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The Consolidated Standards of Reporting Trials (CONSORT) Statement applied to allergen-specific immunotherapy with inhalant allergens: A Global Allergy and Asthma European Network (GA2LEN) article

Randomized trials provide evidence to inform treatment decisions. The Consolidated Standards of Reporting Trials (CONSORT) Statement is a set of recommendations for the reporting of trials.

Objective: We sought to assess the quality of reporting allergen-specific immunotherapy trials according to CONSORT criteria.

Methods: The reporting of the procedure, randomization, dropouts, strict conduct of intention-to-treat (ITT) analysis, and sample size calculation according to CONSORT were assessed in the 46 subcutaneous and 48 sublingual immunotherapy (SLIT) blind, placebo-controlled randomized trials published between 1996 and 2009 in English.

Results: One subcutaneous immunotherapy (2.2%) and 3 SLIT (6.6%) trials met CONSORT Statement criteria. These were used for the registration of sublingual tablets to the European Medicines Agency. In subcutaneous immunotherapy, 16 (35%) studies reported a CONSORT flow chart, and 12 (26%) provided a description of dropouts. Adequate randomization was reported in 9 (35%) studies, and incomplete randomization was reported in 15 (33%). Power analysis was reported in 15 (33%) studies. In SLIT, 20 (42%) studies reported a CONSORT flow chart, and 16 (32%) a description of dropouts. ITT analysis was carried out in 1 (2.2%) SLIT study, and a modified ITT analysis was used in 1 (2.2%) subcutaneous immunotherapy study and 2 (4.4%) SLIT studies. Adequate randomization was reported in 6 (12%) studies, and incomplete randomization was reported in 16 (32%). Power analysis was reported in 15 (27%) studies.

Conclusion: As in other areas of medicine, the quality of reporting of most immunotherapy trials is low, and only 4.2% of SLIT randomized controlled trials met all of the criteria of the CONSORT Statement. Use of the CONSORT criteria should be encouraged.

Cost-effectiveness analysis of fluticasone versus montelukast in children with mild-to-moderate persistent asthma in the Pediatric Asthma Controller Trial

Cost-effectiveness analyses of asthma controller regimens for adults exist, but similar evaluations exclusively for children are few.

Objective: We sought to compare the cost-effectiveness of 2 commonly used asthma controllers, fluticasone and montelukast, with data from the Pediatric Asthma Controller Trial.

Methods: We compared the cost-effectiveness of low-dose fluticasone with that of montelukast in a randomized, controlled, multicenter clinical trial in children with mild-to-moderate persistent asthma. Analyses were also conducted on subgroups based on phenotypic factors. Effectiveness measures included (1) the number of asthma-control days, (2) the percentage of participants with an increase over baseline of FEV1 of 12% or greater, and (3) the number of exacerbations avoided. Costs were analyzed from both a US health care payer’s perspective and a societal perspective.

Results: For all cost-effectiveness measures studied, fluticasone cost less and was more effective than montelukast. For example, fluticasone treatment cost $430 less in mean direct cost (P < .01) and resulted in 40 more asthma-control days (P < .01) during the 48-week study period. Considering sampling uncertainty, fluticasone cost less and was more effective at least 95% of the time. For the high exhaled nitric oxide (eNO) phenotypic subgroup (eNO ≥25 ppb) and more responsive PC20 subgroup (PC20 <2 mg/mL), fluticasone was cost-effective compared with montelukast for all cost-effectiveness measures, whereas not all the effectiveness measures were statistically different for the other 2 phenotypic subgroups.

Conclusion: For children with mild-to-moderate persistent asthma, low-dose fluticasone had lower cost and higher effectiveness compared with montelukast, especially in those with more airway inflammation, as indicated by increased levels of eNO and more responsivity to methacholine.

Worldwide burden of disease from exposure to second-hand smoke: a retrospective analysis of data from 192 countries.

Exposure to second-hand smoke is common in many countries but the magnitude of the problem worldwide is poorly described. We aimed to estimate the worldwide exposure to second-hand smoke and its burden of disease in children and adult non-smokers in 2004.

Prospective validation of 'Allergy-Control-SCORE(TM) ': a novel symptom-medication score for clinical trials.

Combined symptom and medication scores (SMS) are recommended as primary endpoints in clinical trials. Several SMS have been created, but none has been formally validated.

Objective:  To evaluate the validity of the 'Allergy-Control-SCORE(©) (ACS)', a novel instrument to assess patient's allergy severity by recording symptoms and rescue medication.

Methods:  One hundred and twenty-one consenting subjects (age 18-65 year), including 81 patients with allergic rhino-conjunctivitis and/or asthma and 40 healthy controls, participated in the study. They recorded daily nasal, eye, and lung symptoms using a 4-point scale (none, mild, moderate, and severe) and use of anti-symptomatic medication. Pollen counts were monitored during the study period. Symptom and medication scores values were compared to global allergy severity, quality of life, and allergy-related medical consultations. Feasibility was tested through a questionnaire on comprehensibility, easiness of use, and completeness. Retest reliability was assessed by testing consistency, in relation to pollen exposure, and for values recorded during each of 2 consecutive weeks.

Results:  Convergent reliability analysis indicated a highly significant correlation between ACS(©) and global allergy severity (P < 0.0001), quality of life (P < 0.0001), and allergy-related medical consultations (P < 0.0001). Scores were highly related to pollen counts. Allergy-Control-SCORE(©) showed a good retest reliability (r = 0.81; P < 0.0001) and discriminated extremely well between patients with allergy and healthy controls (6.1 ± 4.8 vs 0.2 ± 0.5; t = 10.82; P < 0.0001) with a sensitivity of 97% and a specificity of 87%. Study participants evaluated the feasibility of the SMS as excellent.

Conclusions:  Allergy-Control-SCORE(©) is a valid and reliable instrument to assess allergy severity in clinical trials and observational studies of respiratory allergic diseases.

MeDALL (Mechanisms of the Development of ALLergy): an integrated approach from phenotypes to systems medicine.

The origin of the epidemic of IgE-associated (allergic) diseases is unclear. MeDALL (Mechanisms of the Development of ALLergy), an FP7 European Union project (No. 264357), aims to generate novel knowledge on the mechanisms of initiation of allergy and to propose early diagnosis, prevention, and targets for therapy. A novel phenotype definition and an integrative translational approach are needed to understand how a network of molecular and environmental factors can lead to complex allergic diseases. A novel, stepwise, large-scale, and integrative approach will be led by a network of complementary experts in allergy, epidemiology, allergen biochemistry, immunology, molecular biology, epigenetics, functional genomics, bioinformatics, computational and systems biology.

The following steps are proposed:

  1. Identification of 'classical' and 'novel' phenotypes in existing birth cohorts;
  2. Building discovery of the relevant mechanisms in IgE-associated allergic diseases in existing longitudinal birth cohorts and Karelian children;
  3. Validation and redefinition of classical and novel phenotypes of IgE-associated allergic diseases;
  4. and translational integration of systems biology outcomes into health care, including societal aspects.

MeDALL will lead to:

  • A better understanding of allergic phenotypes, thus expanding current knowledge of the genomic and environmental determinants of allergic diseases in an integrative way;
  • Novel diagnostic tools for the early diagnosis of allergy, targets for the development of novel treatment modalities, and prevention of allergic diseases;
  • Improving the health of European citizens as well as increasing the competitiveness and boosting the innovative capacity of Europe, while addressing global health issues and ethical issues.

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