A review of self-report medication side effect questionnaires for mental health patients

A tolerability burden index in schizophrenia: incorporating patient perspective in clinical trial adverse event reporting

“…Instead, information about patient experiences as reported by clinicians and aggregated for each AE is most commonly presented, without documenting the cumulated impact experienced by a single patient or the patients who do not experience any such events. This limitation of AE reporting in clinical trials is recognized by clinicians, whose perception of tolerability-related treatment burden often differs from the patient experience [1,2]. The reporting is further complicated by serious AEs, which may necessitate withdrawal from a study but may not represent a significant perceived burden to the individual patient, such as increased QT intervals (i.e., the time between the start of the Q wave and the end of the T wave in the electrical rhythm of the heart).…”

“…Indeed, a systematic review of 53 studies concluded that: ‘Antipsychotic adverse effects are diverse and frequently experienced, but are not often systematically assessed’ [9]. The tolerability-related burden associated with these AEs may lead to poor adherence or earlier treatment discontinuation and, as a result, worse functional outcomes [2,11,12]. Several observer-reported and self-reported AE assessment scales for antipsychotic medications are available [2,13–17].…”

“…The tolerability-related burden associated with these AEs may lead to poor adherence or earlier treatment discontinuation and, as a result, worse functional outcomes [2,11,12]. Several observer-reported and self-reported AE assessment scales for antipsychotic medications are available [2,13–17]. Self-reported scales include the Udvalg for Kliniske Undersøgelser (UKU) Side-Effect Rating Scale, the Liverpool University Neuroleptic Side-Effect Rating Scale (LUNSERS), and the Glasgow Antipsychotic Side-Effect Scale (GASS).…”

“…As such, the LUNSERS cannot be readily used to compare the tolerability profiles of antipsychotics and has not been included in many pivotal studies. The GASS resolves some ambiguity of phrasing in the LUNSERS [2] and enables patients to report whether an AE is ‘distressing’ in addition to rating its severity [17]; however, like the LUNSERS, the GASS contains only a subset of the AEs that can occur with antipsychotics and therefore has limited utility. Another approach to estimating AEs is to consider the subjective nature of the AE.…”

Construction and validation of the My Medicines and Me Questionnaire for assessment of the self-reported side effects of psychotropic medication

“…These vary in complexity, length and mode of administration, but provide limited opportunity for users to write and express their individual experiences. In fact, previous research has identified a gap in the development of side-effect SRQs for mental health patients (Ashoorian et al, 2014). A need was identified for a side-effect questionnaire that is applicable to all psychotropic medications that would allow patients to identify the most bothersome side effects and also be provided the opportunity to elaborate on the impact that these effects are having on their lives.…”