Protocol for a Randomised controlled trial to Evaluate the effectiveness and cost benefit of prescribing high dose FLuoride toothpaste in preventing and treating dEntal Caries in high-risk older adulTs (reflect trial).

BACKGROUND: Dental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern. Elderly individuals with heavily restored dentitions represent a clinical challenge and significant financial burden for healthcare systems, especially when their physical and cognitive abilities are in decline. Prescription of higher concentration fluoride toothpaste to prevent caries in older populations is expanding in the UK, significantly increasing costs for the National Health Services (NHS) but the effectiveness and cost benefit of this intervention are uncertain. The Reflect trial will evaluate the effectiveness and cost benefit of General Dental Practitioner (GDP) prescribing of 5000 ppm fluoride toothpaste and usual care compared to usual care alone in individuals 50 years and over with high-risk of caries. METHODS/DESIGN: A pragmatic, open-label, randomised controlled trial involving adults aged 50 years and above attending NHS dental practices identified by their dentist as having high risk of dental caries. Participants will be randomised to prescription of 5000 ppm fluoride toothpaste (frequency, amount and duration decided by GDP) and usual care only. 1200 participants will be recruited from approximately 60 dental practices in England, Scotland and Northern Ireland and followed up for 3 years. The primary outcome will be the proportion of participants receiving any dental treatment due to caries. Secondary outcomes will include coronal and root caries increments measured by independent, blinded examiners, patient reported quality of life measures, and economic outcomes; NHS and patient perspective costs, willingness to pay, net benefit (analysed over the trial follow-up period and modelled lifetime horizon). A parallel qualitative study will investigate GDPs' practises of and beliefs about prescribing the toothpaste and patients' beliefs and experiences of the toothpaste and perceived impacts on their oral health-related behaviours. DISCUSSION: The Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice. TRIAL REGISTRATION: ISRCTN: 2017-002402-13 registered 02/06/2017, first participant recruited 03/05/2018. Ethics Reference No: 17/NE/0329/233335. Funding Body: Health Technology Assessment funding stream of National Institute for Health Research. Funder number: HTA project 16/23/01. Trial Sponsor: Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL. The Trial was prospectively registered.

The psychological and physiological health effects of fatigue.

Background: The issue of employee fatigue is becoming increasingly prominent, particularly in safety-critical industries. Aims: To produce an in-depth review collating the known psychological and physiological health and work effects of fatigue to guide mitigation strategies in safety-critical industries. Methods: Literature searches were conducted via scientific databases using appropriate filters and keywords. The available results were collated into a review and commentary. Results: Decreased sleep duration and chronodisruption have been shown to cause both significant morbidity and mortality. There is a large body of evidence showing strong associations between fatigue, reduced cognition and occupational accidents, as well as increased metabolic and reproductive health sequelae, some forms of cancer and mortality. Additional evidence links fatigue with mental, gastrointestinal, neurological and chronic pain sequelae. Conclusions: Fatigue risk mitigation strategies should be implemented, not only to reduce these short- and long-term health risks in employees of safety-critical industries, but also to create more efficient, productive and effective workplace personnel with longer and more fulfilling careers. This requires improved acute fatigue mitigation, as well as the prevention of cumulative fatigue build-up and the formation of acute-on-chronic fatigue. The health recommendations for fatigue mitigation outlined in this paper are pertinent to all professions where employees have high rates of both acute and chronic fatigue.

Managing patients on bisphosphonates: the practice of primary care dentists before and after the publication of national guidance.

BACKGROUND: In April 2011 the Scottish Dental Clinical Effectiveness Programme published the Oral health management of patients prescribed bisphosphonates guidance document. The aims of this study were to examine whether dentists' practice and beliefs changed after guidance publication to determine whether a knowledge translation intervention was required, and to inform its development. METHODS: Three postal surveys sent to three independent, random samples of dentists throughout Scotland pre- and post-guidance publication. The questionnaire, framed using the theoretical domains framework (TDF), assessed current practice and beliefs relating to recommended management of patients on bisphosphonates. RESULTS: The results (N = 420) suggest that any significant impact the guidance may have had on the recommended management of patients on bisphosphonates by primary care dentists, had reached its peak ten months post publication. A more positive attitude, greater perceived ability, and greater motivation were all associated with significantly more performing of all recommended behaviours at every time point. CONCLUSIONS: Prior to this study, there was little available information about how patients on bisphosphonates were being managed in primary dental care, or what beliefs may be influencing management decisions. This study was able to identify levels of compliance pre- and post-guidance publication and determine that further intervention was necessary to enable sustained uptake of recommendations. Using the TDF to identify beliefs associated with best practice made it possible to suggest theoretically informed strategies for service improvement. The next step is to test the intervention(s) in a randomised controlled trial.

Evidence not practised: the underutilisation of preventive fissure sealants.

International and UK professional organisations, Cochrane systematic reviews, and international and UK guidance documents all support the application of preventive fissure sealants (PFSs) as an effective treatment for reducing caries. However, PFSs are well known to be underutilised in primary care. This paper collates data from PFS-relevant studies in Scotland, which has a large population of children at caries risk, to identify the beliefs and factors dentists perceive as influencing their decision not to provide this treatment. This information provides a platform to suggest how to increase the application of PFSs in this region (a standardised audit incorporating evidence-based behaviour change techniques, supplemental guidance on how to implement gold-standard recommendations in practice, training). This may also be relevant outside of Scotland, as well as to the implementation of other evidence-based behaviours in practice.

Effect of hyperoxic-supplemented interval training on endurance performance in trained cyclists.

The aim of this study was to determine the effect of hyperoxic-supplemented interval training on endurance performance. Using a single-blind, randomised control-trial design, 16 well-trained cyclists were randomly assigned to either hyperoxic or normoxic training. Participants visited the laboratory twice per week, for 4 weeks, to perform high-intensity interval training sessions. A 20 km TT, incremental exercise test and 60s all-out test were conducted pre- and post-intervention. Smaller effects for most physiological measures, including VO 2peak (1.9 ± 4.3%) and lactate threshold (0.3 ± 8.3%), were observed after training in hyperoxia compared to normoxia. There was a small increase in mean power during the 20 km TT after hyperoxia [2.1 ± 3.7%; effect size (ES): - 0.30 ± 0.39] but this was less than that observed after normoxia (4.9 ± 3.9%; ES: - 0.44 ± 0.60). During the 60 s all-out test, the peak relative power was relatively unchanged, whereas mean relative power was increased in normoxia (2.3 ± 3.4%) but not hyperoxia (0.3 ± 1.2%; ES: - 0.34 ± 0.49). Hyperoxic-supplemented interval training in the competitive season had less effect on endurance and high-intensity performance and physiology in trained endurance cyclists compared to interval training in normoxia. Therefore hyperoxic-supplemented training at sea level appears to be not worthwhile for maximising performance in competitive endurance athletes.

Quality control technique to reduce the variability of longitudinal measurement of hemoglobin mass.

The sensitivity of the athlete blood passport to detect blood doping may be improved by the inclusion of total hemoglobin mass (Hb(mass)), but the comparability of Hb(mass) from different laboratories is unknown. To optimize detection sensitivity, the analytical variability associated with Hb(mass) measurement must be minimized. The aim of this study was to investigate the efficacy of using quality controls to minimize the variation in Hb(mass) between laboratories. Three simulated laboratories were set up in one location. Nine participants completed three carbon monoxide (CO) re-breathing tests in each laboratory. One participant completed two CO re-breathing tests in each laboratory. Simultaneously, quality controls containing Low (1-3%) and High (8-11%) concentrations of percent carboxyhemoglobin (%HbCO) were measured to compare hemoximeters in each laboratory. Linear mixed modeling was used to estimate the within-subject variation in Hb(mass), expressed as the coefficient of variation, and to estimate the effect of different laboratories. The analytic variation of Hb(mass) was 2.4% when tests were conducted in different laboratories, which reduced to 1.6% when the model accounted for between-laboratory differences. Adjustment of Hb(mass) values using quality controls achieved a comparable analytic variation of 1.7%. The majority of between-laboratory variation in Hb(mass) originated from the difference between hemoximeters, which could be eliminated using appropriate quality controls.