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.

Exploring the feasibility of general health promotion in UK dental primary care: ENGAGE in Scotland.

Introduction Despite UK dental guidance recommending opportunistic health promotion, it's rare for GDPs to discuss more than oral hygiene with their patients. The ENGAGE intervention incorporates UK guidance and evidence-based behaviour change techniques to motivate patients to make lifestyle changes (reduce smoking, alcohol consumption and/or improve diet). It was designed to take less than five minutes and be delivered during a routine dental check-up, and includes a take-home patient handout signposting to free NHS lifestyle counselling helpline services.Aims To determine the feasibility (patient and GDP acceptance) of implementing ENGAGE in Scottish dental primary care. The overall aim is to examine feasibility UK-wide before testing its effectiveness for influencing patient outcomes in a multi-centre UK trial.Methods Study 1: patient survey: N = 1000 adults from all health boards in Scotland were randomly selected from an NHS data base of medical patients and emailed the study invitation and link to an online questionnaire. Study 2: GDP workshop, audit, survey: N = 50 GDPs across Scotland were invited to participate in the training workshop (limited to the first 20 applicants), implement the intervention with their next 20 adult patients in for a check-up, audit their experience, then complete an online questionnaire.Results Study 1: 200 people completed the survey (52% male; 37% were 55 years or younger; 90% had visited their dentist in the previous 12 months). Less than (<) 15% were asked about their smoking, alcohol intake and/or diet when they last visited their dentist for a check-up; <10% would be embarrassed/offended if their dentist or dental hygienist asked them lifestyle questions during a dental check-up; more than (>) 70% would be reassured by the professionalism of their dentist or dental hygienist if they were asked; <4% would be embarrassed/offended if given a leaflet with NHS helpline information by their dentist. Study 2: N = 18 GDPs from nine out of 14 NHS regional health boards in Scotland delivered the ENGAGE intervention to 335 patients (averaging 18 patients each). N = 17/18 participants agreed that this intervention could be delivered during a check-up, was an improvement on what they currently did and thought that it may make a difference to what their patients thought, felt, and/or did about reducing health risk.Conclusion The ENGAGE intervention is feasible to implement in Scottish dental primary care. Comments from patient and GDP participants will inform its development and further feasibility studies set in other UK regions.

Is further intervention required to translate caries prevention and management recommendations into practice?

AIMS: In April 2010, the Scottish Dental Clinical Effectiveness Programme (SDCEP) published guidance on the Prevention and management of dental caries in children. The aims of this study were to determine if further intervention is required to translate the SDCEP guidance recommendations into practice and to identify salient beliefs associated with recommended practice. METHODS: Two postal surveys circulated to two independent random samples of dentists working in general dental practices in Scotland, before and after the publication of the guidance. The questionnaire items assessed current practice and beliefs relating to the prevention and management of dental caries in children. RESULTS: Response rates of 40% (n = 87) and 45% (n = 131) were achieved. The results highlight a gap between current practice and recommended practice. The majority of dentists do not 'always' perform recommended behaviours and many are following treatment strategies specifically not recommended in the guidance. More positive attitude, greater capability and motivation were significantly associated with performing more guidance recommended risk assessment and prevention behaviours. CONCLUSIONS: These findings highlight the need for further intervention to translate the SDCEP guidance recommendations into practice and give initial insight into the salient beliefs that may serve as targets for future interventions.

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.

What influences the implementation of interceptive orthodontics in primary care?

OBJECTIVE: To understand what influences the implementation of mixed dentition interceptive orthodontic treatment in primary care. METHODS: Postal survey of a random sample of 400 general dental practitioners in Scotland. The questionnaire assessed knowledge, beliefs and attitudes towards providing interceptive treatment in seven different clinical scenarios in order to identify variables that may explain the decision to undertake this treatment. RESULTS: One hundred and one (25%) completed questionnaires were received. Confidence to carry out the treatment plan (16%), knowledge (11%), and age (7%) all significantly predicted intention to provide interceptive treatment. CONCLUSIONS: The greatest barrier to providing interceptive orthodontic care in general dental practice is practitioners' lack of self-confidence relating to the effectiveness of their chosen treatment plan.

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.

Achieving good oral health in children: the importance of a current, relevant and unbiased evidence base in paediatric dentistry.

The Cochrane Collaboration was founded in 1993 as an international, non-profit and independent organisation dedicated to making up-to-date, accurate and reliable information about healthcare readily available. This paper discusses how the Cochrane Oral Health Group reviews have contributed to the oral health evidence base used in the development of many international and U.K. dental guidance documents, particularly in the field of paediatric dentistry.

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.

General dental practitioner views on providing alcohol related health advice; an exploratory study.

OBJECTIVE: To identify salient beliefs of general dental practitioners (GDPs) regarding their role in the identification of alcohol misuse and the provision of an alcohol related health message in the primary dental care setting. METHOD: A convenience sample of 12 GDPs practising in the North Highland region of Scotland underwent semi-structured interview. An inductive approach was used with subsequent basic thematic content analysis performed on the transcripts. RESULTS: GDPs universally agreed that alcohol consumption plays a role in both oral health and general health but this did not translate into effective communication about alcohol during dental consultation. Current knowledge of recommended safe alcohol consumption guidelines was poor - evidence of potential GDP training requirements. The primary barriers related to disruption of the clinician-patient relationship, embarrassment or the perceived irrelevance to the clinical situation. GDPs expressed low confidence in approaching alcohol related problems. CONCLUSIONS: GDPs felt that alcohol based discussions in primary care would not be relevant and would inevitably lead to disruption of the patient-clinician relationship. Further research is necessary to more fully understand the attitudes, behaviour and knowledge of GDPs regarding the provision of alcohol related health advice. The results of this study have informed the design of a paper postal survey for wider distribution.

How to influence patient oral hygiene behavior effectively.

Considerable resources are expended in dealing with dental disease easily prevented with better oral hygiene. The study hypothesis was that an evidence-based intervention, framed with psychological theory, would improve patients' oral hygiene behavior. The impact of trial methodology on trial outcomes was also explored by the conducting of two independent trials, one randomized by patient and one by dentist. The study included 87 dental practices and 778 patients (Patient RCT = 37 dentists/300 patients; Cluster RCT = 50 dentists/478 patients). Controlled for baseline differences, pooled results showed that patients who experienced the intervention had better behavioral (timing, duration, method), cognitive (confidence, planning), and clinical (plaque, gingival bleeding) outcomes. However, clinical outcomes were significantly better only in the Cluster RCT, suggesting that the impact of trial design on results needs to be further explored.

Recall, reassessment and monitoring.

A recall system is a continuing care regime which provides opportunities to reassess and monitor the oral health of patients and to inform future treatment planning. There is some evidence that recall visits have a positive impact on the natural and functional dentition. Unfortunately, there is a general paucity of reliable evidence about the timing of recall visits despite the widely adopted 6-month interval. In response to political, professional and patient uncertainty, the UK National Institute of Health and Clinical Excellence (NICE) convened a guideline development group to consider both best evidence and best practice in this field. The NICE issued a guidance document in 2004 recommending that the individual risk status should determine the patient's recall interval. The recommendations cover risk factors such as caries incidence and restorations; periodontal health and tooth loss, patients' well-being, general health and preventive habits, pain and anxiety. Methods and tools to facilitate and standardize the collection of risk information are currently being developed and/or collated by the Scottish Dental Clinical Effectiveness Programme. The selection of a recall interval is a multifaceted and complex decision involving the judgement of both clinician and patient. More research is needed into the rate of progression of oral diseases and the impact of recall on oral health and quality of life. Nevertheless, the NICE guidance is based on the best available evidence, and it should be used to determine personalized variable time intervals to assess, reassess and monitor the oral health and caries status of patients.

Knowledge may not be the best target for strategies to influence evidence-based practice: using psychological models to understand RCT effects.

BACKGROUND: Interventions to enhance the implementation of evidence-based practice have a varied success rate. This may be due to a lack of understanding of the mechanism by which interventions achieve results. PURPOSE: Use psychological models to further an understanding of trial effects by piggy-backing on a randomised controlled trial testing 2 interventions (Audit & Feedback and Computer-aided Learning) in relation to evidence-based third molar management. METHOD: All participants of the parent trial (64 General Dental Practitioners across Scotland), regardless of intervention group, were invited to complete a questionnaire assessing knowledge and predictive measures from Theory of Planned Behaviour and Social Cognitive Theory. The main outcome was evidence-based extracting behaviour derived from patient records. RESULTS: Neither intervention significantly influenced behaviour in the parent trial. This study revealed that the interventions did enhance knowledge, but knowledge did not predict extraction behaviour. However, the interventions did not influence variables that did predict extraction behaviour (attitude, perceived behavioural control, self-efficacy). Results suggest both interventions failed because neither influenced possible mediating beliefs for the target behavior. CONCLUSION: Using psychology models elucidated intervention effects and allowed the identification of factors associated with evidence based practice, providing the basis for improving future intervention design.

Changing clinicians' behavior: a randomized controlled trial of fees and education.

The fissure-sealing of newly erupted molars is an effective caries prevention treatment, but remains underutilized. Two plausible reasons are the financial disincentive produced by the dental remuneration system, and dentists' lack of awareness of evidence-based practice. The primary hypothesis was that implementation strategies based on remuneration or training in evidence-based healthcare would produce a higher proportion of children receiving sealed second permanent molars than standard care. The four study arms were: fee per sealant treatment, education in evidence-based practice, fee plus education, and control. A cost-effectiveness analysis was conducted. Analysis was based on 133 dentists and 2833 children. After adjustment for baseline differences, the primary outcome was 9.8% higher when a fee was offered. The education intervention had no statistically significant effect. 'Fee only' was the most cost-effective intervention. The study contributes to the incentives in health care provision debate, and led to the introduction of a direct fee for this treatment.

Evaluating dental vocational training: how does Scotland compare to the rest of the UK?

BACKGROUND: UK dental graduates complete a 12-month vocational training programme, but only in Scotland is there mandatory assessment. AIM: To evaluate the effect of mandatory assessment. METHOD: Pragmatic experimental design. UK dental trainees (Cohort 1: 2003-2004; Cohort 2: 2004-2005; Cohort 3: 2005-2006) completed questionnaires assessing stakeholder-identified clinical and non-clinical outcomes pre- and post-training. RESULTS: Response rate = 84%: Scotland (n = 247); other UK (n = 308: 156 (England) + 102 (Wales) + 50 (Northern Ireland)). Compared to other UK trainees, trainees in Scotland were significantly more confident in clinical skills (F(1,555)= 15.49, p <0.001), continuing professional development (F(1,552) = 4.37, p <0.05), felt better prepared for keeping track of new technology (F(1,551) = 9.03, p <0.01) and new evidence (F(1,551)= 3.71, p <0.05); showed more positive attitude toward training (F(1,554) = 5.82, p <0.01), continued professional development (F(1,552) = 4.71, p <0.05), and their job (F(1,553) = 6.93, p <0.01). They also found mandatory assessment significantly more beneficial (Scotland mean = 5.6 (1.9); other UK mean = 4.0 (1.9); F(1,546) = 60.87, p <0.001), more useful (Scotland mean = 5.3 (1.5); other mean = 4.9 (1.7); F(1,549) = 7.474, p <0.01) and more comforting (Scotland mean = 4.1 (1.6); other UK mean = 2.7 (1.6); F(1,547) = 57.47, p <0.001). CONCLUSION: Results suggest it does matter where dental graduates spend their training year in the UK. Support for training under the Scottish mandatory assessment system was robust over three cohorts. This study has shown the value of evaluating different training systems and may inform the development and standardisation of future professional education programmes.

Perceived control predicting the recovery of individual-specific walking behaviours following stroke: testing psychological models and constructs.

OBJECTIVES: Perceived control predicts activity limitations, but there are many control belief concepts and how these are defined and measured has implications for intervention design. This study examined whether individual-specific activity limitations and recovery were predicted by theoretically derived control conceptualizations, the Theory of Planned Behaviour and an integrated model (Theory of Planned Behaviour with the World Health Organization ICF (International Classification of Functioning, Disability and Health) model). DESIGN: This predictive cohort study used measures of impairment, intention and perceived control (perceived behavioural control, Theory of Planned Behaviour; self-efficacy, Social Cognitive Theory; locus of control, Social Learning Theory), assessed 2 weeks after hospital discharge, to predict walking limitation (UK SIP: FLP) and recovery after 6 months. Theoretically derived items were individually tailored for patients' baseline walking limitation. PARTICIPANTS: Two hundred and three stroke patients (124 men and 79 women; mean age = 68.88, SD = 12.31 years) RESULTS: Walking limitation and walking recovery (respectively) were predicted by perceived behavioural control (r = -.36(**), .26(**)) and self-efficacy (r = -.30(**), .22(**)), but not locus of control (r = -.07, .02). Both theoretical models accounted for significant variance in walking limitation and recovery--but not beyond that explained by perceived behavioural control. Predictive power was not improved by modifying the control component or by including impairment in regression equations. CONCLUSIONS: Results suggest that perceived control predicts individual-specific disability and recovery and that reductions in activity limitations may be achieved by manipulating control cognitions. In addition, reducing impairments may not have maximal effect on reducing disability unless beliefs about control over performing the behaviour are also influenced.

What influences intention to become a postgraduate trainer?

OBJECTIVE: Only a small proportion of eligible dentists become dental vocational trainers. The aim of this study was to apply Social Cognitive Theory to further an understanding of beliefs underpinning intention to become a dental vocational trainer. SUBJECTS: Primary care dentists. DESIGN: A self-administered questionnaire was distributed at all continuing professional development courses during November 2004 regardless of course enrolment numbers, content or duration. OUTCOME MEASURE: Intention to train. Predictive measures Attitude toward being a trainer, attitude toward attending the trainer course, and confidence in ability to train (training self-efficacy). RESULTS: Of the 316 respondents, 47% intended never to train. Training self-efficacy accounted for the majority of variance in intention to train (15%, step 1) with attitude to training accounting for a further 4% (step 2) (Hosmer and Lemeshow test: Chi-square = 7.36, df = 8, p = 0.498; 95% CI for EXP(b): training self-efficacy = 1.38-2.06, attitude = 1.17-2.08). Attitude to the trainer course did not enter the regression model. The most influential belief relating to intention to train was confidence in teaching, and for intention never to train was evaluating a trainee's skills. Both intenders and non-intenders believed training and attending training courses would be time-consuming and financially costly, suggesting these are not primary factors in making the decision to become a trainer. CONCLUSIONS: Using a psychological model provided a starting point for understanding intention to become a vocational trainer and a rationale for the format of future interventions. Results suggest intention to train may be influenced by targeting dentists' confidence in teaching and performing evaluative aspects of training.

Effectiveness of strategies to disseminate and implement clinical guidelines for the management of impacted and unerupted third molars in primary dental care, a cluster randomised controlled trial.

OBJECTIVE: To investigate the effectiveness and cost-effectiveness of different guideline implementation strategies, using the Scottish Intercollegiate Guidelines Network (SIGN) Guideline 42 "Management of unerupted and impacted third molar teeth" (published 2000) as a model. DESIGN: A pragmatic, cluster RCT (2x2 factorial design). SUBJECTS: Sixty-three dental practices across Scotland. Clinical records of all 16-24-year-old patients over two, four-month periods in 1999 (pre-intervention) and 2000 (post-intervention) were searched by a clinical researcher blind to the intervention group. Data were also gathered on the costs of the interventions. INTERVENTIONS: Group 1 received a copy of SIGN 42 Guideline and had an opportunity to attend a postgraduate education course (PGEC). In addition to this, group 2 received audit and feedback (A and F). Group 3 received a computer aided learning (CAL) package. Group 4 received A and F and CAL. PRINCIPAL OUTCOME MEASUREMENT: The proportion of patients whose treatment complied with the guideline. RESULTS: The weighted t-test for A and F versus no A and F (P=0.62) and CAL versus no CAL (P=0.76) were not statistically significant. Given the effectiveness results (no difference) the cost effectiveness calculation became a cost-minimisation calculation. The minimum cost intervention in the trial consisted of providing general dental practitioners (GDPs) with guidelines and the option of attending PGEC courses. Routine data which subsequently became available showed a Scotland-wide fall in extractions prior to data collection. CONCLUSION: In an environment in which pre-intervention compliance was unexpectedly high, neither CAL nor A and F increased the dentists' compliance with the SIGN guideline compared with mailing of the guideline and the opportunity to attend a postgraduate course. The cost of the CAL arm of the trial was greater than the A and F arm. Further work is required to understand dental professionals' behaviour in response to guideline implementation strategies.