omics.

Ethics and dissemination

All the ethical and regulatory approvals have been obtained by the ethical committees of the Azienda Ospedaliera Universitaria Integrata of Verona with respect to scientific content and compliance with applicable research and human subjects’ regulation. Given the broader interest of the society toward undernutrition in the elderly, we identify four main target audiences for our research activity: national and local health systems, both internal and external to the project; targeted population (the elderly); general public; and academia. These activities include scientific workshops, public health awareness campaigns, project dedicated website and publication is scientific peer-review journals.

Trial registration number

NCT05343611.

Brief digital self-care intervention for health anxiety in a Swedish Medical University Clinic: a prospective single-group feasibility study

Por: Österman · S. · Hentati · A. · Forsell · E. · Axelsson · E. · Hedman-Lagerlöf · E. · Lindefors · N. · Ivanov · V. Z. · Kraepelien · M.
Objectives

In routine psychiatric care in Stockholm, Sweden, a comprehensive therapist-guided intervention for clinically significant health anxiety is implemented. However, there is a need for more easily accessible self-care interventions to improve treatment dissemination. This study aimed to transform an existing therapist-guided digital intervention into a self-care intervention, reducing patient burden and used clinical resources while maintaining quality and safety.

Design

An uncontrolled feasibility study.

Setting

Conducted at Karolinska Institutet, a medical university in Sweden, with nationwide recruitment trough online advertisements.

Participants

Twenty-five adults used the self-care intervention and underwent telephone assessments, along with completing self-rated questionnaires.

Intervention

The newly developed 8-week self-care intervention was designed to be user-friendly without therapist guidance, and to facilitate high levels of behavioural engagement.

Primary and secondary outcome measures

Indicators of quality and safety, including changes in health anxiety severity (primary), clinician time, participant adherence, perceived credibility/satisfaction with the intervention and adverse events, were benchmarked against a previous study of the more comprehensive intervention it was based on.

Results

Compared with the original guided intervention, the self-care intervention was condensed in terms of text (up to 70% less reading), duration (8 weeks instead of 12) and number of exercises. Quality indicators were similar to the original version. Most participants worked actively with core components in the self-care intervention. Within-group effects on health anxiety from pretreatment to the 3-month follow-up were large (g=1.37; 95% CI 0.74 to 2.00). No serious adverse events were reported.

Conclusions

This brief digital self-care intervention shows potential for increasing access to treatment for individuals with health anxiety while reducing the burden on patients and clinical resources. Future studies should investigate the optimal type of intervention and support for different individuals, and if non-inferiority can be established.

Trial registration number

NCT05446766.

Implementation of a Scalable Online Weight Management Programme in Clinical Settings: Protocol for the PROPS 2.0 Programme (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0)

Por: Cho · J. · Noonan · S. H. · Fay · R. · Apovian · C. M. · McCarthy · A. C. · Blood · A. J. · Samal · L. · Fisher · N. · Orav · J. E. · Plutzky · J. · Block · J. P. · Bates · D. W. · Rozenblum · R. · Tucci · M. · McPartlin · M. · Gordon · W. J. · McManus · K. D. · Morrison-Deutsch · C. · Sci
Introduction

There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings. PROPS 2.0 (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0) aims to adapt and implement the combined intervention from the PROPS Study at scale, in a diverse cross-section of patients and providers.

Methods and analysis

We are implementing PROPS 2.0 across a variety of clinics at Brigham and Women’s Hospital, targeting enrolment of 5000 patients. Providers can refer patients or patients can self-refer. Eligible patients must be ≥20 years old and have a body mass index (BMI) of ≥30 kg/m2 or a BMI of 25–29.9 kg/m2 plus another cardiovascular risk factor or obesity-related condition. After enrolment, patients register for the RestoreHealth online programme/app (HealthFleet Inc.) and participate for 12 months. Patients can engage with the programme and receive personalized feedback from a coach. Patient navigators help to enrol patients, enter updates in the electronic health record, and refer patients to additional resources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is guiding the evaluation.

Ethics and dissemination

The Mass General Brigham Human Research Committee approved this protocol. An implementation guide will be created and disseminated, to help other sites adopt the intervention in the future.

Trial registration number

NCT0555925.

Nationwide survey of physicians familiarity and awareness of diabetes guidelines in China: a cross-sectional study

Por: Jia · L.-y. · Huang · C.-x. · Zhao · N.-j. · Lai · B.-y. · Zhang · Z.-h. · Li · L. · Zhan · N. · Lin · Y.-b. · Cai · M.-n. · Wang · S.-q. · Yan · B. · Liu · J.-p. · Yang · S.-y.
Objective

This study aims to investigate physicians’ familiarity and awareness of four diabetes guidelines and their practice of the recommendations outlined in these guidelines.

Design

A cross-sectional study.

Setting

An online questionnaire survey was conducted among physicians affiliated with the Specialist Committee for Primary Diabetes Care of China Association of Chinese Medicine, using the snowball sampling method to ensure a broader representation of physicians.

Participants

1150 physicians from 192 cities across 30 provinces in China provided complete data.

Results

Tertiary care hospital physicians (TCPs) exhibited the highest familiarity with the Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (91.3%), followed by the National Guidelines for the Prevention and Control of Diabetes in Primary Care (76.8%), the Standards of Medical Care in Diabetes (72.2%) and the Guidelines for Prevention and Treatment of Diabetes in Chinese Medicine (63.8%). Primary care practitioners (PCPs) exhibited familiarity with these four guidelines at about 50% or less. Self-reported reference to modern diabetes guidelines by physicians is more frequent than traditional Chinese medicine (TCM) diabetes guidelines, with rates at 73.2% and 33.8%, respectively. Approximately 90% of physicians provided instructions on self-monitoring of blood glucose to their patients with diabetes. Less than one-third of physicians referred patients to a specialised nutritionist. In terms of health education management, TCPs reported having a diabetes health management team at the rate of 75.7%, followed by secondary care hospital physicians at 57.0% and PCPs at 27.5%. Furthermore, approximately 40% of physicians did not fully grasp hypoglycaemia characteristics.

Conclusions

Familiarity and awareness of the screening guidelines varied among physicians in different hospital settings. Importantly, significant discrepancies were observed between physicians’ awareness and their self-reported reference to modern medicine guidelines and TCM guidelines. It is essential to consistently provide education and training on diabetes management for all physicians, particularly PCPs.

Active close contact investigation of tuberculosis through computer-aided detection and stool Xpert MTB/RIF among people living in Oromia Region, Ethiopia (CADOOL Study): protocol for a prospective, cross-sectional study

Por: Segala · F. V. · Nigussa · W. · Guido · G. · Kenate · B. · Facci · E. · Tsegaye · A. · Gulo · B. · Manenti · F. · Bobosha · K. · Cotugno · S. · Asmare · A. B. · Cavallin · F. · Tilahun · M. · Miccio · M. · Abdissa · A. · Putoto · G. · Saracino · A. · Di Gennaro · F.
Introduction

Pulmonary tuberculosis (TB) is an infectious disease with high incidence in low-income countries (LICs); it remains one of the infectious diseases with the highest mortality in the world, especially in LICs. It is crucial to recognise and diagnose TB as soon as possible, but microbiological tests on sputum are not always sensitive enough. New methods for an early diagnosis of TB are needed. In this study, we will investigate the role of two different tests to detect TB in Ethiopia (where the prevalence of TB is high): molecular search for TB in stool samples with Xpert assay and detection of pulmonary TB signs on chest X-rays with CAD4TB technology.

Methods and analysis

A prospective diagnostic test accuracy study during TB active contact investigation will be conducted. In the referral hospital in Southwest Shoa Zone, Oromia Region, Ethiopia, patients with pulmonary TB and a sputum sample positive for Mycobacterium tuberculosis and household contacts of at least 4 years of age will be enrolled, with a target sample size of 231 patients. Trained staff will label household contacts as ‘possible TB’ cases or not according to their symptoms; when TB is possible, a stool Xpert and computer-aided detection on chest X-ray will be performed, alongside standard diagnostic methods, assessing the diagnostic accuracy of CAD4TB compared with Xpert MTB/RIF during TB contact investigation and the accuracy of stool Xpert compared with sputum Xpert.

Ethics and dissemination

This study has been approved by the Oromia Health Bureau Research Ethics Committee (ref no BFO/MBTFH/1-16/100023). All information obtained will be kept confidential. Selected investigators will have access to data, while international partners will sign a dedicated data protection agreement. Eligible participants will receive brief information about the study before being asked to participate and they will provide written informed consent. Results will be disseminated through peer-reviewed journals.

Trial registration number

NCT05818059.

Risk factors of incontinence-associated dermatitis in older adults: a protocol for systematic review and meta-analysis

Por: Fan · S. · Jiang · H. · Shen · J. · Lin · H. · Yang · L. · Yu · D. · Chen · L.
Introduction

Due to their ageing skin, older adults are more likely to develop incontinence-associated dermatitis (IAD). Although previous attempts to look at the risk factors for IAD in older adults were done, methodological barriers hindered an in-depth understanding. By investigating risk factors for IAD in the ageing population, the development of precise clinical interventions and guidance could be facilitated, which in turn would enhance patient care standards for incontinence management in this target group. To address this knowledge gap, this systematic review with meta-analysis aims to explore the major risk elements linked to IAD among older adults.

Methods and analysis

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols are adhered to in this systematic review and meta-analysis. To achieve its objectives, a comprehensive search strategy PubMed, Embase, Web of Science, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Medline, Chinese Scientific Journal Database (VIP database), WanFang Data Knowledge Service Platform, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, along with other relevant sources published until 18 July 2023 in both English and Chinese languages will be performed. The screening of articles, data abstraction and risk of bias evaluation will be done by two impartial reviewers. RevMan V.5.3 software will be used for data synthesis. The quality of the included study will be assessed using the Newcastle-Ottawa Quality Assessment tool and the Agency for Healthcare Research and Quality. The I2 test will identify the heterogeneity.

Ethics and dissemination

There is no need for ethical approval. Individual patient information or the rights of participants will not be compromised by this protocol. The findings will either be published in a peer-reviewed journal.

PROSPERO registration number

CRD42023442585.

Faith-based organisations and their role in supporting vaccine confidence and uptake: a scoping review protocol

Por: Song · M. Y. · Blake-Hepburn · D. · Fadel · S. · Allin · S. · Ataullahjan · A. · Di Ruggiero · E.
Introduction

Faith-based organisations (FBOs) and religious actors increase vaccine confidence and uptake among ethnoracially minoritised communities in low-income and middle-income countries. During the COVID-19 pandemic and the subsequent vaccine rollout, global organisations such as the WHO and UNICEF called for faith-based collaborations with public health agencies (PHAs). As PHA-FBO partnerships emerge to support vaccine uptake, the scoping review aims to: (1) outline intervention typologies and implementation frameworks guiding interventions; (2) describe the roles of PHAs and FBOs in the design, implementation and evaluation of strategies and (3) synthesise outcomes and evaluations of PHA-FBO vaccine uptake initiatives for ethnoracially minoritised communities.

Methods and analysis

We will perform six library database searches in PROQUEST-Public Health, OVID MEDLINE, Cochrane Library, CINAHL, SCOPUS- all, PROQUEST - Policy File index; three theses repositories, four website searches, five niche journals and 11 document repositories for public health. These databases will be searched for literature that describe partnerships for vaccine confidence and uptake for ethnoracially minoritised populations, involving at least one PHA and one FBO, published in English from January 2011 to October 2023. Two reviewers will pilot-test 20 articles to refine and finalise the inclusion/exclusion criteria and data extraction template. Four reviewers will independently screen and extract the included full-text articles. An implementation science process framework outlining the design, implementation and evaluation of the interventions will be used to capture the array of partnerships and effectiveness of PHA-FBO vaccine uptake initiatives.

Ethics and dissemination

This multiphase Canadian Institutes of Health Research (CIHR) project received ethics approval from the University of Toronto. Findings will be translated into a series of written materials for dissemination to CIHR, and collaborating knowledge users (ie, regional and provincial PHAs), and panel presentations at conferences to inform the development of a best-practices framework for increasing vaccine confidence and uptake.

Evaluation of functional vision and eye-related quality of life in children with congenital ectopia lentis: a prospective cross-sectional study

Por: Liang · X. · Zheng · D. · Young · C. A. · Ma · Y. · Ling · L. · Zou · M. · Liu · S. · Zhang · X. · Jin · G.
Objectives

This study aims to evaluate the effect of congenital ectopia lentis (CEL) on functional vision and eye-related quality of life (ER-QOL) in children and their families using the Paediatric Eye Questionnaire (PedEyeQ).

Design

A questionnaire survey administered via in-person interviews of patients with CEL and their parents.

Participants

51 children with CEL and 53 visually normal controls accompanied by 1 parent completed the survey questionnaires for the study from March 2022 to September 2022.

Outcome measures

PedEyeQ domain scores. Functional vision and ER-QOL of children and their families were evaluated by calculating and comparing the Rasch domain scores of the PedEyeQ.

Results

PedEyeQ domain scores were significantly worse with CEL compared with controls (p

Conclusions

In this study, children with CEL had reduced functional vision and ER-QOL compared with controls. Parents of children with CEL also experience reduced quality of life.

Experiences of individuals with rheumatoid arthritis interacting with health care and the use of a digital self-care application: a qualitative interview study

Por: Viberg Johansson · J. · Blyckert · H. · Schölin Bywall · K.
Objectives

Over the last few decades, there have been significant improvements in the treatment of rheumatoid arthritis (RA), with the development of new treatments and guidelines for teamwork and patient self-care and access to digital tools. This study aimed to explore the experiences of individuals with RA interacting with healthcare. It also looked at how a self-care application, an educational programme called the ‘healthcare encounter’, improved patient–doctor communication.

Design

Semistructured interviews were conducted, and qualitative content analysis was performed.

Setting

The potential participants, individuals with established, or under investigation for, RA diagnosis at rheumatology clinics in Sweden, were asked to participate in the study via a digital self-care application called the Elsa Science Self-care app.

Participants

Ten interviews were performed with participants from nine clinics following a meeting with the rheumatologist or other healthcare personnel between September 2022 and October 2022. Phrases, sentences or paragraphs referring to experiences from healthcare meetings and opinions about the digital programme were identified and coded. Codes that reflected similar concepts were grouped; subcategories were formulated, and categories were connected to their experiences and opinions.

Results

Among our participants, three main categories emerged: the availability of healthcare, individual efforts to have a healthier life and personal interaction with healthcare. Participants described that the ‘healthcare encounter’ educational programme can be a source of information, which confirms, supports and creates a sense of control.

Conclusion

The participants valued being seen and taking part in a dialogue when they had prepared themselves (observed symptoms over time and prepared questions). The implementation of digital self-care applications might need to be incorporated into the healthcare setting, so that both the patients and the healthcare personnel have a shared understanding. Collaboration is essential in this context.

Establishment and validation of a prediction model for myocarditis in Chinese children below 14 years old: a protocol for a retrospective cohort study

Por: Wu · L. · Ji · W. · Huang · Y. · Zeng · H. · Chen · J. · Zou · Y. · Lin · W. · Lin · Y.
Introduction

Paediatric myocarditis, a rare inflammatory disease, often presents without clear early symptoms. Although cardiac troponin I levels can aid in diagnosing myocarditis, they are not definitive indicators. Troponin I levels frequently fluctuate within and outside the reference range, potentially causing misinterpretations by clinicians. Although a negative troponin I result is valuable for excluding myocarditis, its specificity is low. Moreover, the clinical diagnosis of paediatric myocarditis is exceptionally challenging, and accurate early-stage diagnosis and treatment pose difficulties. Currently, the Dallas criteria, involving cardiac biopsy, serves as the gold standard for myocarditis diagnosis. However, this method has several drawbacks and is unsuitable for children, resulting in its limited use.

Methods and analysis

In this study, we will employ multiple logistic regression analysis to develop a predictive model for early childhood myocarditis. This model will assess the patient’s condition at onset and provide the probability of a myocarditis diagnosis. Model performance will be evaluated for accuracy and calibration, and the results will be presented through receiver operating characteristic (ROC) curves and calibration plots. Clinical decision curve analysis, in conjunction with ROC curve analysis, will be employed to determine the optimal cut-off value and calculate the net clinical benefit value for assessing clinical effectiveness. Finally, internal model validation will be conducted using bootstrapping.

Ethics and dissemination

Approval from the Clinical Research Ethics Committee of The Third Affiliated Hospital of Wenzhou Medical University has been obtained. The research findings will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.

Cohort profile: COBLAnCE: a French prospective cohort to study prognostic and predictive factors in bladder cancer and to generate real-world data on treatment patterns, resource use and quality of life

Por: Lebret · T. · Bonastre · J. · Fraslin · A. · Neuzillet · Y. · Droupy · S. · Rebillard · X. · Vordos · D. · Guy · L. · Villers · A. · Schneider · M. · Coloby · P. · Lacoste · J. · Mejean · A. · Lacoste · J. · Descotes · J.-L. · Eschwege · P. · Loison · G. · Blanche · H. · Mariani · O. · Ghale
Purpose

Bladder cancer is a complex disease with a wide range of outcomes. Clinicopathological factors only partially explain the variability between patients in prognosis and treatment response. There is a need for large cohorts collecting extensive data and biological samples to: (1) investigate gene-environment interactions, pathological/molecular classification and biomarker discovery; and (2) describe treatment patterns, outcomes, resource use and quality of life in a real-world setting.

Participants

COBLAnCE (COhort to study BLAdder CancEr) is a French national prospective cohort of patients with bladder cancer recruited between 2012 and 2018 and followed for 6 years. Data on patient and tumour characteristics, treatments, outcomes and biological samples are collected at enrolment and during the follow-up.

Findings to date

We describe the cohort at enrolment according to baseline surgery and tumour type. In total, 1800 patients were included: 1114 patients with non-muscle-invasive bladder cancer (NMIBC) and 76 patients with muscle-invasive bladder cancer (MIBC) had transurethral resection of a bladder tumour without cystectomy, and 610 patients with NMIBC or MIBC underwent cystectomy. Most patients had a solitary lesion (56.3%) without basement membrane invasion (71.7% of Ta and/or Tis). Half of the patients with cystectomy were stage ≤T2 and 60% had non-continent diversion. Surgery included local (n=298) or super-extended lymph node dissections (n=11) and prostate removal (n=492). Among women, 16.5% underwent cystectomy and 81.4% anterior pelvectomy.

Future plans

COBLAnCE will be used for long-term studies of bladder cancer with focus on clinicopathological factors and molecular markers. It will lead to a much-needed improvement in the understanding of the disease. The cohort provides valuable real-world data, enabling researchers to study various research questions, assess routine medical practices and guide medical decision-making.

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