Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL)
Objectives Patient experiences are critical when determining the acceptability of novel interventional pharmaceuticals. Here, we report the development and validation of a product acceptability questionnaire (SPRAY PAL) assessing feasibility, acceptability and tolerability of an intranasal Q-Griffit...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/9/e073735.full |
| _version_ | 1797668556318441472 |
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| author | Elizabeth Cash Kailyn Deitz Kevin L Potts Henry W Nabeta Maryam Zahin Shesh N Rai Gerald W Dryden Kenneth E Palmer |
| author_facet | Elizabeth Cash Kailyn Deitz Kevin L Potts Henry W Nabeta Maryam Zahin Shesh N Rai Gerald W Dryden Kenneth E Palmer |
| author_sort | Elizabeth Cash |
| collection | DOAJ |
| description | Objectives Patient experiences are critical when determining the acceptability of novel interventional pharmaceuticals. Here, we report the development and validation of a product acceptability questionnaire (SPRAY PAL) assessing feasibility, acceptability and tolerability of an intranasal Q-Griffithsin (Q-GRFT) drug product designed for COVID-19 prophylaxis.Design SPRAY PAL validation was undertaken as part of an ongoing phase 1 clinical trial designed to test the safety, pharmacokinetics and tolerability of intranasally administered Q-GRFT for the prevention of SARS-CoV-2 infection.Setting The phase 1 clinical trial took place at a University Outpatient Clinical Trials Unit from November 2021 to September 2023.Participants The initial SPRAY PAL questionnaire was piloted among healthy volunteers ages 25 to 55 in phase 1a of the clinical trial (N=18) and revised for administration in phase 1b for participants ages 24–59 (N=22).Results Spearman correlations tested convergent and discriminant validity. Internal consistency was assessed using Cronbach’s alpha, and test–retest reliability was assessed using intraclass correlation coefficients of responses collected from three repeated questionnaire administrations. The initial version demonstrated excellent internal consistency. The revised version demonstrated very good internal consistency after removal of one item (alpha=0.739). Excellent test–retest reliability (intraclass coefficient=0.927) and adequate convergent (r’s=0.208–0.774) and discriminant (r’s=0.123–0.392) validity were achieved. Subscales adequately distinguished between the constructs of acceptability, feasibility and tolerability.Conclusions The SPRAY PAL product acceptability questionnaire is a valid and reliable patient-reported outcomes measure that can be considered a credible tool for assessing patient-reported information about product acceptability, feasibility of use, tolerability of product and side effects and cost of product for novel intranasal drug formulations. The SPRAY PAL is generalisable, and items may be readily adapted to assess other intranasal formulations.Trial registration numbers NCT05122260 and NCT05437029. |
| first_indexed | 2024-03-11T20:31:03Z |
| format | Article |
| id | doaj.art-2a18f45b48264b5c87c0b95bc7ee4987 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-11T20:31:03Z |
| publishDate | 2023-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-2a18f45b48264b5c87c0b95bc7ee49872023-10-02T08:30:07ZengBMJ Publishing GroupBMJ Open2044-60552023-09-0113910.1136/bmjopen-2023-073735Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL)Elizabeth Cash0Kailyn Deitz1Kevin L Potts2Henry W Nabeta3Maryam Zahin4Shesh N Rai5Gerald W Dryden6Kenneth E Palmer7Department of Otolaryngology, Head and Neck Surgery and Communicative Disorders, University of Louisville School of Medicine, Louisville, Kentucky, USAUniversity of Louisville School of Medicine, Louisville, Kentucky, USADepartment of Otolaryngology, Head and Neck Surgery and Communicative Disorders, University of Louisville School of Medicine, Louisville, Kentucky, USACenter for Predictive Medicine for Biodefense and Emerging Infectious Diseases, University of Louisville School of Medicine, Louisville, Kentucky, USACenter for Predictive Medicine for Biodefense and Emerging Infectious Diseases, University of Louisville School of Medicine, Louisville, Kentucky, USACollege of Medicine Cancer Data Science Center, University of Cincinnati, Cincinnati, Ohio, USADigestive and Liver Health, University of Louisville Physicians Outpatient Center, Louisville, Kentucky, USACenter for Predictive Medicine for Biodefense and Emerging Infectious Diseases, University of Louisville School of Medicine, Louisville, Kentucky, USAObjectives Patient experiences are critical when determining the acceptability of novel interventional pharmaceuticals. Here, we report the development and validation of a product acceptability questionnaire (SPRAY PAL) assessing feasibility, acceptability and tolerability of an intranasal Q-Griffithsin (Q-GRFT) drug product designed for COVID-19 prophylaxis.Design SPRAY PAL validation was undertaken as part of an ongoing phase 1 clinical trial designed to test the safety, pharmacokinetics and tolerability of intranasally administered Q-GRFT for the prevention of SARS-CoV-2 infection.Setting The phase 1 clinical trial took place at a University Outpatient Clinical Trials Unit from November 2021 to September 2023.Participants The initial SPRAY PAL questionnaire was piloted among healthy volunteers ages 25 to 55 in phase 1a of the clinical trial (N=18) and revised for administration in phase 1b for participants ages 24–59 (N=22).Results Spearman correlations tested convergent and discriminant validity. Internal consistency was assessed using Cronbach’s alpha, and test–retest reliability was assessed using intraclass correlation coefficients of responses collected from three repeated questionnaire administrations. The initial version demonstrated excellent internal consistency. The revised version demonstrated very good internal consistency after removal of one item (alpha=0.739). Excellent test–retest reliability (intraclass coefficient=0.927) and adequate convergent (r’s=0.208–0.774) and discriminant (r’s=0.123–0.392) validity were achieved. Subscales adequately distinguished between the constructs of acceptability, feasibility and tolerability.Conclusions The SPRAY PAL product acceptability questionnaire is a valid and reliable patient-reported outcomes measure that can be considered a credible tool for assessing patient-reported information about product acceptability, feasibility of use, tolerability of product and side effects and cost of product for novel intranasal drug formulations. The SPRAY PAL is generalisable, and items may be readily adapted to assess other intranasal formulations.Trial registration numbers NCT05122260 and NCT05437029.https://bmjopen.bmj.com/content/13/9/e073735.full |
| spellingShingle | Elizabeth Cash Kailyn Deitz Kevin L Potts Henry W Nabeta Maryam Zahin Shesh N Rai Gerald W Dryden Kenneth E Palmer Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL) BMJ Open |
| title | Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL) |
| title_full | Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL) |
| title_fullStr | Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL) |
| title_full_unstemmed | Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL) |
| title_short | Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL) |
| title_sort | development and validation of a product acceptability questionnaire for intranasal q griffithsin covid 19 prophylaxis spray pal |
| url | https://bmjopen.bmj.com/content/13/9/e073735.full |
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