Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptations
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...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
European Respiratory Society
2023-05-01
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| Series: | ERJ Open Research |
| Online Access: | http://openres.ersjournals.com/content/9/3/00602-2022.full |
| _version_ | 1797689322639458304 |
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| author | Steve Jones Maxine Flewett Ron Flewett Sharon Lee Bill Vick Milla Thompson Sabine Pinnetti Donald F. Zoz Anna-Maria Hoffmann-Vold Michael Kreuter Toby M. Maher |
| author_facet | Steve Jones Maxine Flewett Ron Flewett Sharon Lee Bill Vick Milla Thompson Sabine Pinnetti Donald F. Zoz Anna-Maria Hoffmann-Vold Michael Kreuter Toby M. Maher |
| author_sort | Steve Jones |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T01:44:02Z |
| format | Article |
| id | doaj.art-0ff8c2d7a0a34cf598fc91e5627dd0bf |
| institution | Directory Open Access Journal |
| issn | 2312-0541 |
| language | English |
| last_indexed | 2024-03-12T01:44:02Z |
| publishDate | 2023-05-01 |
| publisher | European Respiratory Society |
| record_format | Article |
| series | ERJ Open Research |
| spelling | doaj.art-0ff8c2d7a0a34cf598fc91e5627dd0bf2023-09-09T13:53:54ZengEuropean Respiratory SocietyERJ Open Research2312-05412023-05-019310.1183/23120541.00602-202200602-2022Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptationsSteve Jones0Maxine Flewett1Ron Flewett2Sharon Lee3Bill Vick4Milla Thompson5Sabine Pinnetti6Donald F. Zoz7Anna-Maria Hoffmann-Vold8Michael Kreuter9Toby M. Maher10 The European Pulmonary Fibrosis Federation, Overijse, Belgium Pulmonary Foundation Trust, Lichfield, UK Pulmonary Foundation Trust, Lichfield, UK Canadian Pulmonary Fibrosis Foundation, Markham, ON, Canada PF Warriors, Plano, TX, USA Boehringer Ingelheim Finland Ky, Helsinki, Finland Boehringer Ingelheim GmbH & Co. KG, Biberach an der Riss, Germany Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA Department of Rheumatology, Oslo University Hospital, Oslo, Norway Center for Pulmonary Medicine, Department of Pneumology, Mainz University Medical Center and Department of Pulmonary, Critical Care and Sleep Medicine, Marienhaus Clinic Mainz, Mainz, Germany National Heart and Lung Institute, Imperial College London, London, UK 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.http://openres.ersjournals.com/content/9/3/00602-2022.full |
| spellingShingle | Steve Jones Maxine Flewett Ron Flewett Sharon Lee Bill Vick Milla Thompson Sabine Pinnetti Donald F. Zoz Anna-Maria Hoffmann-Vold Michael Kreuter Toby M. Maher Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptations ERJ Open Research |
| title | Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptations |
| title_full | Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptations |
| title_fullStr | Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptations |
| title_full_unstemmed | Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptations |
| title_short | Clinical trial simulations in pulmonary fibrosis: patient-focused insights and adaptations |
| title_sort | clinical trial simulations in pulmonary fibrosis patient focused insights and adaptations |
| url | http://openres.ersjournals.com/content/9/3/00602-2022.full |
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