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Minimum data set for treatment effectiveness in pyoderma gangrenosum (MIDSTEP): an international protocol of an
Olivia M Haddadin1, Michael E Jacobson2, Diana M Chen3
1School of Medicine, Oregon Health and Science University, Portland, OR, USA.
Insights
Developing the Minimum Data Set for Treatment Effectiveness in Pyoderma gangrenosum (MIDSTEP) aims to improve patient outcomes by creating a standardized data set for the Pyoderma Gangrenosum Treatment Effectiveness (PyGaTE) registry. This will enhance clinical decisions and trial design for this rare inflammatory condition.
Area of Science:
- Dermatology
- Clinical Epidemiology
- Health Outcomes Research
Background:
- Pyoderma gangrenosum (PG) is a rare, understudied inflammatory condition with significant patient burden and poor outcomes due to limited treatments and evidence.
- Existing clinical evidence for PG treatments is of low quality, hindering improvements in patient care and treatment strategies.
- High-quality data is essential for advancing PG research, improving clinical decision-making, and informing the design of future clinical trials.
Purpose of the Study:
- To outline the protocol for developing the Minimum Data Set for Treatment Effectiveness in Pyoderma gangrenosum (MIDSTEP).
- To establish a core data set for the Pyoderma Gangrenosum Treatment Effectiveness (PyGaTE) international registry.
- To generate real-world data for improving clinical decisions, informing trial design, and promoting international research in PG.
Main Methods:
- A multi-phase project including literature review for domain item generation.
- An e-Delphi exercise involving diverse stakeholders (experts, patients, advocates) to finalize the core data set.
- Systematic methodology based on COMET guidelines and established registry practices.
Main Results:
- The protocol details a phased approach to developing a standardized data set for PG treatment effectiveness.
- The MIDSTEP project will culminate in the PyGaTE international registry for collecting real-world data.
- Consensus on standardized outcomes and a centralized database will enable systematic comparison and analysis of PG treatments.
Conclusions:
- MIDSTEP and the PyGaTE registry aim to generate and disseminate crucial real-world data to improve PG patient outcomes.
- Standardized data collection will facilitate evidence-based comparisons of existing treatments.
- This initiative holds the potential to develop a gold-standard treatment approach for pyoderma gangrenosum.
Abstract:
Pyoderma gangrenosum (PG) is a rare inflammatory condition with an immense disease burden that remains understudied. With limited approved treatments and low-quality clinical evidence, PG continues to have poor patient outcomes. Unfortunately, improvement in PG treatments and patient care is based on additional research endeavors that can only be developed from existing high-quality data. The following protocol outlines the development of the Minimum Data Set for Treatment Effectiveness in Pyoderma gangrenosum (MIDSTEP), a core set of domains and domain items for the Pyoderma Gangrenosum Treatment Effectiveness (PyGaTE) international registry. The outcomes and benefits are focused on providing real-world data for physicians to improve their clinical decisions on PG treatment and inform clinical trial design, promoting clinical research among the international scientific community. MIDSTEP is a multi-phase project. The first phase will produce a domain item list from a literature review to take into the second phase which would finalize the core data set by an e-Delphi exercise. There will be a single stakeholder group participating together in the e-Delphi consisting of PG experts (healthcare providers, researchers, methodologists, industry representatives, and regulators), ulcerative PG patients, and PG patient advocates. The methodology outlined in the protocol is a systematic method based on several guidelines through COMET and established dermatologic registries and outcome sets with systematic methodologies of their own. The third phase will identify the instruments for the items, the 'when to measure' the items, and the platform for the registry. The last phase is the implementation and continued maintenance of the international registry PyGaTE. By solidifying a consensus on standardized outcomes and collecting information on PG treatment effectiveness in a centralized database, existing treatments can be compared more systematically and analyzed with increased evidence. MIDSTEP and the PyGaTE international registry will have the ambitious goal to generate and disseminate real-world data that can be used by all stakeholders to improve health outcomes for PG patients. Future potential for the outcome of this project includes the development of a gold-standard PG treatment.
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