Proposed Guideline for Minimum Information Stroke Research and Clinical Data Reporting

Abstract

The management and analyses of large datasets is one of the grand challenges of modern biomedical research. Establishing methods to harmonise and standardise data collection, reporting, sharing and the employed data dictionaries, can support the resolution of these challenges whilst improving research quality, data quality and integrity, allowing sustainable knowledge transfer through re-usability, interoperability, reproducibility. The current project aimed to develop and propose a standardised reporting guideline for stroke research and clinical data reporting. Through systematic consolidation and harmonization of published data collection and reporting standards, several recommendations were drafted for the proposed guideline. These recommendations were reviewed by domain-researchers and clinicians using an online survey, developed in REDCap. The survey was completed by 20 international stroke-specialists, majority of respondents were based in Africa (10), followed by America, Europe and Australia (10). Of these respondents; the majority were working as dual clinician-researchers (57%) with more than 10 years' experience in the field (78%). Data elements within the reporting standard were classified as participant-, study-and experiment-level information, further subdivided into essential or optional information, and defined using existing ontologies. The proposed reporting guideline can be employed for research utility and adapted for clinical utility as well. It is accompanied with an associated XML schema for REDCap implementation, to increase the user friendliness of data capturing, sharing, reporting and governance. Ultimately, the adoption of common reporting in stroke research has the potential to ensure that researchers gain the maximum benefit from their generated data and data collections.

Developing Clinical Phenotype Data Collection Standards for Research in Africa

“…Regarding the assessment of the validity of data collection kits, we had limited opportunity to measure the validity of the domain-specific kits in practice within the scope of H3Africa, given the time of development and final release of these kits. To counter this, we sought to assess and ensure the validity of the kits in other ways; therefore, we encouraged collaboration and worked alongside field experts to develop each of the kits, including, as previously illustrated, the Kidney Disease and Stroke kits [ 15 , 16 ]. We also sought additional external feedback on the elements and data collection protocols included in the kits by surveying field experts.…”

“…The PHWG aimed to build a core set of phenotypes to be collected within the consortium and develop protocols to facilitate the collection of these phenotypes. This work was later expanded to cover specific research or disease domains, which were represented in clusters across the consortium [ 15 , 16 ]. Here we describe the development and dissemination of standard phenotype data collection kits for genomics research, which are adapted to ensure their suitability for use in African settings.…”