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AnteayerBMJ Open

Qualitative study exploring the design of a patient-reported symptom-based risk stratification system for suspected head and neck cancer referrals: protocol for work packages 1 and 2 within the EVEREST-HN programme

Por: Albutt · A. · Hardman · J. · McVey · L. · Odo · C. · Paleri · V. · Patterson · J. · Webb · S. · Rousseau · N. · Kellar · I. · Randell · R.
Introduction

Between 2009/2010 and 2019/2020, England witnessed an increase in suspected head and neck cancer (sHNC) referrals from 140 to 404 patients per 100 000 population. 1 in 10 patients are not seen within the 2-week target, contributing to patient anxiety. We will develop a pathway for sHNC referrals, based on the Head and Neck Cancer Risk Calculator. The evolution of a patient-reported symptom-based risk stratification system to redesign the sHNC referral pathway (EVEREST-HN) Programme comprises six work packages (WPs). This protocol describes WP1 and WP2. WP1 will obtain an understanding of language to optimise the SYmptom iNput Clinical (SYNC) system patient-reported symptom questionnaire for sHNC referrals and outline requirements for the SYNC system. WP2 will codesign key elements of the SYNC system, including the SYNC Questionnaire, and accompanying behaviour change materials.

Methods and analysis

WP1 will be conducted at three acute National Health Service (NHS) trusts with variation in service delivery models and ensuring a broad mixture of social, economic and cultural backgrounds of participants. Up to 150 patients with sHNC (n=50 per site) and 15 clinicians (n=5 per site) will be recruited. WP1 will use qualitative methods including interviews, observation and recordings of consultations. Rapid qualitative analysis and inductive thematic analysis will be used to analyse the data. WP2 will recruit lay patient representatives to participate in online focus groups (n=8 per focus group), think-aloud technique and experience-based codesign and will be analysed using qualitative and quantitative approaches.

Ethics and dissemination

The committee for clinical research at The Royal Marsden, a research ethics committee and the Health Research Authority approved this protocol. All participants will give informed consent. Ethical issues of working with patients on an urgent cancer diagnostic pathway have been considered. Findings will be disseminated via journal publications, conference presentations and public engagement activities.

Prospective cohort study of genomic newborn screening: BabyScreen+ pilot study protocol

Por: Lunke · S. · Bouffler · S. E. · Downie · L. · Caruana · J. · Amor · D. J. · Archibald · A. · Bombard · Y. · Christodoulou · J. · Clausen · M. · De Fazio · P. · Greaves · R. F. · Hollizeck · S. · Kanga-Parabia · A. · Lang · N. · Lynch · F. · Peters · R. · Sadedin · S. · Tutty · E. · Eggers
Introduction

Newborn bloodspot screening (NBS) is a highly successful public health programme that uses biochemical and other assays to screen for severe but treatable childhood-onset conditions. Introducing genomic sequencing into NBS programmes increases the range of detectable conditions but raises practical and ethical issues. Evidence from prospectively ascertained cohorts is required to guide policy and future implementation. This study aims to develop, implement and evaluate a genomic NBS (gNBS) pilot programme.

Methods and analysis

The BabyScreen+ study will pilot gNBS in three phases. In the preimplementation phase, study materials, including education resources, decision support and data collection tools, will be designed. Focus groups and key informant interviews will also be undertaken to inform delivery of the study and future gNBS programmes. During the implementation phase, we will prospectively recruit birth parents in Victoria, Australia, to screen 1000 newborns for over 600 severe, treatable, childhood-onset conditions. Clinically accredited whole genome sequencing will be performed following standard NBS using the same sample. High chance results will be returned by genetic healthcare professionals, with follow-on genetic and other confirmatory testing and referral to specialist services as required. The postimplementation phase will evaluate the feasibility of gNBS as the primary aim, and assess ethical, implementation, psychosocial and health economic factors to inform future service delivery.

Ethics and dissemination

This project received ethics approval from the Royal Children’s Hospital Melbourne Research Ethics Committee: HREC/91500/RCHM-2023, HREC/90929/RCHM-2022 and HREC/91392/RCHM-2022. Findings will be disseminated to policy-makers, and through peer-reviewed journals and conferences.

Can an integrated intervention package including peer support increase the proportion of health facility births? A cluster randomised controlled trial in Northern Uganda

Por: Nankabirwa · V. · Mukunya · D. · Ndeezi · G. · Odongkara · B. · Arach · A. A. · Achora · V. · Mugenyi · L. · Sebit · M. B. · Wandabwa · J. N. · Waako · P. · Tylleskär · T. · Tumwine · J. K.
Objective

To assess the effect of an integrated intervention package compared with routine government health services on the frequency of health facility births.

Setting

Three subcounties of Lira district in Northern Uganda.

Design

A cluster randomised controlled trial where a total of 30 clusters were randomised in a ratio of 1:1 to intervention or standard of care.

Participants

Pregnant women at ≥28 weeks of gestation.

Interventions

Participants in the intervention arm received an integrated intervention package of peer support, mobile phone messaging and birthing kits during pregnancy while those in the control arm received routine government health services (‘standard of care’).

Primary and secondary outcome measures

The primary outcome was the proportion of women giving birth at a health facility in the intervention arm compared with the control arm. Secondary outcomes were perinatal and neonatal deaths.

Results

In 2018–2019, 995 pregnant women were included in 15 intervention clusters and 882 in 15 control clusters. The primary outcome was ascertained for all except one participant who died before childbirth. In the intervention arm, 754/994 participants (76%) gave birth at a health facility compared with 500/882 (57%) in the control arm. Participants in the intervention arm were 35% more likely to give birth at a health facility compared with participants in the control arm, (risk ratio 1.35 (95% CI 1.20 to 1.51)) and (risk difference 0.20 (95% CI 0.13 to 0.27)). Adjusting for baseline differences generated similar results. There was no difference in secondary outcomes (perinatal or neonatal mortality or number of postnatal visits) between arms.

Conclusion

The intervention was successful in increasing the proportion of facility-based births but did not reduce perinatal or neonatal mortality.

Trial registration number

NCT02605369

How do they cope? A national cross-sectional study of coping in hospital doctors in Ireland

Por: Doherty · A. · Prihodova · L. · Walsh · G. · Hayes · B.
Objectives

To measure coping strategies and associated psychological distress, burnout and work ability in hospital doctors in Ireland.

Design

National cross-sectional study of randomised sample of trainee and consultant hospital doctors.

Setting

Irish publicly funded hospitals and residential institutions.

Participants

1749 doctors returned surveys (55% response rate).

Outcome measures

Dependent variables were psychological distress (measured using 12-item General Health Questionnaire), burnout (Maslach Burnout Inventory) and work ability (single-item measure). Adaptive and maladaptive coping strategies (Brief Coping Orientation to Problems Experienced) were covariates.

Results

The coping mechanism most frequently reported by this cohort was the adaptive strategy of active planning. Increased mean hours worked (MHW) (OR 1.02; 95% CI 1.01 to 1.03), a low Work Ability Score (OR 3.23; 95% CI 2.47 to 4.23) and maladaptive coping strategies (OR 1.26; 95% CI 1.22 to 1.31) were significantly associated with psychological distress. Adaptive coping was associated with decreased psychological distress (OR 0.98; 95% CI 0.97 to 1.00). Increased MHW (OR 0.98; 95% CI 0.97 to 0.99), insufficient work ability (OR 0.62; 95% CI 0.48 to 0.80) and maladaptive coping (OR 0.87; 95% CI 0.85 to 0.89) were significantly associated with burnout. Increased MHW (OR 0.99; 95% CI 0.98 to 1.00) and maladaptive coping (OR 0.90, 95% CI 0.88 to 0.92) were significantly associated with insufficient work ability.

Conclusions

Adaptive coping is associated with decreased psychological distress but does not mitigate the effect of increased work hours, which are associated with burnout, distress and insufficient work ability, regardless of a doctor’s coping style. The burden of psychological distress on doctors cannot be mitigated meaningfully unless workplace factors are addressed.

Qualitative interview study exploring the perspectives of pregnant women on participating in controlled human infection research in the UK

Por: Dorey · R. B. · Theodosiou · A. A. · Read · R. C. · Vandrevala · T. · Jones · C. E.
Introduction

Pregnant women have been historically excluded from interventional research. While recent efforts have been made to improve their involvement, there remains a disparity in the evidence base for treatments available to pregnant women compared with the non-pregnant population. A significant barrier to the enrolment of pregnant women within research is risk perception and a poor understanding of decision-making in this population.

Objective

Assess the risk perception and influences on decision-making in pregnant women, when considering whether to enrol in a hypothetical interventional research study.

Design

Semistructured interviews were undertaken, and thematic analysis was undertaken of participant responses.

Participants

Twelve pregnant women were enrolled from an antenatal outpatient clinic.

Results

Participants were unanimously positive about enrolling in the proposed hypothetical interventional study. Risk perception was influenced by potential risks to their fetus and their previous experiences of healthcare and research. Participants found the uncertainty in quantifying risk for new research interventions challenging. They were motivated to enrol in research by altruism and found less invasive research interventions more tolerable.

Conclusion

It is vital to understand how pregnant women balance the perceived risks and benefits of interventional research. This may help clinicians and scientists better communicate risk to pregnant women and address the ongoing under-representation of pregnant women in interventional research.

Social determinants of alcohol-related traumatic injury in young adults: a scoping review protocol

Por: Goodon · H. · Czyrnyj · C. · Comaskey · B. · Gawaziuk · J. · Logsetty · S. · Spiwak · R.
Introduction

Limited research examines alcohol-related injury in the context of social determinants of health (SDoH) to guide effective intervention and prevention programmes. SDoH are non-medical factors that impact health such as income, housing and childhood environment. This scoping review aims to explore the role SDoH in childhood have in alcohol-related injury in young adults.

Methods and analysis

The scoping review process will be guided by the methodology framework of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols Extension for Scoping Reviews Guidelines (PRISMA-ScR). The PubMed and SCOPUS databases will be systematically searched. Studies of various designs and methodologies (published in English since 1 January 2000) that examine certain SDoH of interest in relation to alcohol-related injury in adults aged 18–25 years old will be considered for inclusion in this review. Two reviewers will screen all articles identified from the databases independently. Titles and abstracts will be reviewed based on the initial search and included if eligibility criteria are met. Duplicate articles will be removed and full texts will be examined to create a final list of included studies. Any disagreements on the inclusion of any articles will be resolved through discussion and consultation with a third reviewer if necessary.

Ethics and dissemination

As this research does not involve human subjects, ethics approval is not required. The results of this study will be summarised quantitatively through numerical counts and qualitatively through a narrative synthesis. The results from this review will address an important literature gap and inform the development of targeted prevention programmes for alcohol-related injury.

Registration number

This protocol is registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/MYEXA).

Lost in translation: how can education about dementia be effectively integrated into medical school contexts? A realist synthesis

Por: Tullo · E. · Wakeling · L. · Pearse · R. · Kheng Khoo · T. · Teodorczuk · A.
Objectives

The prevalence of dementia in both community and hospital settings requires a clinical workforce that is skilled in diagnosis and management of the condition to competently care for patients. Though evidence of successful educational interventions about dementia exists, effective translation into medical school curricula is the exception rather than the norm.

Design

We adopted a realist synthesis approach following Realist And MEta-narrative Evidence Syntheses: Evolving Standards (RAMESES) guidelines to answer the following questions: (1) what are the barriers to integrating effective interventions about dementia into medical school curricula and (2) where they are successfully delivered, what are the contextual factors that allow for this enactment?

Data sources

We searched PubMed, Embase, CINAHL and PsycINFO using the MesH terms Schools, Medical; Students, Medical; Education, Medical AND Neurocognitive disorders or the closest possible set of terms within each database.

Eligibility criteria

Undergraduate or graduate entry medical school programme, teaching and learning focussing on dementia, evaluating student outcomes (satisfaction, knowledge, skills, attitudes or behaviours), interventions described clearly enough to classify teaching method, any research design (quantitative and qualitative), English language.

Data extraction and synthesis

We used a shared spreadsheet to enter key information about eligible studies and the reasons for excluding studies that did not fit eligibility criteria. We extracted descriptive data about the nature of educational interventions and narrative information as to barriers and facilitators to implementing those interventions.

Results

Our initial literature search identified 16 relevant papers for review. Systematic extraction of data informed the development of an initial programme theory (IPT) structured around four contextual barriers: ‘culture’, ‘concern for patient welfare’, ‘student attitudes’ and ‘logistics’ with associated facilitatory mechanisms embed medical education about dementia.

Conclusions

We outline the process of generating our IPT, including overlap with Cultural Historical Activity Theory. We outline our intention to refine our programme theory through ongoing review of the evidence base and collaboration with stakeholders, with the aim of finalising a model for successful integration of dementia education.

Prevalence and determinants of high-risk human papilloma virus among men who have sex with men in Benin: a cross-sectional study embedded in a demonstration project on pre-exposure prophylaxis against HIV

Por: Diabate · S. · Behanzin · L. · Guedou · F. · Olodo · M. · Goma-Matsetse · A. E. · Aza-Gnandji · M. · Dossouvo · A. · Akpaca · A. · Chagas · E. · Gangbo · F. A. · Zannou · D. M. · Alary · M.
Objectives

This study aims to assess the prevalence and factors associated with anal high-risk human papilloma virus (HR-HPV).

Design

A cross-sectional study conducted from 24 August 2020 to 24 November 2020.

Setting

Primary care, Cotonou, Benin.

Participants

204 HIV-negative men who have sex with men initiating oral pre-exposure prophylaxis.

Primary outcome measure

Anal HR-HPV genotypes using GeneXpert HPV assay. Fourteen HR-HPV were evaluated: HPV-16 and HPV-18/45 in 2 distinct channels and the 11 other genotypes as a pooled result (31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68). The potential independent variables analysed included anal gonorrhoea and chlamydia infections, and sociodemographic and sexual behaviour factors. To assess the determinants of HR-HPV, univariate and multivariate Poisson regression models were performed by using SAS V.9.4.

Results

Mean age±SD was 25.9±4.8 years. 131/204 men claimed insertive sex procured more pleasure. Thirty-two participants, accounting for 15.7% of the study sample, had gonorrhoea and/or chlamydia. The prevalence of any HR-HPV genotype was 36.3% (95% CI 30.0% to 43.0%). In total, 7.8% of men had HPV-16 and 7.4% had HPV-18/45. The prevalence for the pooled genotypes (31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68) was 29.9%. Receptive anal sex during the last 6 months was strongly associated with prevalent HR-HPV infections. The adjusted proportion ratio (aPR) was 1.93 (95% CI 1.31 to 2.83). Gonorrhoea and chlamydia were also associated with the outcome of interest; p value for both infections was

Conclusions

In Benin, anal HR-HPV was common among HIV-negative men who have sex with men. Among this highly vulnerable population, there is a need for integrated preventive and management strategies targeting HPV and other sexually transmitted infections.

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