The Use of Home Spirometry in Pediatric Cystic Fibrosis Patients: Results of a Feasibility Study
Open accessAbstract
Medication adherence is poor among pediatric cystic fibrosis (CF) patients, with adolescents having one of the lowest adherence rates. We wanted to identify an adherence intervention that would be acceptable to CF adolescents and assess its feasibility. We surveyed 40 adolescents with CF and asked about barriers to and motivators for their own adherence and to generate ideas for potential adherence interventions. Since most of the respondents chose frequent spirometry at home and medication reminders for interventions, we selected 5 subjects, 10 to 14 years of age, with CF to test the feasibility of home spirometry and medication reminders in pediatric CF patients. This article summarizes the results of both the survey and the feasibility pilot study.
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There was insufficient information available to calculate the change from baseline in three trials.
“There was insufficient information available to calculate the change from baseline in three trials (Knudsen 2016;Quinn 2004;Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
For Shakkottai 2017, Table 3 in the Results gives baseline and three-month means for both groups, so mean changes from baseline can be calculated. The paper does not report the standard deviation of those changes, but the citing sentence does not specify that it means a change estimate with its variance. This verdict concerns Shakkottai only, not the other two cited trials. (LLM, conf=0.83)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredFor dornase alfa, the review estimated a 0.04 decrease in the intervention group compared to a 0.13 decrease in the control group; for hypertonic saline, the review estimated the increase from baseline as 0.09 in the intervention group compared to a 0.13 drop in the control group (Shakkottai 2017).
“For dornase alfa, we estimated a 0.04 decrease in the intervention group compared to a 0.13 decrease in the control group; for hypertonic saline, we estimated the increase from baseline as 0.09 in the intervention group compared to a 0.13 drop in the control group (Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredOne trial reported all outcomes listed on the clinical trial register in the full trial paper, but the listed trial duration changed from 12 to three months, with no further details provided (Shakkottai 2017).
“One trial reported all outcomes listed on the clinical trial register in the full trial paper, but the listed trial duration changed from 12 to three months, with no further details provided (Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
The Methods and Results describe a registered pilot trial lasting three months and report its outcomes. Our copy does not list the registered outcomes or a 12-month duration, so it cannot establish that all registered outcomes were reported or that the listed duration changed without explanation. (LLM, conf=0.85)
Experimental — accuracy not yet measuredFor Shakkottai 2017, outcome assessors were not blinded because participants were trained by a respiratory therapist who also contacted them weekly.
“Report states that participants were trained on the proper use of their device at enrollment by a respiratory therapist who also contacted them once a week via telephone to record their lung function result and address any questions about the device, so outcome assessors not blinded.”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
The Methods section (page unavailable) says a respiratory therapist trained participants and called them weekly to record their PFT results and answer device questions. It does not identify that therapist as the outcome assessor or state whether outcome assessors were blinded; the Methods also describes other outcomes obtained from medical records. (LLM, conf=0.85)
Experimental — accuracy not yet measuredFor Shakkottai 2017, selective reporting was unclear risk because the study was planned for 12 months but intervention duration changed to 3 months with no details.
“However, this study was planned to be 12 months in duration according to the clinical trial register, but the intervention duration was subsequently changed to 3 months with no details provided.”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
The Methods state that the home-spirometry intervention lasted three months and that the pilot study was registered with ClinicalTrials.gov; the Results also describe a three-month study period. Our copy does not state that the registered plan was 12 months, that the duration changed, or why it changed. It therefore supports the reported duration, but not the claimed discrepancy with the register or the resulting selective-reporting assessment. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Two trials assessed FEV1 % predicted at up to three months; there was no evidence of a difference between groups (MD -3.25, 95% CI -18.13 to 11.64; 2 trials, 40 participants).
“Two trials assessed FEV 1 % predicted at up to three months (Quinn 2004;Shakkottai 2017).There was no evidence of a difference between groups (MD -3.25, 95% CI -18.13 to 11.64; 2 trials, 40 participants; Analysis 1.42).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
After three months, the mean cMPR in the intervention group had increased from baseline by 0.05 and in the control group by 0.04 (Shakkottai 2017).
“A er three months, the mean cMPR in the intervention group had increased from baseline by 0.05 and in the control group by 0.04.”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
The generation of allocation sequence was unclear in three trials (Cottrell 1996; Riekert 2013; Shakkottai 2017) and high in one trial (Gur 2016).
“The generation of allocation sequence was unclear in three trials (Cottrell 1996;Riekert 2013;Shakkottai 2017) and high in one trial (Gur 2016)”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
One trial (5 participants) assessed this outcome at the 'up to three months' time point (Shakkottai 2017), and a second trial (436 participants) reported at over six months and up to 12 months (Quittner 2019).
“One trial (5 participants) assessed this outcome at the 'up to three months' time point (Shakkottai 2017), and a second trial (436 participants) reported at over six months and up to 12 months (Quittner 2019).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
Both trials reported a cMPR measure which included a combination of inhaled therapies and one non-inhaled therapy (Quittner 2019; Shakkottai 2017).
“Both trials reported a cMPR measure which included a combination of inhaled therapies and one non-inhaled therapy (Quittner 2019;Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
Three remaining trials were described as randomised, but no details of the actual randomisation process were given; they were judged to have an unclear risk of bias.
“The three remaining trials were described as randomised, but no details of the actual randomisation process were given; therefore, we judged these trials to have an unclear risk of bias (Cottrell 1996;Riekert 2013;Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
Two trials did not describe withdrawals and were judged unclear risk of bias for incomplete outcome data.
“Two trials did not describe withdrawals, and we judged these to have an unclear risk of bias (Riekert 2013;Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
Three of these trials assessed the total number of exacerbations during trial periods of three months, six months, or 12 months.
“Three of these trials assessed the total number of exacerbations during the trial periods of three months (Shakkottai 2017), six months (Hind 2017), or 12 months (Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
One trial reported the total number of exacerbations in each group only (no means, SDs or ratio data).
“One trial reported the total number of exacerbations in each group only (no means, SDs or ratio data) (Shakkottai 2017), while two trials reported the total number of exacerbations in each group along with unadjusted and adjusted exacerbation rates (incidence rate ratios; 95% CI), adjusted for CF centre and past year IV antibiotic days (Hind 2017;Wildman 2022).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
One trial did not provide a definition for an exacerbation.
“One trial did not provide a definition for an exacerbation (Shakkottai 2017).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
For Shakkottai 2017, allocation concealment was not reported (unclear risk).
“Allocation concealment (selection bias) Unclear risk Not reported.”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
For Shakkottai 2017, no other potential source of bias was identified (low risk).
“Other bias Low risk No other potential source of bias identified.”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
The Results describe baseline differences between the pilot study groups, and the Discussion notes the small sample and short duration. Neither section assesses the study as having low risk of other bias or states that no other potential source of bias was identified; searches for those terms found no such assessment in our copy. (LLM, conf=0.73)
Experimental — accuracy not yet measuredFor Shakkottai 2017, all outcomes listed in the clinical trial register were reported in the full trial paper.
“All outcomes listed in clinical trial register were reported in the full trial paper.”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Shakkottai 2017
The Methods section says the pilot study was registered with ClinicalTrials.gov, and the Results section reports several outcomes. Our copy does not list the registry’s outcomes or compare them with the paper’s reported outcomes, so it cannot establish that all registered outcomes were reported. Searched for registered primary and secondary outcomes and an outcome-reporting comparison; the available passages have no page numbers. (LLM, conf=0.76)
Experimental — accuracy not yet measured
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- Authors
- Shakkottai, A., & Nasr, S. Z.
- Affiliations
- Michigan Medicine (US)
- Corresponding author
- Nasr, Samya Z.
- Venue
- Global Pediatric Health
- Publisher
- SAGE Publications
- Published
- 2017-01-01
- Volume
- 4
- Pages
- 2333794X17690315-2333794X17690315
- ISSN
- 2333-794X (ISSN-L)
- PMC
- PMC5308520
- OpenAlex
- W2588463362
- Cited by
- 16
- References
- 21
- Citations by year
- 2025: 1 · 2023: 5 · 2022: 4 · 2021: 3 · 2020: 2 · 2019: 1
- FWCI
- 0.85
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Global Pediatric Health (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cystic Fibrosis Research Advances
- Health Sciences › Health Professions › Speech and Hearing › Adolescent and Pediatric Healthcare
- Keywords
- cystic fibrosis, home spirometry, medication adherence, adolescents, medication reminders, adherence interventions, barriers and motivators, feasibility, pediatric patients
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