Oliver Pfaar, MD, PhD

Credit: journalallergy.com

The Allergen and Immunotherapy Adherence and Persistence Checklist (APAIT) is a beneficial tool with guidance on identifying sources of potential biases in and the ways these may affect adherence in allergen and immunotherapy (AIT), according to new findings.¹

The research was authored by Oliver Pfaar, MD, PhD, from the Department of Otorhinolaryngology at the University Hospital Marburg in Germany.

Pfaar and his team remarked upon the heterogeneity of studies into AIT that have been performed up until this point, adding that they saw a need for consistency as well as a need for developing recommendations in study methodology.

“Therefore, we have developed the ‘adherence and persistence in AIT (APAIT)’ checklist that can be used as a guide for researchers when designing and reporting retrospective studies that evaluate adherence or persistence to AIT in a real-world setting, or when interpreting such studies,” Pfaar and colleagues wrote.

Background and Findings

At the start of the study, the investigators identified 5 distinct checklists that had a focus on various aspects of study protocol design, that had use of retrospective databases and patient registries, and that had appraisal and reporting of observational studies.

The 5 checklists the team identified included the following:

• The ENCePP Checklist for Study Protocols, which were designed by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
• The Strengthening  the Reporting of Observational Studies in Epidemiology Statement: guidelines for observational study reporting, which were designed by the Equator Network
• A Checklist for medication compliance and persistence studies using retrospective databases, which were designed by ISPOR
• The REal Life EVidence AssessmeNt Tool, which was designed by the Respiratory Effectiveness Group and by EAACI
• Guideline on registry-based studies, which were designed by the European Medicines Agency

The researchers then merged these checklists, and relevant items were selected and customized to be specific to AIT. The checklist that then resulted from their merger was evaluated and discussed by a group of 11 experts in several fields including healthcare, allergy, life sciences, and health technology appraisals, all of whom were from the US, Canada, and Europe.

Overall, the team reported that some of the potential sources of bias included: socioeconomic situation, geographical location, speciality in healthcare, age (adults versus young people), severity of disease, and route of AIT administration.

Some other sources were cost of AIT, education and income, previous AIT treatments, allergens (perennial versus seasonal), comorbidities, prescriber biases, precision in determining adherence or persistence, and frequency of interactions between patients and clinicians.

In their conclusions, the investigators note that the APAIT checklist provides a comprehensive list of items that should be included or given their due consideration when reporting retrospective studies that assess adherence or persistence to AIT.

They divided the checklist into 4 categories, which were ‘study objective,’ ‘design and methods,’ ‘data analysis,’ and ‘results and discussion.’ The categories stress the significance of transparent and clear reporting for patients.

The investigators added that the list also highlights the necessity of considering potential sources of bias in retrospective studies evaluating adherence or persistence to AIT.

“The proposed checklist is novel and highlights an important issue in the allergy field. It aims to be pragmatic, not prescriptive, to guide researchers in conducting and interpreting retrospective adherence and persistence studies in AIT and improve the strength of the evidence,” they wrote.

The team added that further developments of this checklist may find use in a system designed for objectively rating the quality of such studies evaluating adherence or persistence in AIT. This could be most helpful when researchers perform meta-analyses and systematic reviews.

References

1. ^{Pfaar, O., Devillier, P., Schmitt, J., Demoly, P., Hilberg, O., DuBuske, L., Hass, N., Klok, T. and Beutner, C. (2023), Adherence and persistence in allergen immunotherapy (APAIT): a reporting checklist for retrospective studies. Allergy. Accepted Author Manuscript. https://doi.org/10.1111/all.15723.}