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Clinical profile and outcomes of paediatric patients with acute seizures: a prospective cohort study at an urban emergency department of a tertiary hospital in Tanzania

Por: Shayo · F. · Sawe · H. R. · Hyuha · G. M. · Moshi · B. · Gulamhussein · M. A. · Mussa · R. · Mdundo · W. · Rwegoshora · S. · Mfinanga · J. A. · Kilindimo · S. · Weber · E. J.
Objective

Children with seizures require immediate and appropriate intervention in the emergency department (ED). This study describes the clinical profile and outcome of paediatric patients with seizures at the ED in a country with limited resources.

Design

A prospective, observational cohort study of paediatric patients with seizure presenting to an ED conducted over a six-month period from 1 August 2019 to 31 January2020.

Setting

The study was conducted at the ED of Muhimbili National Hospital, a level 1 trauma centre located in Dar es Salaam, Tanzania.

Participants

Paediatric patients aged 1 month to 14 years presenting at the ED with acute seizure, defined as any seizure occurring from 24 hours to 7 days prior to the visit, were included in this study. Patients were consecutively enrolled during times a research assistant was present in the department. Newborns, children with repeat visits or no signs of life on arrival were excluded.

Outcome

The primary outcome was the proportion of paediatric patients presenting with seizures and their mortality rate; secondary outcome was risk factors for mortality.

Result

During the study period, 1011 children were seen in the department, of whom 114 (11.3%) (95% CI 9.3% to 13.3%) presented with seizures. Median age was 24 months (IQR 9–60), 78.1% were under 5 years and 55.3% were males. The majority 76 (66.7%) of the patients presented with generalised seizures. Half 58 (50.9%) of patients presented with fever. Meningitis was the most common aetiology, diagnosed in 30 (26.3%). Overall mortality was 16.7% (95% CI 10.3% to 24.8%). Using negative log binominal analysis, fever (relative risk, RR 2.7), altered mental status (RR 21.1), hypoxia (RR 3.3), abnormal potassium (RR 2.4) and clinical diagnosis of meningitis (RR 3.4) were statistically significantly associated with mortality.

Conclusions

Findings from this study revealed higher incidence of paediatric patients with seizures than that reported in high-income countries and other low-income and middle-income countries. The acuity of illness was high, with 16.7% mortality rate. The presence of fever, altered mental status, hypoxia, abnormal potassium levels and meningitis diagnosis were associated with higher risk of mortality. Further research is needed to develop interventions to improve outcomes in paediatric patients with seizures in our setting.

Perceptions of senior nursing students on how the COVID-19 pandemic influenced their clinical practice in the Northwest Province, South Africa: a qualitative study

Por: Apolinario · S. F. F. · Bam · E. N. · Moagi · M.
Objective

To explore and describe senior nursing students’ perspectives on clinical practice during COVID-19 and provide the most up-to-date information on the quality of clinical experience for nursing students in relation to nursing practice, nursing education, and nursing research.

Design

The research design that was employed is a qualitative, explorative, descriptive in order to explore and describe nursing students’ perceptions of clinical, training during the COVID-19 pandemic.

Setting

The study took place in a local university located in the Northwest province, South Africa.

Participants

The population consisted of 16 senior nursing students who had been exposed to clinical practice during the COVID-19 pandemic. There were 14 women and 2 men. Study included full-time, registered undergraduate nursing students who enrolled in 2019. All nursing students who did not engage in clinical practice before or during COVID-19 were exempt.

Interventions

There were no direct interventions in this study; however, few recommendations were made for each of the themes that emerged in this study.

Primary and secondary outcome measures

The researchers’ aim with the study was to find out the nursing students’ perspective on clinical training during a global pandemic, through interviews and focus group discussions. The researcher did in fact receive such feedback from the participants.

Results

Four major themes emerged: (1) the lack of preceptors to facilitate clinical teaching; (2) not allowed to work in COVID-19 wards; (3) difficulties with online classes and tests and (4) poor communication.

Conclusion

The COVID-19 pandemic influenced how students viewed and experienced clinical training, which in turn had an impact on their learning experiences. These effects also had some impact on their experiences and decisions to continue working as professional nurses.

Determining the impact of an artificial intelligence tool on the management of pulmonary nodules detected incidentally on CT (DOLCE) study protocol: a prospective, non-interventional multicentre UK study

Por: O'Dowd · E. · Berovic · M. · Callister · M. · Chalitsios · C. V. · Chopra · D. · Das · I. · Draper · A. · Garner · J. L. · Gleeson · F. · Janes · S. · Kennedy · M. · Lee · R. · Mauri · F. · McKeever · T. M. · McNulty · W. · Murray · J. · Nair · A. · Park · J. · Rawlinson · J. · Sagoo · G. S.
Introduction

In a small percentage of patients, pulmonary nodules found on CT scans are early lung cancers. Lung cancer detected at an early stage has a much better prognosis. The British Thoracic Society guideline on managing pulmonary nodules recommends using multivariable malignancy risk prediction models to assist in management. While these guidelines seem to be effective in clinical practice, recent data suggest that artificial intelligence (AI)-based malignant-nodule prediction solutions might outperform existing models.

Methods and analysis

This study is a prospective, observational multicentre study to assess the clinical utility of an AI-assisted CT-based lung cancer prediction tool (LCP) for managing incidental solid and part solid pulmonary nodule patients vs standard care. Two thousand patients will be recruited from 12 different UK hospitals. The primary outcome is the difference between standard care and LCP-guided care in terms of the rate of benign nodules and patients with cancer discharged straight after the assessment of the baseline CT scan. Secondary outcomes investigate adherence to clinical guidelines, other measures of changes to clinical management, patient outcomes and cost-effectiveness.

Ethics and dissemination

This study has been reviewed and given a favourable opinion by the South Central—Oxford C Research Ethics Committee in UK (REC reference number: 22/SC/0142).

Study results will be available publicly following peer-reviewed publication in open-access journals. A patient and public involvement group workshop is planned before the study results are available to discuss best methods to disseminate the results. Study results will also be fed back to participating organisations to inform training and procurement activities.

Trial registration number

NCT05389774.

Language Access Systems Improvement initiative: impact on professional interpreter utilisation, a natural experiment

Por: Karliner · L. S. · Gregorich · S. E. · Mutha · S. · Kaplan · C. · Livaudais-Toman · J. · Pathak · S. · Garcia · M. E. · Diamond · L.
Objectives

This study aims to evaluate the Language Access Systems Improvement (LASI) initiative’s impact on professional interpreter utilisation in primary care and to explore patient and clinician perspectives on professional interpreter use.

Design

Multi methods: Quantitative natural experiment pre-LASI and post-LASI, qualitative semistructured interviews with clinicians and focus groups with patients post-LASI.

Setting

Large, academic primary care practice.

Participants

Cantonese, Mandarin, Spanish, English-speaking adult patients and their clinicians.

Intervention

LASI initiative: Implementation of a clinician language proficiency test and simultaneous provision of on-demand access to professional interpreters via video medical interpretation.

Main outcome measures

Quantitative: Proportion of language discordant primary care visits which were professionally interpreted. Qualitative: Salient themes related to professional interpreter use and non-use.

Results

The researchers categorised language concordance for 1475 visits with 152 unique clinicians; 698 were not fully language concordant (202 pre-LASI and 496 post-LASI). Professional interpreter utilisation increased (pre-LASI 57% vs post-LASI 66%; p=0.01); the visits with the lowest percentage of profssional interpreter use post-LASI were those in which clinicians and patients had partial language concordance. In inverse probability weighted analysis, restricting to 499 visits with strict estimated propensity score overlap (100% common support), post-LASI visits had higher odds of using a professional interpreter compared with pre-LASI visits (OR 2.39; 95% CI 1.04 to 5.48). Qualitative results demonstrate video interpretation was convenient and well liked by both clinicians and patients. Some partially bilingual clinicians reported frustration with patient refusal of interpreter services; others reported using the video interpreters as a backup during visits. Views of the care-partner role differed for clinicians and patients. Clinicians reported sometimes having family interpret out of convenience or habit, whereas patients reported wanting family members present for support and advocacy, not interpretation.

Conclusions

LASI increased utilisation of professional interpreters; however, this was least prominent for partially language concordant visits. Health systems wishing to implement LASI or similar interventions will need to support clinicians and patients with partial bilingual skills in their efforts to use professional interpreters.

Trial registration number

HSRP20153367.

Incidence of community-acquired pneumonia among children under 5 years in Suzhou, China: a hospital-based cohort study

Por: Qian · C. · Chen · Q. · Lin · W. · Li · Z. · Zhu · J. · Zhang · J. · Luan · L. · Zheng · B. · Zhao · G. · Tian · J. · Zhang · T.
Objectives

To depict the seasonality and age variations of community-acquired pneumonia (CAP) incidence in the context of the COVID-19 impact.

Design

Retrospective cohort study.

Participants

The observational cohort study was conducted at Soochow University Affiliated Children’s Hospital from January 2017 to June 2021 and involved 132 797 children born in 2017 or 2018. They were followed and identified CAP episodes by screening on the Health Information Systems of outpatients and inpatients in the same hospital.

Outcome

The CAP episodes were defined when the diagnoses coded as J09–J18 or J20–J22. The incidence of CAP was estimated stratified by age, sex, birth year, health status group, season and month, and the rate ratio was calculated and adjusted by a quasi-Poisson regression model. Stratified analysis of incidence of CAP by birth month was conducted to understand the age and seasonal variation.

Results

The overall incidence of CAP among children aged ≤5 years was 130.08 per 1000 person years. Children aged ≤24 months have a higher CAP incidence than those aged >24 months (176.84 vs 72.04 per 1000 person years, p

Conclusions

The burden of CAP among children is considerable. The incidence of CAP among children ≤5 years varied by age and season and decreased during COVID-19 lockdown.

Cognitive function and its associated factors among patients with cancer pain: a multicentre cross-sectional study in China

Por: Zhu · H. · Lin · R. · Wang · J. · Ruan · S. · Hu · T. · Lei · Y. · Ke · X. · Luo · H.
Objective

This research aimed to assess the levels of cognitive function and its contributing factors among individuals experiencing cancer pain (CP) in mainland China.

Design

A descriptive, cross-sectional study.

Setting

The investigation was undertaken within three tertiary oncology hospitals.

Participants

We included 220 hospitalised individuals who reported experiencing cancer-related pain and consented to complete the research questionnaires.

Outcome measures

The collected data encompassed sociodemographic and clinical variables, augmented by results from validated questionnaires. Cognitive impairment (CI) was evaluated using the Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) scale, with scores ranging from 0 to 148. Sleep quality, depression and anxiety were assessed through the Pittsburgh Sleep Quality Index, the Patient Health Questionnaire-9 and the Generalised Anxiety Disorder-7, respectively. A binary logistic regression model was used to identify factors associated with CI in individuals with CP.

Results

Of the 225 individuals approached, 220 (97.8%) participated in the study. The mean FACT-Cog score for those with CP was 101.29 (SD=25.24; range=25–148). The prevalence of CI among these individuals was 35.90%. Sleep quality was rated below medium in 45% of participants with CP. More than moderate pain was reported by 28.2%, with 64.6% experiencing depression and 38.6% experiencing anxiety. Increased odds of developing CI were observed in those with CP (OR 1.422, 95% CI 1.129 to 1.841), depression (OR 1.119, 95% CI 1.029 to 1.2117), anxiety (OR 1.107, 95% CI 1.005 to 1.220), advancing age (OR 1.042, 95% CI 1.013 to 1.073), poor sleep quality (OR 1.126, 95% CI 1.013 to 1.252) and a history of smoking (OR 3.811, 95% CI 1.668 to 8.707).

Conclusions

CI associated with CP is notably prevalent in China. Those older, with a smoking history, inadequate sleep, more severe pain, depression and anxiety, have a heightened risk of CI. Consequently, interventions need to be personalised, addressing these key determinants.

Intervention to increase physical activity and healthy eating among under-represented adolescents: GOAL trial protocol

Por: Robbins · L. B. · Ling · J. · Pfeiffer · K. A. · Kerver · J. M. · Resnicow · K. · McCaffery · H. · Hilliard · A. · Hobbs · L. · Donald · S. · Kaciroti · N.
Introduction

To reduce obesity-related disparities, reaching economically disadvantaged and/or minority status adolescents to assist them in meeting physical activity (PA) and nutrition recommendations is important. To address the problem, a 16-week intervention called Guys/Girls Opt for Activities for Life (GOAL) was designed. The purpose of this randomised controlled trial is to evaluate any effect of the intervention, compared with a control condition, on improving: (1) adolescents’ % body fat (primary outcome), moderate-to-vigorous PA (MVPA), diet quality and cardiorespiratory fitness from 0 to 4 months; (2) body mass index (BMI), overweight/obesity percentage and quality of life from 0 to 4 months and to 13 months; and (3) perceived social support, self-efficacy and motivation from 0 to 4 months with evaluation of any mediating effect on adolescent PA and diet quality. An exploratory aim is to evaluate any effect of the intervention, compared with the control, on improving parents’/guardians’ home environment, MVPA and diet quality from 0 to 4 months; and BMI from 0 to 4 months and to 13 months.

Methods and analysis

Adolescents (fifth to eighth grade) in 14 schools located in underserved urban communities are randomly assigned to the intervention or usual school offerings. One parent per adolescent is enrolled (882 dyads total). Cohort 1 includes four schools (2022–2023). Cohorts 2 and 3 include 5 schools in 2023–2024 and 2024–2025, respectively. The 16-week intervention has three components: (1) after-school GOAL club for adolescents to engage in PA and healthy eating/cooking activities; (2) three parent–adolescent meetings to empower parents to assist adolescents; and (3) GOAL social networking website for parents to share how they helped their adolescent.

Ethics and dissemination

The Michigan State University Biomedical Institutional Review Board provided ethical approval for the study. Findings will be shared via the trial registration database, peer-reviewed publications, conferences and community-oriented strategies.

Trial registration number

NCT04213014.

Where are the inequalities in colorectal cancer care in a country with universal healthcare? A systematic review and narrative synthesis

Por: Pickwell-Smith · B. A. · Spencer · K. · Sadeghi · M. H. · Greenley · S. · Lind · M. · Macleod · U.
Objective

Patients diagnosed with colorectal cancer living in more deprived areas experience worse survival than those in more affluent areas. Those living in more deprived areas face barriers to accessing timely, quality healthcare. These barriers may contribute to socioeconomic inequalities in survival. We evaluated the literature for any association between socioeconomic group, hospital delay and treatments received among patients with colorectal cancer in the UK, a country with universal healthcare.

Design

MEDLINE, EMBASE, CINAHL, CENTRAL, SCIE, AMED and PsycINFO were searched from inception to January 2023. Grey literature, including HMIC, BASE and Google Advanced Search, and forward and backward citation searches were conducted. Two reviewers independently reviewed titles, abstracts and full-text articles. Observational UK-based studies were included if they reported socioeconomic measures and an association with either hospital delay or treatments received. The QUIPS tool assessed bias risk, and a narrative synthesis was conducted. The review is reported to Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020.

Results

41 of the 7209 identified references were included. 12 studies evaluated 7 different hospital intervals. There was a significant association between area-level deprivation and a longer time from first presentation in primary care to diagnosis. 32 studies evaluated treatments received. There were socioeconomic inequalities in surgery and chemotherapy but not radiotherapy.

Conclusion

Patients with colorectal cancer face inequalities across the cancer care continuum. Further research is needed to understand why and what evidence-based actions can reduce these inequalities in treatment. Qualitative research of patients and clinicians conducted across various settings would provide a rich understanding of the complex factors that drive these inequalities. Further research should also consider using a causal approach to future studies to considerably strengthen the interpretation. Clinicians can try and mitigate some potential causes of colorectal cancer inequalities, including signposting to financial advice and patient transport schemes.

PROSPERO registration number

CRD42022347652.

THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised controlled trial protocol

Por: Abdulrehman · J. · Forte · S. · Tomlinson · G. · Solh · Z. · Bolster · L. · Sun · H. · Bartolucci · P. · Kuo · K. H. M.
Introduction

Individuals with sickle cell disease (SCD) and central venous catheters (CVC) are at high risk for venous thromboembolism (VTE). Minimal data exist regarding the use of anticoagulation as thromboprophylaxis of VTE in this demographic, and as a result, clinical equipoise exists. Prophylactic dose rivaroxaban, a direct oral anticoagulant, is efficacious and safe as thromboprophylaxis in other demographics, and may be an optimal agent in SCD with CVC. Prior to conducting a full clinical trial to assess rivaroxaban as thromboprophylaxis in SCD with CVC, a pilot study is needed to gauge its feasibility.

Methods and analysis

THromboprophylaxis In Sickle Cell Disease pilot trial is an investigator-initiated, multicentre, double-blinded, randomised controlled trial (RCT) assessing if it is feasible and safe to conduct an adequately powered RCT comparing rivaroxaban to matching placebo as thromboprophylaxis in those with SCD and CVC. Fifty adult patients with SCD and CVC will be randomised to receive either rivaroxaban 10 mg daily or matching placebo for the duration of the CVC in situ for up to 1 year. After randomisation, follow-up visits will occur every 3 months. The primary outcomes pertain to the feasibility of a full trial and include numbers of eligible and recruited participants. Exploratory outcomes include overall incidence of VTE and bleeding complications, as well as quality of life. If the full trial is feasible, blinding will be maintained and patients in the pilot study will be included in the full trial.

Ethics and dissemination

The trial was initially approved by the University Health Network Research Ethics Board (REB) in Toronto, Canada. All sites will obtain approval from their respective REB prior to commencement of study activities. Study results will be disseminated through presentations at medical conferences and peer-reviewed publications.

Trial registration number

NCT05033314.

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.

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