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ThinkMind // International Journal On Advances in Life Sciences, volume 16, numbers 1 and 2, 2024 // View article lifsci_v16_n12_2024_6
Developing a Process for Gathering and Managing Multi-site User Feedback for a Data Collection Project in a Rare Disease Setting. Using Design Science to Explicate a Knowledge Contribution
 Authors:
Sinéad Impey
Jonathan Turner
Frances Gibbons
Anthony Bolger
Gaye Stephens Stephens
Lucy Hederman
Ciara O'Meara
Ferran De La Varga
John Kommala
Matthew Nicholson
Daniel Farrell
Emmet Morrin
Miriam Galvin
Mark Heverin
Éanna Mac Domhnaill
Robert McFarlane
Dara Meldrum
Deirdre Murray
Orla Hardiman Keywords: amyotrophic lateral sclerosis; design science; knowledge contributions; requirements gathering; data collection Abstract:
Large datasets are required to understand disease progression, investigate treatment options and discover potential cures in rare neurological conditions such as Amyotrophic Lateral Sclerosis. Generating large datasets for such rare conditions requires the participation of multiple specialist clinical sites. The Precision ALS project is a partnership between multiple specialist Amyotrophic Lateral Sclerosis clinical sites (n=10) and industry partners across Europe that seeks to collect and analyse multi-modal data collected from participants with the disease. The project is managed by an expert group comprised of clinical, technical, business, legal and interdisciplinary specialists. Adopting a design science approach, the project created an artefact – a data collection tool. This tool is used by data collectors at each specialist clinical site to capture a range of patient information, including biological and socio-economic data. Applying an iterative approach, the initial user requirements were based on extensive collaborative projects undertaken by clinical sites, which formed the basis of a bespoke worksheet. Additional modifications were introduced through project group discussions and engaging members from one of the clinical specialist sites. The lessons learned from this initial work were formulated into a knowledge contribution in the form of a process for integrating pre-existing paper-based data collection processes, additional requirement gathering and managing user feedback. The process is a way to identify and manage the early digital representation of data gathering paper worksheets, along with the volume and variety of unstructured feedback generated during a diverse range of multi-site user engagements. A central component of the process is three themes that were adapted from the initial feedback and presented as three pillars: Digital Worksheet; Usability; and Process/actors. These three pillars were embedded in a four-step information pipeline (capture, record, review and target), which provided a structure to ensure that the management of this feedback was transparent and auditable from source to decision. This paper describes the knowledge contribution of the user requirements gathering process explicated through a design science approach targeted towards the data collection tool resulting from this process. Pages: 56 to 66 Copyright: Copyright (c) to authors, 2024. Used with permission. Publication date: June 30, 2024 Published in: journal ISSN: 1942-2660
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