Dataset Information

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures.

ABSTRACT: BACKGROUND:Evolving regulatory guidelines recommend routine assessment of the acceptability of pediatric oral medicines throughout clinical development processes. However, such assessment is problematic owing to a lack of standard methods or criteria that define acceptability for children and their caregivers. This research aimed to identify the attributes of acceptability for targeted oral formulation types that are important to children, and to develop content-valid patient- and caregiver-reported outcome acceptability measures for use in the context of clinical drug development. METHODS:A concept-focused literature review and two advisory panel meetings involving researchers, clinicians, and measurement scientists were conducted to identify acceptability attributes that may be relevant to children taking targeted oral medicine formulations. The Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQs), including patient (P-OMAQ-P) and caregiver (P-OMAQ-C) versions, were drafted to assess these attributes. Qualitative concept elicitation (CE) and cognitive debriefing (CD) patient and caregiver interviews were conducted to confirm key acceptability attribute concepts for measurement and to evaluate patient and caregiver ability to understand and respond to the questions. RESULTS:A full-text review of 40 articles identified 24 acceptability attributes that were categorized into 10 overarching domains and organized into a preliminary conceptual model. Feedback from the advisory panel refined the preliminary model. In total, 14 attributes were reported during the CE phase of the interviews (n?=?23 pediatric patients, n?=?13 caregivers); six attributes were included in the final model. The draft P-OMAQ was refined over four waves of CD interviews (n?=?31 pediatric patients, n?=?48 caregivers). The final version of the P-OMAQ-P is a 12-item questionnaire designed for young people aged 8-17?years. The P-OMAQ-C is a 19-item questionnaire designed for adult caregivers of young people aged 6?months to 17?years. There are two versions of each questionnaire: one with a 24-h recall period and one with a 7-day recall period. All items are answered on a 5-point numerical rating scale. CONCLUSIONS:This research supports the content validity of the patient and caregiver versions of the P-OMAQ. Both questionnaires appropriately assess the acceptability of oral medicine formulations from the perspective of pediatric patients and their caregivers.

SUBMITTER: Turner-Bowker DM

PROVIDER: S-EPMC7527387 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures.

Turner-Bowker Diane M DM An Haack Kristina K Krohe Meaghan M Yaworsky Andrew A Vivas Norma N Kelly Masami M Chatterjee Godhuli G Chaston Emily E Mann Erin E Reaney Matthew M

Journal of patient-reported outcomes 20201001 1

<h4>Background</h4>Evolving regulatory guidelines recommend routine assessment of the acceptability of pediatric oral medicines throughout clinical development processes. However, such assessment is problematic owing to a lack of standard methods or criteria that define acceptability for children and their caregivers. This research aimed to identify the attributes of acceptability for targeted oral formulation types that are important to children, and to develop content-valid patient- and caregi ...[more]

PMID: 33000327

Similar Datasets

Project description:BackgroundThe use of patient-reported outcome measures (PROM) and caregiver-reported outcome measures can raise the patient centeredness of treatment and improve the quality of palliative care. Nevertheless, the everyday implementation of self-report in patients and caregivers is complex, and should be adapted for use in specific settings. We aimed to implement a set of outcome measures that included patient and caregiver self- and proxy-reported outcome measures in specialised outpatient palliative care (SOPC). In this study, we explore how the Integrated Palliative Outcome Scale (IPOS), IPOS Views on Care (IPOS VoC) and the Short-form Zarit Caregiver Burden Interview (ZBI-7) can be feasibly, acceptably and appropriately implemented in the daily care routines of SOPC.MethodsFive SOPC teams were trained, and used the outcome measures in daily practice. Team members were mainly nurses and physicians. To investigate their feedback, we used a multi-method qualitative design consisting of focus groups with SOPC-team members (n = 14), field notes of meetings and conversations with the SOPC teams. In an iterative process, we analysed the findings using qualitative content analysis and refined use of the outcome measures.ResultsWe found that integrating patient and caregiver outcome measures into daily care routines in SOPC is feasible. To improve feasibility, acceptability and appropriateness, the resulting burden on patients and relatives should be kept to a minimum, the usefulness of the measures must be understood, they should be used considerately, and administration must be manageable. We removed ZBI-7 from the set of measures as a result of feedback on its content and wording.ConclusionsSOPC-team members have reservations about the implementation of PROM in SOPC, but with appropriate adjustments, its application in daily care is feasible, accepted and perceived as appropriate. Previous to use, SOPC-team members should be trained in how to apply the measures, in the design of manageable processes that include integration into electronic documentation systems, and in ongoing evaluation and support. They should also be taught how useful the measures can be.Trial registrationMay 19th, 2017, German Clinical Trials Register DRKS-ID: DRKS00012421 .

Dataset Information

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures.

Publications

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets