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trials (RCTs) assessing the use of HealOzone for the management of primary root caries and two doctoral theses of three unpublished randomised trials assessing the use of HealOzone for the management of occlusal caries.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

Resonancia magnética versus tomografía computada para la detección de lesiones vasculares agudas en pacientes que consultan por síntomas de accidente cerebrovascular

ResumenAntecedentesLa resonancia magnética (RM) se utiliza cada vez con mayor frecuencia para el diagnóstico del accidente cerebrovascular isquémico agudo aunque ha sido debatida su sensibilidad para la detección precoz de la hemorragia intracerebral. La tomografía computada (TC) se usa ampliamente en el tratamiento clínico del accidente cerebrovascular agudo, especialmente para la exclusión rápida de la hemorragia intracerebral.ObjetivosComparar la precisión diagnóstica de la RM de difusión (RMD) y la CT para el accidente cerebrovascular isquémico agudo, y estimar la precisión diagnóstica de la RMD para el accidente cerebrovascular hemorrágico agudo.Estrategia de búsquedaSe efectuaron búsquedas en MEDLINE y EMBASE (enero de 1995 hasta marzo de 2009) y se examinó la bibliografía de los estudios pertinentes en busca de otras referencias.Criterios de selecciónSe seleccionaron los estudios que compararon RMD y TC en los mismos pacientes para la detección del accidente cerebrovascular isquémico o examinaron la utilidad de la RM para la detección del accidente cerebrovascular hemorrágico, que realizaron la imaginología dentro de las 12 horas de la aparición de los síntomas de accidente cerebrovascular y presentaron datos suficientes como para construir tablas de contingencia.Obtención y análisis de los datosTres autores de forma independiente extrajeron los datos de las características del estudio y las medidas de precisión. Los datos sobre el accidente cerebrovascular isquémico se evaluaron mediante metanálisis de efectos aleatorios y de efectos fijos.Resultados principalesOcho estudios, con un total de 308 participantes, cumplieron los criterios de inclusión. Siete estudios contribuyeron a la evaluación del accidente cerebrovascular isquémico y dos estudios a la evaluación del accidente cerebrovascular hemorrágico. El espectro de pacientes fue relativamente limitado en todos los estudios, los tamaños de las muestras fueron pequeños, hubo un significativo sesgo de incorporación y los procedimientos de cegamiento fueron a menudo incompletos. Entre los pacientes en quienes posteriormente se confirmó el diagnóstico de accidente cerebrovascular isquémico agudo (161/226), las estimaciones de resumen para la RMD fueron: sensibilidad 0,99 (IC del 95%: 0,23 a 1,00), especificidad 0,92 (IC del 95%: 0,83 a 0,97). Las estimaciones de resumen para la TC fueron: sensibilidad 0,39 (IC del 95%: 0,16 a 0,69), especificidad 1,00 (IC del 95%: 0,94 a 1,00).Los dos estudios sobre accidente cerebrovascular hemorrágico informaron estimaciones altas para las secuencias de difusión y ecogradiente pero tenían estándares de referencia inconsistentes. No se calcularon las estimaciones generales para estos dos estudios. No fue posible evaluar la practicidad o los temas relativos a la relación entre costo y efectividad.Conclusiones de los autoresLa RMD parece ser más sensible que la TC para la detección precoz del accidente cerebrovascular isquémico en pacientes sumamente seleccionados. Sin embargo, la variabilidad en la calidad de los estudios incluidos y la presencia de los sesgos de espectro e incorporación tornan dudosa la confiabilidad y la posibilidad de generalizar los resultados observados. Se requieren estudios adicionales bien diseñados, sin sesgos metodológicos, con muestras de pacientes más representativas y estimaciones de la practicidad y los costos, a fin de determinar qué pacientes deben ser sometidos a RM y qué pacientes a TC en el caso de presunto accidente cerebrovascular agudo

Diffusion-weighted imaging and diagnosis of transient ischaemic attack

Peer reviewedPublisher PD

Laparoscopic cholecystectomy versus conservative management for adults with uncomplicated symptomatic gallstones : the C-GALL RCT

Acknowledgements The authors wish to thank the men and women who participated in C-GALL. We also thank the CHaRT data coordinators and trials managers who helped support the study: Zoe Batham, Louise Campbell, Janice Cruden, Dianne Dejean, Jackie Ellington, Andrea Fraser and Bev Smith (data coordinators), Tracey Davidson and Alison McDonald (Trial managers). We are grateful to Kirsty McCormack and John Norrie for their help and advice in developing the grant proposal, to the Programming Team in CHaRT for developing and maintaining the study website. We thank Juliette Snow and Rachael West for their help with contracting, and Louise Cotterell, Kerry Duffus and Anne Buckle for their assistance in managing the budget. Our thanks go also to the Research Governance team (Louise King, Stacey Dawson, Lynn McKay) at the University of Aberdeen for their advice and support during the study. Thanks to Jamie McAllister (NHS Grampian) for providing unit cost data for the within trial economic analysis. Thanks to the Chen et al. for allowing the C-GALL group the use of the Otago ConditionSpecific Questionnaire (OCSQ) for gallstone disease, developed by Chen et al. in the University of Otago, New Zealand.1,2 1. Chen TY, Landmann MG, Potter JC, van Rij AM. Questionnaire to aid priority and outcomes assessment in gallstone disease. ANZ J Surg. 2006;76(7):569-74. 2. Chen TY. A novel set of condition-specific quality of life questionnaires in elective general surgical patient prioritization and outcome assessment [dissertation]. Dunedin (NZ): University of Otago; 2012. Retrieved from http://hdl.handle.net/10523/2588 Members of the PMG for their ongoing support and advice. The independent members of the TSC and DMC, and the staff at the recruiting sites (listed below) who facilitated recruitment, treatment and follow up of trial participants. Trial funding This project was funded by the National Institute for Health Research (NIHR) XXX programme and will be published in full in HTA journal; Vol. XX, No. XXPeer reviewe

A systematic review of clinical trials of pharmacological interventions for acute ischaemic stroke (1955-2008) that were completed, but not published in full

<p>Abstract</p> <p>Background</p> <p>We assessed the prevalence, and potential impact of, trials of pharmacological agents for acute stroke that were completed but not published in full. Failure to publish trial data is to be deprecated as it sets aside the altruism of participants' consent to be exposed to the risks of experimental interventions, potentially biases the assessment of the effects of therapies, and may lead to premature discontinuation of research into promising treatments.</p> <p>Methods</p> <p>We searched the Cochrane Stroke Group's Specialised Register of Trials in June 2008 for completed trials of pharmacological interventions for acute ischaemic stroke, and searched MEDLINE and EMBASE (January 2007 - March 2009) for references to recent full publications. We assessed trial completion status from trial reports, online trials registers and correspondence with experts.</p> <p>Results</p> <p>We identified 940 trials. Of these, 125 (19.6%, 95% confidence interval 16.5-22.6) were completed but not published in full by the point prevalence date. They included 16,058 participants (16 trials had over 300 participants each) and tested 89 different interventions. Twenty-two trials with a total of 4,251 participants reported the number of deaths. In these trials, 636/4251 (15.0%) died.</p> <p>Conclusions</p> <p>Our data suggest that, at the point prevalence date, a substantial body of evidence that was of relevance both to clinical practice in acute stroke and future research in the field was not published in full. Over 16,000 patients had given informed consent and were exposed to the risks of therapy. Responsibility for non-publication lies with investigators, but pharmaceutical companies, research ethics committees, journals and governments can all encourage the timely publication of trial data.</p

QUADAS-C: A Tool for Assessing Risk of Bias in Comparative Diagnostic Accuracy Studies.

Comparative diagnostic test accuracy studies assess and compare the accuracy of 2 or more tests in the same study. Although these studies have the potential to yield reliable evidence regarding comparative accuracy, shortcomings in the design, conduct, and analysis may bias their results. The currently recommended quality assessment tool for diagnostic test accuracy studies, QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2), is not designed for the assessment of test comparisons. The QUADAS-C (Quality Assessment of Diagnostic Accuracy Studies-Comparative) tool was developed as an extension of QUADAS-2 to assess the risk of bias in comparative diagnostic test accuracy studies. Through a 4-round Delphi study involving 24 international experts in test evaluation and a face-to-face consensus meeting, an initial version of the tool was developed that was revised and finalized following a pilot study among potential users. The QUADAS-C tool retains the same 4-domain structure of QUADAS-2 (Patient Selection, Index Test, Reference Standard, and Flow and Timing) and comprises additional questions to each QUADAS-2 domain. A risk-of-bias judgment for comparative accuracy requires a risk-of-bias judgment for the accuracy of each test (resulting from QUADAS-2) and additional criteria specific to test comparisons. Examples of such additional criteria include whether participants either received all index tests or were randomly assigned to index tests, and whether index tests were interpreted with blinding to the results of other index tests. The QUADAS-C tool will be useful for systematic reviews of diagnostic test accuracy addressing comparative questions. Furthermore, researchers may use this tool to identify and avoid risk of bias when designing a comparative diagnostic test accuracy study