• Correction to: The LUCID study: living with ulcerative colitis; identifying the socioeconomic burden in Europe

      Ruiz-Casas, Leonardo; Evans, Jonathan; orcid: 0000-0002-3490-7191; email: jonathan.evans@hcdeconomics.com; Rose, Alison; Pedra, Gabriel Ghizzi; Lobo, Alan; Finnegan, Alan; Hayee, Bu; Peyrin-Biroulet, Laurent; Sturm, Andreas; Burisch, Johan; et al. (BioMed Central, 2021-12-15)
    • Correction to: The role of real-world data in the development of treatment guidelines: a case study on guideline developers’ opinions about using observational data on antibiotic prescribing in primary care

      Steels, Stephanie; email: Stephanie.Steels@manchester.ac.uk; Van der Zande, Marieke; van Staa, Tjeerd Pieter (BioMed Central, 2020-05-26)
      An amendment to this paper has been published and can be accessed via the original article.
    • The cost of severe haemophilia in Europe: the CHESS study

      O’Hara, Jamie; Hughes, David; Camp, Charlotte; Burke, Tom; Carroll, Liz; Diego, Daniel-Anibal G.; University of Chester; HCD Economics, Daresbury; The Haeomophelia Society, London; FedHemo, Madrid (BioMed Central, 2017-05-31)
      Background Severe haemophilia is associated with major psychological and economic burden for patients, caregivers, and the wider health care system. This burden has been quantified and documented for a number of European countries in recent years. However, few studies have taken a standardised methodology across multiple countries simultaneously, and sought to amalgamate all three levels of burden for severe disease. The overall aim of the ‘Cost of Haemophilia in Europe: a Socioeconomic Survey’ (CHESS) study was to capture the annualised economic and psychosocial burden of severe haemophilia in five European countries. A cross-section of haemophilia specialists (surveyed between January and April 2015) provided demographic and clinical information and 12-month ambulatory and secondary care activity for patients via an online survey. In turn, patients provided corresponding direct and indirect non-medical cost information, including work loss and out-of-pocket expenses, as well as information on quality of life and adherence. The direct and indirect costs for the patient sample were calculated and extrapolated to population level. Results Clinical reports for a total of 1,285 patients were received. Five hundred and fifty-two patients (43% of the sample) provided information on indirect costs and health-related quality of life via the PSC. The total annual cost of severe haemophilia across the five countries for 2014 was estimated at EUR 1.4 billion, or just under EUR 200,000 per patient. The highest per-patient costs were in Germany (mean EUR 319,024) and the lowest were in the United Kingdom (mean EUR 129,365), with a study average of EUR 199,541. As expected, consumption of clotting factor replacement therapy represented the vast majority of costs (up to 99%). Indirect costs are driven by patient and caregiver work loss. Conclusions The results of the CHESS study reflect previous research findings suggesting that costs of factor replacement therapy account for the vast majority of the cost burden in severe haemophilia. However, the importance of the indirect impact of haemophilia on the patient and family should not be overlooked. The CHESS study highlights the benefits of observational study methodologies in capturing a ‘snapshot’ of information for patients with rare diseases.
    • Critical research gaps and translational priorities for the successful prevention and treatment of breast cancer

      Eccles, Suzanne A.; Aboagye, Eric O.; Ali, Simak; Anderson, Annie S.; Armes, Jo; Berditchevski, Fedor; Blaydes, Jeremy P.; Brennan, Keith; Brown, Nicola J.; Bryant, Helen E.; et al. (BioMed Central, 2013-10-01)
      Introduction: Breast cancer remains a significant scientific, clinical and societal challenge. This gap analysis has reviewed and critically assessed enduring issues and new challenges emerging from recent research, and proposes strategies for translating solutions into practice. Methods More than 100 internationally recognised specialist breast cancer scientists, clinicians and healthcare professionals collaborated to address nine thematic areas: genetics, epigenetics and epidemiology; molecular pathology and cell biology; hormonal influences and endocrine therapy; imaging, detection and screening; current/novel therapies and biomarkers; drug resistance; metastasis, angiogenesis, circulating tumour cells, cancer ‘stem’ cells; risk and prevention; living with and managing breast cancer and its treatment. The groups developed summary papers through an iterative process which, following further appraisal from experts and patients, were melded into this summary account. Results The 10 major gaps identified were: (1) understanding the functions and contextual interactions of genetic and epigenetic changes in normal breast development and during malignant transformation; (2) how to implement sustainable lifestyle changes (diet, exercise and weight) and chemopreventive strategies; (3) the need for tailored screening approaches including clinically actionable tests; (4) enhancing knowledge of molecular drivers behind breast cancer subtypes, progression and metastasis; (5) understanding the molecular mechanisms of tumour heterogeneity, dormancy, de novo or acquired resistance and how to target key nodes in these dynamic processes; (6) developing validated markers for chemosensitivity and radiosensitivity; (7) understanding the optimal duration, sequencing and rational combinations of treatment for improved personalised therapy; (8) validating multimodality imaging biomarkers for minimally invasive diagnosis and monitoring of responses in primary and metastatic disease; (9) developing interventions and support to improve the survivorship experience; (10) a continuing need for clinical material for translational research derived from normal breast, blood, primary, relapsed, metastatic and drug-resistant cancers with expert bioinformatics support to maximise its utility. The proposed infrastructural enablers include enhanced resources to support clinically relevant in vitro and in vivo tumour models; improved access to appropriate, fully annotated clinical samples; extended biomarker discovery, validation and standardisation; and facilitated cross-discipline working. Conclusions With resources to conduct further high-quality targeted research focusing on the gaps identified, increased knowledge translating into improved clinical care should be achievable within five years.
    • Detection of MCM5 as a novel non-invasive aid for the diagnosis of endometrial and ovarian tumours

      Stockley, J.; Akhand, R.; Kennedy, A.; Nyberg, C.; Crosbie, E. J.; Edmondson, R. J.; orcid: 0000-0003-2553-4423; email: richard.edmondson@manchester.ac.uk (BioMed Central, 2020-10-15)
      Abstract: Background: MCM5 is a protein involved in DNA replication, facilitating cell proliferation. In normal epithelium MCM5 expression is restricted to the cells in the basal proliferative compartments, however in the presence of a tumour MCM5 positive cells are present at the surface epithelium and are shed into bodily fluids. The aim of this study was to determine the sensitivity of MCM5 as a biomarker for the detection of endometrial and ovarian cancer. Methods: Patients with known ovarian or endometrial cancers, or known benign gynaecological conditions, were enrolled. Informed consent was obtained prior to the collection of full void urine, and either a vaginal tampon (worn for 6–8 h), or a vaginal swab. Vaginal secretions were extracted from the tampon or swab, centrifuged and lysed. Urine samples were centrifuged and lysed. MCM5 levels were determined by MCM5-ELISA (Arquer Diagnostics Ltd). Results: 125 patients completed the study protocol, 41 patients had endometrial cancer, 26 ovarian cancer, and 58 benign controls. All patients provided a urine sample and either a tampon or vaginal swab sample. Urine MCM5 levels were higher in cancer patients than controls (p < 0.0001), there was no significant difference in levels between tampon samples or vaginal swab samples in cancer patients when compared to controls. Performance of MCM5 to discriminate cancer from benign disease was high with an area under the ROC curve of 0.83 for endometrial cancer and 0.68 for ovarian cancer. Using a cut off of 12 pg/mL, overall sensitivity for endometrial cancer was 87.8, and 61.5% for ovarian cancer with a specificity of 75.9%. Conclusions: MCM5 is a novel sensitive and specific biomarker for the detection of ovarian and endometrial tumours in urine samples, which is likely to have clinical utility as a diagnostic aid.
    • Developing and implementing guidelines on culturally adapting the Addenbrooke’s cognitive examination version III (ACE-III): a qualitative illustration

      Waheed, Waquas; Mirza, Nadine; orcid: 0000-0002-1308-9046; email: nadine.mirza@postgrad.manchester.ac.uk; Waheed, Muhammed Wali; Malik, Abid; Panagioti, Maria (BioMed Central, 2020-10-06)
      Abstract: Background: Cognitive tests currently used in healthcare and research settings do not account for bias in performance that arises due to cultural context. At present there are no universally accepted steps or minimum criteria for culturally adapting cognitive tests. We propose a methodology for developing specific guidelines to culturally adapt a specific cognitive test and used this to develop guidelines for the ACE-III. We then demonstrated their implementation by using them to produce an ACE-III Urdu for a British South Asian population. Methods: This was a several stage qualitative study. We combined information from our systematic review on the translation and cultural adaptation of the ACE-III with feedback from previous ACE-III adaptors. This identified steps for cultural adaptation. We formatted these into question-by-question guidelines. These guidelines, along with feedback from focus groups with potential users were used to develop ACE-III Urdu questions. Clinical experts reviewed these questions to finalise an ACE-III Urdu. Results: Our systematic review found 32 adaptations and we received feedback from seven adaptors to develop the guidelines. With these guidelines and two focus groups with 12 participants a sample ACE-III Urdu was developed. A consensus meeting of two psychiatrists with a South Asian background and familiarity with cognitive tests and cultural adaptation finalised the ACE-III Urdu. Conclusions: We developed a set of guidelines for culturally adapting the ACE-III that can be used by future adaptors for their own language or cultural context. We demonstrated how guidelines on cultural adaptation can be developed for any cognitive test and how they can be used to adapt it.
    • Development and feasibility of a Swallowing intervention Package (SiP) for patients receiving radiotherapy treatment for head and neck cancer—the SiP study protocol

      Wells, Mary; King, Emma; Toft, Kate; MacAulay, Fiona; Patterson, Joanne; Dougall, Nadine; Hulbert-Williams, Nicholas J.; Boa, Sally; Slaven, Eleanor; Cowie, Julie; et al. (BioMed Central, 2016-08-04)
      Background Head and neck cancer (HNC) is the sixth most common cancer worldwide, and the functional, psychological and social consequences of HNC cancer and its treatment can be severe and chronic. Dysphagia (swallowing problems) affects up to two thirds of patients undergoing combined chemoradiotherapy. Recent reviews suggest that prophylactic swallowing exercises may improve a range of short- and long-term outcomes; however, the importance of psychological and behavioural factors on adherence to swallowing exercises has not been adequately studied. This study aims to develop and test the feasibility of a Swallowing intervention Package (SiP) designed in partnership with patients, speech and language therapists (SLTs) and other members of the head and neck multi-disciplinary team (MDT), for patients undergoing chemoradiotherapy (CRT) or radiotherapy (RT) for head and neck cancer. Methods/design This feasibility study uses quantitative and qualitative research methods, within a quasi-experimental design, to assess whether patients will tolerate and adhere to the SiP intervention, which aspects of the intervention can be implemented and which cannot, whether treatment fidelity can be achieved across different contexts, whether study processes and outcome measures will be feasible and acceptable and to what extent the intervention is likely to have an impact on swallowing dysfunction and quality of life. Patients are being recruited from five sites in Scotland and England (three interventions and two usual care). The SLT based in the relevant intervention centre teaches the exercise programme and provides supporting materials. A combination of patient-reported outcome measures (PROMs), adherence measures and clinical swallowing assessments are used prior to intervention (baseline), at the end of treatment, 3 and 6 months post-treatment. Discussion This collaborative study has taken a unique approach to the development of a patient-centred and evidence-based swallowing intervention. The introduction of an e-SiP app provides an exploration of the use of technology in delivering this intervention. The study provides an opportunity to examine the feasibility of delivering and participating in a supported swallowing intervention across several different NHS sites and will provide the evidence needed to refine intervention and study processes for a future trial. Trial registration NCRI portfolio, 18192 & 20259
    • Development and validation of a multivariable prediction model for infection-related complications in patients with common infections in UK primary care and the extent of risk-based prescribing of antibiotics

      Mistry, Chirag; Palin, Victoria; Li, Yan; Martin, Glen P.; Jenkins, David; Welfare, William; Ashcroft, Darren M.; van Staa, Tjeerd; email: tjeerd.vanstaa@manchester.ac.uk (BioMed Central, 2020-05-21)
      Abstract: Background: Antimicrobial resistance is driven by the overuse of antibiotics. This study aimed to develop and validate clinical prediction models for the risk of infection-related hospital admission with upper respiratory infection (URTI), lower respiratory infection (LRTI) and urinary tract infection (UTI). These models were used to investigate whether there is an association between the risk of an infection-related complication and the probability of receiving an antibiotic prescription. Methods: The study used electronic health record data from general practices contributing to the Clinical Practice Research Datalink (CPRD GOLD) and Welsh Secure Anonymised Information Linkage (SAIL), both linked to hospital records. Patients who visited their general practitioner with an incidental URTI, LRTI or UTI were included and followed for 30 days for hospitalisation due to infection-related complications. Predictors included age, gender, clinical and medication risk factors, ethnicity and socioeconomic status. Cox proportional hazards regression models were used with predicted risks independently validated in SAIL. Results: The derivation and validation cohorts included 8.1 and 2.7 million patients in CPRD and SAIL, respectively. A total of 7125 (0.09%) hospital admissions occurred in CPRD and 7685 (0.28%) in SAIL. Important predictors included age and measures of comorbidity. Initial attempts at validating in SAIL (i.e. transporting the models with no adjustment) indicated the need to recalibrate the models for age and underlying incidence of infections; internal bootstrap validation of these updated models yielded C-statistics of 0.63 (LRTI), 0.69 (URTI) and 0.73 (UTI) indicating good calibration. For all three infection types, the rate of antibiotic prescribing was not associated with patients’ risk of infection-related hospital admissions. Conclusion: The risk for infection-related hospital admissions varied substantially between patients, but prescribing of antibiotics in primary care was not associated with risk of hospitalisation due to infection-related complications. Our findings highlight the potential role of clinical prediction models to help inform decisions of prescribing of antibiotics in primary care.
    • Development of mental healthcare in Cambodia: barriers and opportunities

      Parry, Sarah J.; orcid: 0000-0002-9730-3547; email: sarah.parry11@nhs.net; Ean, Nil; Sinclair, Shirley P.; Wilkinson, Ewan; orcid: 0000-0002-2167-8756 (BioMed Central, 2020-07-29)
      Abstract: Background: Despite the increasing recognition globally of the importance of mental health for sustainable development, significant barriers remain to developing mental health services in low- and middle-income countries. This study explored the particular barriers and opportunities for developing mental health services in Cambodia and how these compared with those described in other low- and middle-income countries. Methods: For this qualitative study, 18 experienced mental health professionals from different disciplines were selected using purposive sampling. Semi-structured interviews were carried out in Phnom Penh and thematic analysis of the data was completed. Results: Five key themes were identified: (1) Prioritising mental health in Cambodia, (2) Strengthening collaborations between mental health stakeholders, (3) Developing a mental healthcare model appropriate for the Cambodian culture and context, (4) Increasing the quantity and (5) Improving the quality of mental healthcare. All five themes were referred to by all 18 participants and the two most repeated themes were (2) Strengthening collaborations and (5) Improving the quality of mental healthcare. Conclusions: The themes identified in this study both corroborate previous barriers identified to developing mental health services in low- and middle-income countries and shed new light on opportunities of particular importance in Cambodia. Strengthening collaborations between key stakeholders in mental health and prioritising the quality of mental health education, training and service provision were both cited as being significant opportunities for enhancing the development of mental health services in Cambodia. These have not been widely described before as being important factors.
    • Developmentally appropriate transitional care during the Covid-19 pandemic for young people with juvenile-onset rheumatic and musculoskeletal diseases: the rationale for a position statement

      McDonagh, Janet E.; orcid: 0000-0002-4555-7270; email: janet.mcdonagh@manchester.ac.uk; Tattersall, Rachel; Clinch, Jacqui; Swan, Joanne; Foster, Helen E.; McCann, Liza (BioMed Central, 2021-08-25)
      Abstract: Background: The importance of developmentally appropriate transitional care in young people with juvenile-onset rheumatic and musculoskeletal disease is well recognised. The Paediatric Rheumatology European Society (PReS) / European League Against Rheumatism (EULAR) Taskforce has developed international recommendations and standards for transitional care and a growing evidence base supports the positive benefits of such care. However, there is also evidence that universal implementation has yet to be realised. In 2020, against this background the COVID-19 pandemic arrived with significant impact on all our lives, young and old, patient, public and professional alike. The unfortunate reality of the pandemic with potential for unfavourable outcomes on healthcare provision during transition was acknowledged by the PReS working groups in a position statement to support healthcare professionals, young people and their caregivers. Aim: The aim of this review is to present the literature which provides the rationale for the recommendations in the PReS Position Statement. Summary: The following areas are specifically addressed: the prime importance of care coordination; the impact of the pandemic on the various aspects of the transition process; the importance of ensuring continuity of medication supply; the pros and cons of telemedicine with young people; ensuring meaningful involvement of young people in service development and the importance of core adolescent health practices such as routine developmental assessment psychosocial screening and appropriate parental involvement during transitional care.
    • Diabetes and eating disorders: an exploration of ‘Diabulimia’

      Coleman, Sophie Elizabeth; email: sophie.coleman-2@postgrad.manchester.ac.uk; Caswell, Noreen (BioMed Central, 2020-09-23)
      Abstract: Background: ‘Diabulimia’ is the term given to the deliberate administration of insufficient insulin for the purpose of weight loss. Although Diabulimia can be life-threatening and prevalence rates in diabetes are high, there is a lack of research for how to effectively support people with the condition. This exploratory study aimed to provide much-needed information to healthcare professionals and guide the focus for future research. Methods: Forty-five individuals with Type 1 diabetes mellitus (T1DM) and a history of insulin misuse completed an online questionnaire. This included an assessment of their eating disorder psychopathology with the Eating Disorder Examination Questionnaire (EDE-Q) and 16 open-ended questions exploring their experience of Diabulimia. The responses to the open-ended questions were analysed using thematic analysis. Results: The average global EDE-Q score was 3.96 (1.21), which is consistent with eating disorder populations. Common themes identified were concerns about weight, difficulty coping with diabetes, past trauma, and the importance of relationships. Experiences with health professionals were overwhelmingly negative. Most participants had experienced serious medical intervention due to Diabulimia and were fully aware of the consequences of insulin restriction. Conclusions: Overall, individuals believed that a greater awareness of Diabulimia and more training for healthcare professionals is needed. While education on insulin misuse may be a necessary first step in treatment, psychological support is crucial. To deliver effective treatment, clinicians should be aware of the specific issues facing those with Diabulimia. The current study identified themes that clinicians may find useful to consider.
    • Distinct patterns of disease activity over time in patients with active SLE revealed using latent class trajectory models

      Reynolds, John A.; Prattley, Jennifer; Geifman, Nophar; Lunt, Mark; Gordon, Caroline; Bruce, Ian N.; orcid: 0000-0003-3047-500X; email: ian.bruce@manchester.ac.uk (BioMed Central, 2021-07-29)
      Abstract: Background: Systemic lupus erythematosus (SLE) is a heterogeneous systemic autoimmune condition for which there are limited licensed therapies. Clinical trial design is challenging in SLE due at least in part to imperfect outcome measures. Improved understanding of how disease activity changes over time could inform future trial design. The aim of this study was to determine whether distinct trajectories of disease activity over time occur in patients with active SLE within a clinical trial setting and to identify factors associated with these trajectories. Methods: Latent class trajectory models were fitted to a clinical trial dataset of a monoclonal antibody targeting CD22 (Epratuzumab) in patients with active SLE using the numerical BILAG-2004 score (nBILAG). The baseline characteristics of patients in each class and changes in prednisolone over time were identified. Exploratory PK-PD modelling was used to examine cumulative drug exposure in relation to latent class membership. Results: Five trajectories of disease activity were identified, with 3 principal classes: non-responders (NR), slow responders (SR) and rapid-responders (RR). In both the SR and RR groups, significant changes in disease activity were evident within the first 90 days of the trial. The SR and RR patients had significantly higher baseline disease activity, exposure to epratuzumab and activity in specific BILAG domains, whilst NR had lower steroid use at baseline and less change in steroid dose early in the trial. Conclusions: Longitudinal nBILAG scores reveal different trajectories of disease activity and may offer advantages over fixed endpoints. Corticosteroid use however remains an important confounder in lupus trials and can influence early response. Changes in disease activity and steroid dose early in the trial were associated with the overall disease activity trajectory, supporting the feasibility of performing adaptive trial designs in SLE.
    • Distinct transcriptional programs stratify ovarian cancer cell lines into the five major histological subtypes

      Barnes, Bethany M.; Nelson, Louisa; Tighe, Anthony; Burghel, George J.; Lin, I-Hsuan; Desai, Sudha; McGrail, Joanne C.; Morgan, Robert D.; Taylor, Stephen S.; orcid: 0000-0003-4621-9326; email: stephen.taylor@manchester.ac.uk (BioMed Central, 2021-09-01)
      Abstract: Background: Epithelial ovarian cancer (OC) is a heterogenous disease consisting of five major histologically distinct subtypes: high-grade serous (HGSOC), low-grade serous (LGSOC), endometrioid (ENOC), clear cell (CCOC) and mucinous (MOC). Although HGSOC is the most prevalent subtype, representing 70–80% of cases, a 2013 landmark study by Domcke et al. found that the most frequently used OC cell lines are not molecularly representative of this subtype. This raises the question, if not HGSOC, from which subtype do these cell lines derive? Indeed, non-HGSOC subtypes often respond poorly to chemotherapy; therefore, representative models are imperative for developing new targeted therapeutics. Methods: Non-negative matrix factorisation (NMF) was applied to transcriptomic data from 44 OC cell lines in the Cancer Cell Line Encyclopedia, assessing the quality of clustering into 2–10 groups. Epithelial OC subtypes were assigned to cell lines optimally clustered into five transcriptionally distinct classes, confirmed by integration with subtype-specific mutations. A transcriptional subtype classifier was then developed by trialling three machine learning algorithms using subtype-specific metagenes defined by NMF. The ability of classifiers to predict subtype was tested using RNA sequencing of a living biobank of patient-derived OC models. Results: Application of NMF optimally clustered the 44 cell lines into five transcriptionally distinct groups. Close inspection of orthogonal datasets revealed this five-cluster delineation corresponds to the five major OC subtypes. This NMF-based classification validates the Domcke et al. analysis, in identifying lines most representative of HGSOC, and additionally identifies models representing the four other subtypes. However, NMF of the cell lines into two clusters did not align with the dualistic model of OC and suggests this classification is an oversimplification. Subtype designation of patient-derived models by a random forest transcriptional classifier aligned with prior diagnosis in 76% of unambiguous cases. In cases where there was disagreement, this often indicated potential alternative diagnosis, supported by a review of histological, molecular and clinical features. Conclusions: This robust classification informs the selection of the most appropriate models for all five histotypes. Following further refinement on larger training cohorts, the transcriptional classification may represent a useful tool to support the classification of new model systems of OC subtypes.
    • Eating for 1, Healthy and Active for 2; feasibility of delivering novel, compact training for midwives to build knowledge and confidence in giving nutrition, physical activity and weight management advice during pregnancy

      Basu, Andrea J.; Kennedy, Lynne; Tocque, Karen; Jones, Sharn; University of Chester; Wrexham Maelor Hospital (BioMed Central, 2014-07-04)
      Background: Women in Wales are more likely to be obese in pregnancy than in any other United Kingdom (UK) country. Midwives are ideally placed to explore nutrition, physical activity and weight management concerns however qualitative studies indicate they lack confidence in raising the sensitive issue of weight. Acknowledging this and the reality of finite time and resources, this study aimed to deliver compact training on nutrition, physical activity and weight management during pregnancy to increase the knowledge and confidence of midwives in this subject. Methods A compact training package for midwives was developed comprising of evidence based nutrition, physical activity and weight management guidance for pregnancy. Training was promoted via midwifery leads and delivered within the Health Board. Questionnaires based on statements from national public health guidance were used to assess changes in self-reported knowledge and confidence pre and post training. Descriptive statistics were applied and 95% confidence intervals were calculated. Results 43 midwives registered for training, 32 (74%) attended and completed the questionnaires. Although, pre training knowledge and confidence varied between participants, statistically significant improvements in self-reported knowledge and confidence were observed post training. 97% indicated knowledge of pregnancy specific food and nutrition messages as ‘better’ (95% CI 85 to 100), as opposed to 3% stating ‘stayed the same’ – 60% stated ‘much better’. 83% indicated confidence to explain the risks of raised BMI in pregnancy was either ‘much’ or ‘somewhat better’ (95% CI 66 to 93), as opposed to 17% stating ‘stayed the same’. 89% indicated confidence to discuss eating habits and physical activity was ‘much’ or ‘somewhat better’ (95% CI 73 to 97) as opposed to 11% stating ‘stayed the same’. Emergent themes highlighted that training was positively received and relevant to midwifery practice. Conclusions This study provides early indications that a compact nutrition, physical activity and weight management training package improves midwives self-reported knowledge and confidence. Cascading training across the midwifery service in the Health Board and conducting further studies to elicit longer term impact on midwifery practice and patient outcomes are recommended.
    • Enhancing the Behaviour Change Wheel with synthesis, stakeholder involvement and decision-making: a case example using the ‘Enhancing the Quality of Psychological Interventions Delivered by Telephone’ (EQUITy) research programme

      Faija, Cintia L.; Gellatly, Judith; orcid: 0000-0002-5134-5581; email: Judith.l.gellatly@manchester.ac.uk; Barkham, Michael; Lovell, Karina; Rushton, Kelly; Welsh, Charlotte; Brooks, Helen; Ardern, Kerry; Bee, Penny; Armitage, Christopher J. (BioMed Central, 2021-05-14)
      Abstract: Background: Using frameworks such as the Behaviour Change Wheel to develop behaviour change interventions can be challenging because judgement is needed at various points in the process and it is not always clear how uncertainties can be resolved. We propose a transparent and systematic three-phase process to transition from a research evidence base to a behaviour change intervention. The three phases entail evidence synthesis, stakeholder involvement and decision-making. We present the systematic development of an intervention to enhance the quality of psychological treatment delivered by telephone, as a worked example of this process. Method: In phase 1 (evidence synthesis), we propose that the capabilities (C), opportunities (O) and motivations (M) model of behaviour change (COM-B) can be used to support the synthesis of a varied corpus of empirical evidence and to identify domains to be included in a proposed behaviour change intervention. In phase 2 (stakeholder involvement), we propose that formal consensus procedures (e.g. the RAND Health/University of California-Los Angeles Appropriateness Methodology) can be used to facilitate discussions of proposed domains with stakeholder groups. In phase 3 (decision-making), we propose that behavioural scientists identify (with public/patient input) intervention functions and behaviour change techniques using the acceptability, practicability, effectiveness/cost-effectiveness, affordability, safety/side-effects and equity (APEASE) criteria. Results: The COM-B model was a useful tool that allowed a multidisciplinary research team, many of whom had no prior knowledge of behavioural science, to synthesise effectively a varied corpus of evidence (phase 1: evidence synthesis). The RAND Health/University of California-Los Angeles Appropriateness Methodology provided a transparent means of involving stakeholders (patients, practitioners and key informants in the present example), a structured way in which they could identify which of 93 domains identified in phase 1 were essential for inclusion in the intervention (phase 2: stakeholder involvement). Phase 3 (decision-making) was able to draw on existing Behaviour Change Wheel resources to revisit phases 1 and 2 and facilitate agreement among behavioural scientists on the final intervention modules. Behaviour changes were required at service, practitioner, patient and community levels. Conclusion: Frameworks offer a foundation for intervention development but require additional elucidation at each stage of the process. The decisions adopted in this study are designed to provide an example on how to resolve challenges while designing a behaviour change intervention. We propose a three-phase process, which represents a transparent and systematic framework for developing behaviour change interventions in any setting.
    • Epidemiology of the extent of recreational noise exposure and hearing protection use: cross-sectional survey in a nationally representative UK adult population sample

      Armitage, Christopher J.; orcid: 0000-0003-2365-1765; email: chris.armitage@manchester.ac.uk; Loughran, Michael T.; Munro, Kevin J. (BioMed Central, 2020-10-09)
      Abstract: Background: Hearing loss is prevalent and disabling, yet little is known about the extent of recreational noise exposure and hearing protection use. The aim of the present research was to estimate the extent of recreational noise exposure and hearing protection use in a sample representative of the UK adult population. Methods: We conducted a cross-sectional survey of 10,401 UK adults who were representative of the population. Results: More than 7000 people (n = 7590, 73.0%) reported exposure to recreational noise excluding headphone and earphone use in the last 12 months. Just 158 people (2.1%) reported wearing hearing protection for every noisy recreational activity. Age (younger people) and beliefs of a behavioral (as opposed to genetic) cause of hearing loss were predictive of both higher recreational noise exposure and greater hearing protection use. Men were more exposed to recreational noise but women were less likely to use hearing protection. Conclusions: For the first time, the present research quantifies the recreational noise exposure and low levels of hearing protection use in a representative sample of the UK population. The biggest public health gains are likely to be achieved through interventions targeted at younger people and in explaining behavioral (as opposed to genetic) causes of hearing loss.
    • Ethnic and minority group differences in engagement with COVID-19 vaccination programmes – at Pandemic Pace; when vaccine confidence in mass rollout meets local vaccine hesitancy

      Reid, John A.; orcid: 0000-0002-0073-398X; email: john.reid@chester.ac.uk; Mabhala, Mzwandile A. (BioMed Central, 2021-05-27)
      Abstract: Israel, the UK, the USA, and some other wealthier countries lead in the implementation of COVID-19 vaccine mass vaccination programmes. Evidence from these countries indicates that their ethnic minorities could be as disproportionately disadvantaged in COVID-19 vaccines roll-out as they were affected by COVID-19-related serious illnesses. Their disadvantage is linked to their lower social status and fewer social goods compared with dominant population groups. Albeit limited by methodology, early studies attribute lower uptake of COVID-19 amongst ethnic minorities to the wider determinants of vaccine uptake, hesitancy or lack of vaccine confidence, including lower levels of trust and greater concerns about vaccine safety. Early sentinel studies are needed in all early adopter countries. One emerging theme among those of reproductive age in minority communities concerns a worry regarding COVID-19 vaccine’s potential adverse effect on fertility. Respected professional groups reassure this is not a credible rationale. Drug and vaccine regulators use understandable, cautious and conditional language in emergency licencing of new gene-based vaccines. Technical assessments on whether there is any potential genotoxicity or reproductive toxicity should be more emphatic. From a public health perspective, sentinel studies should identify such community concerns and act early to produce convincing explanations and evidence. Local public health workforces need to be diverse, multiskilled, and able to engage well with minorities and vulnerable groups. The local Directors of Public Health in the UK are based in each local government area and have a remit and opportunity to stimulate speedy action to increase vaccine uptake. During the rapid Pandemic Pace of the vaccines roll-out, extra efforts to minimise uptake variations are likely to achieve improvements in the next year or two. We expect variations will not disappear however, given that underlying inequalities persist in less inclusive social systems.
    • Ethnic and minority group differences in engagement with COVID-19 vaccination programmes – at Pandemic Pace; when vaccine confidence in mass rollout meets local vaccine hesitancy

      Reid, John A.; orcid: 0000-0002-0073-398X; email: john.reid@chester.ac.uk; Mabhala, Mzwandile A. (BioMed Central, 2021-05-27)
      Abstract: Israel, the UK, the USA, and some other wealthier countries lead in the implementation of COVID-19 vaccine mass vaccination programmes. Evidence from these countries indicates that their ethnic minorities could be as disproportionately disadvantaged in COVID-19 vaccines roll-out as they were affected by COVID-19-related serious illnesses. Their disadvantage is linked to their lower social status and fewer social goods compared with dominant population groups. Albeit limited by methodology, early studies attribute lower uptake of COVID-19 amongst ethnic minorities to the wider determinants of vaccine uptake, hesitancy or lack of vaccine confidence, including lower levels of trust and greater concerns about vaccine safety. Early sentinel studies are needed in all early adopter countries. One emerging theme among those of reproductive age in minority communities concerns a worry regarding COVID-19 vaccine’s potential adverse effect on fertility. Respected professional groups reassure this is not a credible rationale. Drug and vaccine regulators use understandable, cautious and conditional language in emergency licencing of new gene-based vaccines. Technical assessments on whether there is any potential genotoxicity or reproductive toxicity should be more emphatic. From a public health perspective, sentinel studies should identify such community concerns and act early to produce convincing explanations and evidence. Local public health workforces need to be diverse, multiskilled, and able to engage well with minorities and vulnerable groups. The local Directors of Public Health in the UK are based in each local government area and have a remit and opportunity to stimulate speedy action to increase vaccine uptake. During the rapid Pandemic Pace of the vaccines roll-out, extra efforts to minimise uptake variations are likely to achieve improvements in the next year or two. We expect variations will not disappear however, given that underlying inequalities persist in less inclusive social systems.
    • Ethnic and minority group differences in engagement with COVID-19 vaccination programmes – at Pandemic Pace; when vaccine confidence in mass rollout meets local vaccine hesitancy

      Reid, John A.; orcid: 0000-0002-0073-398X; email: john.reid@chester.ac.uk; Mabhala, Mzwandile A. (BioMed Central, 2021-05-27)
      Abstract: Israel, the UK, the USA, and some other wealthier countries lead in the implementation of COVID-19 vaccine mass vaccination programmes. Evidence from these countries indicates that their ethnic minorities could be as disproportionately disadvantaged in COVID-19 vaccines roll-out as they were affected by COVID-19-related serious illnesses. Their disadvantage is linked to their lower social status and fewer social goods compared with dominant population groups. Albeit limited by methodology, early studies attribute lower uptake of COVID-19 amongst ethnic minorities to the wider determinants of vaccine uptake, hesitancy or lack of vaccine confidence, including lower levels of trust and greater concerns about vaccine safety. Early sentinel studies are needed in all early adopter countries. One emerging theme among those of reproductive age in minority communities concerns a worry regarding COVID-19 vaccine’s potential adverse effect on fertility. Respected professional groups reassure this is not a credible rationale. Drug and vaccine regulators use understandable, cautious and conditional language in emergency licencing of new gene-based vaccines. Technical assessments on whether there is any potential genotoxicity or reproductive toxicity should be more emphatic. From a public health perspective, sentinel studies should identify such community concerns and act early to produce convincing explanations and evidence. Local public health workforces need to be diverse, multiskilled, and able to engage well with minorities and vulnerable groups. The local Directors of Public Health in the UK are based in each local government area and have a remit and opportunity to stimulate speedy action to increase vaccine uptake. During the rapid Pandemic Pace of the vaccines roll-out, extra efforts to minimise uptake variations are likely to achieve improvements in the next year or two. We expect variations will not disappear however, given that underlying inequalities persist in less inclusive social systems.
    • Ethnic and minority group differences in engagement with COVID-19 vaccination programmes – at Pandemic Pace; when vaccine confidence in mass rollout meets local vaccine hesitancy

      Reid, John A.; orcid: 0000-0002-0073-398X; email: john.reid@chester.ac.uk; Mabhala, Mzwandile A. (BioMed Central, 2021-05-27)
      Abstract: Israel, the UK, the USA, and some other wealthier countries lead in the implementation of COVID-19 vaccine mass vaccination programmes. Evidence from these countries indicates that their ethnic minorities could be as disproportionately disadvantaged in COVID-19 vaccines roll-out as they were affected by COVID-19-related serious illnesses. Their disadvantage is linked to their lower social status and fewer social goods compared with dominant population groups. Albeit limited by methodology, early studies attribute lower uptake of COVID-19 amongst ethnic minorities to the wider determinants of vaccine uptake, hesitancy or lack of vaccine confidence, including lower levels of trust and greater concerns about vaccine safety. Early sentinel studies are needed in all early adopter countries. One emerging theme among those of reproductive age in minority communities concerns a worry regarding COVID-19 vaccine’s potential adverse effect on fertility. Respected professional groups reassure this is not a credible rationale. Drug and vaccine regulators use understandable, cautious and conditional language in emergency licencing of new gene-based vaccines. Technical assessments on whether there is any potential genotoxicity or reproductive toxicity should be more emphatic. From a public health perspective, sentinel studies should identify such community concerns and act early to produce convincing explanations and evidence. Local public health workforces need to be diverse, multiskilled, and able to engage well with minorities and vulnerable groups. The local Directors of Public Health in the UK are based in each local government area and have a remit and opportunity to stimulate speedy action to increase vaccine uptake. During the rapid Pandemic Pace of the vaccines roll-out, extra efforts to minimise uptake variations are likely to achieve improvements in the next year or two. We expect variations will not disappear however, given that underlying inequalities persist in less inclusive social systems.