Behavioural intervention to promote the uptake of planned care in urgent dental care attenders: a feasibility randomised controlled trial.

BACKGROUND: Urgent dental care may be the only place where many people, especially vulnerable groups, access care. This presents an opportunity for delivery of a behavioural intervention promoting planned dental visiting, which may help address one of the factors contributing to a socio-economic gradient in oral health. Although we know that cueing events such as having a cancer diagnosis may create a 'teachable moment' stimulating positive changes in health behaviour, we do not know whether delivering an opportunistic intervention in urgent dental care is feasible and acceptable to patients. METHODS: The feasibility study aimed to recruit 60 patients in a Dental Hospital and dental practices delivering urgent care within and outside working hours. Follow-up was by telephone, e mail and post over 4 months. RESULTS: Although the recruitment window was shortened because of COVID-19, of 47 patients assessed for eligibility, 28 were enrolled (70.1% of screened patients provided consent). A relatively high proportion were from disadvantaged backgrounds (46.4%, 13/28 receiving State benefits). Retention was 82.1% (23/28), which was also the rate of completion of the Oral Health Impact Profile co-primary outcome. The other primary outcome involved linking participant details at recruitment, with centrally-held data on services provided, with 84.6% (22/26) records partly or fully successfully matched. All intervention participants received at least some of the intervention, although we identified aspects of dental nurse training which would improve intervention fidelity. CONCLUSIONS: Despite recruitment being impacted by the pandemic, when the majority of clinical trials experienced reduced rates of recruitment, we found a high recruitment and consenting rate, even though patients were approached opportunistically to be enrolled in the trial and potentially receive an intervention. Retention rates were also high even though a relatively high proportion had a low socio-economic background. Therefore, even though patients may be in pain, and had not anticipated involvement before their urgent care visit, the study indicated that this was a feasible and acceptable setting in which to position an opportunistic intervention. This has the potential to harness the potential of the 'teachable moment' in people's lives, and provide support to help address health inequalities. TRIAL REGISTRATION: ISRCTN 10,853,330 07/10/2019.

Behavioural intervention to promote the uptake of planned care in urgent dental care attenders: study protocol for the RETURN randomised controlled trial.

BACKGROUND: People with disadvantaged backgrounds are less likely to visit the dentist for planned care, even though they have disproportionately poorer oral health. They are correspondingly more likely to experience dental problems and use urgent dental care, general practices and Accident and Emergency departments, which not only makes meeting their needs expensive, but, since these services often rely on prescriptions rather than addressing the clinical cause, can contribute to antimicrobial resistance. METHODS: The RETURN intervention has been developed with substantial community co-production, to be delivered opportunistically in urgent dental care settings. This brief intervention is delivered by dental nurses and involves material relevant to the 'in-group' targeted. The material includes booklets relating to barriers to planned dental visiting with corresponding short video clips featuring local people and including a modelling element. Dental nurses are trained to have supportive and non-judgemental conversations, assisting patients to set personal goals and action plans, which are reinforced in a follow-up text within a few weeks. A randomised controlled trial will be undertaken in 3 types of sites: dental practices delivering urgent care (a) within working hours, (b) out of hours, and (c) in a Dental Hospital. The trial will recruit 1180 adult urgent dental care users over 12 months, who have not visited a dentist for a planned care appointment for 2 years or more and do not have a dentist who they visit for routine care. It aims to investigate the effectiveness and cost-effectiveness of the intervention and to explore whether the intervention has different effects across the socio-economic gradient. Participants will be followed up at 6, 12 and 18 months after randomisation. Co-primary outcomes are attendance at a dental practice for planned care within 12 months and self-reported oral health-related quality of life at 12 months. DISCUSSION: This is a pragmatic trial, evaluating the effectiveness of the intervention under the usual condition in which it might be applied. Since dental practices work as independent contractors to the NHS, this brings implementation and fidelity challenges which will be explored and described in embedded qualitative work. TRIAL REGISTRATION: ISRCTN registry identifier ISRCTN84666712. Registered 12/04/2021.

Twitter communication of the UK public on dental health and care during a COVID lockdown: "My kingdom for a dentist".

BACKGROUND: The COVID-19 pandemic forced a UK-wide closure of dental services. An understanding of public concerns about dental care was urgently needed to inform careful resumption of paused dental services. AIM: To describe public concerns about dental care during lockdown. BASIC RESEARCH DESIGN: Framework analysis of relevant Twitter posts identified collected using the Awario tool. RESULTS: Of 1863 tweets manually screened for eligibility, 285 were relevant, as they contained views expressed by the public. The number of tweets by country were proportionate to the population size. The key views expressed in tweets focused on: 'oral health impact' ('oral health and self-care', 'types of dental problems', 'managing symptoms at home', 'views on consequences of delaying treatment') and 'dental service or care provision' ('views on managing dental care response', 'experiences with access to dental care'). CONCLUSIONS: The impact of COVID-19 on dental services raised many physical and mental health concerns for the public, highlighting their importance. Online profiles and social media communication platforms can be used to provide convenient, and timely information on public perceptions of dental care.

Child Caries Management: A Randomized Controlled Trial in Dental Practice.

This multicenter 3-arm, parallel-group, patient-randomized controlled trial compared clinical effectiveness of 3 treatment strategies over 3 y for managing dental caries in primary teeth in UK primary dental care. Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion were randomized across 3 arms (1:1:1 via centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants). Parents, children, and dentists were not blind to allocated arm. Co-primary outcomes were 1) the proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection during follow-up (minimum, 23 mo). In sum, 1,144 participants were randomized (C+P, n = 386; B+P, n = 381; PA, n = 377) by 72 general dental practitioners, of whom 1,058 (C+P, n = 352; B+P, n = 352; PA, n = 354) attended at least 1 study visit and were included in the primary analysis. The median follow-up was 33.8 mo (interquartile range, 23.8 to 36.7). Proportions of participants with at least 1 episode of dental pain and/or infection were as follows: C+P, 42%; B+P, 40%; PA, 45%. There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P. The mean (SD) number of episodes of dental pain and/or infection were as follows: C+P, 0.62 (0.95); B+P, 0.58 (0.87); and PA, 0.72 (0.98). Superiority could not be concluded for number of episodes between B+P (adjusted incident rate ratio (97.5% CI): 0.95 [0.75 to 1.21]) or PA (1.18 [0.94 to 1.48]) and C+P. In conclusion, there was no evidence of a difference among the 3 treatment approaches for incidence or number of episodes of dental pain and/or infection experienced by these participants with high caries risk and established disease (trial registration: ISRCTN77044005).

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.

Prioritizing research areas for antibiotic stewardship programmes in hospitals: a behavioural perspective consensus paper.

SCOPE: Antibiotic stewardship programmes (ASPs) are necessary in hospitals to improve the judicious use of antibiotics. While ASPs require complex change of key behaviours on individual, team organization and policy levels, evidence from the behavioural sciences is underutilized in antibiotic stewardship studies across the world, including high-income countries (HICs). A consensus procedure was performed to propose research priority areas for optimizing effective implementation of ASPs in hospital settings using a behavioural perspective. METHODS: A workgroup for behavioural approaches to ASPs was convened in response to the fourth call for leading expert network proposals by the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR). Eighteen clinical and academic specialists in antibiotic stewardship, implementation science and behaviour change from four HICs with publicly funded healthcare systems (e.g. Canada, Germany, Norway and the UK) met face-to-face to agree on broad research priority areas using a structured consensus method. Question addressed and recommendations: The consensus process assessing the ten identified research priority areas resulted in recommendations that need urgent scientific interest and funding to optimize effective implementation of ASPs for hospital inpatients in HICs with publicly funded healthcare systems. We suggest and detail behavioural science evidence-guided research efforts in the following areas: (a) comprehensively identifying barriers and facilitators to implementing ASPs and clinical recommendations intended to optimize antibiotic prescribing; (b) identifying actors ('who') and actions ('what needs to be done') of ASPs and clinical teams; (c) synthesizing available evidence to support future research and planning for ASPs; (d) specifying the activities in current ASPs with the purpose of defining a control group for comparison with new initiatives; (e) defining a balanced set of outcomes and measures to evaluate the effects of interventions focused on reducing unnecessary exposure to antibiotics; (f) conducting robust evaluations of ASPs with built-in process evaluations and fidelity assessments; (g) defining and designing ASPs; (h) establishing the evidence base for impact of ASPs on resistance; (i) investigating the role and impact of government and policy contexts on ASPs; and (j) understanding what matters to patients in ASPs in hospitals. CONCLUSIONS: Assessment, revisions and updates of our priority-setting exercise should be considered at intervals of 2 years. To propose research priority areas in low- and middle-income countries, the methodology reported here could be applied.

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.

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.

Twenty years of the Cochrane Collaboration.

The Cochrane Collaboration is 20 years old this year. Established in 1993, the Collaboration has sought to provide an up-to-date, critical evidence base for all those involved in health care decision-making at a variety of levels. This article illustrates the work of the Cochrane Oral Health Group, based at the University of Manchester, UK.

Current practices and intention to provide alcohol-related health advice in primary dental care.

OBJECTIVES: To determine whether general dental practitioners (GDPs) currently provide alcohol-related advice (ARA) and to inform the development of an intervention, should one be required. METHOD: Cross-sectional postal survey of a random sample of 300 GDPs in Scotland. The questionnaire assessed beliefs derived from psychological models that explain behaviour in terms of beliefs that are amenable to change, and so may inform development of an intervention to encourage the provision of ARA. RESULTS: Sixty percent of GDPs responded. Eighty-three percent of participating GDPs (145/175) had not provided ARA to patients in the previous ten working days. Attitude (perceived consequences), control beliefs (perceived difficulty), subjective norm (perceived social pressure), and self-efficacy (confidence) significantly predicted intention to provide ARA. Alcohol-related knowledge or personal alcohol behaviour did not predict intention to provide ARA. CONCLUSIONS: There is scope to increase the provision of ARA in primary care dentistry and this study identified predictive beliefs, which could be targeted to encourage this behaviour. The next phase is to develop and test an intervention to encourage GDPs to provide ARA.

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.

The development of evidence-based guidelines on mouth care for children, teenagers and young adults treated for cancer.

The aim was to produce evidence-based guidelines on mouth care for children, teenagers and young adults receiving chemotherapy and/or radiotherapy. Systematic reviews were undertaken and research was graded according to the methods of the Scottish Intercollegiate Guidelines Network. Where no relevant research was identified, an opinion-gathering process was undertaken. 'Best practice' recommendations were developed with regard to appropriate dental care and basic oral hygiene. An evaluation of oral assessment tools identified seven which had been assessed for reliability and/or validity. Only Eilers' Oral Assessment Guide was felt to be relevant for daily clinical practice. A variety of interventions have been used for the management of oral mucositis, candidiasis, xerostomia and herpes simplex virus; few are supported by research evidence. Careful oral management of children treated for cancer can improve the quality of life during treatment. The guidelines have the potential to improve patient care by promoting interventions of proven benefit and discouraging use of ineffective or potentially harmful practices which may result in adverse patient outcomes.

A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell's palsy: the BELLS study.

OBJECTIVE: To determine whether oral prednisolone or aciclovir, used separately or in combination, early in the course of Bell's palsy, improves the chances of recovery at 3 and 9 months. DESIGN: A 2 x 2 factorial randomised double-blind trial. Patients were randomly assigned to treatment by an automated telephone service using a permuted block randomisation technique with block sizes of four or eight, and no stratification. SETTING: Mainland Scotland, with referrals mainly from general practice to 17 hospital trial sites. PARTICIPANTS: Adults (aged 16 years or older) with unilateral facial nerve weakness of no identifiable cause presenting to primary care, the emergency department or NHS24 within 72 hours of symptom onset. INTERVENTIONS: Patients were randomised to receive active preparations or placebo for 10 days: (1) prednisolone (50 mg per day, 2 x 25-mg capsules) and aciclovir (2000 mg per day, 5 x 400-mg capsules); (2) prednisolone and placebo (lactose, indistinguishable); (3) aciclovir and placebo; and (4) placebo and placebo. OUTCOME MEASURES: The primary outcome was recovery of facial function assessed by the House-Brackmann scale. Secondary outcomes included health status, pain, self-perceived appearance and cost-effectiveness. RESULTS: Final outcomes were available for 496 patients, balanced for gender; mean age 44 years; initial facial paralysis moderate to severe. One half of patients initiated treatment within 24 hours of onset of symptoms, one-third within 24-48 hours and the remainder within 48-72 hours. Of the completed patients, 357 had recovered by 3 months and 80 at 9 months, leaving 59 with a residual deficit. There were significant differences in complete recovery at 3 months between the prednisolone comparison groups (83.0% for prednisolone, 63.6% for no prednisolone, a difference of + 19.4%; 95% confidence interval (CI): + 11.7% to + 27.1%, p < 0.001). The number needed to treat (NNT) in order to achieve one additional complete recovery was 6 (95% CI: 4 to 9). There was no significant difference between the aciclovir comparison groups (71.2% for aciclovir and 75.7% for no aciclovir). Nine-month assessments of patients recovered were 94.4% for prednisolone compared with 81.6% for no prednisolone, a difference of + 12.8% (95% CI: + 7.2% to + 18.4%, p < 0.001); the NNT was 8 (95% CI: 6 to 14). Proportions recovered at 9 months were 85.4% for aciclovir and 90.8% for no aciclovir, a difference of -5.3%. There was no significant prednisolone-aciclovir interaction at 3 months or at 9 months. Outcome differences by individual treatment (the four-arm model) showed significant differences. At 3 months the recovery rate was 86.3% in the prednisolone treatment group, 79.7% in the aciclovir-prednisolone group, 64.7% in the placebo group and 62.5% in the aciclovir group. At 9 months the recovery rates were respectively 96.1%, 92.7%, 85.3% and 78.1%. The increase in recovery rate conferred by the addition of prednisolone (both for prednisolone over placebo and for aciclovir-prednisolone over aciclovir) is highly statistically significant (p < 0.001). There were no significant differences in secondary measures apart from Health Utilities Index Mark 3 (HUI3) at 9 months in those treated with prednisolone. CONCLUSIONS: This study provided robust evidence to support the early use of oral prednisolone in Bell's palsy as an effective treatment which may be considered cost-effective. Treatment with aciclovir, either alone or with steroids, had no effect on outcome.

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.

Interventions for the treatment of oral and oropharyngeal cancers: surgical treatment.

BACKGROUND: Oral and oropharyngeal cancers can be managed by surgery alone or with any combination of radiotherapy, chemotherapy and immunotherapy/biotherapy. Opinions on the surgical treatment, the optimal combinational therapy and the sequence of treatments in combinational therapy varies enormously. OBJECTIVES: To determine which surgical treatment modalities for oral and oropharyngeal cancers lead to the best outcomes compared with other surgical, radiotherapy, chemotherapy or immunotherapy/biotherapy combinations. SEARCH STRATEGY: Electronic search of the Cochrane Oral Health Group Trials Register, CENTRAL, MEDLINE, OLDMEDLINE, EMBASE, AMED and the National Cancer Trials Database. Reference lists from relevant articles were searched and the authors of eligible trials were contacted. Date of the most recent searches: July 2007. SELECTION CRITERIA: Randomised controlled trials of surgery alone or in combination with chemotherapy, radiotherapy or immunotherapy/biotherapy for the treatment of primary oral or oropharyngeal cancer or both. DATA COLLECTION AND ANALYSIS: A minimum of two review authors conducted data extraction. Risk ratios were calculated for dichotomous outcomes at different time intervals, and hazard ratios were extracted or calculated for disease-free survival, total mortality, and disease-related mortality. Additional information from trial authors was sought. Data on adverse events were collected from the trial reports. MAIN RESULTS: Thirty-one trials satisfied the inclusion criteria, only 13 of which were assessed as low risk of bias. Trials were grouped into 12 main comparisons. There were no trials that compared different surgical modalities of the primary tumour itself. However, there were a number of trials comparing different approaches to managing the cervical lymph nodes. The majority of treatment regimens under evaluation were surgery in combination with other modalities. As individual treatment regimens within each comparison varied, meta-analysis was inappropriate in most instances. Only two trials could be pooled, comparing concomitant radio/chemotherapy (with surgery) versus radiotherapy (with surgery). A statistically significant difference was shown for disease-free survival (hazard ratio 0.77, 95% confidence interval (CI): 0.64 to 0.92) and total mortality (hazard ratio 0.78, 95% CI: 0.64 to 0.95) in favour of the concomitant chemotherapy and radiotherapy (with surgery) arm. No other treatment regimens showed consistent statistically significant results across the outcomes measured. AUTHORS' CONCLUSIONS: There is some evidence that concomitant radio/chemotherapy (with surgery) is more effective than radiotherapy (with surgery) and may benefit outcomes in patients with more advanced oral and oropharyngeal cancers. As these trials were based on head and neck studies, future studies should evaluate this treatment regimen specifically in oral and oropharyngeal cancers separately and also address tumour staging and its impact on outcomes. In general, future studies are encouraged to evaluate site-specific and stage-specific data for oral and oropharyngeal cancers. Future trials should include health-related quality of life assessment as an outcome measure. There is a need for a consolidated standardised approach to reporting adverse events.

Interventions for preventing oral mucositis for patients with cancer receiving treatment.

BACKGROUND: Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite the use of a variety of agents to prevent them. One of these side effects is oral mucositis (mouth ulcers). OBJECTIVES: To evaluate the effectiveness of prophylactic agents for oral mucositis in patients with cancer receiving treatment, compared with other potentially active interventions, placebo or no treatment. SEARCH STRATEGY: The Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE were searched. Reference lists from relevant articles were scanned and the authors of eligible studies were contacted to identify trials and obtain additional information. Date of most recent searches: June 2006: CENTRAL (The Cochrane Library 2006, Issue 2). SELECTION CRITERIA: Trials were selected if they met the following criteria: design - random allocation of participants; participants - anyone with cancer receiving chemotherapy or radiotherapy treatment for cancer; interventions - agents prescribed to prevent oral mucositis; outcomes - prevention of mucositis, pain, amount of analgesia, dysphagia, systemic infection, length of hospitalisation, cost and patient quality of life. DATA COLLECTION AND ANALYSIS: Information regarding methods, participants, interventions and outcome measures and results were independently extracted, in duplicate, by two review authors. Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. The Cochrane Collaboration statistical guidelines were followed and risk ratios (RR) calculated using random-effects models. MAIN RESULTS: Two hundred and seventy-seven studies were eligible. One hundred and eighty-eight were excluded for various reasons, usually as there was no useable information on mucositis. Of the 89 useable studies all had data for mucositis comprising 7523 randomised patients. Interventions evaluated were: acyclovir, allopurinol mouthrinse, aloe vera, antibiotic pastille or paste, benzydamine, beta carotene, calcium phosphate, camomile, Chinese medicine, chlorhexidine, etoposide, folinic acid, glutamine, granulocyte/macrophage colony-stimulating factor (GM-CSF), histamine gel, honey, hydrolytic enzymes, ice chips, iseganan, keratinocyte GF, misonidazole, pilocarpine, pentoxifylline, povidone, prednisone, propantheline anticholinergic, prostaglandin, sucralfate, systemic antibiotic clarithromycin, traumeel, zinc sulphate. Of the 33 interventions included in trials, 12 showed some evidence of a benefit (albeit sometimes weak) for either preventing or reducing the severity of mucositis. Interventions where there was more than one trial in the meta-analysis finding a significant difference when compared with a placebo or no treatment were: amifostine which provided minimal benefit in preventing mild and moderate mucositis RRs = 0.95 (95% confidence interval (CI) 0.92 to 0.98) and 0.88 (95% CI 0.80 to 0.98); Chinese medicine showed a benefit at all three dichotomies of mucositis with RR values of 0.44 (95% CI 0.20 to 0.96), 0.44 (95% CI 0.33 to 0.59) and 0.16 (95% CI 0.07 to 0.35) for increasing levels of mucositis severity; hydrolytic enzymes reduced moderate and severe mucositis with RRs = 0.52 (95% CI 0.36 to 0.74) and 0.17 (95% CI 0.06 to 0.52); and ice chips prevented mucositis at all levels RRs = 0.64 (95% CI 0.50 to 0.82), 0.38 (95% CI 0.23 to 0.62), and 0.24 (95% CI 0.12 to 0.48). Other interventions showing some benefit with only one study were: benzydamine, calcium phosphate, etoposide bolus, honey, iseganan, oral care, zinc sulphate. The general reporting of RCTs, especially concealment of randomisation, was poor. However, the assessments of the quality of the randomisation improved when the authors provided additional information. AUTHORS' CONCLUSIONS: Several of the interventions were found to have some benefit at preventing or reducing the severity of mucositis associated with cancer treatment. The strength of the evidence was variable and implications for practice include consideration that benefits may be specific for certain cancer types and treatment. There is a need for well designed and conducted trials with sufficient numbers of participants to perform subgroup analyses by type of disease and chemotherapeutic agent.