SPS Plenary Session | May 21, 2019 9:45 am | Maala Bhatt and Joseph Cravero
The prospect of conducting sedation research in a clinical setting is exciting and full of promise but a challenge in many respects. During this session, Drs. Bhatt and Cravero provided a thoughtful and comprehensive approach for conducting sedation research, providing both practical guidelines and examples from their own experience.
A unique feature of sedation research highlighted by Dr. Bhatt was the fact that many of the outcomes of interest are rare (e.g. serious adverse events), thereby necessitating either a multicenter approach or a multi-year approach. It was noted that although sedation registry studies (such as the PSRC) are typically regarded as observational and below the randomized control trial (RCT) in the hierarchy of evidence, some argue that registry studies may actually provide stronger evidence than RCTs for sedation research because they present data drawn from “real world” conditions, rather than the controlled, experimental environment of an RCT.
In addition, registry studies have been able to describe variations in treatments and outcomes and identify risk factors for rare outcomes that would have been impossible to determine with an RCT. However, Dr. Bhatt pointed out that caveats for registry studies include: the need to collect data in a naturalistic manner (i.e. data collected as part of patient encounter, not as part of a study protocol); missed patients must be minimized so that patients in the registry are representative of the population of interest; registries must be designed to fulfill a specific purpose; and, data elements must have specific and consistent data definitions, be collected in a uniform manner for every patient, and be those that clinicians would typically use for diagnosis and management.
Dr. Bhatt’s advice for finding the right question for a sedation study would be to find a topic that aligns with institutional and service line priorities and falls within the intersect of three things: issues the system cares about, data the system tracks, and issues that you care about and want to track.
During this talk, Dr. Cravero introduced what will certainly become the oft-cited “Bob Ross Approach” to clinical research: “Making something mundane fun and interesting.” He has encouraged this approach at his own institution with weekly meetings where they “try to act like a start-up” with an open forum for ideas, discussing questions that are of personal interest to themselves and their practice, fostering a sense of communal purpose and progress, and supplementing said meetings with brownies, coffee and occasionally kale.
He reminded us that a tiny minority of what we do in practice is actually evidence-based and that there will always be a wealth of questions to be asked and answered, many of which can be elicited by simply identifying what you are interested in and what is important to your sedation service. In addition, Dr. Cravero pointed out that the ongoing evolution of the EMR has made all kinds of new, hybrid clinical trials possible, and he encouraged us to consider this when designing sedation studies. He concluded by saying that clinical sedation research can be a part of everyone’s everyday work and is worthwhile because it can help us and other people do a better job for our patients. “If you have a better idea, then just prove it and tell other people about it!”