Evidence map›Paper›PMID 37260456›Full record

ArticleERJ open research2023

Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptations.

Steve Jones, Maxine Flewett, Ron Flewett, Sharon Lee, Bill Vick, Milla Thompson, Sabine Pinnetti, Donald F Zoz, Anna-Maria Hoffmann-Vold, Michael Kreuter and 1 more

Abstract read
In one paragraph

Article in ERJ open research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Steve JonesThe European Pulmonary Fibrosis Federation, Overijse, Belgium.
Maxine FlewettPulmonary Foundation Trust, Lichfield, UK.
Ron FlewettPulmonary Foundation Trust, Lichfield, UK.
Sharon LeeCanadian Pulmonary Fibrosis Foundation, Markham, ON, Canada.
Bill VickPF Warriors, Plano, TX, USA.
Milla ThompsonBoehringer Ingelheim Finland Ky, Helsinki, Finland.
Sabine PinnettiBoehringer Ingelheim GmbH & Co. KG, Biberach an der Riss, Germany.
Donald F ZozBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Anna-Maria Hoffmann-VoldDepartment of Rheumatology, Oslo University Hospital, Oslo, Norway.
Michael KreuterCenter for Pulmonary Medicine, Department of Pneumology, Mainz University Medical Center and Department of Pulmonary, Critical Care and Sleep Medicine, Marienhaus Clinic Mainz, Mainz, Germany.ORCID https://orcid.org/0000-0003-4402-2159
Toby M MaherNational Heart and Lung Institute, Imperial College London, London, UK.ORCID https://orcid.org/0000-0001-7192-9149

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Patient recruitment and retention are a challenge when conducting clinical trials in patients with pulmonary fibrosis, including idiopathic pulmonary fibrosis and other interstitial lung diseases. This study aimed to understand and address the barriers associated with trial participation for these populations. Methods: Nine patients, nine caregivers and three healthcare professionals participated in virtual simulations of planned phase III trials. During the simulations, participants received information about the trials and either tested a home spirometry device or watched a home spirometry demonstration, before providing their insights in debriefs. The findings were interpreted in advisory boards with representatives from patient organisations and expert investigators. Results: Regarding barriers to participation, patient fatigue and breathlessness were emphasised as posing challenges for travel, visit length and completion of onsite assessments. Lack of information, support and appreciation were also identified as factors that may exacerbate anxiety and negatively affect participant retention rates. Feedback on the home spirometry was mixed, with participants appreciating being able to complete the test at home but worrying about device handling. Based on the insights gained, patient-friendly adaptations were made to the trial protocol and conduct, including remote assessment of patient-reported outcomes, increased visit flexibility, travel support services, patient and caregiver information campaigns, and training of investigators on patients' needs. Conclusions: Participants identified important barriers to participation, which led to patient-friendly changes being made to the planned trials. As a result, participation in the planned trials should be less burdensome, with improved recruitment and retention rates, and ultimately, improved data quality.

Identifiers

PMID37260456
PMCPMC10227627

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.