Effectiveness of strategies to increase participation in school-based epidemiological surveys: a rapid review.

OBJECTIVE: Rapid review of the literature on strategies to increase participation rates in school-based epidemiological surveys. BASIC RESEARCH DESIGN: Rapid review. MEDLINE and Embase databases were searched for articles written in English from 2000 onwards. Synthesised evidence and primary research were included as data sources from peer reviewed journals and reports. INTERVENTIONS: Any strategy aiming to increase participation in school-based health surveys. The comparator was usual procedure or an alternative strategy to increase participation. MAIN OUTCOME MEASURES: Primary outcomes included participation and consent rates. Secondary outcomes were feasibility, acceptability and adverse effects. RESULTS: The search identified 591 unique records, of which 587 were excluded. Four studies were suitable for inclusion, including one systematic review, one randomised controlled trial, one cross-sectional study and one retrospective analysis. Based on very low certainty evidence, recommendations for maximising participation rates in one systematic review of US studies included: promoting the survey to school staff, parents and students; disseminating study information using direct rather than mediated methods; offering incentives to schools, staff and participants; following up non-responders; and employing a research team member to co-ordinate and monitor recruitment. However, UK studies found that different strategies did not increase participation more than that achieved by a standard approach (delivery of covering letter/consent forms via the child with no follow-up of non-responders). CONCLUSION: Given the lack of evidence of effectiveness of alternative strategies in the UK, additional measures beyond existing standard approaches for active consent cannot be recommended.

Enamel Caries Detection and Diagnosis: An Analysis of Systematic Reviews.

Detection and diagnosis of caries-typically undertaken through a visual-tactile examination, often with supporting radiographic investigations-is commonly regarded as being broadly effective at detecting caries that has progressed into dentine and reached a threshold where restoration is necessary. With earlier detection comes an opportunity to stabilize disease or even remineralize the tooth surface, maximizing retention of tooth tissue and preventing a lifelong cycle of restoration. We undertook a formal comparative analysis of the diagnostic accuracy of different technologies to detect and inform the diagnosis of early caries using published Cochrane systematic reviews. Forming the basis of our comparative analysis were 5 Cochrane diagnostic test accuracy systematic reviews evaluating fluorescence, visual or visual-tactile classification systems, imaging, transillumination and optical coherence tomography, and electrical conductance or impedance technologies. Acceptable reference standards included histology, operative exploration, or enhanced visual assessment (with or without tooth separation) as appropriate. We conducted 2 analyses based on study design: a fully within-study, within-person analysis and a network meta-analysis based on direct and indirect comparisons. Nineteen studies provided data for the fully within-person analysis and 64 studies for the network meta-analysis. Of the 5 technologies evaluated, the greatest pairwise differences were observed in summary sensitivity points for imaging and all other technologies, but summary specificity points were broadly similar. For both analyses, the wide 95% prediction intervals indicated the uncertainty of future diagnostic accuracy across all technologies. The certainty of evidence was low, downgraded for study limitations, inconsistency, and indirectness. Summary estimates of diagnostic accuracy for most technologies indicate that the degree of certitude with which a decision is made regarding the presence or absence of disease may be enhanced with the use of such devices. However, given the broad prediction intervals, it is challenging to predict their accuracy in any future "real world" context.

Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus.

BACKGROUND: Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)-a standardized group of outcomes important to key international stakeholders-that should be reported by future trials in this field. METHODS: Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized. RESULTS: Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and 'serious' adverse events. CONCLUSION: A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence.

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.

Cochrane and the COMET initiative: developing the evidence base in oral medicine.

All clinicians in medicine and dentistry aim to deliver evidence-based practice; however, it is widely recognised that the current evidence base for interventions in oral medicine, as with many other specialties, is of a low quality. The highest level of evidence is considered to be the systematic review and meta-analysis. The Cochrane Collaboration and the Cochrane Oral Health group produce high quality systematic reviews, however, despite the large number of trials carried out for treatments in oral medicine, the results are often not able to be utilised to guide clinical care due to the various methodological limitations of the trials including the heterogeneity of outcome measures used. To improve the strength of the evidence base this will need to change. The Comet initiative aims to support the development of core outcome sets which are used to allow homogeneity of outcome measures in trials and therefore will allow pooling of data for meta-analysis in future systematic reviews. This paper explores the complexities involved in producing evidence for oral medicine interventions and introduces an approach for developing core outcome sets in oral medicine.

Open access to journal articles in oncology: current situation and citation impact.

BACKGROUND: Recent years have seen numerous efforts and resources devoted to the development of open access (OA), but the current OA situation of the oncology literature remains unknown. We conducted this cross-sectional study to determine the current share and provision methods of OA in the field of oncology, identify predictors of OA status (OA versus non-OA), and study the association between OA and citation counts. MATERIALS AND METHODS: PubMed was searched for oncology-related, peer-reviewed journal articles published in December 2014. Google, Google Scholar, PubMed, ResearchGate, OpenDOAR and OAIster were manually checked to assess the OA status of each included article. Citation data were extracted from Web of Science, Scopus and Google Scholar. Descriptive statistics were used to summarize the OA proportion (primary outcome) and OA provision methods. Multivariable logistic regression and multilevel generalized linear model analyses were performed to study predictors of OA status and the association between OA and citation counts, respectively. RESULTS: In a random sample of 1000 articles, 912 were deemed eligible and therefore included. Of these, the full-texts of 530 articles (58.1%; 95% CI: 54.9-61.3) were freely available online: 314 (34.4%) were available from publishers ('Gold road' to OA), 424 (46.5%) were available via self-archiving ('Green road' to OA). According to multivariable regression analyses, impact factor, publisher type, language, research type, number of authors, continent of origin, and country income were significant predictors of articles' OA status; OA articles received a citation rate 1.24 times the incidence rate for non-OA articles (95% CI: 1.05-1.47; P = 0.012). CONCLUSIONS: Based on our sample, in the field of oncology, 42% of recent journal articles are behind the pay-wall (non-OA) 1 year after publication; the 'Green road' of providing OA is more common than the 'Gold road'; OA is associated with higher citation counts.

Guidelines on the timing and frequency of bitewing radiography: a systematic review.

Objectives To identify guidelines on when and how frequently bitewing radiographs should be used in dentistry for the diagnosis of caries, and to provide an objective appraisal of their quality.Data sources MEDLINE (OVID), US National Guideline Clearinghouse (www.guideline.gov) and the Royal College of Surgeons of England (https://www.rcseng.ac.uk/fds/publications-clinical-guidelines/clinical_guidelines) websites were searched using a variety of relevant search terms (2 August 2016).Data selection Publications were included if they made recommendations on the issue of when and how frequently radiographs should be used in any dentally-related specialty pertaining to the diagnosis of caries; and/or if they were aimed at the individual practitioner (any health professional working within dentistry) and/or patients.Data analysis Thirteen published guidelines were included and assessed using the AGREE II instrument.Conclusions There was a significant variation amongst the guidelines in the recommendations at what age radiography should be undertaken. There was also disagreement on the frequency of repeat radiographs and how this is influenced by the age of the patient and their caries risk.

Feasibility study: assessing the efficacy and social acceptability of using dental hygienist-therapists as front-line clinicians.

Background The oral health of the adult population has been improving in the United Kingdom decade upon decade. Over half of dental service activity in the National Health Service (NHS) is limited to a check-up without any further treatment. This raises a question as to whether check-ups could be provided by dental hygienist-therapists, rather than general dental practitioners. The aim of this study was to assess the feasibility of a definitive trial to evaluate the costs and effects of using dental hygienist-therapists to undertake the check-up.Methods/design Adult NHS patients were randomised into three arms in two dental practices: patients who only saw dental hygienist-therapists for a check-up, those that saw the general dental practitioner and dental hygienist-therapist alternatively and a control, where patients only saw the general dental practitioner for their check-up. The study ran for 15 months. The primary outcome measures of the study were patient recruitment, retention and fidelity. A parallel and embedded qualitative study was undertaken which recorded the views of participating patients to determine the social acceptability of the intervention.Results Sixty patients participated in the study. The initial recruitment rate for the study was 33.7%. This figure increased to over 82.1% when telephone calls or face-to-face recruitment was utilised. The retention rates were 60% for both the dental hygienist-therapist only group and the alternate general dental practitioner and dental hygienist-therapist group, compared to 70% for the general dental practitioner only group. Fifteen patients were interviewed in the qualitative study and supported a team approach to the provision of check-ups in the NHS. Conclusion This study demonstrates the feasibility of a definitive trial to evaluate the costs and effects of using dental-hygienist-therapists to undertake the check-up.

Surveys on Reporting Guideline Usage in Dental Journals.

The objectives of this study were 1) to find out if and how authors and peer reviewers for dental journals are encouraged to use reporting guidelines (RGs); 2) to identify factors related to RG endorsement; and 3) to assess the knowledge, opinions, and future plans of dental journal editors in chief (EICs) on RGs. A total of 109 peer-reviewed and original research-oriented dental journals that were indexed in the MEDLINE and/or SCIE database in 2015 were included. The "instructions to authors" and "instructions to reviewers" of these journals were identified and retrieved from journals' official websites. Any mention of RGs or other related policies were sought and extracted. In addition, an anonymous survey of the EICs of the included journals was conducted with a validated questionnaire. All 109 journals provided "instructions to authors," among which 55 (50.5%) mentioned RGs. Only the CONSORT (45.0%), PRISMA (13.8%), and STROBE (12.8%) guidelines were mentioned by >10% of the included journals. Statistical analyses suggest that RGs were more frequently mentioned by SCIE-indexed journals (P < 0.001), higher-impact journals (P = 0.002), and journals that endorsed the ICMJE recommendations (P < 0.001). "Instructions to reviewers" were available online for only 9 journals (8.3%), 3 of which mentioned RGs. For the EIC survey, the response rate was 32.1% (35 of 109). Twenty-six editors (74.3%) stated that they knew what RGs were before receiving our questionnaire. Twenty-four editors (68.6%) believed that RGs should be adopted by all refereed dental journals where appropriate. RGs are important tools for enhancing research reporting and reducing avoidable research waste, but currently they are not widely endorsed by dental journals. Joint efforts by all stakeholders to further promote RG usage in dentistry are needed.

A national survey of the public's views on quality in dental care.

BACKGROUND: There is a lack of evidence and poor understanding of quality measurement and improvement in dentistry. The aim of this study was to undertake a nationally representative survey of the public in England to explore their views on the meaning of quality in dentistry. METHODS: A cross sectional survey of the adult population (18 years and over) of England was undertaken. A sample size of 500 was set to provide a precision to plus or minus 5% after allowing for item non-response. A quota sampling approach was used, with predetermined quotas set for sex, age, working status and tenure to ensure the sample was nationally representative. Question selection and design were informed by the literature and a series of interviews with the public. Simple content analysis was used to identify themes in the responses to open questions. Dental service use, gender, age, ethnicity and social class were recorded. Frequency distributions were computed and outputs were cross-tabulated with various population sub-group categories. RESULTS: Five hundred and thirteen people were interviewed. Approximately 20% of patients reported that their care was suboptimal; a third thought it was poor value for money and 20% did not trust their dentist. Good interpersonal communication, politeness and being put at ease were the most important factors that elicited positive responses. Negative factors were cost of care and waiting times. In making an assessment of quality, access (40% of all responses), technical quality of care (35%), professionalism (30%), hygiene/cleanliness (30%), staff attitude (27%), pain-free treatment (23%), value for money (22%), and staff putting patients at ease (21%) all emerged as important factors. CONCLUSIONS: Quality in dentistry is multi-dimensional in nature, and includes different elements and emphases to other areas of healthcare. The results will inform the development of a measure of quality in dentistry.

The efficacy of screening for common dental diseases by hygiene-therapists: a diagnostic test accuracy study.

Regularly attending adult patients are increasingly asymptomatic and not in need of treatment when attending for their routine dental examinations. As oral health improves further, using the general dental practitioner to undertake the "checkup" on regular "low-risk" patients represents a substantial and potentially unnecessary cost for state-funded systems. Given recent regulatory changes in the United Kingdom, it is now theoretically possible to delegate a range of tasks to hygiene-therapists. This has the potential to release the general dental practitioner's time and increase the capacity to care. The aim of this study is to compare the diagnostic test accuracy of hygiene-therapists when screening for dental caries and periodontal disease in regularly attending asymptomatic adults who attend for their checkup. A visual screen by hygiene-therapists acted as the index test, and the general dental practitioner acted as the reference standard. Consenting asymptomatic adult patients, who were regularly attending patients at 10 practices across the Northwest of England, entered the study. Both sets of clinicians made an assessment of dental caries and periodontal disease. The primary outcomes measured were the sensitivity and specificity values for dental caries and periodontal disease. In total, 1899 patients were screened. The summary point for sensitivity of dental care professionals when screening for caries and periodontal disease was 0.81 (95% CI, 0.74 to 0.87) and 0.89 (0.86 to 0.92), respectively. The summary point for specificity of dental care professionals when screening for caries and periodontal disease was 0.87 (0.78 to 0.92) and 0.75 (0.66 to 0.82), respectively. The results suggest that hygiene-therapists could be used to screen for dental caries and periodontal disease. This has important ramifications for service design in public-funded health systems.

Guidelines for clinical use of CBCT: a review.

OBJECTIVES: To identify guidelines on the clinical use of CBCT in dental and maxillofacial radiology, in particular selection criteria, to consider how they were produced, to appraise their quality objectively and to compare their recommendations. METHODS: A literature search using MEDLINE (Ovid(®)) was undertaken prospectively from 1 January 2000 to identify published material classifiable as "guidelines" pertaining to the use of CBCT in dentistry. This was supplemented by searches on websites, an internet search engine, hand searching of theses and by information from personal contacts. Quality assessment of publications was performed using the AGREE II instrument. Publications were examined for areas of agreement and disagreement. RESULTS: 26 publications were identified, 11 of which were specifically written to give guidelines on the clinical use of CBCT and contained sections on selection criteria. The remainder were a heterogeneous mixture of publications that included guidelines relating to CBCT. Two had used a formal evidence-based approach for guideline development and two used consensus methods. The quality of publications was frequently low as assessed using AGREE II, with many lacking evidence of adequate methodology. There was broad agreement between publications on clinical use, apart from treatment planning, in implant dentistry. CONCLUSIONS: Reporting of guideline development is often poorly presented. Guideline development panels should aim to perform and report their work using the AGREE II instrument as a template to raise standards and avoid the risk of suspicions of bias.

Conventional radiography and cross-sectional imaging when planning dental implants in the anterior edentulous mandible to support an overdenture: a systematic review.

The objectives for this systematic review were to determine if the pre-operative availability of cross-sectional imaging, such as cone beam CT, has a diagnostic impact, therapeutic impact or impact on patients' outcome when placing two dental implants in the anterior mandible to support an overdenture. The Cochrane Oral Health Group's Trials Register (CENTRAL), MEDLINE® and Embase were searched up to, and including, February 2013. Studies were considered eligible for inclusion if they compared the impact of conventional and cross-sectional imaging when placing dental implants in sites including the anterior mandible. An adapted quality assessment tool was used for the assessment of the risk of bias in included studies. Pooled quantitative analysis was not possible and, therefore, synthesis was qualitative. Of 2374 potentially eligible papers, 5 studies were included. Little can be determined from a synthesis of these studies because of their small number, clinical diversity and high risks of bias. Notwithstanding, it may be tentatively inferred that cross-sectional imaging has a therapeutic impact in the more challenging cases. In terms of impact, this review has found no evidence to support any specific imaging modality when planning dental implant placement in any region of the mouth. Therefore, those who argue that cross-sectional imaging should be used for the assessment of all dental implant sites are unsupported by evidence.

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.

Parents' experiences of caring for a child with a cleft lip and/or palate: a review of the literature.

This review brings together for the first time the existing quantitative and qualitative research evidence about the experiences of parents caring for a child with a cleft. It summarizes salient themes on the emotional, social and service-related experiences of parents and critiques the literature to date, comparing it with wider, selected literature from the field of children's long-term conditions, including disability. The review suggests that there are similarities and differences between the literatures, in terms of research focus and approach. Similarities are found across children's conditions in the perspectives of parents on emotional, social and service-related aspects, although much of the cleft literature is focused on the early stages of children's lives. However, the quality of cleft research to date about parents' experiences has also been variable, with a narrow emphasis on cross-sectional, deficit-orientated psychological approaches focused mainly on mothers. Despite a substantial literature, little qualitative research has examined parents' perspectives in-depth, particularly about their child's treatment journey. This contrasts with the wider children's literature, which has traditionally drawn not only on psychological approaches but also on the broader perspectives of sociology, social policy, nursing and health services research, using both qualitative and quantitative methods, often in integrated ways. Such approaches have been able to highlight a greater range of experiences from both mothers and fathers, about caring for a child with a long-term condition and views about treatment. The review identifies a lack of comparable research in the cleft field to examine parents' experiences and needs at different stages of their children's lives. Above all, research is needed to investigate how both mothers and fathers might experience the long-term and complex treatment journey as children become older and to elicit their views about decision making for cleft treatments, particularly elective surgeries.

Cochrane reviews on the benefits/risks of fluoride toothpastes.

This concise review presents two Cochrane Reviews undertaken to determine: (1) the relative effectiveness of fluoride toothpastes of different concentrations in preventing dental caries in children and adolescents; and (2) the relationship between the use of topical fluorides in young children and their risk of developing dental fluorosis. To determine the relative effectiveness of fluoride toothpastes of different concentrations, we undertook a network meta-analysis utilizing both direct and indirect comparisons from randomized controlled trials (RCTs). The review examining fluorosis included evidence from experimental and observational studies. The findings of the reviews confirm the benefits of using fluoride toothpaste, when compared with placebo, in preventing caries in children and adolescents, but only significantly for fluoride concentrations of 1000 ppm and above. The relative caries-preventive effects of fluoride toothpastes of different concentrations increase with higher fluoride concentration. However, there is weak, unreliable evidence that starting the use of fluoride toothpaste in children under 12 months of age may be associated with an increased risk of fluorosis. The decision of what fluoride levels to use for children under 6 years should be balanced between the risk of developing dental caries and that of mild fluorosis.

Using Cochrane reviews for oral diseases.

OBJECTIVES: To provide readers with information about the Cochrane Oral Health Group and how the reviews on oral diseases have contributed to guideline developments and the commissioning of trials. MATERIALS AND METHODS: Examples have been selected from the reviews published on The Cochrane Library. Descriptions are given of how these reviews have been used in guideline development and commissioning of trials. Readers are updated on reviews focused on the management of oral cancer and the new venture of diagnostic test reviews. RESULTS: Reviews on the management of oral diseases due to cancer treatments have been included in guidelines and changed practice in the UK. Cochrane reviews on Bell's Palsy have led to a randomised controlled trial which has changed the evidence base. The Cochrane review on recall intervals between routine appointments has input into the NICE guideline and resulted in a randomised controlled trial to look at different intervals including a risk-based interval. CONCLUSION: We hope this article will give readers information on the work of the Cochrane Oral Health Group and insight into the diversity of reviews in oral diseases. The reviews are successfully being used to change practice and as background for the funding of large-scale clinical trials.

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.

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.