Management of periodontitis in patients with type 2 diabetes : the clinical and biological response

Type 2 diabetes (T2DM) is a risk factor for periodontal disease, however the pathogenic links between the two disease are not completely understood. Both diseases are considered to be inflammatory conditions and, therefore, cytokines are likely to play a role in the shared susceptibility between the two diseases. Therefore, the study evaluated, longitudinally over 12 months, the impact of periodontal therapy on clinical outcomes, glycaemic control, hsCRP, lipids and local and systemic levels of IL-6, TNF- α, IL-1β and IFN-γ in patients with T2DM. 101 T2DM and 83 non-diabetic subjects were recruited and, of these, periodontitis was diagnosed in 47 T2DM and 48 non-diabetic subjects. Pre-treatment, subjects with T2DM had significantly higher BMI and significantly lower systolic BP and cholesterol compared to non-diabetic subjects. Serum levels of TNF-α, IL-1β and IFN-γ were significantly higher in subjects with T2DM compared to non-diabetic subjects. Regardless of diabetic status, GCF and salivary levels of IL-1β were significant predictors of the clinical periodontal condition. In T2DM and non-diabetic subjects, all clinical periodontal outcomes were significantly improved at 3, 6 and 12 months following NSM and both groups demonstrated significant reductions in GCF IL-1β levels at 3, 6 and 12 months. In nondiabetic subjects, a significant reduction in non-HDL and cholesterol was seen 6 months after NSM. In subjects with T2DM, serum TNF-α was significantly reduced 3 and 6 months after NSM. In subjects with T2DM, HbA1c showed 0.45% and 0.40% reductions at 3 and 12 months after NSM, although these reductions did not achieve statistical significance. Abstract XVII In conclusion, periodontal therapy led to significant reductions in GCF IL-1β in all subjects, and also produced a significant reduction in circulating levels of TNF-α in subjects with T2DM. Furthermore, IL-1β in saliva and GCF appear to be good prognostic markers for periodontitis regardless of diabetes status.EThOS - Electronic Theses Online ServiceRoyal College of Surgeons EdinburghDunhill Medical TrustGBUnited Kingdo

Promoting co-production in the generation and use of research evidence to improve service provision in special care dentistry

Special care dentistry (SCD) provides holistic oral service provision for people with complex health and care needs. These can include physical, sensory, intellectual, mental, medical, emotional or social impairment or disability or, more often, a combination of these factors. The level of disability within these population groups can vary, and a proportion of people will have multiple and overlapping impairments and/or medical conditions. This paper explores a number of possible research methods that may better reflect the diversity and challenges of this population group, where the emphasis is placed on co-production and co-design

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.</p

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.</p

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

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

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

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

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)

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