Measurement properties of an asthma symptom and rescue medication use diary

Clark, Marci; Martin, Susan; Svedsäter, Henrik; Dale, Peter; Jacques, Loretta

doi:10.3109/02770903.2014.947430

Cited by 10 publications

(13 citation statements)

References 44 publications

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“…In line with the qualitative data, quantitative analyses generated estimates of 1 to 2 additional SFDs in a week as meaningful. This is consistent with previous quantitative MID estimates for SFDs generated in adolescents 11 and adults, 11,19 but less reflective of a smaller qualitative interview study in adolescents and adults. 20 The meaningful change estimates generated by the 0.5 SD approach in both the phase II studies most closely reflect prior quantitative RFD MID estimates of around 1 day in adolescents/adults.…”

Section: Discussionsupporting

confidence: 90%

“…6 Self-or caregivercompleted daily diaries are also often implemented in clinical trials to measure symptom severity and frequency and rescue medication use. 7e10 Although a variety of diary-derived symptom score and rescue medication use endpoints can be calculated, the proportion of symptom-free days (SFDs; ie, percentage of days [24-hour periods] when the patient reports no asthma symptoms during the treatment period, based on morning and evening diary data) 11 and rescue medication-free days (RFDs; ie, percentage of days [24-hour periods] when a patient reports zero puffs of rescue medication taken during the treatment period, based on morning and evening diary data) 11 are frequently used as clinical trial endpoints. 12 These endpoints are particularly valuable for pediatric patients because young children may have difficulty in characterizing symptom severity.…”

Section: Introductionmentioning

confidence: 99%

“…20 A more recent quantitative analysis of clinical trial data and a qualitative analysis of interviews in patients aged !12 years reported MID ranges of 7.7% to 14.7% (2.3-4.4 days/month) for SFDs and 8.4% to 15.6% for RFDs (2.5-4.7 days/month), respectively. 11 In children, MID estimates of 1.6 and 1.9 in C-ACT total score and ACT total score, respectively, have been reported; 21 nevertheless, similar estimates for SFDs and RFDs in children are lacking. The terms "meaningful important change" and "MID" are often used interchangeably, although in pediatric studies, where participating children may struggle with the abstract concept of the "smallest important change," it is more appropriate to evaluate the level of change that children would consider to have a meaningful impact on their lives.…”

Section: Introductionmentioning

confidence: 99%

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Use of Both Qualitative and Quantitative Methods to Estimate Meaningful Change Thresholds for Key Endpoints in Pediatric Asthma Trials

et al. 2019

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Introduction: Diary-derived symptom score and rescue medication use endpoints, such as symptom-free days (SFDs) and rescue medication-free days (RFD), are frequently used as clinical trial endpoints. Estimates of meaningful change for SFDs and RFDs have not been generated in pediatric populations. This research aimed to generate evidence supporting estimates of the individual withinpatient changes that constitute an important or meaningful change in SFDs, RFDs, and updated estimates on the Childhood Asthma Control Test (C-ACT) in pediatric asthma populations aged 5-11 years. Methods: Semistructured, qualitative interviews were conducted with children (ages 8-11 years) who had asthma and parents/caregivers of children (4-11 years) with asthma. Before the interview (4-9 days) participants were asked to complete a morning and evening diary. Results: On average, parent/caregiver estimates of the difference in SFDs between a "very bad" and a "little bad" week for their children's asthma were largely concordant with the values reported by their children (differences of 1.8 and 1.4 SFDs, respectively). Both parents/ caregivers and children were able to articulate what a meaningful level of change would be on the C-ACT at the item level. This qualitative study generated C-ACT item-level meaningful change estimates in the region of 1-3 category change, which potentially suggests that, if scaled up to represent C-ACT total score, this would lead to change estimates of 7-15 points. Conclusions: Our findings suggest that both children with asthma and parents/caregivers can quantitatively estimate and to some extent qualitatively articulate meaningful change in SFDs and RFDs.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Use of Both Qualitative and Quantitative Methods to Estimate Meaningful Change Thresholds for Key Endpoints in Pediatric Asthma Trials

et al. 2019

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“…Additionally, notable increases in symptom-free 24-h periods were observed for both VI 12.5 and VI 25 groups. The increase in rescue-free 24-h periods observed in the VI 25 group and those in symptom-free 24-h periods in the VI 12.5 and VI 25 groups exceed the lower bounds of the published minimal important differences in adults [ 26 ]. This finding indirectly supports the importance of including more than just lung function measurements in the main analyses of studies in children.…”

Section: Discussionmentioning

confidence: 97%

Randomised trial of once-daily vilanterol in children with asthma on inhaled corticosteroid therapy

et al. 2016

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BackgroundInhaled corticosteroids (ICS) are effective maintenance treatments for childhood asthma; however, many children remain uncontrolled. Vilanterol (VI) is an inhaled long-acting beta-2 agonist which, in combination with the ICS fluticasone furoate, is being explored as a once-daily treatment for asthma in children. We evaluated the dose–response, efficacy, and safety of once-daily VI (6.25 μg, 12.5 μg and 25 μg) administered in the evening over 4 weeks, on background fluticasone propionate (FP) in children with asthma inadequately controlled on ICS.MethodsThis was a Phase IIb, multicentre, randomised, double-blind, parallel-group, placebo-controlled study in children ages 5–11 years with persistent asthma on ICS and as-needed short-acting beta-agonist. The study comprised a 4-week run-in, 4-week treatment period, and 1-week follow-up. From study start, children replaced their current ICS with open-label FP 100 μg twice daily. Children were randomised to receive placebo, VI 6.25 μg, VI 12.5 μg or VI 25 μg once daily. Primary endpoint was treatment difference between VI 25 and placebo groups in mean change from baseline in evening peak expiratory flow averaged over the 4-week treatment. Secondary endpoints included change from baseline in trough forced expiratory volume in one second (FEV1) at Week 4 and change from baseline in percentage of rescue-free and symptom-free 24-h periods. Safety assessments included incidence of adverse events (AEs) and asthma exacerbations.ResultsIn total, 456 children comprised the intention-to-treat population. The adjusted treatment difference between VI 25 and placebo groups for the primary endpoint was not statistically significant (p = 0.227) so no statistical inference was made for other VI dose comparisons or other endpoints. No difference in change from baseline in trough FEV1 was observed for any VI treatments versus placebo; however, VI 25 resulted in an additional 0.6 rescue-free days and 0.7 symptom-free days per week versus placebo. The incidence of AEs was slightly higher in the VI groups (28–33 %) versus placebo (22 %). Nine children experienced asthma exacerbations during the treatment period.ConclusionVI plus FP did not result in significant improvements in lung function versus placebo plus FP, but was well tolerated at all doses assessed.Trial registrationNCT01573767 (ClinicalTrials.gov).

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“…It also can help participants reduce recall bias. However, in the current literature, research using asthma-related diaries has focused more on measuring the scores of asthma symptoms and medication usage [16, 17]. The dynamic information of daily activity and exposure was not collected for assessing the risk factors and the occurrence of asthma symptoms.…”

Section: Introductionmentioning

confidence: 99%

Assessing effects of personal behaviors and environmental exposure on asthma episodes: a diary-based approach

Chan

Chu

et al. 2019

BMC Pulm Med

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BackgroundQuantifying the effects of personal health behaviors and environmental exposure on asthma flare-ups is a challenge. Most studies have focused on monitoring the symptoms and drug usage for relieving symptoms. In this study, we emphasize the need to understand how personal and environmental conditions are related to the occurrence of asthma symptoms.MethodsWe designed an online health diary platform to collect personal health behaviors from children, their parents and other adults with any allergic diseases including asthma, allergic rhinitis, atopic dermatitis and allergic conjunctivitis. The participants used mobile devices or computers to record their daily health-related activities such as sleep, exercise, diet, perception of air quality and temperature, and asthma symptoms. The participants also recorded secondhand smoke exposure and the time of activities, which were combined with ambient air quality measurements for calculating personal air pollution exposure. A generalized linear mixed model was used to estimate the effects of the factors.ResultsDuring the study period (January 2017–June 2017, and October 2017–September 2018), 132 participants provided 25,016 diary entries, and 84 participants had experienced asthma symptoms in 1458 diary entries. The results showed some different risk factors for the minors and adults. For minors, high-intensity exercise, contact with persons with influenza-like illness (ILI) and the perception of hot temperature and bad indoor air quality were associated with the occurrence of asthma episodes. The identified risk factors for the adult participants included having dehumidifiers at home, exposure to secondhand smoke, having bad sleep quality, contact with persons with ILI, not eating fruit and seafood, perceiving cold temperature, bad quality of indoor and outdoor air, and exposure to high concentration of ozone.ConclusionsThe revealed personal risk factors and perceptions of air quality and temperature may provide guidance on behavioral change for people susceptible to asthma to help control acute onset and severe exacerbation of asthma flare-ups.

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Measurement properties of an asthma symptom and rescue medication use diary

Abstract: The ASRMU diary captures the disease-specific concepts of greatest importance to asthma patients and provides important information for asthma diagnosis and treatment evaluation.

Cited by 10 publications

References 44 publications

Use of Both Qualitative and Quantitative Methods to Estimate Meaningful Change Thresholds for Key Endpoints in Pediatric Asthma Trials

Use of Both Qualitative and Quantitative Methods to Estimate Meaningful Change Thresholds for Key Endpoints in Pediatric Asthma Trials

Randomised trial of once-daily vilanterol in children with asthma on inhaled corticosteroid therapy

Assessing effects of personal behaviors and environmental exposure on asthma episodes: a diary-based approach

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