Systematic review of the effectiveness and cost-effectiveness of Healozone for the treatment of occlusal pit/fissure caries and root caries.

Objectives: To assess the effectiveness and cost-effectiveness of HealOzone® (CurOzone USA Inc., Ontario, Canada) for the management of pit and fissure caries, and root caries. The complete HealOzone procedure involves the direct application of ozone gas to the caries lesion on the tooth surface, the use of a remineralising solution immediately after application of ozone and the supply of a ‘patient kit’, which consists of toothpaste, oral rinse and oral spray all containing fluoride. Data sources: Electronic databases up to May 2004 (except Conference Papers Index, which were searched up to May 2002). Review methods: A systematic review of the effectiveness of HealOzone for the management of tooth decay was carried out. A systematic review of existing economic evaluations of ozone for dental caries was also planned but no suitable studies were identified. The economic evaluation included in the industry submission was critically appraised and summarised. A Markov model was constructed to explore possible cost-effectiveness aspects of HealOzone in addition to current management of dental caries. Results: Five full-text reports and five studies published as abstracts met the inclusion criteria. The five full-text reports consisted of two randomised controlled trials (RCTs) assessing the use of HealOzone for the management of primary root caries and two doctoral theses of three unpublished randomised trials assessing the use of HealOzone for the management of occlusal caries. Of the abstracts, four assessed the effects of HealOzone for the management of occlusal caries and one the effects of HealOzone for the management of root caries. Overall, the quality of the studies was modest, with many important methodological aspects not reported (e.g. concealment of allocation, blinding procedures, compliance of patients with home treatment). In particular, there were some concerns about the choice of statistical analyses. In most of the full-text studies analyses were undertaken at lesion level, ignoring the clustering of lesions within patients. The nature of the methodological concerns was sufficient to raise doubts about the validity of the included studies’ findings. A quantitative synthesis of results was deemed inappropriate. On the whole, there is not enough evidence from published RCTs on which to judge the effectiveness of ozone for the management of both occlusal and root caries. The perspective adopted for the study was that of the NHS and Personal Social Services. The analysis, carried out over a 5-year period, indicated that treatment using current management plus HealOzone cost more than current management alone for non-cavitated pit and fissure caries (£40.49 versus £24.78), but cost less for non-cavitated root caries (£14.63 versus £21.45). Given the limitations of the calculations these figures should be regarded as illustrative, not definitive. It was not possible to measure health benefits in terms of quality-adjusted life-years, due to uncertainties around the evidence of clinical effectiveness, and to the fact that the adverse events avoided are transient (e.g. pain from injection of local anaesthetic, fear of the drill). One-way sensitivity analysis was applied to the model. However, owing to the limitations of the economic analysis, this should be regarded as merely speculative. For non-cavitated pit and fissure caries, the HealOzone option was always more expensive than current management when the probability of cure using the HealOzone option was 70% or lower. For non-cavitated root caries the costs of the HealOzone comparator were lower than those of current management only when cure rates from HealOzone were at least 80%. The costs of current management were higher than those of the HealOzone option when the cure rate for current management was 40% or lower. One-way sensitivity analysis was also performed using similar NHS Statement of Dental Remuneration codes to those that are used in the industry submission. This did not alter the results for non-cavitated pit fissure caries as the discounted net present value of current management remained lower than that of the HealOzone comparator (£22.65 versus £33.39). Conclusions: Any treatment that preserves teeth and avoids fillings is welcome. However, the current evidence base for HealOzone is insufficient to conclude that it is a cost-effective addition to the management and treatment of occlusal and root caries. To make a decision on whether HealOzone is a cost-effective alternative to current preventive methods for the management of dental caries, further research into its clinical effectiveness is required. Independent RCTs of the effectiveness and cost-effectiveness of HealOzone for the management of occlusal caries and root caries need to be properly conducted with adequate design, outcome measures and methods for statistical analyses

Conservative interventions for urinary or faecal incontinence, or both, in adults with multiple sclerosis

© 2018 The Cochrane Collaboration. This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of conservative interventions for urinary or faecal incontinence (or both) in adults with multiple sclerosis, compared to no treatment, sham and usual care, any other active treatment, or another conservative treatment. To critically appraise and summarise the current evidence on resource use, costs and cost effectiveness of conservative interventions for adults with urinary or faecal incontinence (or both) and MS. We will make the following comparisons. Conservative treatment versus no treatment Conservative treatment versus sham treatment Conservative treatment versus usual care Conservative treatment versus pharmacological treatment Conservative treatment versus surgical treatment Conservative treatment versus any other conservative treatmen

Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin) : study protocol for a randomized controlled trial

Peer reviewedPublisher PD

Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital : a multicentre randomised controlled trial

Copyright © 2012 Elsevier Ltd. All rights reserved. PMID: 23134837 [PubMed - indexed for MEDLINE]Peer reviewedPostprin

Systematic review of the effectiveness and cost-effectiveness of HealOzone® for the treatment of occlusal pit/fissure caries and root caries

Objectives: To assess the effectiveness and cost-effectiveness of HealOzone® (CurOzone USA Inc., Ontario, Canada) for the management of pit and fissure caries, and root caries. The complete HealOzone procedure involves the direct application of ozone gas to the caries lesion on the tooth surface, the use of a remineralising solution immediately after application of ozone and the supply of a ‘patient kit’, which consists of toothpaste, oral rinse and oral spray all containing fluoride. Data sources: Electronic databases up to May 2004 (except Conference Papers Index, which were searched up to May 2002). Review methods: A systematic review of the effectiveness of HealOzone for the management of tooth decay was carried out. A systematic review of existing economic evaluations of ozone for dental caries was also planned but no suitable studies were identified. The economic evaluation included in the industry submission was critically appraised and summarised. A Markov model was constructed to explore possible cost-effectiveness aspects of HealOzone in addition to current management of dental caries. Results: Five full-text reports and five studies published as abstracts met the inclusion criteria. The five full-text reports consisted of two randomised controlled trials (RCTs) assessing the use of HealOzone for the management of primary root caries and two doctoral theses of three unpublished randomised trials assessing the use of HealOzone for the management of occlusal caries. Of the abstracts, four assessed the effects of HealOzone for the management of occlusal caries and one the effects of HealOzone for the management of root caries. Overall, the quality of the studies was modest, with many important methodological aspects not reported (e.g. concealment of allocation, blinding procedures, compliance of patients with home treatment). In particular, there were some concerns about the choice of statistical analyses. In most of the full-text studies analyses were undertaken at lesion level, ignoring the clustering of lesions within patients. The nature of the methodological concerns was sufficient to raise doubts about the validity of the included studies’ findings. A quantitative synthesis of results was deemed inappropriate. On the whole, there is not enough evidence from published RCTs on which to judge the effectiveness of ozone for the management of both occlusal and root caries. The perspective adopted for the study was that of the NHS and Personal Social Services. The analysis, carried out over a 5-year period, indicated that treatment using current management plus HealOzone cost more than current management alone for non-cavitated pit and fissure caries (£40.49 versus £24.78), but cost less for non-cavitated root caries (£14.63 versus £21.45). Given the limitations of the calculations these figures should be regarded as illustrative, not definitive. It was not possible to measure health benefits in terms of quality-adjusted life-years, due to uncertainties around the evidence of clinical effectiveness, and to the fact that the adverse events avoided are transient (e.g. pain from injection of local anaesthetic, fear of the drill). One-way sensitivity analysis was applied to the model. However, owing to the limitations of the economic analysis, this should be regarded as merely speculative. For non-cavitated pit and fissure caries, the HealOzone option was always more expensive than current management when the probability of cure using the HealOzone option was 70% or lower. For non-cavitated root caries the costs of the HealOzone comparator were lower than those of current management only when cure rates from HealOzone were at least 80%. The costs of current management were higher than those of the HealOzone option when the cure rate for current management was 40% or lower. One-way sensitivity analysis was also performed using similar NHS Statement of Dental Remuneration codes to those that are used in the industry submission. This did not alter the results for non-cavitated pit fissure caries as the discounted net present value of current management remained lower than that of the HealOzone comparator (£22.65 versus £33.39). Conclusions: Any treatment that preserves teeth and avoids fillings is welcome. However, the current evidence base for HealOzone is insufficient to conclude that it is a cost-effective addition to the management and treatment of occlusal and root caries. To make a decision on whether HealOzone is a cost-effective alternative to current preventive methods for the management of dental caries, further research into its clinical effectiveness is required. Independent RCTs of the effectiveness and cost-effectiveness of HealOzone for the management of occlusal caries and root caries need to be properly conducted with adequate design, outcome measures and methods for statistical analyses

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

Funding Information: This work was funded by the National Institute of Health Research, Health Technology Assessment programme: project number HTA‐12/127/157. Funding information Dr. Dwayne Boyers reports grants from UK NIHR during the conduct of the study. Ms. Mary Kilonzo reports grants from UK NIHR during the conduct of the study. Kiron Bhal: I have been a speaker and trainer for the following companies in the past Astellas, Pfizer, AMS, Contura, Allergan and others, where I have received honorariums and sponsorship towards attending scientific conferences. Professor James N'Dow reports HTA General Committee 2016–2018. Professor Graeme MacLennan reports grants from UK NIHR during the conduct of the study. Professor John Norrie reports grants from the University of Edinburgh, outside the submitted work; and past and present member of the following: HTA Commissioning Sub‐Board (EOI), NIHR CTU Standing Advisory Committee, NIHR HTA & EME Editorial Board, Pre‐Exposure Prophylaxis Impact Review Panel, EME Strategy Advisory Committee, EME—Funding Committee Members, EME Funding Committee Sub‐Group Remit & Comp Check, HTA General Committee, HTA Funding Committee Policy Group (formerly CSG) and HTA Commissioning Committee. HTA post‐funding committee teleconference 2016–2019; COVID‐19 reviewing 2020. Professor Mohamed Abdel‐Fattah: None in the last 5 years. Before 2015, I have been a speaker, consultant and/or surgical trainer for a number of industrial companies (Astellas, Ethicon, Bard, Pfizer, AMS, Coloplast and others): I have been reimbursed my travel expenses; and on occasions received personal honorariums; proctorship fees and sponsorship towards attending scientific conferences. Research grant from Coloplast managed by the University of Aberdeen. A limited number of my trainees attended pharmaceutical‐sponsored educational/leadership workshops and/or received assistance in presenting their research work at scientific conferences. Was Chairman of the Scottish Pelvic Floor Network (SPFN), which at the time received financial sponsorship from various industrial companies (including all those mentioned above) and non‐profit organisations for its annual meetings and surgical workshops. The SPFN provided an educational grant funding the PI at the highest recruiting site to attend the International Continence Society annual scientific conference in Brazil in 2014. Ongoing: I receive travel sponsorship and occasionally speaker‘s fees from numerous national and international conferences and non‐profit organisations when invited as a guest speaker and/or expert surgeon. In 2019, and at request from NHS Grampian, I attended 2 educational meetings for setting up sacral nerve stimulation service partially funded by Medtronic. I am the Chief Investigator for four NIHR—HTA‐funded studies. I do not hold (and never held) any shares (or similar) in any of the industrial companies (medical or non‐medical). To the best of my knowledge, none of the above have influenced my research or clinical practice. Publisher Copyright: © 2023 The Authors. BJUI Compass published by John Wiley & Sons Ltd on behalf of BJU International Company.Peer reviewedPublisher PD

Systematic review of the effectiveness of preventing and treating Staphylococcus aureus carriage in reducing peritoneal catheter-related infections

Objectives: To determine the clinical effectiveness and cost-effectiveness of (1) alternative strategies for the prevention of Staphylococcus aureus carriage in patients on peritoneal dialysis (PD) and (2) alternative strategies for the eradication of S. aureus carriage in patients on PD. Data sources: Major electronic databases were searched up to December 2005 (MEDLINE Extra up to 6 January 2006). Review methods: Electronic searches were undertaken to identify published and unpublished reports of randomised controlled trials and systematic reviews evaluating the effectiveness of preventing and treating S. aureus carriage on peritoneal catheterrelated infections. The quality of the included studies was assessed and data synthesised. Where data were not sufficient for formal meta-analysis, a qualitative narrative review looking for consistency between studies was performed. Results: Twenty-two relevant trials were found. These fell into several groups: the first split is between prophylactic trials, aiming to prevent carriage, and trials which aimed to eradicate carriage in those who already had it; the second split is between antiseptics and antibiotics; and the third split is between those that included patients having the catheter inserted before dialysis started and people already on dialysis. Many of the trials were small or short-term. The quality was often not good by today’s standards. The body of evidence suggested a reduction in exit-site infections, but this did not seem to lead to a significant reduction in peritonitis, although to some extent this reflected insufficient power in the studies and a low incidence of peritonitis in them. The costs of interventions to prevent or treat S. aureus carriage are relatively modest. For example, the annual cost of antibiotic treatment of S. aureus carriage per identified carrier of S. aureus was estimated at £179 (£73 screening and £106 cost of antibiotic). However, without better data on the effectiveness of the interventions, it is not clear whether such costs are offset by the cost of treating infections and averting changes from peritoneal dialysis to haemodialysis. Although treatment is not expensive, the lack of convincing evidence of clinical effectiveness made cost-effectiveness analysis unrewarding at present. However, consideration was given to the factors needed in a hypothetical model describing patient pathways from methods to prevent S. aureus carriage, its detection and treatment and the detection and treatment of the consequences of S. aureus (e.g. catheter infections and peritonitis). Had data been available, the model would have compared the costeffectiveness of alternative interventions from the perspective of the UK NHS, but as such it helped identify what future research would be needed to fill the gaps. Conclusions: The importance of peritonitis isnot in doubt. It is the main cause of people having to switch from peritoneal dialysis to haemodialysis, which then leads to reduced quality of life for patients and increased costs to the NHS. Unfortunately, the present evidence base for the prevention of peritonitis is disappointing; it suggests that the interventions reduce exit-site infections, but not peritonitis, although this may be due to trials being in too small numbers for too short periods. Trials are needed with larger numbers of patients for longer durations.No peer reviewPublisher PD

A cost-utility analysis of multivitamin and multimineral supplements in men and women aged 65 years and over

Background and Aims As people age there is a progressive dysregulation of the immune system that may lead to an increased risk of infections, which may precipitate hospital admission in people with chronic heart or respiratory diseases. Mineral and vitamin supplementation in older people could therefore influence infections in older people. However, the evidence from the available randomised controlled trials is mixed. The aim of the study was to assess the relative efficiency of multivitamin and multimineral supplementation compared with no supplementation. Methods Cost-utility analysis alongside a randomised controlled trial. Participants aged 65 years or over from six general practices in Grampian, Scotland were studied. They were randomised to one tablet daily of either a multivitamin and multimineral supplement or matching placebo. Exclusion criteria were: use of mineral, vitamin or fish oil supplements in the previous three months (one month for water soluble vitamins), vitamin B12 injection in the last three months. Results Nine hundred and ten participants were recruited (454 placebo and 456 supplementation). Use of health service resources and costs were similar between the two groups. The supplementation arm was more costly although this was not statistically significant (£15 per person, 95% CI -3.75 to 34.95). After adjusting for minimisation and baseline EQ-5D scores supplementation was associated with fewer QALYs per person (–0.018, 95% CI -0.04 to 0.002). It was highly unlikely that supplementation would be considered cost-effective. Conclusions The evidence from this study suggests that it is highly unlikely that supplementation could be considered cost-effective.Peer reviewedAuthor versio

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

Funding: The study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project number: 12/127/157). The full project report is available from the funder’s website: https://www.journalslibrary.nihr.ac.uk/hta/BTSA6148%23/abstract. The full citation for the funder report is: Abdel-Fattah M, Cooper D, Davidson T, Kilonzo M, Boyers D, Bhal K, et al. Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT. Health Technol Assess 2022;26(47). The Health Economics Research Unit and Health Services Research Unit are both funded by the Chief Scientist’s Office (CSO) of the Scottish government health directorates. The SIMS trial was registered as: ISRCTN93264234.Peer reviewedPublisher PD

Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial

This is the final version. Available on open access from BMJ Publishing Group via the DOI in this recordIntroduction Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. Methods and analysis This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. Ethics and dissemination Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review. Trial registration number ISRCTN57746448; Pre-results.National Institute for Health Research (NIHR