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Development of a Report Card for Identifying Local Sublingual Immunotherapy Events in Clinical Trials

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Abstract

Background

The sublingual immunotherapy (SLIT) Report Card was developed to capture patient-reported local reactions from the administration of SLIT, based on the World Allergy Organization side-effect grading system. The objective was to evaluate understandability, usability, and translatability of the paper and electronic versions of the SLIT Report Card.

Methods

Adults (aged 18+ years), adolescents (aged 12–17 years), and parents/caregivers and their children (aged 5–11 years) participated in two rounds of interviews, testing the paper version in Round 1, and both the paper and electronic versions in Round 2. Interviews assessed comprehension and usability by subjects. Translatability identified potential issues related to translation or cultural relevance.

Results

Ten adults, ten adolescents, and ten parent/child dyads were interviewed. In general, subjects demonstrated a clear understanding of the instrument’s content. However, some subjects were uncertain of or suggested clarifying the meaning of certain terms, including tablet, ulcer, taste alteration, uvula, nausea, and itching in the ear. The translatability assessment also identified uvula and nausea as potentially problematic for translation. Subjects could use the electronic device and found navigation ‘easy’, with only a few minor suggestions made to improve usability. Some wording and formatting changes were made based on subjects’ feedback and the translatability assessment.

Conclusion

The SLIT Report Card was refined following best practices for instrument development, including cognitive interviewing, usability, and translatability assessment. The refined SLIT Report Card is appropriate for comprehensively and systematically collecting SLIT-related local reactions directly from subjects in a clinical trial setting, taking into account the World Allergy Organization grading system.

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Acknowledgements

We acknowledge the contributions of our following colleagues: Eric Balascio (CRF Health) managed the technical side of the project, including the presentation of the instrument on an electronic device; Barbara Skerritt (ICON) helped with project planning and reviewing of the research questions and documents; and Laura Towns and Adelina Lear (ICON) managed and collated the translatability assessment.

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Authors and Affiliations

  1. Merck Research Laboratories, Merck Sharp & Dohme, Corp., North Wales, PA, USA

    Josephine Norquist, Tiffany Tanzosh, Haojie Li & Beata Iskold

  2. ICON COA, Bethesda, MD, USA

    Emuella Flood, Thelma Rose Ganser & Helen Marson-Smith

Authors
  1. Josephine Norquist
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  2. Emuella Flood
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  3. Tiffany Tanzosh
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  4. Haojie Li
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  5. Beata Iskold
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  6. Thelma Rose Ganser
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  7. Helen Marson-Smith
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Corresponding author

Correspondence to Josephine Norquist.

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Funding

Funding from Merck Sharp & Dohme was obtained by Norquist; administrative, technical, or logistic support was provided by Norquist and Tanzosh.

Conflict of interest

Josephine Norquist, Tiffany Tanzosh, Haojie Li, and Beata Iskold are employees of Merck Sharp & Dohme, who sponsored the study. Emuella Flood, Thelma Rose Ganser, and Helen Marson-Smith were employed by ICON during the study, which was paid by CRFHealth to perform the research.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Consent for publication

Informed consent was obtained from all individual participants included in the study.

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Norquist, J., Flood, E., Tanzosh, T. et al. Development of a Report Card for Identifying Local Sublingual Immunotherapy Events in Clinical Trials. Patient 10, 439–446 (2017). https://doi.org/10.1007/s40271-017-0217-0

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  • DOI: https://doi.org/10.1007/s40271-017-0217-0

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