Citizen science to improve patient and public involvement in GUideline Implementation in oral health and DEntistry (the GUIDE platform).

BACKGROUND: Citizen science is a way to democratise science by involving groups of citizens in the research process. Clinical guidelines are used to improve practice, but their implementation can be limited. Involving patients and the public can enhance guideline implementation, but there is uncertainty about the best approaches to achieve this. Citizen science is a potential way to involve patients and the public in improving clinical guideline implementation. We aimed to explore the application of citizen science methods to involve patients and the public in the dissemination and implementation of clinical guidelines in oral health and dentistry. METHODS: We developed GUIDE (GUideline Implementation in oral health and DEntistry), a citizen science online platform, using a participatory approach with researchers, oral health professionals, guideline developers and citizens. Recruitment was conducted exclusively online. The platform focused on prespecified challenges related to oral health assessment guidelines, and asked citizens to generate ideas, as well as vote and comment on other citizens' ideas to improve those challenges. Citizens also shared their views via surveys and two online synchronous group meetings. Data were collected on participant's demographics, platform engagement and experience of taking part. The most promising idea category was identified by an advisory group based on engagement, feasibility and relevance. We presented quantitative data using descriptive statistics and analysed qualitative data using inductive and deductive thematic analysis. RESULTS: The platform was open for 6 months and we recruited 189 citizens, from which over 90 citizens actively engaged with the platform. Most citizens were over 34 years (64%), female (58%) and had a university degree (50%). They generated 128 ideas, 146 comments and 248 votes. The challenge that led to most engagement was related to prevention and oral health self-care. To take this challenge forward, citizens generated a further 36 ideas to improve a pre-existing National Health Service oral care prevention leaflet. Citizens discussed motivations to take part in the platform (understanding, values, self-care), reasons to stay engaged (communication and feedback, outputs and impact, and relevance of topics discussed) and suggestions to improve future platforms. CONCLUSION: Citizen science is an effective approach to generate and prioritise ideas from a group of citizens to improve oral health and dental services. Prevention and oral health self-care were of particular interest to citizens. More research is needed to ensure recruitment of a diverse group of citizens and to improve retention in citizen science projects. PATIENT OR PUBLIC CONTRIBUTION: This project was inherently conducted with the input of public partners (citizen scientists) in all key aspects of its conduct and interpretation. In addition, two public partners were part of the research team and contributed to the design of the project, as well as key decisions related to its conduct, analysis, interpretation and dissemination and are co-authors of this manuscript.

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Importance: Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal. Objective: To develop a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for factorial trials. Design: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT extension for factorial trials was developed by (1) generating a list of reporting recommendations for factorial trials using a scoping review of methodological articles identified using a MEDLINE search (from inception to May 2019) and supplemented with relevant articles from the personal collections of the authors; (2) a 3-round Delphi survey between January and June 2022 to identify additional items and assess the importance of each item, completed by 104 panelists from 14 countries; and (3) a hybrid consensus meeting attended by 15 panelists to finalize the selection and wording of items for the checklist. Findings: This CONSORT extension for factorial trials modifies 16 of the 37 items in the CONSORT 2010 checklist and adds 1 new item. The rationale for the importance of each item is provided. Key recommendations are (1) the reason for using a factorial design should be reported, including whether an interaction is hypothesized, (2) the treatment groups that form the main comparisons should be clearly identified, and (3) for each main comparison, the estimated interaction effect and its precision should be reported. Conclusions and Relevance: This extension of the CONSORT 2010 Statement provides guidance on the reporting of factorial randomized trials and should facilitate greater understanding of and transparency in their reporting.

Estimands for factorial trials.

Factorial trials offer an efficient method to evaluate multiple interventions in a single trial, however the use of additional treatments can obscure research objectives, leading to inappropriate analytical methods and interpretation of results. We define a set of estimands for factorial trials, and describe a framework for applying these estimands, with the aim of clarifying trial objectives and ensuring appropriate primary and sensitivity analyses are chosen. This framework is intended for use in factorial trials where the intent is to conduct "two-trials-in-one" (ie, to separately evaluate the effects of treatments A and B), and is comprised of four steps: (i) specifying how additional treatment(s) (eg, treatment B) will be handled in the estimand, and how intercurrent events affecting the additional treatment(s) will be handled; (ii) designating the appropriate factorial estimator as the primary analysis strategy; (iii) evaluating the interaction to assess the plausibility of the assumptions underpinning the factorial estimator; and (iv) performing a sensitivity analysis using an appropriate multiarm estimator to evaluate to what extent departures from the underlying assumption of no interaction may affect results. We show that adjustment for other factors is necessary for noncollapsible effect measures (such as odds ratio), and through a trial re-analysis we find that failure to consider the estimand could lead to inappropriate interpretation of results. We conclude that careful use of the estimands framework clarifies research objectives and reduces the risk of misinterpretation of trial results, and should become a standard part of both the protocol and reporting of factorial trials.

Development of a Root Caries Prediction Model in a Population of Dental Attenders.

Root caries prevalence is increasing as populations age and retain more of their natural dentition. However, there is generally no accepted practice to identify individuals at risk of disease. There is a need for the development of a root caries prediction model to support clinicians to guide targeted prevention strategies. The aim of this study was to develop a prediction model for root caries in a population of regular dental attenders. Clinical and patient-reported predictors were collected at baseline by routine clinical examination and patient questionnaires. Clinical examinations were conducted at the 4-year timepoint by trained outcome assessors blind to baseline data to record root caries data at two thresholds - root caries present on any teeth (RC > 0) and root caries present on three or more teeth (RC ≥ 3). Multiple logistic regression analyses were performed with the number of participants with root caries at each outcome threshold utilized as the outcome and baseline predictors as the candidate predictors. An automatic backwards elimination process was conducted to select predictors for the final model at each threshold. The sensitivity, specificity, and c-statistic of each model's performance was assessed. A total of 1,432 patient participants were included within this prediction model, with 324 (22.6%) presenting with at least one root caries lesion, and 97 (6.8%) with lesions on three or more teeth. The final prediction model at the RC >0 threshold included increasing age, having ≥9 restored teeth at baseline, smoking, lack of knowledge of spitting toothpaste without rinsing following toothbrushing, decreasing dental anxiety, and worsening OHRQoL. The model sensitivity was 71.4%, specificity 69.5%, and c-statistic 0.79 (95% CI: 0.76, 0.81). The predictors included in the final prediction model at the RC ≥ 3 threshold included increasing age, smoking, and lack of knowledge of spitting toothpaste without rinsing following toothbrushing. The model sensitivity was 76.5%, specificity 73.6%, and c-statistic 0.81 (95% CI: 0.77, 0.86). To the authors' knowledge, this is the largest published root caries prediction model, with statistics indicating good model fit and providing confidence in its robustness. The performance of the risk model indicates that adults at risk of developing root caries can be accurately identified, with superior performance in the identification of adults at risk of multiple lesions.

Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.

BACKGROUND: Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception. METHODS: We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 µg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete). FINDINGS: Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred. INTERPRETATION: Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception. FUNDING: National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).

Diagnostic Accuracy of Monitoring Tests of Fellow Eyes in Patients with Unilateral Neovascular Age-Related Macular Degeneration: Early Detection of Neovascular Age-Related Macular Degeneration Study.

PURPOSE: To evaluate the diagnostic accuracy of routinely used tests of visual function and retinal morphology compared with fundus fluorescein angiography (FFA) to detect onset of active macular neovascularization in unaffected fellow eyes of patients with unilateral neovascular age-related macular degeneration (nAMD). DESIGN: Prospective diagnostic accuracy cohort study conducted in 24 eye clinics in the United Kingdom over 3 years. PARTICIPANTS: Older adults (>50 years) with recently diagnosed unilateral nAMD with a fellow (study) eye free of nAMD. METHODS: Self-reported vision, Amsler, clinic-measured visual acuity (VA), fundus assessment, and spectral domain OCT. The reference standard is FFA. MAIN OUTCOME MEASURES: Sensitivity and specificity of the 5 index tests. RESULTS: Of 552 participants monitored for up to 3 years, 145 (26.3%) developed active nAMD in the study eye, of whom 120 had an FFA at detection and constituted the primary analysis cohort. Index test positives at nAMD detection in those confirmed by FFA were self-reported vision much worse (5), distortion on Amsler (33), 10-letter decrease in acuity from baseline (36), fundus examination (64), and OCT (110). Percentage index test sensitivities were: self-reported vision 4.2 (95% confidence interval [CI], 1.6-9.8); Amsler 33.7 (95% CI, 25.1-43.5); VA 30.0 (95% CI, 22.5-38.7); fundus examination 53.8 (95% CI, 44.8-62.5); and OCT 91.7 (95% CI, 85.2-95.6). All 5 index test specificities were high at 97.0 (95% CI, 94.6-98.5), 81.4 (95% CI, 76.4-85.5), 66.3 (95% CI, 61.0-71.1), 97.6 (95% CI, 95.3-98.9), and 87.8 (95% CI, 83.8-90.9), respectively. The combination of OCT with one other index test that was a secondary outcome measure increased sensitivity marginally and decreased specificity for all combinations except fundus examination. CONCLUSIONS: Tests of self-reported change in vision, unmasking of new distortion, measurements of acuity, and fundus checks to diagnose active nAMD performed poorly in contrast to OCT. Our findings support a change to guidelines in clinical practice to monitor for onset of nAMD.

Have you had bleeding from your gums? Self-report to identify giNGival inflammation (The SING diagnostic accuracy and diagnostic model development study).

AIM: To assess the diagnostic performance of self-reported oral health questions and develop a diagnostic model with additional risk factors to predict clinical gingival inflammation in systemically healthy adults in the United Kingdom. METHODS: Gingival inflammation was measured by trained staff and defined as bleeding on probing (present if bleeding sites ≥ 30%). Sensitivity and specificity of self-reported questions were calculated; a diagnostic model to predict gingival inflammation was developed and its performance (calibration and discrimination) assessed. RESULTS: We included 2853 participants. Self-reported questions about bleeding gums had the best performance: the highest sensitivity was 0.73 (95% CI 0.70, 0.75) for a Likert item and the highest specificity 0.89 (95% CI 0.87, 0.90) for a binary question. The final diagnostic model included self-reported bleeding, oral health behaviour, smoking status, previous scale and polish received. Its area under the curve was 0.65 (95% CI 0.63-0.67). CONCLUSION: This is the largest assessment of diagnostic performance of self-reported oral health questions and the first diagnostic model developed to diagnose gingival inflammation. A self-reported bleeding question or our model could be used to rule in gingival inflammation since they showed good sensitivity, but are limited in identifying healthy individuals and should be externally validated.

Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis.

BACKGROUND: Bulbar urethral stricture is a common cause for urinary symptoms in men and its two main treatment options both have drawbacks with little evidence on their relative cost-effectiveness. Current guidelines on the management of recurrent bulbar urethral stricture have been predominantly based on expert opinion and panel consensus. OBJECTIVE: To assess the relative cost-effectiveness of open urethroplasty and endoscopic urethrotomy as treatment for recurrent urethral stricture in men. METHODS: Set in the UK National Health Service with recruitment from 38 hospital sites, a randomised controlled trial of open urethroplasty and endoscopic urethrotomy with 6-monthly follow-up over 24 months was conducted. Two hundred and twenty-two men requiring operative treatment for recurrence of bulbar urethral stricture and having had at least one previous intervention for stricture were recruited. Effectiveness was measured by quality- adjusted life years (QALYs) derived from EQ-5D 5L. Cost-effectiveness was measured by the incremental cost per QALY gained over 24 months using a within trial analysis and a Markov model with a 10-year time horizon. RESULTS: In the within trial, urethroplasty cost on average more than urethrotomy (cost difference: £2148 [95% CI 689, 3606]) and resulted in a similar number of QALYs on average (QALY difference: - 0.01 [95% CI - 0.17, 0.14)] over 24 months. The Markov model produced similar results. Sensitivity analyses using multiple imputation, suggested that the results were robust, despite observed missing data. CONCLUSIONS: Based on current practice and evidence, urethrotomy is a cost-effective treatment compared with urethroplasty. KEYPOINTS: Urethrotomy and urethroplasty both led to symptom improvement for men with bulbar urethral stricture-a common cause for urinary symptoms in men; Urethroplasty appeared unlikely to offer good value for money compared to urethrotomy based on current evidence. TRIAL REGISTRATION: ISRCTN: 98009168 (date: 29 November 2012) and it is also in the UK NIHR Portfolio (reference 13507). Trial protocol: The latest version (1.8) of the full protocol is available at: www.journalslibrary.nihr.ac.uk/programmes/hta/105723/ #/ and a published version is also available: Stephenson R, Carnell S, Johnson N, Brown R, Wilkinson J, Mundy A, et al. Open urethroplasty versus endoscopic urethrotomy-clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial. Trials 2015;16:600. https://doi.org/10.1186/s13063-015-1120-4. Trial main clinical results publication: Goulao B, Carnell S, Shen J, MacLennan G, Norrie J, Cook J, et al. Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial), European Urology, Volume 78, Issue 4, 2020, Pages 572-580.

Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care.

BACKGROUND: Dental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth. METHOD: This is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes. DISCUSSION: SCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN. TRIAL REGISTRATION NUMBER: ISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search .

Antimicrobial mouthwashes (gargling) and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to improve patient outcomes and to protect healthcare workers treating them.

BACKGROUND: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of patients with infection are irrigated with antimicrobial solutions, this may help the patients by killing any coronavirus present at those sites. It may also reduce the risk of the active infection being passed to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose. OBJECTIVES: To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to both the patients and the HCWs caring for them. SEARCH METHODS: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.  SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.   We sought studies comparing antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered with any frequency or dosage to suspected/confirmed COVID-19 patients. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) RECOVERY* (www.recoverytrial.net) outcomes in patients (mortality; hospitalisation status; use of ventilation; use of renal dialysis or haemofiltration); 2) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 3) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 4) change in COVID-19 viral load in patients; 5) COVID-19 viral content of aerosol (when present); 6) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 7) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We found no completed studies to include in this review. We identified 16 ongoing studies (including 14 RCTs), which aim to enrol nearly 1250 participants. The interventions included in these trials are ArtemiC (artemisinin, curcumin, frankincense and vitamin C), Citrox (a bioflavonoid), cetylpyridinium chloride, chlorhexidine, chlorine dioxide, essential oils, hydrogen peroxide, hypertonic saline, Kerecis spray (omega 3 viruxide - containing neem oil and St John's wort), neem extract, nitric oxide releasing solution, povidone iodine and saline with baby shampoo.  AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by a number of RCTs and other studies. We are concerned that few of the ongoing studies specifically state that they will evaluate adverse events such as changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.

Antimicrobial mouthwashes (gargling) and nasal sprays to protect healthcare workers when undertaking aerosol-generating procedures (AGPs) on patients without suspected or confirmed COVID-19 infection.

BACKGROUND: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. The risks of transmission of infection are greater when a patient is undergoing an aerosol-generating procedure (AGP). Not all those with COVID-19 infection are symptomatic, or suspected of harbouring the infection. If a patient who is not known to have or suspected of having COVID-19 infection is to undergo an AGP, it would nonetheless be sensible to minimise the risk to those HCWs treating them. If the mouth and nose of an individual undergoing an AGP are irrigated with antimicrobial solutions, this may be a simple and safe method of reducing the risk of any covert infection being passed to HCWs through droplet transmission or direct contact. Alternatively, the use of antimicrobial solutions by the HCW may decrease the chance of them acquiring COVID-19 infection. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose. OBJECTIVES: To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to HCWs and/or patients when undertaking AGPs on patients without suspected or confirmed COVID-19 infection. SEARCH METHODS: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.  SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.   We sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to the patient or HCW before and/or after an AGP. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs or patients; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) COVID-19 viral content of aerosol (when present); 4) change in COVID-19 viral load at site(s) of irrigation; 5) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 6) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We found no completed studies to include in this review.   AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review, nor any ongoing studies. The absence of completed studies is not surprising given the relatively recent emergence of COVID-19 infection. However, we are disappointed that this important clinical question is not being addressed by ongoing studies.

Use of antimicrobial mouthwashes (gargling) and nasal sprays by healthcare workers to protect them when treating patients with suspected or confirmed COVID-19 infection.

BACKGROUND: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of HCWs are irrigated with antimicrobial solutions, this may help reduce the risk of active infection being passed from infected patients to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves, or alterations in the natural microbial flora of the mouth or nose. Understanding these possible side effects is particularly important when the HCWs are otherwise fit and well. OBJECTIVES: To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays used by healthcare workers (HCWs) to protect themselves when treating patients with suspected or confirmed COVID-19 infection. SEARCH METHODS: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.  SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed randomised controlled trials (RCTs). We therefore planned to include the following types of studies: RCTs; quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.   We sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to HCWs, with or without the same intervention being given to the patients with COVID-19. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) viral content of aerosol, when present (if intervention administered to patients); 4) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 5) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We found no completed studies to include in this review. We identified three ongoing studies (including two RCTs), which aim to enrol nearly 700 participants. The interventions included in these trials are povidone iodine, nitric oxide and GLS-1200 oral spray (the constituent of this spray is unclear and may not be antimicrobial in nature).   AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by two RCTs and a non-randomised study. We are concerned that only one of the ongoing studies specifically states that it will evaluate adverse events and it is not clear if this will include changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular, where those receiving the intervention are otherwise fit and well, it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.

Malnutrition among older adults living in Portuguese nursing homes: the PEN-3S study.

OBJECTIVE: To characterise the nutritional status and to identify malnutrition-associated variables of older adults living in Portuguese nursing homes. DESIGN: Cross-sectional study. Data on demographic and socio-economic characteristics, self-reported morbidity, eating-related problems, nutritional status, cognitive function, depression symptoms, loneliness feelings and functional status were collected by trained nutritionists through a computer-assisted face-to-face structured interview followed by standardised anthropometric measurements. Logistic regression was used to identify factors associated with being at risk of malnutrition/malnourished. SETTING: Portuguese nursing homes. SUBJECTS: Nationally representative sample of the Portuguese population aged 65 years or over living in nursing homes. RESULTS: A total of 1186 individuals (mean age 83·4 years; 72·8 % women) accepted to participate. According to the Mini Nutritional Assessment, 4·8 (95 % CI 3·2, 7·3) % were identified as malnourished and 38·7 (95 % CI 33·5, 44·2) % were at risk of malnutrition. These percentages increased with age and were significantly higher for women. Logistic regression showed (OR; 95 % CI) that older adults reporting no or little appetite (6·5; 2·7, 15·3), those revealing symptoms of depression (2·6; 1·6, 4·2) and those who were more dependent in their daily living activities (4·7; 2·0, 11·1) were also at higher odds of being malnourished or at risk of malnutrition. CONCLUSIONS: Malnutrition and risk of malnutrition are prevalent among nursing home residents in Portugal. It is crucial to routinely screen for nutritional disorders, as well as risk factors such as symptoms of depression and lower functional status, to prevent and treat malnutrition.

INTERVAL (investigation of NICE technologies for enabling risk-variable-adjusted-length) dental recalls trial: a multicentre randomised controlled trial investigating the best dental recall interval for optimum, cost-effective maintenance of oral health in dentate adults attending dental primary care.

BACKGROUND: Traditionally, patients at low risk and high risk of developing dental disease have been encouraged to attend dental recall appointments at regular intervals of six months between appointments. The lack of evidence for the effect that different recall intervals between dental check-ups have on patient outcomes, provider workload and healthcare costs is causing considerable uncertainty for the profession and patients, despite the publication of the NICE Guideline on dental recall. The need for primary research has been highlighted in the Health Technology Assessment Group's systematic review of routine dental check-ups, which found little evidence to support or refute the practice of encouraging 6-monthly dental check-ups in adults. The more recent Cochrane review on recall interval concluded there was insufficient evidence to draw any conclusions regarding the potential beneficial or harmful effects of altering the recall interval between dental check-ups. There is therefore an urgent need to assess the relative effectiveness and cost-benefit of different dental recall intervals in a robust, sufficiently powered randomised control trial (RCT) in primary dental care. METHODS: This is a four year multi-centre, parallel-group, randomised controlled trial with blinded outcome assessment based in dental primary care in the UK. Practitioners will recruit 2372 dentate adult patients. Patient participants will be randomised to one of three groups: fixed-period six month recall, risk-based recall, or fixed-period twenty-four month recall. Outcome data will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcomes measure gingival inflammation/bleeding on probing and oral health-related quality of life. DISCUSSION: INTERVAL will provide evidence for the most clinically-effective and cost-beneficial recall interval for maintaining optimum oral health in dentate adults attending general dental practice. TRIAL REGISTRATION: ISRCTN95933794 (Date assigned 20/08/2008).

National survey of the Portuguese elderly nutritional status: study protocol.

BACKGROUND: Worldwide we are facing a serious demographic challenge due to the dramatic growth of the population over 60 years. It is expected that the proportion of this population will nearly double from 12 to 22 %, between 2015 and 2050. This demographic shift comes with major health and socio-economic concerns. Nutrition is a fundamental determinant of both health and disease and its role in extending a healthy lifespan is the object of considerable research. Notably, malnutrition is one of the main threats to health and quality of life among the elderly. Therefore, knowledge about nutritional status among the elderly is essential for the promotion and maintenance of healthy ageing and to support the development of health protection policies and equity in elderly health care. METHODS: This is a nationwide nutrition survey of the Portuguese population over 65 years old, with data collection through face-to-face interviews. A representative and random sample of community dwelling elderly and nursing homes residents will be obtained by multistage sampling stratified per main Portuguese regions, sex and age groups. Minimum sample size was estimated to be 2077 elderly (979 in the community and 1098 in nursing homes). Data will be collected on food habits and eating patterns, nutritional status, food insecurity, lifestyle, self-rated general health status and self-reported diseases, functionality, loneliness, cognitive function, emotional status and demographic and socio-economic characterization. DISCUSSION: This is the first national survey to evaluate the prevalence of nutritional risk and malnutrition of the Portuguese population above 65 years old, including those living in nursing homes. It will allow the identification of population subgroups of elderly with increased odds of malnutrition and nutritional risk. In addition, this survey will contribute to the identification of psychosocial and clinical predictors of malnutrition among elderly, which is an important risk factor for other devastating medical conditions.

"The power imbalance was blown out the window": developing and implementing creative workshops to enhance communication of statistics in patient and public involvement in clinical trials.

BACKGROUND: Despite the importance of statistical and numerical aspects in key decisions related to clinical trials and their impact in patient's care, patient and public involvement remains underdeveloped in this field. Communication is a barrier to enable successful involvement of patients and the public in numerical aspects. Treatment important differences, a crucial numerical aspect in trials, is considered a priority for patient and public involvement. Creative methods have been proposed to improve communication of technical concepts with members of the public; and to democratise and improve inclusivity in patient and public involvement in health research. METHODS: Working with creative professionals, public partners, and statisticians, we aimed to develop, pilot and implement creative workshops to promote a shared understanding of treatment important differences; and co-develop creative prototypes that could be used to communicate the statistical concept to a wider audience in the future. Three 2 to 4 h creative workshops based in the UK were delivered. The first two workshops included 22 participants. They were online and worked as pilots to refine the final in-person workshop via participant feedback and discussion. The final workshop focused on treatment important differences, and we collected information from participants on expectations, subjective numeracy, and experience. RESULTS: The final workshop included 13 participants (5 creative professionals, 4 public partners, and 4 clinical trial statisticians). Participants reported creative workshops helped improve communication of treatment important differences between stakeholders reaching a common understanding of their meaning; and helped democratise knowledge exchange. Each group developed a creative prototype to communicate about treatment important differences with a wider audience, including a song, game, and a cartoon. Participants recommended the format to improve communication of other statistical or complex concepts between stakeholders. CONCLUSIONS: Creative workshops can promote shared understanding of complex, statistical concepts and co-development of creative outputs amongst stakeholders. Future work should explore generalisability of the intervention, and what outcomes might be important to consider when implementing creative workshops in patient and public involvement practice.

Patient and public involvement in clinical trials helps improve their relevance. Decisions related to numbers in trials consider information related to patients and their clinical experience, but patients and the public are rarely involved in these decisions. One barrier to achieve this is communication: numbers can be challenging to discuss. Creative methods (including writing, dancing, drawing) have been suggested as a potential way to improve communication of numbers with a wide audience. Working with creative professionals, public partners, and statisticians we developed, piloted, and implemented a creative workshop focusing on improving communication by reaching a common understanding between participants of a specific numerical concept related to clinical trials and where patient and public involvement is crucial. The creative workshop aimed to facilitate mutual learning between creative professionals, members of the public, and statisticians; and to promote co-development of creative outputs to describe the same numerical concept to a wider audience. Workshop participants felt the creative workshops improved communication of the numerical concept and helped everyone feel heard. Workshop participants were particularly interested in visual methods to support communication, and recommended creative workshops should be used to improve communication of other statistical and complex concepts.

Public perspective on potential treatment intervention harm in clinical trials-terminology and communication.

BACKGROUND: Randomised controlled trials (RCTs) are typically designed to determine beneficial intervention effects. In addition, an important aspect of every trial is to collect data on any potential harmful effects, with the aim of ensuring that the benefit-risk balance is appropriate. The language used by trialists to describe these potential harmful effects is inconsistent. In pharmacological trials, researchers collect adverse events; when a causal relationship is suspected adverse events are further classified as adverse reactions. Academic researchers have moved to collectively refer to these as harm outcomes; the pharmaceutical industry refer to these events as safety outcomes. In trials of complex interventions, phrases such as unintended consequences or effects are used. With the inconsistent use of terminology by researchers and the potential benefits to be gained from harmonising communications, we sought public opinion on terminology used to describe harmful effects and how these outcomes are communicated in the scientific literature, as well as in public facing material on medications. METHODS: We held two in-person public involvement meetings with public partners, in London and Aberdeen in 2023. Both meetings followed a pre-specified format. We provided a background to the topic including the information researchers collect on potential harms in clinical trials and shared examples on how this information gets presented in practice. We then discussed public partners' perspectives on terminology used and communication of intervention harm in academic journals and in public facing materials. A summary of these discussions and the main topics raised by public partners are presented. RESULTS: Public partners endorsed the use of different terms for different situations, preferring the use of 'side-effect' across all contexts and reserving the use of 'harm' to indicate more severe events. Generally, public partners were happy with the type of information presented in public facing materials but discussions revealed that presentation of information on public NHS websites led to misconceptions about harm. CONCLUSION: This work provides a starting point on preferred terminology by patients and the public to describe potential harmful intervention effects. Whilst researchers have tried to seek agreement, public partners endorsed use of different terms for different situations. We highlight some key areas for improvement in public facing materials that are necessary to avoid miscommunication and incorrect perception of harm.

Sustainable oral healthcare: what is it and how do we achieve it?

In recent years, there has been an increase in interest in what environmental sustainability means for healthcare, including oral health and dentistry. To help facilitate discussions among key stakeholders in this area, the Scottish Dental Clinical Effectiveness Programme held a workshop in November 2022. The purpose of this workshop was to explore current thinking on the subject of sustainability as it relates to oral health and to help stakeholders identify how to engage with the sustainability agenda. This paper presents an overview of the presentations and discussions from the workshop and highlights potential avenues for future work and collaboration.

Using re-randomisation designs to increase the efficiency and applicability of retention studies within trials: a case study.

BACKGROUND: Poor retention in randomised trials can lead to serious consequences to their validity. Studies within trials (SWATs) are used to identify the most effective interventions to increase retention. Many interventions could be applied at any follow-up time point, but SWATs commonly assess interventions at a single time point, which can reduce efficiency. METHODS: The re-randomisation design allows participants to be re-enrolled and re-randomised whenever a new retention opportunity occurs (i.e. a new follow-up time point where the intervention could be applied). The main advantages are as follows: (a) it allows the estimation of an average effect across time points, thus increasing generalisability; (b) it can be more efficient than a parallel arm trial due to increased sample size; and (c) it allows subgroup analyses to estimate effectiveness at different time points. We present a case study where the re-randomisation design is used in a SWAT. RESULTS: In our case study, the host trial is a dental trial with two available follow-up points. The Sticker SWAT tests whether adding the trial logo's sticker to the questionnaire's envelope will result in a higher response rate compared with not adding the sticker. The primary outcome is the response rate to postal questionnaires. The re-randomisation design could double the available sample size compared to a parallel arm trial, resulting in the ability to detect an effect size around 28% smaller. CONCLUSION: The re-randomisation design can increase the efficiency and generalisability of SWATs for trials with multiple follow-up time points.

Designing infographics in health research with patients and the public: A scoping review protocol.

Information graphics or infographics combine visual representations of information or data with text. They have been used in health research to disseminate research findings, translate knowledge and address challenges in health communication to lay audiences. There is emerging evidence of the design of infographics with the involvement of patients and the public in health research. Approaches to involvement include public and patient involvement, patient engagement and participatory research approaches. To date, there has been no comprehensive review of the literature on the design of infographics with patients and the public in health research. This paper presents a protocol and methodological framework for a scoping review to identify and map the available evidence for the involvement of patients and the public in infographics design in health research. It has been informed by preliminary searches and discussions and will guide the conduct and reporting of this review.