Single-Incision Mini-Slings for Stress Urinary Incontinence in Women.

BACKGROUND: Until recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited. METHODS: We performed a pragmatic, noninferiority, randomized trial comparing mini-slings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points. RESULTS: A total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, -1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group. CONCLUSIONS: Single-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up. (Funded by the National Institute for Health Research.).

Care processes and outcomes of deprivation across the clinical course of kidney disease: findings from a high-income country with universal healthcare.

BACKGROUND: No single study contrasts the extent and consequences of inequity of kidney care across the clinical course of kidney disease. METHODS: This population study of Grampian (UK) followed incident presentations of acute kidney injury (AKI) and incident estimated glomerular filtration rate (eGFR) thresholds of <60, <45 and <30 mL/min/1.73 m2 in separate cohorts (2011-2021). The key exposure was area-level deprivation (lowest quintile of the Scottish Index of Multiple Deprivation). Outcomes were care processes (monitoring, prescribing, appointments, unscheduled care), long-term mortality and kidney failure. Modelling involved multivariable logistic regression, negative binomial regression and cause-specific Cox models with and without adjustment of comorbidities. RESULTS: There were 41 313, 51 190, 32 171 and 17 781 new presentations of AKI and eGFR thresholds <60, <45 and <30  mL/min/1.73 m2. A total of 6.1-7.8% of the population was from deprived areas and (versus all others) presented on average 5 years younger, with more diabetes and pulmonary and liver disease. Those from deprived areas were more likely to present initially in hospital, less likely to receive community monitoring, less likely to attend appointments and more likely to have an unplanned emergency department or hospital admission episode. Deprivation had the greatest association with long-term kidney failure at the eGFR <60 mL/min/1.73 m2 threshold {adjusted hazard ratio [HR] 1.48 [95% confidence interval (CI) 1.17-1.87]} and this association decreased with advancing disease severity [HR 1.09 (95% CI 0.93-1.28) at eGFR <30 mL/min/1.73 m2), with a similar pattern for mortality. Across all analyses the most detrimental associations of deprivation were an eGFR threshold <60 mL/min/1.73 m2, AKI, males and those <65 years of age. CONCLUSIONS: Even in a high-income country with universal healthcare, serious and consistent inequities in kidney care exist. The poorer care and outcomes with area-level deprivation were greater earlier in the disease course.

PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse.

INTRODUCTION AND HYPOTHESIS: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse. METHODS: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures. RESULTS: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups. CONCLUSIONS: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

Importance: Bleeding is the most common cause of preventable death after trauma. Objective: To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage. Design, Setting, and Participants: Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days. Intervention: Patients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44). Main Outcomes and Measures: The primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death. Results: Of the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours. Conclusions and Relevance: In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone. Trial Registration: isrctn.org Identifier: ISRCTN16184981.

Treatment of periodontitis for glycaemic control in people with diabetes mellitus.

BACKGROUND: Glycaemic control is a key component in diabetes mellitus (diabetes) management. Periodontitis is the inflammation and destruction of the underlying supporting tissues of the teeth. Some studies have suggested a bidirectional relationship between glycaemic control and periodontitis.  Treatment for periodontitis involves subgingival instrumentation, which is the professional removal of plaque, calculus, and debris from below the gumline using hand or ultrasonic instruments. This is known variously as scaling and root planing, mechanical debridement, or non-surgical periodontal treatment. Subgingival instrumentation is sometimes accompanied by local or systemic antimicrobials, and occasionally by surgical intervention to cut away gum tissue when periodontitis is severe. This review is part one of an update of a review published in 2010 and first updated in 2015, and evaluates periodontal treatment versus no intervention or usual care.  OBJECTIVES: To investigate the effects of periodontal treatment on glycaemic control in people with diabetes mellitus and periodontitis. SEARCH METHODS: An information specialist searched six bibliographic databases up to 7 September 2021 and additional search methods were used to identify published, unpublished, and ongoing studies.  SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) of people with type 1 or type 2 diabetes mellitus and a diagnosis of periodontitis that compared subgingival instrumentation (sometimes with surgical treatment or adjunctive antimicrobial therapy or both) to no active intervention or 'usual care' (oral hygiene instruction, education or support interventions, and/or supragingival scaling (also known as PMPR, professional mechanical plaque removal)). To be included, the RCTs had to have lasted at least 3 months and have measured HbA1c (glycated haemoglobin). DATA COLLECTION AND ANALYSIS: At least two review authors independently examined the titles and abstracts retrieved by the search, selected the included trials, extracted data from included trials, and assessed included trials for risk of bias. Where necessary and possible, we attempted to contact study authors. Our primary outcome was blood glucose levels measured as glycated (glycosylated) haemoglobin assay (HbA1c), which can be reported as a percentage of total haemoglobin or as millimoles per mole (mmol/mol). Our secondary outcomes included adverse effects, periodontal indices (bleeding on probing, clinical attachment level, gingival index, plaque index, and probing pocket depth), quality of life, cost implications, and diabetic complications. MAIN RESULTS: We included 35 studies, which randomised 3249 participants to periodontal treatment or control. All studies used a parallel-RCT design and followed up participants for between 3 and 12 months. The studies focused on people with type 2 diabetes, other than one study that included participants with type 1 or type 2 diabetes. Most studies were mixed in terms of whether metabolic control of participants at baseline was good, fair, or poor. Most studies were carried out in secondary care.  We assessed two studies as being at low risk of bias, 14 studies at high risk of bias, and the risk of bias in 19 studies was unclear. We undertook a sensitivity analysis for our primary outcome based on studies at low risk of bias and this supported the main findings. Moderate-certainty evidence from 30 studies (2443 analysed participants) showed an absolute reduction in HbA1c of 0.43% (4.7 mmol/mol) 3 to 4 months after treatment of periodontitis (95% confidence interval (CI) -0.59% to -0.28%; -6.4 mmol/mol to -3.0 mmol/mol). Similarly, after 6 months, we found an absolute reduction in HbA1c of 0.30% (3.3 mmol/mol) (95% CI -0.52% to -0.08%; -5.7 mmol/mol to -0.9 mmol/mol; 12 studies, 1457 participants), and after 12 months, an absolute reduction of 0.50% (5.4 mmol/mol) (95% CI -0.55% to -0.45%; -6.0 mmol/mol to -4.9 mmol/mol; 1 study, 264 participants). Studies that measured adverse effects generally reported that no or only mild harms occurred, and any serious adverse events were similar in intervention and control arms. However, adverse effects of periodontal treatments were not evaluated in most studies. AUTHORS' CONCLUSIONS: Our 2022 update of this review has doubled the number of included studies and participants, which has led to a change in our conclusions about the primary outcome of glycaemic control and in our level of certainty in this conclusion. We now have moderate-certainty evidence that periodontal treatment using subgingival instrumentation improves glycaemic control in people with both periodontitis and diabetes by a clinically significant amount when compared to no treatment or usual care. Further trials evaluating periodontal treatment versus no treatment/usual care are unlikely to change the overall conclusion reached in this review.

Current and Projected Financial Burden of Emergency General Surgery for Adults in Scotland's Single Payer Healthcare System: A Cost Analysis of Hospital Admissions.

OBJECTIVE: To calculate the current and projected financial burden of EGS hospital admissions in a single-payer healthcare system. SUMMARY OF BACKGROUND DATA: EGS is an important acute care service, which demands significant healthcare resources. EGS admissions and associated costs have increased over time, associated with an aging demographic. The National Health Service is the sole provider of emergency care in Scotland. METHODS: Principal, high and low Scottish population projections were obtained for 2016 until 2041. EGS admission data were projected using an ordinary least squares linear regression model. An exponential function, fitted to historical length of hospital stay (LOS) data, was used to project future LOS. Historical hospital unit cost per bed day was projected using a linear regression model. EGS cost was calculated to 2041 by multiplying annual projections of population, admission rates, LOS, and cost per bed day. RESULTS: The adult (age >15) Scottish population is projected to increase from 4.5 million to 4.8 million between 2016 and 2041. During this time, EGS admissions are expected to increase from 83,132 to 101,090 per year, cost per bed day from £786 to £1534, and overall EGS cost from £187.3 million to £202.5 million. CONCLUSIONS: The future financial burden of EGS in Scotland is projected to increase moderately between 2016 and 2041. This is in sharp contrast to previous studies from settings such as the United States. However, if no further reductions in LOS or cost per bed day are made, especially for elderly patients, the cost of EGS will rise dramatically.

Cost-effectiveness and value of information analysis of NephroCheck and NGAL tests compared to standard care for the diagnosis of acute kidney injury.

BACKGROUND: Early and accurate acute kidney injury (AKI) detection may improve patient outcomes and reduce health service costs. This study evaluates the diagnostic accuracy and cost-effectiveness of NephroCheck and NGAL (urine and plasma) biomarker tests used alongside standard care, compared with standard care to detect AKI in hospitalised UK adults. METHODS: A 90-day decision tree and lifetime Markov cohort model predicted costs, quality adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) from a UK NHS perspective. Test accuracy was informed by a meta-analysis of diagnostic accuracy studies. Clinical trial and observational data informed the link between AKI and health outcomes, health state probabilities, costs and utilities. Value of information (VOI) analysis informed future research priorities. RESULTS: Under base case assumptions, the biomarker tests were not cost-effective with ICERs of £105,965 (NephroCheck), £539,041 (NGAL urine BioPorto), £633,846 (NGAL plasma BioPorto) and £725,061 (NGAL urine ARCHITECT) per QALY gained compared to standard care. Results were uncertain, due to limited trial data, with probabilities of cost-effectiveness at £20,000 per QALY ranging from 0 to 99% and 0 to 56% for NephroCheck and NGAL tests respectively. The expected value of perfect information (EVPI) was £66 M, which demonstrated that additional research to resolve decision uncertainty is worthwhile. CONCLUSIONS: Current evidence is inadequate to support the cost-effectiveness of general use of biomarker tests. Future research evaluating the clinical and cost-effectiveness of test guided implementation of protective care bundles is necessary. Improving the evidence base around the impact of tests on AKI staging, and of AKI staging on clinical outcomes would have the greatest impact on reducing decision uncertainty.

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 .

Pit and fissure sealants versus fluoride varnishes for preventing dental decay in the permanent teeth of children and adolescents.

BACKGROUND: Most of the detected increment in dental caries among children above the age of six years and adolescents is confined to occlusal surfaces of posterior permanent molars. Dental sealants and fluoride varnishes are much used to prevent caries. As the effectiveness of both interventions in controlling caries as compared with no intervention has been demonstrated previously, this review aimed to evaluate their relative effectiveness. It updates a review published originally in 2006 and updated in 2010 and in 2016. OBJECTIVES: Our primary objective was to evaluate the relative effectiveness of dental sealants (i.e. fissure sealant) compared with fluoride varnishes, or fissure sealants plus fluoride varnishes compared with fluoride varnishes alone, for preventing dental caries in the occlusal surfaces of permanent teeth of children and adolescents. Our secondary objectives were to evaluate whether effectiveness is influenced by sealant material type and length of follow-up, document and report on data concerning adverse events associated with sealants and fluoride varnishes, and report the cost effectiveness of dental sealants versus fluoride varnish in caries prevention. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 19 March 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2020, Issue 2), MEDLINE Ovid (1946 to 19 March 2020) and Embase Ovid (1980 to 19 March 2020). We searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. There were no restrictions on the language or date of publication. SELECTION CRITERIA: We included randomised controlled trials with at least 12 months of follow-up comparing fissure sealants, or fissure sealants plus fluoride varnishes, versus fluoride varnishes, for preventing caries in the occlusal surfaces of permanent posterior teeth (i.e. premolar or molar teeth), in participants younger than 20 years of age at the start of the study. DATA COLLECTION AND ANALYSIS: At least two review authors independently screened search results, extracted data from included studies and assessed their risk of bias. We attempted to contact study authors to obtain missing or unclear information. We grouped and analysed studies on the basis of sealant material type: resin-based sealant or glass ionomer-based sealant (glass ionomer and resin-modified glass ionomer sealant), and different follow-up periods. We calculated the odds ratio (OR) for risk of caries on occlusal surfaces of permanent molar teeth. For trials with a split-mouth design, we used the Becker-Balagtas OR. One cluster-randomised trial provided precise estimates in terms of risk ratio (RR), which we used. For continuous outcomes and data, we used means and standard deviations to obtain mean differences (MD). For meta-analysis, we used the random-effects model when we combined data from four or more studies. We presented all measures with 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE criteria. MAIN RESULTS: We included 11 trials with 3374 participants aged five to 10 years when trials started. Three trials are new since the 2016 update. Two trials did not contribute data to our analysis. Sealant versus fluoride varnish Resin-based fissure sealants versus fluoride varnishes Seven trials evaluated this comparison (five contributing data). We are uncertain if resin-based sealants may be better than fluoride varnish, or vice versa, for preventing caries in first permanent molars at two to three years' follow-up (OR 0.67, 95% CI 0.37 to 1.19; I2 = 84%; 4 studies, 1683 children evaluated). One study measuring decayed, missing and filled permanent surfaces (DMFS) and decayed, missing and filled permanent teeth (DMFT) increment at two years suggested a small benefit for fissure sealant (DMFS MD -0.09, 95% CI -0.15 to -0.03; DMFT MD -0.08, 95% CI -0.14 to -0.02; 542 participants), though this may not be clinically significant. One small study, at high risk of bias, reported a benefit for sealant after four years in preventing caries (RR 0.42, 95% CI 0.21 to 0.84; 75 children) and at nine years (RR 0.48, 95% CI 0.29 to 0.79; 75 children). We assessed each of these results as having very low certainty. Glass ionomer-based sealants versus fluoride varnishes Three trials evaluated this comparison: one trial with chemically cured glass ionomer and two with resin-modified glass ionomer. Studies were clinically diverse, so we did not conduct a meta-analysis. In general, the studies found no benefit of one intervention over another at one, two and three years, although one study, which also included oral health education, suggested a benefit from sealants over varnish for children at high risk of caries. We assessed this evidence as very low certainty. Sealant plus fluoride varnish versus fluoride varnish alone One split-mouth trial analysing 92 children at two-year follow-up found in favour of resin-based fissure sealant plus fluoride varnish over fluoride varnish only (OR 0.30, 95% CI 0.17 to 0.55), which represented a clinically meaningful effect of a 77% reduction in caries after two years; however, we assessed this evidence as very low certainty. Adverse events Five trials (1801 participants) (four using resin-based sealant material and one using resin-modified glass ionomer) reported that no adverse events resulted from use of sealants or fluoride varnishes over one to nine years. The other studies did not mention adverse events. AUTHORS' CONCLUSIONS: Applying fluoride varnish or resin-based fissure sealants to first permanent molars helps prevent occlusal caries, but it has not been possible in this review to reach reliable conclusions about which one is better to apply. The available studies do not suggest either intervention is superior, but we assessed this evidence as having very low certainty. We found very low-certainty evidence that placing resin-based sealant as well as applying fluoride varnish works better than applying fluoride varnish alone. Fourteen studies are currently ongoing and their findings may allow us to draw firmer conclusions about whether sealants and varnish work equally well or whether one is better than the other.

Recall intervals for oral health in primary care patients.

BACKGROUND: There is ongoing debate about the frequency with which patients should attend for a dental check-up and the effects on oral health of the interval between check-ups. Recommendations regarding optimal recall intervals vary between countries and dental healthcare systems, but 6-month dental check-ups have traditionally been advocated by general dental practitioners in many high-income countries. This review updates a version first published in 2005, and updated in 2007 and 2013. OBJECTIVES: To determine the optimal recall interval of dental check-up for oral health in a primary care setting. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 17 January 2020), the Cochrane Central Register of Controlled Trials (CENTRAL; in the Cochrane Library, 2019, Issue 12), MEDLINE Ovid (1946 to 17 January 2020), and Embase Ovid (1980 to 17 January 2020). We also searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. We placed no restrictions on the language or date of publication when searching. SELECTION CRITERIA: We included randomised controlled trials (RCTs) assessing the effects of different dental recall intervals in a primary care setting. DATA COLLECTION AND ANALYSIS: Two review authors screened search results against inclusion criteria, extracted data and assessed risk of bias, independently and in duplicate. We contacted study authors for clarification or further information where necessary and feasible. We expressed the estimate of effect as mean difference (MD) with 95% confidence intervals (CIs) for continuous outcomes and risk ratios (RR) with 95% CIs for dichotomous outcomes. We assessed the certainty of the evidence using GRADE. MAIN RESULTS: We included two studies with data from 1736 participants. One study was conducted in a public dental service clinic in Norway and involved participants under 20 years of age who were regular attenders at dental appointments. It compared 12-month with 24-month recall intervals and measured outcomes at two years. The other study was conducted in UK general dental practices and involved adults who were regular attenders, which was defined as having attended the dentist at least once in the previous two years. It compared the effects of 6-month, 24-month and risk-based recall intervals, and measured outcomes at four years. The main outcomes we considered were dental caries, gingival bleeding and oral-health-related quality of life. Neither study measured other potential adverse effects. 24-month versus 12-month recall at 2 years' follow-up Due to the very low certainty of evidence from one trial, it is unclear if there is an important difference in caries experience between assignment to a 24-month or a 12-month recall. For 3- to 5-year-olds with primary teeth, the mean difference (MD) in dmfs (decayed, missing, and filled tooth surfaces) increment was 0.90 (95% CI -0.16 to 1.96; 58 participants). For 16- to 20-year-olds with permanent teeth, the MD in DMFS increment was 0.86 (95% CI -0.03 to 1.75; 127 participants). The trial did not assess other clinical outcomes of relevance to this review. Risk-based recall versus 6-month recall at 4 years' follow-up We found high-certainty evidence from one trial of adults that there is little to no difference between risk-based and 6-month recall intervals for the outcomes: number of tooth surfaces with any caries (ICDAS 1 to 6; MD 0.15, 95% CI -0.77 to 1.08; 1478 participants); proportion of sites with gingival bleeding (MD 0.78%, 95% CI -1.17% to 2.73%; 1472 participants); oral-health-related quality of life (MD in OHIP-14 scores -0.35, 95% CI -1.02 to 0.32; 1551 participants). There is probably little to no difference in the prevalence of moderate to extensive caries (ICDAS 3 to 6) between the groups (RR 1.04, 95% CI 0.99 to 1.09; 1478 participants; moderate-certainty evidence). 24-month recall versus 6-month recall at 4 years' follow-up We found moderate-certainty evidence from one trial of adults that there is probably little to no difference between 24-month and 6-month recall intervals for the outcomes: number of tooth surfaces with any caries (MD -0.60, 95% CI -2.54 to 1.34; 271 participants); percentage of sites with gingival bleeding (MD -0.91%, 95% CI -5.02% to 3.20%; 271 participants). There may be little to no difference between the groups in the prevalence of moderate to extensive caries (RR 1.05, 95% CI 0.92 to 1.20; 271 participants; low-certainty evidence). We found high-certainty evidence that there is little to no difference in oral-health-related quality of life between the groups (MD in OHIP-14 scores -0.24, 95% CI -1.55 to 1.07; 305 participants). Risk-based recall versus 24-month recall at 4 years' follow-up We found moderate-certainty evidence from one trial of adults that there is probably little to no difference between risk-based and 24-month recall intervals for the outcomes: prevalence of moderate to extensive caries (RR 1.06, 95% CI 0.95 to 1.19; 279 participants); number of tooth surfaces with any caries (MD 1.40, 95% CI -0.69 to 3.49; 279 participants). We found high-certainty evidence that there is no important difference between the groups in the percentage of sites with gingival bleeding (MD -0.07%, 95% CI -4.10% to 3.96%; 279 participants); or in oral-health-related quality of life (MD in OHIP-14 scores -0.37, 95% CI -1.69 to 0.95; 298 participants). AUTHORS' CONCLUSIONS: For adults attending dental check-ups in primary care settings, there is little to no difference between risk-based and 6-month recall intervals in the number of tooth surfaces with any caries, gingival bleeding and oral-health-related quality of life over a 4-year period (high-certainty evidence). There is probably little to no difference between the recall strategies in the prevalence of moderate to extensive caries (moderate-certainty evidence). When comparing 24-month with either 6-month or risk-based recall intervals for adults, there is moderate- to high-certainty evidence that there is little to no difference in the number of tooth surfaces with any caries, gingival bleeding and oral-health-related quality of life over a 4-year period. The available evidence on recall intervals between dental check-ups for children and adolescents is uncertain. The two trials we included in the review did not assess adverse effects of different recall strategies.

Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT).

BACKGROUND: The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy. Existing trials of these augmentations are individually too small to be conclusive. We aimed to compare the outcomes of prolapse repair involving either synthetic mesh inlays or biological grafts against standard repair in women. METHODS: We did two pragmatic, parallel-group, multicentre, randomised controlled trials for our study (PROSPECT [PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials]) in 35 centres (a mix of secondary and tertiary referral hospitals) in the UK. We recruited women undergoing primary transvaginal anterior or posterior compartment prolapse surgery by 65 gynaecological surgeons in these centres. We randomly assigned participants by a remote web-based randomisation system to one of the two trials: comparing standard (native tissue) repair alone with standard repair augmented with either synthetic mesh (the mesh trial) or biological graft (the graft trial). We assigned women (1:1:1 or 1:1) within three strata: assigned to one of the three treatment options, comparison of standard repair with mesh, and comparison of standard repair with graft. Participants, ward staff, and outcome assessors were masked to randomisation where possible; masking was obviously not possible for the surgeon. Follow-up was for 2 years after the surgery; the primary outcomes, measured at 1 year and 2 years, were participant-reported prolapse symptoms (i.e. the Pelvic Organ Prolapse Symptom Score [POP-SS]) and condition-specific (ie, prolapse-related) quality-of-life scores, analysed in the modified intention-to-treat population. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN60695184. FINDINGS: Between Jan 8, 2010, and Aug 30, 2013, we randomly allocated 1352 women to treatment, of whom 1348 were included in the analysis. 865 women were included in the mesh trial (430 to standard repair alone, 435 to mesh augmentation) and 735 were included in the graft trial (367 to standard repair alone, 368 to graft augmentation). Because the analyses were carried out separately for each trial (mesh trial and graft trial) some women in the standard repair arm assigned to all treatment options were included in the standard repair group of both trials. 23 of these women did not receive any surgery (15 in the mesh trial, 13 in the graft trial; five were included in both trials) and were included in the baseline analyses only. Mean POP-SS at 1 year did not differ substantially between comparisons (standard 5·4 [SD 5·5] vs mesh 5·5 [5·1], mean difference 0·00, 95% CI -0·70 to 0·71; p=0·99; standard 5·5 [SD 5·6] vs graft 5·6 [5·6]; mean difference -0·15, -0·93 to 0·63; p=0·71). Mean prolapse-related quality-of-life scores also did not differ between groups at 1 year (standard 2·0 [SD 2·7] vs mesh 2·2 [2·7], mean difference 0·13, 95% CI -0·25 to 0·51; p=0·50; standard 2·2 [SD 2·8] vs graft 2·4 [2·9]; mean difference 0·13, -0·30 to 0·56; p=0·54). Mean POP-SS at 2 years were: standard 4·9 (SD 5·1) versus mesh 5·3 (5·1), mean difference 0·32, 95% CI -0·39 to 1·03; p=0·37; standard 4·9 (SD 5·1) versus graft 5·5 (5·7); mean difference 0·32, -0·48 to 1·12; p=0·43. Prolapse-related quality-of-life scores at 2 years were: standard 1·9 (SD 2·5) versus mesh 2·2 (2·6), mean difference 0·15, 95% CI -0·23 to 0·54; p=0·44; standard 2·0 (2·5) versus graft 2·2 (2·8); mean difference 0·10, -0·33 to 0·52; p=0·66. Serious adverse events such as infection, urinary retention, or dyspareunia or other pain, excluding mesh complications, occurred with similar frequency in the groups over 1 year (mesh trial: 31/430 [7%] with standard repair vs 34/435 [8%] with mesh, risk ratio [RR] 1·08, 95% CI 0·68 to 1·72; p=0·73; graft trial: 23/367 [6%] with standard repair vs 36/368 [10%] with graft, RR 1·57, 0·95 to 2·59; p=0·08). The cumulative number of women with a mesh complication over 2 years in women actually exposed to synthetic mesh was 51 (12%) of 434. INTERPRETATION: Augmentation of a vaginal repair with mesh or graft material did not improve women's outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short term, but more than one in ten women had a mesh complication. Therefore, follow-up is vital to identify any longer-term potential benefits and serious adverse effects of mesh or graft reinforcement in vaginal prolapse surgery. FUNDING: UK National Institute of Health Research.

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).

Stability of Willingness to Pay: Does Time and Treatment Allocation in a Randomized Controlled Trial Influence Willingness to Pay?

BACKGROUND: Willingness-to-pay (WTP) estimates are useful to policy makers only if they are generalizable beyond the moment when they are collected. To understand the "shelf life" of preference estimates, preference stability needs be tested over substantial periods of time. METHODS: We tested the stability of WTP for preventative dental care (scale and polish) using a payment-card contingent valuation question administered to 909 randomized controlled trial participants at 4 time points: baseline (prerandomization) and at annual intervals for 3 years. Trial participants were regular attenders at National Health Service dental practices. Participants were randomly offered different frequencies (intensities) of scale polish (no scale and polish, 1 scale and polish per year, 2 scale and polishes per year). We also examined whether treatment allocation to these different treatment intensities influenced the stability of WTP. Interval regression methods were used to test for changes in WTP over time while controlling for changes in 2 determinants of WTP. Individual-level changes were also examined as well as the WTP function over time. RESULTS: We found that at the aggregate level, mean WTP values were stable over time. The results were similar by trial arm. Individuals allocated to the arm with the highest scale and polish intensity (2 per year) had a slight increase in WTP toward the latter part of the trial. There was considerable variation at the individual level. The WTP function was stable over time. CONCLUSIONS: The payment-card contingent valuation method can produce stable WTP values in health over time. Future research should explore the generalizability of these results in other populations, for less familiar health care services, and using alternative elicitation methods. HIGHLIGHTS: Stated preferences are commonly used to value health care.Willingness-to-pay (WTP) estimates are useful only if they have a "shelf life."Little is known about the stability of WTP for health care.We test the stability of WTP for dental care over 3 y.Our results show that the contingent valuation method can produce stable WTP values.

UK general population's willingness to pay for dental check-ups.

OBJECTIVES: Choices about which dental treatments to provide in a publicly funded system should be guided by the value that the general population place on those treatments. The aim of this study was to estimate United Kingdom (UK) general population willingness to pay (WTP) for dental check-ups, and to investigate what factors influence WTP. METHODS: WTP was elicited using a hypothetical question in an online survey. The sample consisted of 594 participants, nationally representative of the UK general population in terms of age and gender. Regression analysis was used to examine what factors are associated with WTP. Analyses were conducted including and excluding protest answers. RESULTS: The mean WTP for a dental check-up is £31.32 for the full sample and £33.17 excluding protest answers. Respondents on higher incomes and those with higher university education had higher WTP. Respondents in Scotland were WTP less than respondents living in the rest of the UK which may be the result of NHS dental check-ups being free to patients in Scotland. CONCLUSION: The general UK population value dental check-ups. This study provides estimates of WTP for dental check-ups which can be used in Cost-Benefit Analyses.

Three-year cost utility analysis of mini versus standard slings: A trial based economic evaluation.

Objective: To report on the cost-effectiveness of adjustable anchored single-incision mini-slings (mini-slings) compared with tension-free standard mid-urethral slings (standard slings) in the surgical management of female stress urinary incontinence (SUI). Patients and Methods: Data on resource use and quality were collected from women aged ≥18 years with predominant SUI undergoing mid-urethral sling procedures in 21 UK hospitals. Resource use and quality of life (QoL) data were prospectively collected alongside the Single-Incision Mini-Slings versus standard synthetic mid-urethral slings Randomised Control Trial (SIMS RCT), for surgical treatment of SUI in women. A health service provider's (National Health Service [NHS]) perspective with 3-year follow-up was adopted to estimate the costs of the intervention and all subsequent resource use. A generic instrument, EuroQol EQ-5D-3L, was used to estimate the QoL. Results are reported as incremental costs, quality adjusted life years (QALYs) and incremental cost per QALY. Results: Base case analysis results show that although mini-slings cost less, there was no significant difference in costs: mini-slings versus standard slings: £-6 [95% CI -228-208] or in QALYs: 0.005 [95% CI -0.068-0.073] over the 3-year follow-up. There is substantial uncertainty, with a 56% and 44% probability that mini-slings and standard slings are the most cost-effective treatment, respectively, at a £20 000 willingness-to-pay threshold value for a QALY. Conclusions: At 3 years, there is no significant difference between mini-slings and standard slings in costs and QALYs. There is still some uncertainty over the long-term complications and failure rates of the devices used in the treatment of SUI; therefore, it is important to establish the long-term clinical and cost-effectiveness of these procedures.

Comparison of an adjustable anchored single-incision mini-sling, Ajust(®) , with a standard mid-urethral sling, TVT-O(TM) : a health economic evaluation.

OBJECTIVES: To assess the cost, quality of life (QoL) and cost-effectiveness of a single-incision mini-sling (SIMS; Ajust(®) , C. R. Bard Inc., New Providence, NJ, USA) compared with a standard mid-urethral sling (SMUS; TVT-O™, Ethicon Inc., Somerville, NJ, USA) in the surgical management of female stress urinary incontinence. PATIENTS AND METHODS: A total of 137 women, in a secondary care setting, were randomized between October 2009 and October 2011 to undergo SIMS placement (n = 69) under local anaesthesia as an opt-out policy or SMUS placement (n = 68) under general anaesthesia. Clinical outcome measures included the patient-reported success rate (Patient Global Impression of Improvement [PGI-I]) and the impact on the patients' QoL (King's Health Questionnaire [KHQ]). Health economic data (cost and quality-adjusted life year [QALY] data) were compared using linear regression models to generate an incremental cost per QALY estimate, in order to determine a measure of cost-effectiveness. Deterministic sensitivity analyses investigated uncertainty in the results, and non-parametric bootstrapping techniques were used to estimate a probability of cost-effectiveness. RESULTS: There were no significant differences between the groups in terms of the KHQ total score (P = 0.27) or the patient-reported success rate (P = 1.00, odds ratio: 0.895; 95% confidence interval [CI]: 0.344 to 2.330). There was no significant difference in QALYs for the SIMS group compared with the SMUS group (mean difference: -0.003; 95% CI: -0.008 to +0.002). The SIMS was on average less costly, -£142.41 95% CI: (-316.99 to 32.17) and generated cost savings of £48 419 per QALY loss with 94% probability of cost savings to the health services. Taking a wider perspective on the costing analysis by including the wider community benefit associated with the significantly earlier return to work observed in the SIMS group (P = 0.006, 95% CI: 11.756 to 17.217), there was an increase in cost savings to -£477, (95% CI: -823.65 to -129.63), with a probability of 100% of cost savings to the wider economy. CONCLUSIONS: The adjustable anchored SIMS (Ajust), performed under local anaesthesia as an opt-out policy, delivers cost savings to the health service provider when compared with the SMUS (TVT-O), and is likely to be cost-effective up to 1 year after placement. Further research should be undertaken to confirm the results of our study over longer follow-up and should explore patient preferences alongside an adequately powered non-inferiority randomized controlled trial.

IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care.

BACKGROUND: Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. METHODS/DESIGN: This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0-3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI.Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases.The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the gingival margin; oral hygiene self-efficacy and net benefits. DISCUSSION: IQuaD will provide evidence for the most clinically-effective and cost-effective approach to managing periodontal disease in dentate adults in Primary Care. This will support general dental practitioners and patients in treatment decision making. TRIAL REGISTRATION: Protocol ID: ISRCTN56465715.

Patient preferences for stress urinary incontinence treatments: a discrete choice experiment.

OBJECTIVES: To elicit and value patient preferences for the processes and outcomes of surgical management of stress urinary incontinence in women. DESIGN: A discrete choice experiment survey to elicit preferences for type of anaesthesia, postoperative recovery time, treatment success, adverse events, impact on daily activities and cost. An experimental design generated 40 choice tasks, and each respondent completed 1 block of 10 and 2 validity tests. Analysis was by multinomial logistical regression. SETTING: N=21 UK hospitals. PARTICIPANTS: N=325 adult women who were a subsample of those randomised to the single-incision mini-slings clinical trial. OUTCOMES: Patient preferences; valuation obtained using willingness to pay. RESULTS: N=227 of 325 (70%) returned a questionnaire, and 94% of those completed all choice tasks. Respondents preferred general anaesthesia, shorter recovery times, improved stress urinary incontinence symptoms and avoidance of adverse events. Women were willing to pay (mean (95% CI)) £76 (£33 to £119) per day of reduction in recovery time following surgery. They valued increases in Patient Global Impression of Improvement, ranging from £8173 (£5459 to £10 887) for 'improved' to £11 706 (£8267 to £15 144) for 'very much improved' symptoms, compared with no symptom improvement. This was offset by negative values attached to the avoidance of complications ranging between £-8022 (£-10 661 to £-5383) and £-10 632 (£-14 077 to £-7187) compared to no complications. Women valued treatments that reduced the need to avoid daily activities, with willingness to pay ranging from £-967 (£-2199 to £266) for rarely avoiding activities to £-5338 (£-7258 to £-3417) for frequently avoiding daily activities compared with no avoidance. CONCLUSION: This discrete choice experiment demonstrates that patients place considerable value on improvement in stress urinary incontinence symptoms and avoidance of treatment complications. Trade-offs between symptom improvement and adverse event risk should be considered within shared decision-making. The willingness to pay values from this study can be used in future cost-benefit analyses. TRIAL REGISTRATION NUMBER: ISRCTN: 93264234; Post-results.

A Systematic Review of the Evidence for Non-surgical Weight Management for Adults with Severe Obesity: What is Cost Effective and What are the Implications for the Design of Health Services?

PURPOSE OF REVIEW: Severe obesity (BMI ≥ 35 kg/m2) increases premature mortality and reduces quality-of-life. Obesity-related disease (ORD) places substantial burden on health systems. This review summarises the cost-effectiveness evidence for non-surgical weight management programmes (WMPs) for adults with severe obesity. RECENT FINDINGS: Whilst evidence shows bariatric surgery is often cost-effective, there is no clear consensus on the cost-effectiveness of non-surgical WMPs. Thirty-two studies were included. Most were short-term evaluations that did not capture the long-term costs and consequences of ORD. Decision models often included only a subset of relevant ORDs, and made varying assumptions about the rate of weight regain over time. A lack of sensitivity analyses limited interpretation of results. Heterogeneity in the definition of WMPs and usual care prevents formal evidence synthesis. We were unable to establish the most cost-effective WMPs. Addressing these limitations may help future studies provide more robust cost-effectiveness evidence for decision makers.

UK general population willingness to pay for scale and polish, and detailed and personalized oral hygiene advice.

OBJECTIVES: Understanding the value the general population place on dentistry services is important for policymakers to aide service planning. Willingness to pay (WTP) is an economic method used to elicit the value of a good or service. The aim of this study is to estimate United Kingdom (UK) general population WTP for commonly provided scale and polish, and detailed and personalized oral hygiene advice (OHA), and to investigate what factors influence WTP. METHODS: Participants completed an online hypothetical WTP survey for scale and polish and detailed and personalized oral hygiene advice. The estimation sample consisted of 1405 participants, nationally representative of the UK general population in terms of age and sex. Regression analysis was used to estimate WTP and determine what factors are associated with WTP. Analyses were conducted including and excluding protest answers. RESULTS: The mean (SD) WTP for a scale and polish is £26.77 (£21.91) excluding protest answers and £24.80 (£22.71) for the full sample. The mean (SD) WTP for detailed and personalized OHA is £16.56 (£19.75) excluding protest answers and £12.77 (£22.28) for the full sample. Participants on higher incomes, private attenders and those who stated that maintaining clean and healthy gums was important had higher WTP for both services. Participants in Scotland and Northern Ireland were WTP less than their English counterparts, reflecting the different regional specific payment systems. CONCLUSION: The general UK population value scale and polish, and detailed and personalized OHA. This study provides estimates of WTP for these services which can be used to inform resource allocation decisions.