Research priorities for therapeutic plasma exchange in critically ill patients.

Therapeutic plasma exchange (TPE) is a therapeutic intervention that separates plasma from blood cells to remove pathological factors or to replenish deficient factors. The use of TPE is increasing over the last decades. However, despite a good theoretical rationale and biological plausibility for TPE as a therapy for numerous diseases or syndromes associated with critical illness, TPE in the intensive care unit (ICU) setting has not been studied extensively. A group of eighteen experts around the globe from different clinical backgrounds used a modified Delphi method to phrase key research questions related to "TPE in the critically ill patient". These questions focused on: (1) the pathophysiological role of the removal and replacement process, (2) optimal timing of treatment, (3) dosing and treatment regimes, (4) risk-benefit assumptions and (5) novel indications in need of exploration. For all five topics, the current understanding as well as gaps in knowledge and future directions were assessed. The content should stimulate future research in the field and novel clinical applications.

EU expert panels for high-risk devices - another level of review?

The new EU regulations for medical device and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. These newly formed committees have published three opinions for medical devices and fifteen opinions for IVDs. The opinions offer a detailed and critical review of data from both the manufacturer and notified body, which give insight into the nature of their review processes. In 2022, Regulation (EU) 2022/123 gave responsibility for the oversight of those expert panels to the EMA. This move suggests a more active role for the EMA in the approval of medical devices in ways that will impact future device submissions. The additional review will bring a new level of complexity and criticism into an already strained review process. Copyright © 2022, TOPRA. All rights reserved.

An Adaptation of the RAND/UCLA Modified Delphi Panel Method in the Time of COVID-19.

The RAND/UCLA modified Delphi panel method is a formal group consensus process that systematically and quantitatively combines expert opinion and evidence by asking panelists to rate, discuss, then re-rate items. The method has been used to develop medical society guidelines, other clinical practice guidelines, disease classification systems, research agendas, and quality improvement interventions. Traditionally, a group of experts meet in person to discuss results of a first-round survey. After the meeting, experts complete a second-round survey used to develop areas of consensus. During the COVID-19 pandemic, this aspect of the method was not possible. As such, we have adapted the method to conduct virtual RAND/UCLA modified Delphi panels. In this study, we present a targeted literature review to describe and summarize the existing evidence on the RAND/UCLA modified Delphi panel method and outline our adaptation for conducting these panels virtually. Transitioning from in-person to virtual meetings was not without challenges, but there have also been unexpected advantages. The method we describe here can be a cost-effective and efficient alternative for researchers and clinicians.

Informing the Development of a Standardized Clinical Definition of Neonatal Abstinence Syndrome: Protocol for a Modified-Delphi Expert Panel.

BACKGROUND: Neonatal abstinence syndrome (NAS) is a postnatal withdrawal syndrome that most commonly results from prenatal opioid exposure. Every 15 minutes, an infant is born in the United States with signs of NAS. The field lacks a standardized clinical definition of NAS, complicating discussions on programmatic and policy development to support opioid-exposed mothers and infants. OBJECTIVE: The goal of this paper is to describe a protocol for a systematic expert panel process to inform the development of a clinical definition of NAS. METHODS: We will conduct two three-round online modified-Delphi panels using the ExpertLens system and will follow the recommendations for Conducting and REporting of DElphi Studies (CREDES). One panel will focus on developing key components of a clinical definition of NAS, and the second panel will focus on neonatal opioid withdrawal syndrome (NOWS), which is a term that has come into use to differentiate opioid-exposed infants from infants exposed to other substances in utero. However, there is lack of agreement on the precise clinical definition of NOWS and how it is distinct from or overlaps with NAS. Each panel will complete two rating rounds and a discussion round using a similar protocol. We will analyze all rating data descriptively and determine the presence of agreement within and between the two panels. We will also perform thematic analysis of the qualitative comments to contextualize the panel findings. RESULTS: The panels were convened between October 29 and December 17, 2020. Their results were disseminated and discussed at a national conference on NAS that took place on March 17-18, 2021. CONCLUSIONS: A standardized clinical definition of NAS will help to better characterize NAS incidence and to design effective clinical, public health, and policy interventions to support opioid-exposed mother-infant dyads. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25387.

Delphi methodology in healthcare research: How to decide its appropriateness.

The Delphi technique is a systematic process of forecasting using the collective opinion of panel members. The structured method of developing consensus among panel members using Delphi methodology has gained acceptance in diverse fields of medicine. The Delphi methods assumed a pivotal role in the last few decades to develop best practice guidance using collective intelligence where research is limited, ethically/logistically difficult or evidence is conflicting. However, the attempts to assess the quality standard of Delphi studies have reported significant variance, and details of the process followed are usually unclear. We recommend systematic quality tools for evaluation of Delphi methodology; identification of problem area of research, selection of panel, anonymity of panelists, controlled feedback, iterative Delphi rounds, consensus criteria, analysis of consensus, closing criteria, and stability of the results. Based on these nine qualitative evaluation points, we assessed the quality of Delphi studies in the medical field related to coronavirus disease 2019. There was inconsistency in reporting vital elements of Delphi methods such as identification of panel members, defining consensus, closing criteria for rounds, and presenting the results. We propose our evaluation points for researchers, medical journal editorial boards, and reviewers to evaluate the quality of the Delphi methods in healthcare research.