Hashimoto 2011.
| Methods | Randomised, parallel, multicentred trial comparing 2 oral corticosteroid tapering strategies. The 2 strategies were: internet‐based monitoring system (internet strategy) or conventional treatment based on GINA guidelines (conventional strategy) | |
| Participants | 150 people were assessed for eligibility, 95 participants were randomised. 89 participants were included in the ITT analysis. Internet strategy N = 51, mean age 48.5 (SD 12.5), 23 male, 28 female. Conventional strategy N = 38, mean age 52.4 (SD 11.7), 18 male, 20 female. All participants were outpatients from 2 tertiary academic hospitals or 4 large community hospitals in the Netherlands. Inclusion criteria: Aged 18 to 75 years, diagnosis of severe refractory asthma as per ATS minor and major criteria. Their asthma needed to be uncontrolled and being assessed by a respiratory physician for at least 1 year, currently on oral corticosteroids, high doses of ICS and long‐acting bronchodilators. Exclusion criteria: Smokers or non‐smokers with history of > 15 pack‐years. No internet or mobile telephone |
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| Interventions | Monthly visits for 6 months with usual respiratory physician. Daily, participants registered their dose of oral corticosteroids, lung function, and FeNO before taking their medications. Weekly, they completed the ACT. AQLQ completed at baseline and 3 monthly after this. Participants also registered every asthma event such as hospital visit, deterioration in symptoms, and antibiotic use. Internet strategy: Had steroid dose adjusted based on the 3 components: electronic diary, in‐built algorithm (which includes FeNO levels), and monitoring support, e.g. coaching by study nurse and monitoring data, which was entered. Conventional strategy: Their oral steroids down‐titrated by the respiratory physician at their monthly visit. The physicians treated the participants based on GINA guidelines for patients with severe asthma |
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| Outcomes | Primary outcomes: Cumulative sparing of oral corticosteroids (actual cumulative dose minus the expected cumulative dose), ACT, and AQLQ. Secondary outcomes: Global satisfaction scale, FEV1, number of exacerbations, and days of hospitalisation |
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| Notes | No information provided on how successful the daily monitoring was and how compliant participants were with daily tasks. Funding: This study was funded by the Netherlands Organisation for Health Research and Development (ZonMw). Equipment for the analysis of nitric oxide was provided by Aerocrine AB. The funding sources had no role in the study design, data collection, analysis or interpretation, or in the decision to submit this article for publication |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated |
| Allocation concealment (selection bias) | Unclear risk | 'Unblinded after randomisation'; implies it was concealed, but no details |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Non blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Non blinded therefore high risk of detection bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcome data reported |
| Selective reporting (reporting bias) | Low risk | All data reported |
| Other bias | Unclear risk | Nil information provided in the published article regarding success in obtaining FeNO on each visit |