title: Designing adverse event forms for real-world reporting: participatory research in Uganda.
abstract: The wide-scale roll-out of artemisinin combination therapies (ACTs) for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV) relies on adverse event (AE) reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings to improve quality and quantity of drug safety reports as new medicines are scaled-up.
authors.affiliation: Liverpool School of Tropical Medicine, Liverpool, United Kingdom. ecdavies@ymail.com
authors.forename: Emma C
authors.initials: EC
authors.lastname: Davies
authors.forename: Clare I R
authors.initials: CI
authors.lastname: Chandler
authors.forename: Simeon H S
authors.initials: SH
authors.lastname: Innocent
authors.forename: Charles
authors.initials: C
authors.lastname: Kalumuna
authors.forename: Dianne J
authors.initials: DJ
authors.lastname: Terlouw
authors.forename: David G
authors.initials: DG
authors.lastname: Lalloo
authors.forename: Sarah G
authors.initials: SG
authors.lastname: Staedke
authors.forename: Ane
authors.initials: A
authors.lastname: Haaland
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000890:Anti-Infective Agents / Q000009:adverse effects; D037621:Artemisinins / Q000009:adverse effects*; D055812:Community-Based Participatory Research / Q000379:methods*; D016903:Drug Monitoring / Q000379:methods; D004359:Drug Therapy, Combination / Q000009:adverse effects; D006801:Humans; D008288:Malaria / Q000188:drug therapy*; D060735:Pharmacovigilance; D015203:Reproducibility of Results; D012107:Research Design; D014454:Uganda
chemical_list: D000890:Anti-Infective Agents; D037621:Artemisinins; C031327:artemisinin