Dataset Information

Randomized, cross-over evaluation of mobile phone vs paper diary in subjects with mild to moderate persistent asthma.

ABSTRACT: UNLABELLED:Diaries are frequently used to evaluate therapy. Forgetfulness, however, can lead to missed entries. With paper diaries, these missing entries can be backfilled, compromising the reasons for using a diary. Electronic diaries are a potential means of mitigating this limitation. The pilot study was conducted to evaluate use of a mobile phone diary. Twelve subjects with mild persistent asthma were randomly assigned to mobile or paper diary for 2 weeks and then crossed over to use the other diary type for next 2 weeks. Of the 12 subjects, 7 preferred the mobile diary. However, the mean prevalence of missing data was greater when using the mobile (18% ± 9%) compared to paper diary (9% ± 4%; P = 0.05). In conclusion, the mobile diary was preferred by slightly more subjects. The greater prevalence of missing data when using this diary most likely results from the inability to backfill missing entries. TRIAL REGISTRATION:Clintrials.gov NCT00367263 (http://clinicaltrials.gov/ct2/show/NCT00367263).

SUBMITTER: Meltzer EO

PROVIDER: S-EPMC2606655 | biostudies-literature | 2008

REPOSITORIES: biostudies-literature

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Randomized, cross-over evaluation of mobile phone vs paper diary in subjects with mild to moderate persistent asthma.

Meltzer Eli O EO Kelley Norma N Hovell Melbourne F MF

The open respiratory medicine journal 20080905

<h4>Unlabelled</h4>Diaries are frequently used to evaluate therapy. Forgetfulness, however, can lead to missed entries. With paper diaries, these missing entries can be backfilled, compromising the reasons for using a diary. Electronic diaries are a potential means of mitigating this limitation. The pilot study was conducted to evaluate use of a mobile phone diary. Twelve subjects with mild persistent asthma were randomly assigned to mobile or paper diary for 2 weeks and then crossed over to use ...[more]

PMID: 19412327

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Project description:BackgroundAlthough obesity has been hypothesized to worsen asthma, data from studies of subjects with well-characterized asthma are lacking.ObjectiveWe sought to evaluate the relationship between body mass index (BMI), asthma impairment, and response to therapy.MethodsBMI (in kilograms per meter squared) and asthma phenotypic and treatment response data were extracted from Asthma Clinical Research Network studies. The cross-sectional relationship between BMI and asthma impairment was analyzed, as was the longitudinal relationship between BMI and response to asthma controller therapies.ResultsOne thousand two hundred sixty-five subjects with mild-to-moderate persistent asthma were evaluated. Analyses of lean versus overweight/obese asthmatic subjects demonstrated small differences in FEV1 (3.05 vs 2.91 L, P = .001), FEV1/forced vital capacity ratio (mean, 83.5% vs 82.4%; P = .01), rescue albuterol use (1.1 vs 1.2 puffs per day, P = .03), and asthma-related quality of life (5.77 vs 5.59, P = .0004). Overweight/obese asthmatic subjects demonstrated a smaller improvement in exhaled nitric oxide levels with inhaled corticosteroid (ICS) treatment than did lean asthmatic subjects (3.6 vs 6.5 ppb, P = .04). With ICS/long-acting beta-agonist treatment, overweight/obese asthmatic subjects demonstrated smaller improvements in lung function than lean asthmatic subjects, with an 80 mL (P = .04) and 1.7% (P = .02) lesser improvement in FEV1 and FEV1/forced vital capacity ratio, respectively. Significant differences in therapeutic response to leukotriene modifiers between BMI categories were not observed.ConclusionsIncreased BMI is not associated with clinically significant worsening of impairment in subjects with mild-to-moderate persistent asthma. There is a modest association between increased BMI and reduced therapeutic effect of ICS-containing regimens in this patient population. Prospective studies evaluating the effect of being overweight or obese on treatment response in asthma are warranted.

Project description:BackgroundThe cost-effectiveness of using a mobile diary app as an adjunct in dialectical behavior therapy (DBT) in patients with borderline personality disorder is unknown.ObjectiveThis study aims to perform an economic evaluation of a mobile diary app compared with paper-based diary cards in DBT treatment for patients with borderline personality disorder in a psychiatric outpatient facility.MethodsThis study was conducted alongside a pragmatic, multicenter, randomized controlled trial. The participants were recruited at 5 Danish psychiatric outpatient facilities and were randomized to register the emotions, urges, and skills used in a mobile diary app or on paper-based diary cards. The participants in both groups received DBT delivered by the therapists. A cost-consequence analysis with a time horizon of 12 months was performed. Consequences included quality-adjusted life years (QALYs), depression severity, borderline severity, suicidal behavior, health care use, treatment compliance, and system usability. All relevant costs were included. Focus group interviews were conducted with patients, therapists, researchers, and industry representatives to discuss the potential advantages and disadvantages of using a mobile diary app.ResultsA total of 78 participants were included in the analysis. An insignificantly higher number of participants in the paper group dropped out before the start of treatment (P=.07). Of those starting treatment, participants in the app group had an average of 37.1 (SE 27.55) more days of treatment and recorded an average of 3.16 (SE 5.10) more skills per week than participants in the paper group. Participants in both groups had a QALY gain and a decrease in depression severity, borderline severity, and suicidal behavior. Significant differences were found in favor of the paper group for both QALY gain (adjusted difference -0.054; SE 0.03) and reduction in depression severity (adjusted difference -1.11; SE 1.57). The between-group difference in total costs ranged from US $107.37 to US $322.10 per participant during the 12 months. The use of services in the health care sector was similar across both time points and groups (difference: psychiatric hospitalization <5 and <5; general practice -1.32; SE 3.68 and 2.02; SE 3.19). Overall, the patients showed high acceptability and considered the app as being easy to use. Therapists worried about potential negative influences on the therapist-patient interaction from new work tasks accompanying the introduction of the new technology but pointed at innovation potential from digital database registrations.ConclusionsThis study suggests both positive and negative consequences of mobile diary apps as adjuncts to DBT compared with paper diary cards. More research is needed to draw conclusions regarding its cost-effectiveness.Trial registrationClinicalTrials.gov NCT03191565; http://clinicaltrials.gov/ct2/show/NCT03191565.International registered report identifier (irrid)RR2-10.2196/17737.

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Project description:BACKGROUND:Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS:In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS:Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P=0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P=0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P=0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P=0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P=0.94), or adverse events. CONCLUSIONS:Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).

Dataset Information

Randomized, cross-over evaluation of mobile phone vs paper diary in subjects with mild to moderate persistent asthma.

Publications

Randomized, cross-over evaluation of mobile phone vs paper diary in subjects with mild to moderate persistent asthma.

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