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Comparative effectiveness of biologics in patients with rheumatoid arthritis stratified by body mass index: a cohort study in a Swiss registry

Objectives

Obesity is associated with lower treatment response in patients with rheumatoid arthritis (RA). In patients with obesity, abatacept was suggested as a preferable option to tumour necrosis factor-alpha inhibitors. We aimed to assess the comparative effectiveness of etanercept, infliximab and abatacept, compared with adalimumab, in patients with RA with obesity. Secondarily, we also investigated this in patients with overweight and normal weight for completeness.

Design

Observational cohort study.

Setting

Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) registry (1997–2019).

Participants

Adult patients with RA from the SCQM registry who received etanercept, infliximab, abatacept or adalimumab as their first biological or targeted synthetic disease-modifying antirheumatic drug were classified based on their body mass index (BMI) at the start of that treatment in three cohorts: obese, overweight, normal weight. They were followed for a maximum of 1 year.

Exposure

The study exposure of interest was the patients’ first biological, particularly: etanercept, infliximab and abatacept, compared with adalimumab.

Primary and secondary outcome measures

The primary study outcome was remission within 12 months, defined as 28-joint Disease Activity Score (DAS28)

Results

The study included 443 obese, 829 overweight and 1243 normal weight patients with RA. There were no statistically significant differences in the odds of DAS28-remission at ≤12 months for etanercept, infliximab and abatacept, compared with adalimumab, in any of the BMI cohorts.

Conclusions

No differences in DAS28-remission were found between the study drugs and adalimumab as first biologic in patients with RA, independently of the BMI cohort. We did not find evidence that treatment with abatacept increased the likelihood of remission compared with adalimumab among obese patients with RA.

Research on the barriers to accessing sexual healthcare for sexually diverse Muslim men: protocol for a scoping review

Por: Noor · M. N. · Shaw · S. Y. · Linton · J. · Lorway · R.
Introduction

Sexually diverse Muslim men are seen to be at a higher risk for HIV and other sexually transmitted infections due to their limited access to sexual healthcare services. We outline a protocol to conduct a scoping review of research on the barriers that may impede these men’s access to sexual healthcare.

Methods and analysis

To conduct this scoping review, we will follow the methodological framework developed by Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses’ extension for scoping reviews. To classify the barriers to sexual healthcare, we will employ Bronfenbrenner’s socioecological model as a conceptual framework. We will conduct a literature search via Medline, Embase and Global Health (OVID); Scopus; CINAHL on EBSCOhost along with several other EBSCOhost databases (Academic Search Complete, Canadian Reference Centre, Alternative Press Index, Family & Society Studies Worldwide, Social Work Abstracts) and Google Scholar, published until November 2023. Journal articles, published in the English language, describing quantitative and qualitative research on sexual healthcare access barriers for sexually diverse Muslim men will be included in the review. Commentaries and correspondences, along with grey literature including research reports and conference abstracts, as well as studies that do not include men with the Muslim faith, will be considered ineligible. Following screening of titles and abstracts, we will conduct a full-text screening to determine the final number of studies to be included in the review. A Microsoft Excel spreadsheet will be used to extract study characteristics, and information on sexual healthcare access barriers will be classified according to the socioecological model’s core concepts.

Ethics and dissemination

Our review does not require ethics approval. We will disseminate the review findings through peer-reviewed academic journals, seminars and conference presentations.

Association between tuberculosis and pregnancy outcomes: a retrospective cohort study of women in Cape Town, South Africa

Por: Meehan · S.-A. · Hesseling · A. C. · von Delft · A. · Marx · F. M. · Hughes · J. A. · Bock · P. · Banke-Thomas · A. · Dunbar · R. · Phelanyane · F. · Smith · M. · Osman · M.
Background

Tuberculosis (TB) remains a leading cause of mortality among women of childbearing age and a significant contributor to maternal mortality. Pregnant women with TB are at high risk of adverse pregnancy outcomes. This study aimed to determine risk factors for an adverse pregnancy outcome among pregnant women diagnosed with TB.

Methods

Using TB programmatic data, this retrospective cohort analysis included all women who were routinely diagnosed with TB in the public sector between October 2018 and March 2020 in two health subdistricts of Cape Town, and who were documented to be pregnant during their TB episode. Adverse pregnancy outcome was defined as either a live birth of an infant weighing

Results

Of 248 pregnant women, half (52%) were living with HIV; all were on antiretroviral therapy at the time of their TB diagnosis. Pregnancy outcomes were documented in 215 (87%) women, of whom 74 (34%) had an adverse pregnancy outcome. Being older (35–44 years vs 25–34 years (adjusted OR (aOR): 3.99; 95% CI: 1.37 to 11.57), living with HIV (aOR: 2.72; 95% CI: 0.99 to 4.63), having an unfavourable TB outcome (aOR: 2.29; 95% CI: 1.03 to 5.08) and having presented to antenatal services ≤1 month prior to delivery (aOR: 10.57; 95% CI: 4.01 to 27.89) were associated with higher odds of an adverse pregnancy outcome.

Conclusions

Pregnancy outcomes among women with TB were poor, irrespective of HIV status. Pregnant women with TB are a complex population who need additional support prior to, during and after TB treatment to improve TB treatment and pregnancy outcomes. Pregnancy status should be considered for inclusion in TB registries.

Assessing the heterogeneity of the impact of COVID-19 incidence on all-cause excess mortality among healthcare districts in Lombardy, Italy, to evaluate the local response to the pandemic: an ecological study

Por: Paganuzzi · M. · Nattino · G. · Ghilardi · G. I. · Costantino · G. · Rossi · C. · Cortellaro · F. · Cosentini · R. · Paglia · S. · Migliori · M. · Mira · A. · Bertolini · G. · On behalf of the Fenice network
Objectives

The fragmentation of the response to the COVID-19 pandemic at national, regional and local levels is a possible source of variability in the impact of the pandemic on society. This study aims to assess how much of this variability affected the burden of COVID-19, measured in terms of all-cause 2020 excess mortality.

Design

Ecological retrospective study.

Setting

Lombardy region of Italy, 2015–2020.

Outcome measures

We evaluated the relationship between the intensity of the epidemics and excess mortality, assessing the heterogeneity of this relationship across the 91 districts after adjusting for relevant confounders.

Results

The epidemic intensity was quantified as the COVID-19 hospitalisations per 1000 inhabitants. Five confounders were identified through a directed acyclic graph: age distribution, population density, pro-capita gross domestic product, restriction policy and population mobility.

Analyses were based on a negative binomial regression model with district-specific random effects. We found a strong, positive association between COVID-19 hospitalisations and 2020 excess mortality (p

Conclusions

The homogeneous effect of the COVID-19 spread on the excess mortality in the Lombardy districts suggests that, despite the unprecedented conditions, the pandemic reactions did not result in health disparities in the region.

Is reduced heart rate variability associated with functional somatic disorders? A cross-sectional population-based study; DanFunD

Por: Jorgensen · T. · Dantoft · T. M. · Petersen · M. W. · Gormsen · L. · Winter-Jensen · M. · Fink · P. · Linneberg · A. · Benros · M. E. · Eplov · L. F. · Bjerregaard · A. A. · Schovsbo · S. U. · Brinth · L. S.
Objectives

It has been hypothesised that functional somatic disorders (FSD) could be initiated by sympathetic predominance in the autonomic nervous system as measured by low heart rate variability (HRV). Earlier studies on the association between HRV and FSD are small case–control studies hampered by selection bias and do not consider the great overlap between the various FSDs. The aim of the present study is to assess any associations between HRV and various FSDs and whether chronic stress confounds such an association.

Design

A cross-sectional general population-based study.

Setting

The Danish Study of Functional Somatic Disorders conducted 2013–2015 in 10 municipalities in the western part of Greater Copenhagen, Denmark.

Participants

A total of 6891 men and women aged 18–72 years were included in the analyses after exclusion of 602 persons with missing HRV data. Various delimitations of FSD (chronic fatigue, chronic widespread pain, irritable bowel and bodily distress syndrome) were identified by validated questionnaires and diagnostic interviews. HRV parameters in time and frequency domains were calculated from successive beat-to-beat heart rate (HR) data using the ‘E-motion’ HR monitor device during 7 min of supine rest. Chronic stress was assessed by Cohen’s self-perceived stress scale.

Outcome measures

Logistic regression analyses were used to calculate possible associations between the various delimitations of FSD and HRV adjusting for chronic stress.

Results

Persons with FSD had a slightly higher mean HR and lower HRV as measured by time domain parameters, whereas associations with frequency domain parameters were not consistent. Adjusting for chronic stress attenuated associations slightly.

Conclusion

The study supports a sympathetic predominance in persons with FSD, which could not be entirely explained by chronic stress. However, it is not possible to conclude whether the association is a causal factor to or a consequence of FSD.

Empowering Ontarios long-term care residents to shape the place they call home: a codesign protocol

Por: Lee · C. · Tripp · D. · McVie · M. · Fineczko · J. · Ramsden · G. · Hothi · S. · Langston · J. · Gilhuly · J. · Collingwood · B. · McAiney · C. · McGilton · K. S. · Bethell · J.
Background

Canada’s long-term care (LTC) homes were founded on an institutional model that viewed residents as passive recipients of care. Many homes continue to follow this model leaving residents removed from operational decision-making within their homes. However, involving residents in the design of their LTC home’s environment, programmes and operations can improve the residents’ quality of life and other outcomes. This codesign project creates a toolkit/resource for LTC homes to facilitate meaningful resident engagement in their home’s organisational design and governance.

Method

This three-part project consists of a scoping review, qualitative interviews, toolkit/resource development and prototyping. In part 1, we conduct a scoping review to synthesise existing knowledge on approaches to engaging LTC home residents in organisational design and governance of their LTC homes, as well as explore barriers, challenges and facilitators of engagement, considerations for diversity and cognitive change, and approaches to evaluation. In part 2, we will have interviews and focus groups with residents, team members (staff) and administrators to assess community capacity to implement and sustain a programme to engage LTC residents in organisational design and governance of their LTC homes. The third part of our project uses these findings to help codesign toolkit(s)/resource(s) to enable the engagement of LTC residents in the organisational design and governance of their LTC homes.

Ethics and dissemination

The project is conducted in partnership with the Ontario Association of Residents’ Councils. We will leverage their communication to disseminate findings and support the use of the codesigned toolkit(s)/resource(S) with knowledge users. We will also publish the study results in an academic journal and present at conferences, webinars and workshops. These results can influence practices within LTC homes by inspiring an organisational culture where residents help shape the place they call home. The interviews and focus groups, conducted in part 2, have been submitted to the University Health Network Research Ethics Board.

Balloon dilation for the treatment of male urethral strictures: a systematic review and meta-analysis

Por: Li · X. · Xu · C. · Ji · X. · Zhu · Z. · Cai · T. · Guo · Z. · Lin · J.
Objective

The use of minimally invasive endoluminal treatment for urethral strictures has been a subject for debate for several decades. The aim of this study was to review and discuss the safety, efficacy and factors influencing the clinical application of balloon dilation for the treatment of male urethral strictures.

Design

Systematic review and meta-analysis.

Data sources

Embase, Medline, Web of Science, Cochrane Library and Scopus were searched for publications published before 17 July 2022.

Study selection

Two independent researchers screened and assessed the results, and all clinical studies on balloon dilation for the treatment of urethral strictures in men were included.

Data extraction and synthesis

The success rate, rate of adverse events, International Prostate Symptom Scores, maximum uroflow (Qmax) and postvoid residual urine volume were the main outcomes. Stata V.14.0 was used for statistical analysis.

Results

Fifteen studies with 715 patients were ultimately included in this systematic review. The pooled results of eight studies showed that the reported success rate of simple balloon dilation for male urethral strictures was 67.07% (95% confidence interval [CI]: 55.92% to 77.36%). The maximum urinary flow rate at 3 months (risk ratio [RR]= 2.6510, 95% CI: 1.0681 to 4.2338, p

Conclusion

Balloon dilation may be an intermediate step before urethroplasty and is a promising alternative therapy to simple dilation and DVIU. The balloon is a promising drug delivery tool, and paclitaxel drug-coated balloon dilation is effective in reducing retreatment rates in patients with recurrent anterior urethral strictures. The aetiology, location, length, previous treatment of urethral stricture may be associated with the efficacy of balloon dilation.

PROSPERO registration number

CRD42022334403.

Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

Por: Brittain · G. · Petrie · J. · Duffy · K. E. M. · Glover · R. · Hullock · K. · Papaioannou · D. · Roldan · E. · Beecher · C. · Bursnall · M. · Ciccarelli · O. · Coles · A. J. · Cooper · C. · Giovannoni · G. · Gabriel · I. · Kazmi · M. · Kyriakou · C. · Nicholas · R. · Paling · D. · Peniket
Introduction

Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.

Methods and analysis

StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.

Ethics and dissemination

The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.

Trial registration number

ISRCTN88667898.

Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol

Por: PelvEx Collaborative · West · West · Drami · Denys · Glyn · Sutton · Tiernan · Behrenbruch · Guerra · Waters · Woodward · Applin · Charles · Rose · Pape · van Ramshorst · Mirnezami · Aalbers · Abdul Aziz · Abecasis · Abraham-Nordling · Akiyoshi · Alahmadi · Alberda · Albert · And
Introduction

The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. ‘PelvEx—Beating the empty pelvis syndrome’ aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome.

Methods and analysis

A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting.

Ethics and dissemination

The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome.

Trial registration number

NCT05683795.

Sepsis policy, guidelines and standards in Canada: a jurisdictional scoping review protocol

Por: Sheikh · F. · Chechulina · V. · Daneman · N. · Garber · G. E. · Hendrick · K. · Kissoon · N. · Loubani · O. · Russell · K. · Fox-Robichaud · A. · Schwartz · L. · Barrett · K.
Introduction

To our knowledge, this study is the first to identify and describe current sepsis policies, clinical practice guidelines, and health professional training standards in Canada to inform evidence-based policy recommendations.

Methods and analysis

This study will be designed and reported according to the Arksey and O’Malley framework for scoping reviews and the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews. EMBASE, CINAHL, Medline, Turning Research Into Practice and Policy Commons will be searched for policies, clinical practice guidelines and health professional training standards published or updated in 2010 onwards, and related to the identification, management or reporting of sepsis in Canada. Additional sources of evidence will be identified by searching the websites of Canadian organisations responsible for regulating the training of healthcare professionals and reporting health outcomes. All potentially eligible sources of evidence will be reviewed for inclusion, followed by data extraction, independently and in duplicate. The included policies will be collated and summarised to inform future evidence-based sepsis policy recommendations.

Ethics and dissemination

The proposed study does not require ethics approval. The results of the study will be submitted for publication in a peer-reviewed journal and presented at local, national and international forums.

Effectiveness of dexmedetomidine during surgery under general anaesthesia on patient-centred outcomes: a systematic review and Bayesian meta-analysis protocol

Por: Verret · M. · Le · J. B. P. · Lalu · M. M. · McIsaac · D. I. · Nicholls · S. · Turgeon · A. F. · Hutton · B. · Zivkovic · F. · Graham · M. · Le · M. · Geist · A. · Berube · M. · Gilron · I. · Poulin · P. · Daudt · H. · Martel · G. · McVicar · J. · Moloo · H. · Fergusson · D. A.
Introduction

Dexmedetomidine is a promising pharmaceutical strategy to minimise opioid use during surgery. Despite its growing use, it is uncertain whether dexmedetomidine can improve patient-centred outcomes such as quality of recovery and pain.

Methods and analysis

We will conduct a systematic review and meta-analysis following the recommendations of the Cochrane Handbook for Systematic Reviews. We will search MEDLINE, Embase, CENTRAL, Web of Science and CINAHL approximately in October 2023. We will include randomised controlled trials evaluating the impact of systemic intraoperative dexmedetomidine on patient-centred outcomes. Patient-centred outcome definition will be based on the consensus definition established by the Standardised Endpoints in Perioperative Medicine initiative (StEP-COMPAC). Our primary outcome will be the quality of recovery after surgery. Our secondary outcomes will be patient well-being, function, health-related quality of life, life impact, multidimensional assessment of postoperative acute pain, chronic pain, persistent postoperative opioid use, opioid-related adverse events, hospital length of stay and adverse events. Two reviewers will independently screen and identify trials and extract data. We will evaluate the risk of bias of trials using the Cochrane Risk of Bias Tool (RoB 2.0). We will synthesise data using a random effects Bayesian model framework, estimating the probability of achieving a benefit and its clinical significance. We will assess statistical heterogeneity with the tau-squared and explore sources of heterogeneity with meta-regression. We have involved patient partners, clinicians, methodologists, and key partner organisations in the development of this protocol, and we plan to continue this collaboration throughout all phases of this systematic review.

Ethics and dissemination

Our systematic review does not require research ethics approval. It will help inform current clinical practice guidelines and guide development of future randomised controlled trials. The results will be disseminated in open-access peer-reviewed journals, presented at conferences and shared among collaborators and networks.

PROSPERO registration number

CRD42023439896.

Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

Por: Al-Hendy · A. · Segars · J. H. · Taylor · H. S. · Gonzalez · F. · Siblini · H. · Zamah · M. · Alkelani · H. · Singh · B. · Flores · V. A. · Christman · G. M. · Johnson · J. J. · Huang · H. · Zhang · H.
Introduction

Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

Methods and analysis

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

Ethics and dissemination

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

Trial registration number

NCT05364008.

Climate footprint of industry-sponsored clinical research: an analysis of a phase-1 randomised clinical study and discussion of opportunities to reduce its impact

Por: LaRoche · J. K. · Alvarenga · R. · Collins · M. · Costelloe · T. · De Soete · W. · Faludi · J. · Rens · K.
Objective

This study aims to calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from all in-scope activities involved in a phase-1 clinical study.

Design

Retrospective analysis.

Data source

Internal data held by Janssen Pharmaceuticals.

Studies included

Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019 and 2021.

Main outcome

Measure CO2 equivalents (CO2e) for in-scope clinical trial activities calculated according to intergovernmental panel on climate change 2021 impact assessment methodology.

Results

The CO2e emissions generated by the trial were 17.65 tonnes. This is equivalent to the emissions generated by driving an average petrol-fueled family car 71 004 km or roughly 1.8 times around the circumference of the Earth. Commuting to the clinical site by the study participants generated the most emissions (5419 kg, 31% of overall emissions), followed by trial site utilities (2725 kg, 16% of overall emissions) and site staff travel (2560 kg, 15% of overall emissions). In total, the movement of people (participant travel, site staff travel and trial site staff travel) accounted for 8914 kg or 51% of overall trial emissions.

Conclusions

Decentralised trial models which seek to bring clinical trial operations closer to the participant offer opportunities to reduce participant travel. The electrification of sponsor vehicle fleets and society’s transition towards electric vehicles may result in further reductions.

Trial registration number

NCT04208061.

Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients (PISCES): protocol for a randomised controlled trial

Por: Lok · C. E. · Hemmelgarn · B. R. · Moist · L. M. · Polkinghorne · K. · Tomlinson · G. · Tonelli · M.
Introduction

Patients with kidney failure with replacement therapy (KFRT) suffer premature cardiovascular (CV) mortality and events with few proven pharmacological interventions. Omega-3 polyunsaturated essential fatty acids (n-3 PUFAs) are associated with a reduced risk of CV events and death in non-dialysis patients and in patients with established CV disease but n-3 PUFAs have not been evaluated in the high risk KFRT patient population.

Methods and analysis

This multicentre randomised, placebo controlled, parallel pragmatic clinical trial tests the hypothesis that oral supplementation with n-3 PUFA, when added to usual care, leads to a reduction in the rate of serious CV events in haemodialysis patients when compared with usual care plus matching placebo. A target sample size of 1100 KFRT patients will be recruited from 26 dialysis units in Canada and Australia and randomised to n-3 PUFA or matched placebo in a 1:1 ratio with an expected intervention period of at least 3.5 years. The primary outcome to be analysed and compared between intervention groups is the rate of all, not just the first, serious CV events which include sudden and non-sudden cardiac death, fatal and non-fatal myocardial infarction, stroke, and peripheral vascular disease events.

Ethics and dissemination

This study has been approved by all institutional ethics review boards involved in the study. Participants could only be enrolled following informed written consent. Results will be published in peer-reviewed journals and presented at scientific and clinical conferences.

Trial registration number

ISRCTN00691795

Characterising respiratory infections among hospitalised children during the COVID-19 pandemic in southeastern China: a cross-sectional study of pathogens and clinical association

Por: Huang · H. · Wu · B. · Lin · W.
Objective

Children with acute respiratory tract infections (ARTIs) pose significantly burden on healthcare facilities due to high hospitalisation rates and mortality. However, limited epidemiological and clinical characteristics data on ARTIs in southeastern China during the COVID-19 pandemic exists.

Design

Cross-sectional.

Setting

Tertiary hospital associated with the First Affiliated Hospital, Fujian Medical University, China.

Participants

1007 hospitalised children diagnosed with ARTIs, aged 30 days to 15 years, were enrolled in this study from 1 January 2020 to 31 December 2021.

Outcome measure

The primary outcomes are the rate of pathogen infections in children with ARTIs. Secondary outcomes are the description of risk factors associated with ARTIs in children.

Results

Of the 1007 enrolled children, 28.2%, 42.2%, 21.8% and 7.7% were diagnosed with upper respiratory tract infection, bronchopneumonia, bronchitis and pneumonia, respectively. Mycoplasma pneumoniae (MP) was the most prevalent pathogen (31.9%), followed by influenza B virus (IFVB; 29.1%) and influenza A virus (IFVA; 19.1%). The study found that children under 1 year old (older than 30 days: ORIFVB=12.50; ORMP=8.53), children aged 1–3 years (ORMP=1.62), the winter season (ORIFVA=1.36), the time from symptoms onset to hospitalisation (ORMP=1.10) and increased precipitation (ORLP=1.01) were high-risk factors for ARTIs.

Conclusion

This investigation offers significant insights into the prevalence and distribution of common pathogens among children experiencing ARTIs in the context of the COVID-19 pandemic. The discernment of high-risk factors linked to these pathogens enhances our understanding of the epidemiological characteristics of ARTIs in children.

Baduanjin exercise intervention trial: research protocol of a randomised controlled trial for frail kidney transplant recipients

Por: Lin · K. · Fang · J. · Zhang · S. · Ding · Z. · Hu · Y. · Zhang · B. · Guo · X. · Liu · H. · Zhao · P.
Introduction

Frailty is one of the most common comorbidities in kidney transplant recipients (KTRs). Physical, psychological and social frailty could be improved by exercise intervention. Baduanjin, also known as Eight-section Brocades, is a type of traditional Chinese medicine exercise characterised by the interplay between physical postures and movements, breathing and mind. It can help frail patients strengthen their upper and lower body muscles, improve their mood, quality of life and frailty. However, the effectiveness of Baduanjin on frail KTRs remains unknown. Therefore, we will conduct a randomised controlled trial (RCT) to evaluate the effectiveness of Baduanjin on frail KTRs.

Methods and analysis

This protocol describes an assessor and analyst blinded, parallel RCT for frail KTRs comparing Baduanjin group (n=72) with care-as-usual group (n=72). The primary outcomes are frailty assessed by Frailty Phenotype scale and Tilburg Frailty Indicator scale, and muscle strength assessed by a grip strength metre. The secondary outcomes are quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (MOS SF-36) and depression assessed by the Hospital Anxiety and Depression Scale. All these data will be collected at the baseline, after 3, 6, 9 and 12 months, respectively. Two-way mixed analysis of variance (ANOVA) will be used to test the effectiveness of Baduanjin exercise. Qualitative interviews with participants in the intervention group will also be performed after 6 months. Themes will be extracted from interview transcripts using NVivo software.

Ethics and dissemination

The Ethics Committees of Beijing University of Chinese Medicine (2022BZYLL1018) and China-Japan Friendship Hospital (2022-KY-250) had approved the study. The organ donors were all from China-Japan Friendship Hospital. They provided informed consent and they were not executed prisoners. We have provided BMJ Open with documentation from the hospital that indicates that the organs will be harvested ethically. The findings of this study will be disseminated through peer-reviewed journals, international conferences, media reports and briefings.

Trial registration number

ChiCTR2100041730

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.

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