Exhaled nitric oxide measurements: Correction equation to compare hand-held device to stationary analyzer

Pizzimenti, Stefano; Bugiani, Massimiliano; Piccioni, Pavilio; Heffler, Enrico; Carosso, Aurelia; Guida, Giuseppe; Rolla, Giovanni

doi:10.1016/j.rmed.2008.04.006

Cited by 40 publications

(40 citation statements)

References 22 publications

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“…[44][45][46] When considering the mean values recorded in each study, differences between studies ranged from 0.3 to 9 ppb. NIOX MINO was found to give largely similar results to the Niox chemiluminescent device in five studies 39,41,43,45,46 but gave higher FeNO readings in two other studies.…”

Section: Niox Mino Compared With the Niox Chemiluminescent Device In mentioning

confidence: 99%

“…42,44 l Correlation coefficients ranged from 0.73 to 0.998. l Bland-Altman analyses were not reported in a consistent way, with some studies using proportions, some using absolute values and some using log values. It is not clear whether log transformation is appropriate as results varied across studies and were apparently conflicting on this point.…”

Section: Niox Mino Compared With the Niox Chemiluminescent Device In mentioning

confidence: 99%

“…One study 39 demonstrated that the AUC and cut-off points derived to diagnose asthma using the Niox chemiluminescent device or NIOX MINO were very similar (this study used a case-control design and so data were not includable in the diagnostic review), supporting the conclusion that the Niox chemiluminescent device and NIOX MINO are roughly interchangeable. However, another study 44 reported a correction factor that should be used to convert NIOX MINO values to Niox values. Three 50,51,54,65 of the remaining four studies demonstrate how cut-off points derived using measurements from different devices can be very different, with 7 ppb, 9 ppb and 10 ppb differences.…”

Section: Nobreath Compared With Chemiluminescent Devices In Adults Anmentioning

confidence: 99%

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Measurement of exhaled nitric oxide concentration in asthma: a systematic review and economic evaluation of NIOX MINO, NIOX VERO and NObreath

Harnan

Tappenden

Essat

et al. 2015

Health Technol Assess

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BackgroundHigh fractions of exhaled nitric oxide (FeNO) in the breath of patients with symptoms of asthma are correlated with high levels of eosinophils and indicate that a patient is likely to respond to inhaled corticosteroids. This may have a role in the diagnosis and management of asthma.ObjectiveTo assess the diagnostic accuracy, clinical effectiveness and cost-effectiveness of the hand-held electrochemical devices NIOX MINO®(Aerocrine, Solna, Sweden), NIOX VERO®(Aerocrine) and NObreath®(Bedfont Scientific, Maidstone, UK) for the diagnosis and management of asthma.Data sourcesSystematic searches were carried out between March 2013 and April 2013 from database inception. Databases searched included MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, Science Citation Index Expanded and Conference Proceedings Citation Index – Science. Trial registers such as ClinicalTrials.gov and themetaRegister of Controlled Trials were also searched in March 2013. All searches were updated in September 2013.Review methodsA rapid review was conducted to assess the equivalence of hand-held and chemiluminescent FeNO monitors. Systematic reviews of diagnostic accuracy and management efficacy were conducted. A systematic review of economic analyses was also conducted and two de novo health economic models were developed. All three reviews were undertaken according to robust high-quality methodology.ResultsThe rapid review (27 studies) found varying levels of agreement between monitors (Bland–Altman 95% limits of agreement up to ±10 parts per billion), with better agreement at lower FeNO values. Correlation was good (generallyr > 0.9). The diagnostic accuracy review identified 22 studies in adults (all ages) and four in children. No studies used NObreath or NIOX VERO and seven used NIOX MINO. Estimates of diagnostic accuracy varied widely. FeNO used in combination with another test altered diagnostic accuracy only slightly. High levels of heterogeneity precluded meta-analysis. Limited observations included that FeNO may be more reliable and useful as a rule-in than as a rule-out test; lower cut-off values in children and in smokers may be appropriate; and FeNO may be less reliable in the elderly. The management review identified five randomised controlled trials in adults, one in pregnant asthmatics and seven in children. Despite clinical heterogeneity, exacerbation rates were lower in all studies but not generally statistically significantly so. Effects on inhaled corticosteroid (ICS) use were inconsistent, possibly because of differences in management protocols, differential effectiveness in adults and children and differences in population severity. One UK diagnostic model and one management model were identified. Aerocrine also submitted diagnostic and management models. All had significant limitations including short time horizons and the selective use of efficacy evidence. The de novo diagnostic model suggested that the expected difference in quality-adjusted life-year (QALY) gains between diagnostic options is likely to be very small. Airway hyper-responsiveness by methacholine challenge test is expected to produce the greatest QALY gain but with an expected incremental cost-effectiveness ratio (ICER) compared with FeNO (NObreath) in combination with bronchodilator reversibility of £1.125M per QALY gained. All remaining options are expected to be dominated. The de novo management model indicates that the ICER of guidelines plus FeNO monitoring using NObreath compared with guidelines alone in children is expected to be approximately £45,200 per QALY gained. Within the adult subgroup, FeNO monitoring using NObreath compared with guidelines alone is expected to have an ICER of approximately £2100 per QALY gained. The results are particularly sensitive to assumptions regarding changes in ICS use over time, the number of nurse visits for FeNO monitoring and duration of effect.ConclusionsLimitations of the evidence base impose considerable uncertainty on all analyses. Equivalence of devices was assumed but not assured. Evidence for diagnosis is difficult to interpret in the context of inserting FeNO monitoring into a diagnostic pathway. Evidence for management is also inconclusive, but largely consistent with FeNO monitoring resulting in fewer exacerbations, with a small or zero reduction in ICS use in adults and a possible increased ICS use in children or patients with more severe asthma. It is unclear which specific management protocol is likely to be most effective. The economic analysis indicates that FeNO monitoring could have value in diagnostic and management settings. The diagnostic model indicates that FeNO monitoring plus bronchodilator reversibility dominates many other diagnostic tests. FeNO-guided management has the potential to be cost-effective, although this is largely dependent on the duration of effect. The conclusions drawn from both models require strong technical value judgements with respect to several aspects of the decision problem in which little or no empirical evidence exists. There are many potential directions for further work, including investigations into which management protocol is best and long-term follow-up in both diagnosis and management studies.Study registrationThis study is registered as PROSPERO CRD42013004149.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Niox Mino Compared With the Niox Chemiluminescent Device In mentioning

confidence: 99%

Section: Niox Mino Compared With the Niox Chemiluminescent Device In mentioning

confidence: 99%

Section: Nobreath Compared With Chemiluminescent Devices In Adults Anmentioning

confidence: 99%

See 1 more Smart Citation

Measurement of exhaled nitric oxide concentration in asthma: a systematic review and economic evaluation of NIOX MINO, NIOX VERO and NObreath

Harnan

Tappenden

Essat

et al. 2015

Health Technol Assess

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“…In this respect, the recently introduced hand-held and relatively inexpensive NO electrochemical analyzer (MINO®) seems an asset, promoting widespread use of eNO in both clinical and research settings [139]. Exhaled NO values measured with the MINO® were found to be reproducible and in agreement with the stationary units [139][140][141]. Conclusively, most technical issues surrounding eNO measurements appear to be resolved or manageable and the remaining question is the clinical relevance (and disease specificity) of this biomarker [142].…”

Section: Recommendationsmentioning

confidence: 99%

Biomarkers in asthma and allergic rhinitis

Diamant

Boot

Mantzouranis

et al. 2010

Pulmonary Pharmacology & Therapeutics

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“…The reliability of these portable devices has only been assessed in a handful of small studies and data from exhaled NO studies suggest readings differ between handheld and stationary devices [18]. We undertook a systematic literature review to assess the diagnostic accuracy of nNO measurement, highlighting the different analysers and respiratory manoeuvres currently used.…”

Section: Introductionmentioning

confidence: 99%

Nasal nitric oxide screening for primary ciliary dyskinesia: systematic review and meta-analysis

et al. 2014

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Nasal nitric oxide (nNO) concentrations are low in patients with primary ciliary dyskinesia (PCD) providing a noninvasive screening test.We conducted a systematic review of the literature to examine the utility of nNO in screening for PCD, in particular 1) different respiratory manoeuvres during sampling (velum closure, tidal breathing, etc.), 2) accuracy in screening young/uncooperative children, 3) stationary versus portable analysers, and 4) nNO in ''atypical'' PCD.96 papers were assessed according to modified PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria and 22 were included in this review.Meta-analysis of 11 studies comparing nNO during a velum closure breath hold gave a mean¡SD nNO of 19.4¡18.6 nL?min -1 in PCD (n5478) and 265.0¡118.9 nL?min -1 in healthy controls (n5338). Weighted mean difference for PCD versus healthy controls was 231.1 nL?min -1 (95% CI 193.3-268.9; n5338) and 114.1 nL?min -1 (95% CI 101.5-126.8; n5415) for PCD versus cystic fibrosis. Five studies of nNO measurement during tidal breathing demonstrated that this is an acceptable manoeuvre in young children where velum closure is not possible, but the discriminatory value was reduced. Four small studies of portable NO analysers suggest these are reliable tools for screening for PCD. However, nNO must be interpreted alongside clinical suspicion. Future studies should focus on standardising sampling techniques and reporting. @ERSpublications Nasal nitric oxide is a useful and increasingly versatile screening tool in primary ciliary dyskinesia at all ages http://ow.ly/AR5mqThis article has supplementary material available from erj.ersjournals.com

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Exhaled nitric oxide measurements: Correction equation to compare hand-held device to stationary analyzer

Cited by 40 publications

References 22 publications

Measurement of exhaled nitric oxide concentration in asthma: a systematic review and economic evaluation of NIOX MINO, NIOX VERO and NObreath

Measurement of exhaled nitric oxide concentration in asthma: a systematic review and economic evaluation of NIOX MINO, NIOX VERO and NObreath

Biomarkers in asthma and allergic rhinitis

Nasal nitric oxide screening for primary ciliary dyskinesia: systematic review and meta-analysis

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