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Understanding preferences for behaviour change support as part of the NHS Health Check: a qualitative study with adults from underserved minoritised ethnic communities

Por: Griffiths · S. · Bartlett · Y. K. · French · D. P. · McMillan · B.
Introduction

NHS Health Checks (NHSHCs) provide individuals with cardiovascular disease (CVD) risk scores alongside advice and signposting to behaviour change support. A particular problem is that the support people receive is often poorly delivered, absent or not tailored to the needs of people in deprived communities, which risks exacerbating health inequalities. Improving this support is critical if NHSHCs are to achieve their goals of prevention and equity.

Objectives

To explore needs and preferences for behaviour change support among adults in deprived areas, using a digital prototype presenting CVD risk information and signposting to services.

Design

A longitudinal qualitative study involving focus groups and semi-structured follow-up interviews.

Participants and setting

Adults from minoritised ethnic groups eligible for NHSHCs, recruited online and through a community centre, with both methods targeting high-deprivation areas.

Method

Participants were first shown the digital prototype in focus groups to generate discussion. Follow-up interviews captured more in-depth reflections on needs for behaviour change support. Data were analysed using reflexive thematic analysis.

Results

We conducted four focus groups and 20 follow-up interviews with 23 adults, predominantly of South Asian ethnicity living in areas of high deprivation. We developed three themes: (1) Trusted information to counter confusion and misinformation; (2) Support that makes change feel possible and meaningful, through culturally and personally relevant advice that addresses unhelpful beliefs about risk reduction and behaviour change and (3) Ensuring access to inclusive, socially connected environments that feel supportive and conducive to action.

Conclusions

For minoritised ethnic adults in deprived areas, NHSHC support should build on everyday practices and foster positive perceptions of services. Alongside service-level changes, policy action is needed to remove structural barriers (eg, cost, safety) that limit people’s ability to act on advice. Such changes could enhance the programme’s contribution to reducing inequalities in CVD prevention.

Impact of drug-resistance diagnosis based on whole-genome sequencing on the treatment adequacy of patients with drug-resistant pulmonary tuberculosis in the state of Sao Paulo, Brazil: a protocol for a non-randomised controlled trial (Gen-TB ProCura)

Por: Rosa · C. D. · Ferrazoli · L. · dos Santos · D. P. · Pedace · C. · Soler-Camargo · N. C. · Silva-Pereira · T. T. · Brandao · A. P. · Bollela · V. R. · Cruz · A. L. G. · Feliciano · C. S. · Ferreira · P. R. A. · Jorge · E. P. · de Miranda · S. S. · de Oliveira · R. S. · Oliveira · M.
Introduction

Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.

Methods and analysis

We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.

Ethics and dissemination

Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.

Trial registration number

U1111-1308-4669.

Effect of music therapy on vital signs and heart rate variability of paediatric patients during the extubation process in the paediatric intensive care unit: a multicentre randomised clinical trial protocol

Por: Beltran · Y. M. · Charum · D. P. · Zuluaga · C. A. · Vega · M. A. · Benavides-Cruz · J. · Amarillo · M. · Canon · E. · Alvarez · I. · Ramirez-Moreno · J. · Paez · L. · Garzon · M. C. · Calderon · P. D. · Quintero · T. C. · Moreno · J. · Ettenberger · M.
Introduction

A successful extubation process is critical for the future health outcomes of paediatric patients, as it tests the functioning of the respiratory system without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety or discomfort in patients, which may sometimes lead to an increased likelihood of reintubation. Music-based interventions and therapies have been shown to be effective in reducing anxiety and stress levels in ventilated patients in the paediatric intensive care unit (PICU), but studies evaluating the effect of music therapy during the extubation process in the PICU are scarce.

Methods and analysis

This is a pragmatic multicentre randomised clinical trial with two parallel arms. The intervention group will receive standard care + music therapy during the extubation process, and the control group will receive standard care alone. The main outcome measure is heart rate, which will be measured every minute for 5 min pre-extubation, during the extubation process and up to 10 min postextubation. Secondary outcome measures are: oxygen saturation, respiratory rate, blood pressure and heart rate variability. A total of 82 patients will be randomised.

Ethics and dissemination

This study was approved by the Research Ethics Committee of the Fundación Universitaria Sanitas (CEIFUS 1356-24, date of approval: 3 May 2024). All parents or legal guardians of patients will sign a written informed consent, and if applicable, assent from participants will be sought. The results will be disseminated through publications in peer-reviewed journals, conferences and presentations at the hospitals’ clinical committees.

Protocol version

Version 1.0, 18 December 2024.

Trial registration number

NCT06591533, trial registration date: 10 September 2024.

Efficacy of virtual reality in reducing pain, anxiety and fear in hospitalised children: a systematic review and meta-analysis protocol

Introduction

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

Method and analysis

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

Ethics and dissemination

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

PROSPERO registration number

CRD42024568297.

Global mapping of oral health plans, programmes and policies in countries with universal health coverage: a scoping review protocol

Introduction

This review aims to map oral health plans, programmes and policies worldwide in countries with universal health coverage.

Methods and analysis

This protocol describes a scoping review that will follow the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review checklist, guided by the PCC framework: Population—countries with universal health coverage (78 globally recognised); Concept—oral health plans, programmes and policies; Context—integration into health systems. Searches will be conducted in MEDLINE (PubMed), Scopus, Web of Science, Embase, Health System Evidence and Epistemonikos, with no restrictions on date, language or study type. Grey literature will be accessed through Google Scholar, OpenThesis and the Brazilian Digital Library of Theses and Dissertations. Official documents from ministries of health and international bodies, including the WHO and the International Monetary Fund, will also be reviewed. Two independent reviewers will screen titles and abstracts; a third will resolve disagreements. Eligible records will undergo full-text review. Data will be extracted into predefined categories reflecting health system components: population, structure, services, governance and oral health indicators. Results will be presented using tables, charts and figures to illustrate strategies and innovations.

Ethics and dissemination

This review does not involve primary data collection and does not require ethical approval. Results will be disseminated through a peer-reviewed publication and presentations at academic conferences and scientific events.

Study registration

Open Science Framework (DOI 10.17605/OSF.IO/RCP8N).

Effectiveness of aromatherapy in pain relief postcardiac surgery: a systematic review and meta-analysis protocol

Introduction

Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.

Methods and analysis

Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.

Ethics and dissemination

This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.

PROSPERO registration number

CRD42024568532.

'For the love of God, just refer me: a co-produced qualitative study of the experiences of people with Tourette Syndrome and tic disorders accessing healthcare services in the UK

Por: Babbage · C. M. · Davies · E. B. · Jones · D. P. · Stevenson · P. · Salvage · J. · Anderson · S. · McNally · E. · Groom · M. J.
Objectives

Chronic tic disorders (CTDs)—such as Tourette Syndrome (TS)—are neurodevelopmental disorders affecting at least 1% of the population, causing repetitive involuntary movements and vocalisations known as tics. This study aimed to explore the lived experiences of accessing healthcare for people with CTD or TS and their families in the United Kingdom (UK), as part of a larger programme of work to inform change to healthcare services for this population.

Design

Informed and designed with extensive patient and public involvement, the design utilised qualitative research using focus groups. Reflexive thematic analysis was used to analyse the data.

Setting

Participants were recruited via online support groups, social media and research registers.

Participants

Seven focus groups were held separately with young people with tics (n=2), adults with tics (n=10) and parents/guardians of children with tics (n=11), led by a lived experience expert (coauthor PS) and facilitated by researchers. Discussion focused on three areas: the impact of living with tics, experience accessing healthcare for tics and management of tics.

Results

Five themes were developed highlighting challenges across the healthcare pathway, including gaining a diagnosis, and receiving treatment, resulting in the use of self-support methods to reduce tic expression or the impact of tics. Themes also illustrated perceptions that healthcare provider's knowledge impacted initial interactions with the healthcare system, and how healthcare systems were not felt to be prioritising CTDs.

Conclusions

The findings highlight a lack of prioritisation for tic disorders compounded by a healthcare structure which does not support a complex condition that requires a multidisciplinary approach. This research calls for improvements to UK healthcare services for CTD.

Propofol-based versus sevoflurane-based anaesthesia for deceased donor kidney transplantation: the VAPOR-2 study protocol for an international multicentre randomised controlled trial

Por: Huisman · G. J. J. · Berger · S. P. · Thyrrestrup · P. S. · Hausken · J. · Veelo · D. P. · Guirado · L. · Pol · R. · Jensen · L. L. · Tonnessen · T. I. · Bemelman · F. J. · Facundo · C. · THE VAPOR-2 STUDY GROUP · Tamasi · K. · Lunter · G. · Jespersen · B. · Leuvenink · H. G. D. · Str
Introduction

Ischaemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively affects patient and graft outcomes. Anaesthetic conditioning (AC) refers to the use of anaesthetic agents to mitigate IRI. AC is particularly associated with volatile anaesthetic (VA) agents and to a lesser extent to intravenous agents like propofol. VA like sevoflurane interferes with many of the processes underlying IRI and exerts renal protective properties in various models of injury and inflammation. We hypothesise that a sevoflurane-based anaesthesia is able to induce AC and thereby reduce post-transplant renal injury, reflected in improved graft and patient outcome, compared with a propofol-based anaesthesia in transplant recipients of a deceased donor kidney.

Methods and analysis

Investigator-initiated, multicentre, randomised, controlled and prospective clinical trial with two parallel groups. The study will include 488 kidney transplant recipients from donation after brain death (DBD) or donation after circulatory death (DCD) donors. Participants are randomised in a 1:1 design to a sevoflurane (intervention) or propofol (control) group. The primary endpoint is the incidence of delayed graft function in recipients of DCD and DBD donor kidneys and/or 1-year biopsy-proven and treated acute rejection. Secondary endpoints include functional delayed graft function defined as failure of serum creatinine levels to decrease by at least 10% per day for three consecutive days; primary non-function is defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kinds, estimated glomerular filtration rate at 1 week and 3 and 12 months calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; readmissions at 3 and 12 months, graft survival and all-cause mortality at 12 months.

Ethics and dissemination

The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2025.

Trial registration number

NCT02727296.

Establishing a framework of measurement for use in Long COVID research and practice: protocol for a scoping review involving evidence review and consultation

Por: McDuff · K. · Bhereur · A. · Kadakia · Z. · Corrales-Medina · V. F. · Gross · D. P. · Janaudis-Ferreira · T. · Lam · G. · Naik · H. · Paterson · T. S. E. · Sanchez-Ramirez · D. C. · Sasseville · M. · Sekar · A. · Vohra · S. · Bayley · M. · Birch · S. · Busse · J. W. · Cameron · J. I. · K
Introduction

Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers.

Methods and analysis

We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O’Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? Evidence review: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team.

Ethics and dissemination

Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.

Method for Observing SMOKing and vaping bEhaviours (MOSMOKE): development and validation of a systematic observation tool

Por: Benton · J. S. · Berg · S. · Kapadi · A. · Bendel · N. · Jerram · J. · French · D. P.
Objective

Policies and interventions increasingly aim to reduce smoking in outdoor public spaces, but evidence on factors influencing smoking in specific locations remains limited. Systematic observation can unobtrusively assess behaviours in environmental contexts, reducing biases from self-report. This study aims to develop and test the reliability and validity of MOSMOKE (Method for Observing SMOKing and vaping bEhaviours): a new tool for assessing the number of people holding or inhaling a cigarette or vape in public spaces.

Design

MOSMOKE was adapted from a previously validated observation tool for assessing physical activity and well-being behaviours. Following piloting and refinement, inter-rater reliability for assessing smoking, vaping and age group classification was analysed using intraclass correlation coefficients (ICCs). A main study assessed criterion-related validity through 32 hours of observations over 4 days. A 2x2 study design was used, with four sites selected that varied by two environmental characteristics: presence of a smoking bin and adjacency to an office block.

Setting

Four public spaces in Manchester, UK.

Results

Inter-rater reliability was ‘good’ (ICCs>0.75; n=4) or ‘excellent’ (ICCs>0.90; n=2) for smoking behaviours, and mostly ‘good’ (n=4) or ‘excellent’ (n=1) for vaping behaviours. Observed differences in smoking and vaping behaviours across sites aligned with prespecified hypotheses that smoking would be more prevalent near smoking bins (p=0.02) and office entrances (p=0.006), supporting criterion-related validity.

Conclusions

This study provides preliminary evidence that MOSMOKE is a reliable and valid tool for unobtrusively assessing smoking and vaping in public spaces. It can be used to evaluate policies and interventions targeting smoking or vaping in specific environmental contexts. MOSMOKE is freely available, with a detailed manual to support its use.

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