A new questionnaire for assessment of adverse events associated with triptans: methods of assessment influence the results. Preliminary results

Abstract

Triptans are the treatment of choice for migraine sufferers with disabling attacks. However,

Patient-Reported Questionnaires to Identify Adverse Drug Reactions: A Systematic Review

“…After screening 1563 studies once 1171 duplicates were removed, 78 full-text articles were assessed for eligibility. A total of 19 patient-reported questionnaires met the inclusion criteria for this systematic review [7,15,16,[27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42]. The PRISMA flowchart for study selection is presented in Figure 1.…”

“…Table 2 shows a breakdown of the different characteristics of each of the questionnaires such as which medication classes they focus on and the number of side-effect-related items and domains or sections within the questionnaire. Out of the 19 questionnaires, eight (42%) focused on mental health medications [15,27,31,35,36,39,41,42], four (21%) were general questionnaires applicable to any medication [7,16,28,38], two (11%) focused on antiepileptics [30,40], two (11%) focused on inhaled medications for asthma and COPD [29,33], one (5%) focused on diabetes medications [34], one (5%) focused on chemotherapy [37], and one (5%) focused on triptans [32] (Table 1). Table 2 shows a breakdown of the different characteristics of each of the questionnaires such as which medication classes they focus on and the number of side-effectrelated items and domains or sections within the questionnaire.…”

Early Onset of Efficacy and Consistency of Response Across Multiple Migraine Attacks From the Randomized COMPASS Study: AVP‐825 Breath Powered®Exhalation Delivery System (Sumatriptan Nasal Powder) vs Oral Sumatriptan

“…In the primary COMPASS publication, it was noted that the incidence of triptan-related adverse events, described as "atypical triptan sensations," is significantly higher and more accurate when the patient is queried as opposed to when the information is obtained via spontaneous report. 9,19,20 Because these adverse events can be disturbing for patients, negatively impact compliance, and reduce treatment satisfaction, care should be taken when considering the tolerability data of triptans based only on spontaneous reporting in clinical trials. In the COMPASS trial, the incidence of atypical triptan sensations was a prespecified outcome based on data from patients who were specifically queried about these symptoms.…”

Initial development and testing of an instrument for patient self-assessment of adverse drug reactions

“…This enabled a probability score to be computed, by summing 'Yes' responses from statements 1-7, which covered experiences likely to contribute positively to causal association, and 'No' responses from statements 8-10, covering experiences, which could reduce the likelihood of causal association. Respondents were then asked to assign the total score, ranging from 0 to 10, into four possible options, similar to the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality categories: 'Not a side effect' (Score 0), 'Possible side effect' (1)(2)(3)(4), 'Probable side effect' (5)(6)(7)(8) and 'Highly probable side effect' (9)(10). No weighting was used to render the tool as easy to use as possible.…”

“…5 Such questionnaires require patients to differentiate probable ADRs from other adverse events, with the potential for questionnaire structure to affect reporting rate and symptom accuracy. [6][7][8][9][10][11] Self-assessment ADR questionnaires commonly contain open-ended questions or checklists of side effects requiring patients to report subjective symptoms; thus, these instruments are useful for screening for suspected ADRs and could be useful in various disciplines such as community pharmacy, medicine or nursing, as well as in drug development. 5 Some also collects information about ADR characteristics including symptom onset, frequency, severity and seriousness, start and stop date of using the medicine and attribution of the symptoms.…”