Exploring dental treatment decision-making experiences of people living with dementia and family carers.

INTRODUCTION: People living with dementia can have complex dental care needs. Dentists and patients should make treatment decisions together, yet some people living with dementia may be unable to make their own decisions about their dental care. Dental treatment decision-making and patients' experiences of this process have not been comprehensively researched. OBJECTIVE: This study aimed to explore the dental treatment decision-making perspectives and experiences of people living with dementia and their family members. METHODS: Semi-structured interviews were undertaken with 8 people living with dementia and 17 family caregivers. A constructivist grounded theory approach was adopted, using a maximum variation sample. Qualitative data collection and analysis occurred concurrently. Data underwent initial open coding followed by more focused coding, supported by reflexive memo writing, which supported data categorisation. RESULTS: People living with dementia reported wanting to be understood as unique individuals with specific needs. All participants described wanting to be actively involved in dental treatment decisions. However, many felt that they were insufficiently involved in treatment decision-making. This perceived underinvolvement meant that some people living with dementia and family members felt the treatment outcomes they sought were neither discussed nor considered. CONCLUSION: People living with dementia and carers had specific expectations of dental care yet felt passive in decision-making despite their desire to be involved in this process. Dentists should seek to actively establish patients' preferences, regardless of mental capacity and consider these in discussions and decisions about dental treatment.

Genetic Architecture of Acute Myocarditis and the Overlap With Inherited Cardiomyopathy.

BACKGROUND: Acute myocarditis is an inflammatory condition that may herald the onset of dilated cardiomyopathy (DCM) or arrhythmogenic cardiomyopathy (ACM). We investigated the frequency and clinical consequences of DCM and ACM genetic variants in a population-based cohort of patients with acute myocarditis. METHODS: This was a population-based cohort of 336 consecutive patients with acute myocarditis enrolled in London and Maastricht. All participants underwent targeted DNA sequencing for well-characterized cardiomyopathy-associated genes with comparison to healthy controls (n=1053) sequenced on the same platform. Case ascertainment in England was assessed against national hospital admission data. The primary outcome was all-cause mortality. RESULTS: Variants that would be considered pathogenic if found in a patient with DCM or ACM were identified in 8% of myocarditis cases compared with <1% of healthy controls (P=0.0097). In the London cohort (n=230; median age, 33 years; 84% men), patients were representative of national myocarditis admissions (median age, 32 years; 71% men; 66% case ascertainment), and there was enrichment of rare truncating variants (tv) in ACM-associated genes (3.1% of cases versus 0.4% of controls; odds ratio, 8.2; P=0.001). This was driven predominantly by DSP-tv in patients with normal LV ejection fraction and ventricular arrhythmia. In Maastricht (n=106; median age, 54 years; 61% men), there was enrichment of rare truncating variants in DCM-associated genes, particularly TTN-tv, found in 7% (all with left ventricular ejection fraction <50%) compared with 1% in controls (odds ratio, 3.6; P=0.0116). Across both cohorts over a median of 5.0 years (interquartile range, 3.9-7.8 years), all-cause mortality was 5.4%. Two-thirds of deaths were cardiovascular, attributable to worsening heart failure (92%) or sudden cardiac death (8%). The 5-year mortality risk was 3.3% in genotype-negative patients versus 11.1% for genotype-positive patients (Padjusted=0.08). CONCLUSIONS: We identified DCM- or ACM-associated genetic variants in 8% of patients with acute myocarditis. This was dominated by the identification of DSP-tv in those with normal left ventricular ejection fraction and TTN-tv in those with reduced left ventricular ejection fraction. Despite differences between cohorts, these variants have clinical implications for treatment, risk stratification, and family screening. Genetic counseling and testing should be considered in patients with acute myocarditis to help reassure the majority while improving the management of those with an underlying genetic variant.

Putting guidelines into practice: Using co-design to develop a complex intervention based on NG48 to enable care staff to provide daily oral care to older people living in care homes.

OBJECTIVES: (1) Explore the challenges of providing daily oral care in care homes; (2) understand oral care practices provided by care home staff; (3) co-design practical resources supporting care home staff in these activities. METHODS: Three Sheffield care homes were identified via the "ENRICH Research Ready Care Home Network," and three to six staff per site were recruited as co-design partners. Design researchers led three co-design workshops exploring care home staff's experiences of providing daily oral care, including challenges, coping strategies and the role of current guidelines. New resources were prototyped to support the use of guidelines in practice. The design researchers developed final resources to enable the use of these guidelines in-practice-in-context. FINDINGS: Care home staff operate under time and resource constraints. The proportion of residents with dementia and other neurodegenerative conditions is rapidly increasing. Care home staff face challenges when residents adopt "refusal behaviours" and balancing daily oral care needs with resident and carer safety becomes complex. Care home staff have developed many coping strategies to navigate "refusal behaviours." Supporting resources need to "fit" within the complexities of practice-in-context. CONCLUSIONS: The provision of daily oral care practices in care homes is complex and challenging. The co-design process revealed care home staff have a "library" of context-specific practical knowledge and coping strategies. This study offers insights into the process of making guidelines usable for professionals in their contexts of practice, exploring the agenda of implementing evidence-based guidelines.

Measurement properties, interpretability and feasibility of instruments measuring oral health and orofacial pain in dependent adults: a systematic review.

BACKGROUND: Dependent adults have been shown to have a greater experience of oral health deterioration and orofacial pain. This is partly because their non-dental caregivers may not easily identify oral health problems and orofacial pain experienced by them. Thus, this systematic review aimed to investigate measurement properties, interpretability and feasibility of instruments assessing oral health and orofacial pain in dependent adults, which can be used by the non-dental caregivers to establish oral care plans for those who are dependent upon them. METHODS: Seven bibliographic databases were searched: MEDLINE, Embase, CINAHL, CENTRAL, HTA, OATD and OpenGrey. Citations and reference lists of the included studies were also manually searched. Two authors independently screened titles and abstracts, and then full texts. A quality assessment of included studies was conducted independently by two authors using the COSMIN Risk of Bias checklist. The best evidence synthesis method was used to synthesise results from different studies for each measurement property per measurement instrument by integrating the overall rating for each measurement property per measurement instrument with its quality level of evidence. RESULTS: Nineteen eligible studies were included, which reported the development, measurement properties' evaluation, interpretability and feasibility of nine oral health and three orofacial pain measurement instruments. Methodological quality of the included studies ranged from very good to inadequate. None of the identified measurement instruments has been adequately and comprehensively tested. CONCLUSIONS: While several measurement instruments were identified in this systematic review, more evidence is needed to be able to more comprehensively evaluate these instruments. Among those identified, the OPS-NVI demonstrated sufficient construct validity, while the OHAT and the THROAT demonstrated sufficient reliability. These instruments therefore have potential for future use with more confidence once other measurement properties, interpretability and feasibility have been sufficiently tested and evaluated.

Enhancing shared and surrogate decision making for people living with dementia: A systematic review of the effectiveness of interventions.

BACKGROUND: Dementia can have a profound impact on decision making. People living with dementia (PLwD) often need to make decisions about health care, and, as dementia progresses, decisions may need to be made on their behalf. Specific interventions may support this process. REVIEW QUESTION: What interventions are effective in improving shared decision making or surrogate decision making on the health care of PLwD? METHODS: A narrative systematic review of existing literature was conducted. Seven databases, grey literature and key journals were searched. After exclusion by title, abstracts then full texts were reviewed collaboratively to manage any disagreements. RESULTS: Eight studies met the inclusion criteria. Two articles, including one RCT, evaluated decision aids regarding the use of enteral feeding in advanced dementia. Six further articles, including five RCTs, were found which evaluated the effectiveness of interventions supporting patients or carers with advance care planning. CONCLUSION: Decision-making interventions typically consist of multiple components which aim to establish preferences for future health care. Advance care planning interventions supported aspects of the decision-making processes but their impact on decision quality was rarely evaluated. Interventions did not increase the concordance of decisions with a person's values. The decision-specific interventions are unlikely to produce benefit in other decision contexts. PATIENT INVOLVEMENT: Two caregivers, a public stakeholder group and a carer group were consulted in the design of the wider study to which this review relates. Six PLwD refined the research questions addressed in this paper.

Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial.

BACKGROUND: Patients with dilated cardiomyopathy whose symptoms and cardiac function have recovered often ask whether their medications can be stopped. The safety of withdrawing treatment in this situation is unknown. METHODS: We did an open-label, pilot, randomised trial to examine the effect of phased withdrawal of heart failure medications in patients with previous dilated cardiomyopathy who were now asymptomatic, whose left ventricular ejection fraction (LVEF) had improved from less than 40% to 50% or greater, whose left ventricular end-diastolic volume (LVEDV) had normalised, and who had an N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) concentration less than 250 ng/L. Patients were recruited from a network of hospitals in the UK, assessed at one centre (Royal Brompton and Harefield NHS Foundation Trust, London, UK), and randomly assigned (1:1) to phased withdrawal or continuation of treatment. After 6 months, patients in the continued treatment group had treatment withdrawn by the same method. The primary endpoint was a relapse of dilated cardiomyopathy within 6 months, defined by a reduction in LVEF of more than 10% and to less than 50%, an increase in LVEDV by more than 10% and to higher than the normal range, a two-fold rise in NT-pro-BNP concentration and to more than 400 ng/L, or clinical evidence of heart failure, at which point treatments were re-established. The primary analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02859311. FINDINGS: Between April 21, 2016, and Aug 22, 2017, 51 patients were enrolled. 25 were randomly assigned to the treatment withdrawal group and 26 to continue treatment. Over the first 6 months, 11 (44%) patients randomly assigned to treatment withdrawal met the primary endpoint of relapse compared with none of those assigned to continue treatment (Kaplan-Meier estimate of event rate 45·7% [95% CI 28·5-67·2]; p=0·0001). After 6 months, 25 (96%) of 26 patients assigned initially to continue treatment attempted its withdrawal. During the following 6 months, nine patients met the primary endpoint of relapse (Kaplan-Meier estimate of event rate 36·0% [95% CI 20·6-57·8]). No deaths were reported in either group and three serious adverse events were reported in the treatment withdrawal group: hospital admissions for non-cardiac chest pain, sepsis, and an elective procedure. INTERPRETATION: Many patients deemed to have recovered from dilated cardiomyopathy will relapse following treatment withdrawal. Until robust predictors of relapse are defined, treatment should continue indefinitely. FUNDING: British Heart Foundation, Alexander Jansons Foundation, Royal Brompton Hospital and Imperial College London, Imperial College Biomedical Research Centre, Wellcome Trust, and Rosetrees Trust.

Treatment of periodontitis reduces systemic inflammation in type 2 diabetes.

AIMS: To assess the impact of periodontal treatment on systemic inflammation in type 2 diabetes. MATERIALS AND METHODS: Adults with type 2 diabetes (n = 83) and without diabetes (controls, n = 75) were recruited, and participants with periodontitis received periodontal treatment and 12 months' follow-up. Biomarkers for periodontal inflammation (gingival crevicular fluid interleukin-6, tumour necrosis factor-α, interleukin-1ß, interferon-γ, matrix metalloproteinase-8, matrix metalloproteinase-9, adiponectin) and serum markers of inflammation and diabetes control (glycated haemoglobin, high sensitivity C-reactive protein, interleukin-6, tumour necrosis factor-α, interleukin-1ß, interferon-γ, leptin, adiponectin) were measured. Structural equation modelling was used to evaluate periodontal treatment effects on oral and systemic inflammation. RESULTS: Periodontal treatment resulted in significant improvements in clinical status and reductions in gingival crevicular fluid biomarkers from baseline to month 12. Structural equation modelling identified that, at baseline, individuals with diabetes and periodontitis had significantly higher systemic inflammation than non-diabetic controls with periodontitis (Δ = 0.20, p = .002), with no significant differences between groups for oral inflammation. There was a greater reduction in systemic inflammation following periodontal treatment in individuals with diabetes and periodontitis compared to those with periodontitis but not diabetes (Δ = -0.25, p = .01). CONCLUSIONS: Diabetes and periodontitis together appear to increase systemic inflammation, with evidence of reductions following periodontal treatment.

Orofacial pain assessment and management for patients with dementia: A meta-ethnography.

Delivering dental treatment for patients with dementia can be challenging, and the complexity of treatment provision can increase as dementia progresses. Treatment at the later stages of dementia can be associated with ethical challenges and procedural risk meaning that a comprehensive patient assessment is crucial; the presence of orofacial pain is a key indication for active intervention from dental teams. To explore the process of oro-facial pain assessment and management, a comprehensive review of qualitative literature was undertaken by searching six electronic databases. No literature specific to orofacial pain assessment was identified. The inclusion criteria were widened to explore assessment and management of pain in general for patients with dementia. Meta-ethnography with reciprocal translation was used to identify key concepts and themes and synthesise information applicable to the dental setting. Three major themes arose as follows: challenges with pain assessment, challenges with pain management and logistics and education. Healthcare teams struggle with pain identification in patients with dementia though many signs were identified which may suggest a patient is experiencing pain. The long-term knowledge of individual patients held by family members and care teams can allow identification of deviation from patients' normal states; this knowledge can assist healthcare professionals in determining whether to provide specific treatments or interventions. Pain assessment tools were found to be problematic and are unlikely to be a practical solution to use for complex patients in dental settings. Education for dental and wider care teams on orofacial pain would be highly valuable; yet, this needs to be based on suitable evidence.

Clinical and technical considerations in the analysis of gingival crevicular fluid.

Despite the technical challenges involved when collecting, processing and analyzing gingival crevicular fluid samples, research using gingival crevicular fluid has, and will continue to play, a fundamental role in expanding our understanding of periodontal pathogenesis and healing outcomes following treatment. A review of the literature, however, clearly demonstrates that there is considerable variation in the methods used for collection, processing and analysis of gingival crevicular fluid samples by different research groups around the world. Inconsistent or inadequate reporting impairs interpretation of results, prevents accurate comparison of data between studies and potentially limits the conclusions that can be made from a larger body of evidence. The precise methods used for collection and analysis of gingival crevicular fluid (including calibration studies required before definitive clinical studies) should be reported in detail, either in the methods section of published papers or as an online supplementary file, so that other researchers may reproduce the methodology. Only with clear and transparent reporting will the full impact of future gingival crevicular fluid research be realized. This paper discusses the complexities of gingival crevicular fluid collection and analysis and provides guidance to researchers working in this field.

Implementation issues and barriers for assessing oral health in dependent patients after stroke: A qualitative study.

OBJECTIVES: To explore implementation issues and potential barriers for assessing oral health in dependent post-stroke patients. METHODS: Semi-structured interviews were conducted with a purposively identified sample of healthcare service providers who work in two National Health Service (NHS) Trusts in the north of England. Interviews were conducted until data saturation was achieved (n = 30). Data were analysed using the constant comparative method. RESULTS: Six themes were drawn out in this study, which described potential barriers to assessing oral health in post-stroke patients, aspects of oral health that need assessment, streamlining the oral health assessment, input methods for oral health assessment, characteristics of assessors, and how oral care should be planned. CONCLUSIONS: Assessment of oral health for post-stroke patients has been viewed as a complex task because of several identified barriers. Several suggestions have been proposed to overcome these barriers, aiming to enable more feasible and effective oral health assessments for post-stroke patients. CLINICAL SIGNIFICANCE: The findings from this study have the potential to contribute to developing oral health measurement instruments that might be more successfully implemented and guide oral care planning for dependent patients after stroke.

Establishing an empirical conceptual model of oral health in dependent adults: Systematic review.

AIM: This qualitative evidence synthesis was performed to establish a conceptual model of oral health in dependent adults that defines the construct of oral health and describes its interrelationships based on dependent adults' and their caregivers' experiences and views. METHODS: Six bibliographic databases were searched: MEDLINE, Embase, PsycINFO, CINAHL, OATD, and OpenGrey. Citations and reference lists were manually searched. A quality assessment of included studies was conducted independently by two reviewers using the Critical Appraisal Skills Programme (CASP) checklist. The 'best fit' framework synthesis method was applied. Data were coded against an a priori framework and data not captured by this framework were thematically analyzed. To assess the confidence of the findings from this review, the Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) approach was used. RESULTS: Twenty-seven eligible studies were included from 6126 retrieved studies. Four themes were generated to further understand oral health in dependent adults: oral health status, oral health impact, oral care, and oral health value. CONCLUSION: This synthesis and conceptual model offer a better understanding of oral health in dependent adults and subsequently provide a starting point to guide establishment of person-centred oral care interventions.

Oral health decline in patients after stroke: a qualitative study.

Introduction To develop and implement effective oral care interventions for patients after stroke, there is a need to understand the causes behind the decline in their oral health. This qualitative study was, therefore, undertaken to explore experiences and views of health service providers about the causes of oral health decline in this group of patients.Methods A purposively selected sample of healthcare service providers who work in two NHS Trusts in the North of England were interviewed utilising a semi-structured interview technique. Interviews were conducted with the assistance of a topic guide and continued until data saturation (n = 30) was reached. The constant comparative approach was used to analyse the data.Results Two major factors, perceived by the participants, were thought to cause oral health decline in patients after stroke. Post-stroke neurological deficits resulting in oral-related functional disturbances was the first. The second was the barriers leading to difficulties in performing or receiving daily oral care. These barriers were related to the patients, their service providers, or the environment in which care is being delivered.Conclusions This study described the major factors affecting the oral health of patients after stroke, which can offer a starting point for developing effective oral care interventions for them.

Changes in clinical and imaging variables during withdrawal of heart failure therapy in recovered dilated cardiomyopathy.

AIMS: This study aimed to profile the changes in non-invasive clinical, biochemical, and imaging markers during withdrawal of therapy in patients with recovered dilated cardiomyopathy, providing insights into the pathophysiology of relapse. METHODS AND RESULTS: Clinical, biochemical, and imaging data from patients during phased withdrawal of therapy in the randomized or single-arm cross-over phases of TRED-HF were profiled. Clinical variables were measured at each study visit and imaging variables were measured at baseline, 16 weeks, and 6 months. Amongst the 49 patients [35% women, mean age 53.6 years (standard deviation 11.6)] who withdrew therapy, 20 relapsed. Increases in mean heart rate [7.6 beats per minute (95% confidence interval, CI, 4.5, 10.7)], systolic blood pressure [6.6 mmHg (95% CI 2.7, 10.5)], and diastolic blood pressure [5.8 mmHg (95% CI 3.1, 8.5)] were observed within 4-8 weeks of starting to withdraw therapy. A rise in mean left ventricular (LV) mass [5.1 g/m2 (95% CI 2.8, 7.3)] and LV end-diastolic volume [3.9 mL/m2 (95% CI 1.1, 6.7)] and a reduction in mean LV ejection fraction [-4.2 (95% CI -6.6, -1.8)] were seen by 16 weeks, the earliest imaging follow-up. Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) fell immediately after withdrawing beta-blockers and only tended to increase 6 months after beginning therapy withdrawal [mean change in log NT-proBNP at 6 months: 0.2 (95% CI -0.1, 0.4)]. CONCLUSIONS: Changes in plasma NT-proBNP are a late feature of relapse, often months after a reduction in LV function. A rise in heart rate and blood pressure is observed soon after withdrawing therapy in recovered dilated cardiomyopathy, typically accompanied or closely followed by early changes in LV structure and function.

A qualitative exploration of participant and investigator perspectives from the TRED-HF trial.

AIMS: We explored the experiences and motivations of participants and staff who took part in the TRED-HF trial (Therapy withdrawal in REcovered Dilated cardiomyopathy). METHODS AND RESULTS: We conducted a qualitative study, using semi-structured interviews, with participants (n = 12) and the research team (n = 4) from the TRED-HF trial. Interviews were carried out in 2019 and were audio-recorded and transcribed. Data were managed using NVivo and analysed using framework analysis. A patient representative provided guidance on the interpretation of findings and presentation of themes to ensure these remained meaningful, and an accurate representation, to those living with dilated cardiomyopathy. Three key themes emerged from the data: (i) perception of health; (ii) experiences and relationships with healthcare services and researchers; and (iii) perception of risk. Study participants held differing perceptions of their health; some did not consider themselves to have a heart condition or disagreed with the medical term 'heart failure'. Relationships between participants, research staff, and clinical management teams influenced participants' experiences and decision making during the trial, including following clinical advice. There were differences in participants' perceptions of risk and their decisions to take heart failure medication after the trial was completed. Although the original TRED-HF trial did not provide the results many had hoped for, a strong motivator for taking part was the opportunity to withdraw medication in a safely monitored environment which had been previously considered by some participants before. Investigators acknowledged that the insights gained from the study can now be used to support evidence-based conversations with patients. CONCLUSIONS: For people whose dilated cardiomyopathy is in remission, decisions to continue, reduce, or stop their medication are influenced by perceptions of personal health, perceive risk and the important of work, employment, recreation, relationships, and long-term plans. The unique relationship between patient and cardiologist provides opportunities to promote honest discussion about adherence to medication and personalized long-term management.

Impact of diabetes and periodontal status on life quality.

OBJECTIVES: To investigate impact of periodontal status on quality of life (QoL) in type-1 (T1D) and type-2 (T2D) diabetes patients pre- and post-periodontal treatment using the Well-being Questionnaire 12 (W-BQ12) and Audit of Diabetes-Dependent Quality of Life-19 (ADDQoL-19). METHODS: W-BQ12 and ADDQoL-19 were self-completed by 56 T1D and 77 T2D patients at baseline and by those with periodontitis 3 and 6-months after therapy. RESULTS: At baseline, T1D patients had significantly higher general W-BQ12 [Median (IQR); 24.00 (20.25-27.75)] and positive well-being scores [8.00 (6.00-9.00)] (indicating better QoL) compared to T2D patients [22.00 (15.50-26.00) and 6.00 (3.50-9.00)], respectively (p < 0.05). Within both groups, general W-BQ12 scores did not differ significantly between patients with periodontal health, gingivitis, or periodontitis (p > 0.05). Significantly higher general W-BQ12 scores were observed in T1D patients at month 3 [28.00 (22.00-29.50)] compared to baseline [22.00 (17.00-24.50)] (p < 0.01), suggesting an initial improvement in QoL post-treatment. ADDQoL-19 identified that diabetes had greatest impact on the domain 'freedom to eat', with participants placing most importance on 'family life'. No significant changes in ADDQoL-19 scores were seen post-treatment (p > 0.05). CONCLUSIONS: Diabetes had impacts upon aspects of life quality in both T1D and T2D patients, though any additional impact based on periodontal status was not observed when using W-BQ12 and ADDQoL-19.

Heart Rate as a Marker of Relapse During Withdrawal of Therapy in Recovered Dilated Cardiomyopathy.

OBJECTIVES: The objective of this study was to determine the relationship between heart rate and relapse among patients in the TRED-HF (Therapy withdrawal in REcovered Dilated cardiomyopathy trial). BACKGROUND: Understanding markers and mechanisms of relapse among patients with recovered dilated cardiomyopathy (DCM) may enable personalized management. METHODS: The relationship between serial heart rate measurements and relapse was examined among patients in the TRED-HF trial, a randomized trial which examined the safety and feasibility of withdrawing heart failure therapy from 51 patients with recovered DCM over 6 months. In total, 25 patients were randomized to therapy withdrawal and 26 to continue therapy, of whom 25 subsequently began therapy withdrawal in a single arm crossover phase. RESULTS: The mean ± SD heart rate for those who had therapy withdrawn and did not relapse was 64.6 ± 10.7 beats/min at baseline and 74.7 ± 10.4 beats/min at follow-up, compared to 68.3 ± 11.3 beats/min at baseline and 86.1 ± 11.8 beats/min at follow-up for those who relapsed. After adjusting for differences in heart rate at baseline, patients who had therapy withdrawn and relapsed had a 10.4 beats/min (95% CI: 4.0-16.8) greater rise in heart rate than patients who had therapy withdrawn and did not relapse (P = 0.002). After data were adjusted for age, log N-terminal pro-B-type natriuretic peptide, and left ventricular ejection fraction (LVEF), heart rate (per 10 beats/min; hazard ratio [HR]: 1.65; 95% CI: 1.10-2.57; P = 0.01) and change in heart rate from baseline (per 10 beats/min; HR: 1.70; 95% CI: 1.12-2.57; p = 0.01) were associated with relapse. The results remained qualitatively the same after adjusting for beta-blocker dose. CONCLUSIONS: For patients with DCM and improved LVEF, the rise in heart rate after treatment is withdrawn treatment identifies patients who are more likely to relapse. Whether the increase in heart rate is a marker or a mediator of relapse requires investigation. (Therapy withdrawal in REcovered Dilated cardiomyopathy trial [TRED]; NCT02859311).

Improving the oral health of older people in care homes (TOPIC): a protocol for a feasibility study.

BACKGROUND: Evidence for interventions promoting oral health amongst care home residents is weak. The National Institute for Health and Care Excellence (NICE) guideline NG48 aims to maintain and improve the oral health of care home residents. A co-design process that worked with residents and care home staff to understand how the NG48 guideline could be best implemented in practice has been undertaken to refine a complex intervention. The aim of this study is to assess the feasibility of the intervention to inform a future larger scale definitive trial. METHODS: This is a protocol for a pragmatic cluster randomised controlled trial with a 12-month follow-up that will be undertaken in 12 care homes across two sites (six in London, six in Northern Ireland). Care homes randomised to the intervention arm (n = 6) will receive the complex intervention based on the NG48 guideline, whilst care homes randomised to the control arm (n = 6) will continue with routine practice. The intervention will include a training package for care home staff to promote knowledge and skills in oral health promotion, the use of the Oral Health Assessment Tool on residents by trained care home staff, and a 'support worker assisted' daily tooth-brushing regime with toothpaste containing 1500 ppm fluoride. An average of ten residents, aged 65 years or over who have at least one natural tooth, will be recruited in each care home resulting in a recruited sample of 120 participants. Assessments will be undertaken at baseline, 6 months and 12 months, and will include a dental examination and questionnaires on general health and oral health administered by a research assistant. A parallel process evaluation involving semi-structured interviews will be undertaken to explore how the intervention could be embedded in standard practice. Rates of recruitment and retention, and intervention fidelity will also be recorded. A cost-consequence model will determine the relevance of different outcome measures in the decision-making context. DISCUSSION: The study will provide valuable information for trialists, policymakers, clinicians and care home staff on the feasibility and associated costs of oral health promotion in UK care homes. TRIAL REGISTRATION: ISRCTN10276613. Registered on 17th April 2020. http://www.isrctn.com/ISRCTN10276613 .

Development of a core outcome set for oral health services research involving dependent older adults (DECADE): a study protocol.

BACKGROUND: Oral healthcare service provision for dependent older adults is often poor. For dental services to provide more responsive and equitable care, evidence-based approaches are needed. To facilitate future research, the development and application of a core outcome set would be beneficial. The aim of this study is to develop a core outcome set for oral health services research involving dependent older adults. METHODS: A multi-step process involving consensus methods and including key stakeholders will be undertaken. This will involve identifying potentially relevant outcomes through a systematic review of previous studies examining the effectiveness of strategies to prevent oral disease in dependent older adults, combined with semi-structured interviews with key stakeholders. Stakeholders will include dependent older adults, family members, carers, care-home managers, health professionals, researchers, dental commissioners and policymakers. To condense and prioritise the long list of outcomes generated by the systematic review and semi-structured interviews, a Delphi survey consisting of several rounds with key stakeholders, as mentioned above, will be undertaken. The 9-point Likert scale proposed by the GRADE Working Group will facilitate this consensus process. Following the Delphi survey, a face-to-face consensus meeting with key stakeholders will be conducted where the stakeholders will anonymously vote and decide on what outcomes should be included in the finalised core outcome set. DISCUSSION: Developing a core set of outcomes that are clinically and patient-centred will help improve the design, conduct and reporting of oral health services research involving dependent older adults, and ultimately strengthen the evidence base for high-quality oral health care for dependent older adults. TRIAL REGISTRATION: The study was registered with the COMET initiative on 9 January 2018 http://www.cometinitiative.org/studies/details/1081?result=true .

Care pathways and provision in bariatric dental care: an exploration of patients' and dentists' experiences in the North East of England.

Introduction Levels of obesity in the UK are increasing. The suitability and safety of dental care delivery can be affected by obesity. When patients' weight exceeds that of a normal dental chair, referral to specialist settings can be appropriate, yet no research has explored the process of care for this group.Aims This study aimed to explore the experiences of patients and dentists regarding referral to bariatric dental care facilities.Method Semi-structured interviews were completed with patients referred to a bariatric dental service and referring dentists. Interview transcripts were analysed thematically.Results Twelve dentists and eight patients participated. Both groups were aware that obesity influenced care and had concerns about the safety of treatment. Dentists were cautious about discussing weight though patients were willing to discuss this. The challenges in identifying weight and organising appropriate care were key issues affecting both patients and dentists.Conclusion Dentists should engage in discussions regarding obesity without hesitation, where appropriate. Redesigned patient-focused care pathways to direct patients to accessible services would help reduce stigma and improve safety for patients with obesity.

The need for further oral health research surrounding the provision of dental treatment for people with drug dependency.

The aim of this article is to highlight the need for further research in providing dental care for people with drug dependency. The association between people who misuse substances and dental disease is widely known occurrence, yet there have been few studies conducted in the UK surrounding this issue due to the nature of the cohort. Further to this, there are a multitude of barriers to accessing/seeking dental care that exist for those with drug dependency. Going forward, there is a need for the development of a new service model where dental care is part of a multidisciplinary team working towards treating people with drug dependency in a holistic way.