Ask any two sedation providers what an adverse event in procedural sedation is and you will likely get two different answers. Whether the events that occur during sedation are “adverse” or not are debated, plus a standardized definition of any individual event during procedural sedation has been challenging. Research manuscripts often select their own definitions for adverse outcomes; some further subdividing events by severity. Organizations track and monitor sedation outcomes as part of their quality and safety monitoring programs, again choosing for themselves which events they consider to be most valuable for their organization.
In an article published in January of this year by M.G. Roback et al in the British Journal of Anaesthesia, the International Committee for the Advancement of Procedural Sedation (ICAPS) has taken on the challenge of developing a practical tool for quality monitoring as well as sedation researchers that evaluates sedation outcomes in an objective way to reduce the disparities between reporting. The tool (or tools, there is one for research and one for clinical use) is called TROOPS or “Tracking and Reporting Outcomes of Procedural Sedation”. 1 The tool was developed by an international group of experts in the fields of anesthesia, dentistry, pediatrics, emergency medicine, critical care and gastroenterology using the Delphi method and is intended for use by all types of sedation providers in any type of location.
The quality improvement tool divides outcomes into Intermediate and Sentinel. Sentinel events are items that are “life threatening and warrant immediate reporting and the highest level of peer scrutiny”. Intermediate outcomes are those that “can endanger patients if not promptly managed or reflect suboptimal sedation quality or patient experience”. Each of these categories is subdivided into Airway/Breathing, Circulation, Neuro and lastly Sedation Quality & Patient Experience. This last category takes into account both the provider and patient and family satisfaction. Intermediate events will periodically occur within procedural sedation and should not be life threatening when managed accordingly by a well-trained team. But, because sentinel events are rare, the authors argue that tracking intermediate events are important as surrogate measures to “estimate the quality of a given sedation system.” Recognizing that one tool could not serve clinical quality improvement as well as research purposes, the research tool has a third category of outcomes – “Minor” – which has an additional subsection of GI.
One of the debates over time has been whether it matters if an intervention is planned or unplanned for it to be considered an adverse event. The ICAPS approached this debate and chose to resolve it by concluding that any intervention recorded on the TROOPS tool would be unplanned. They acknowledged that different providers (e.g. typically anesthetists vs non-anesthetists) may have a different expectation as to planned interventions but this approach makes the tool usable by all providers.
TROOPS avoided defining events by duration and thresholds (i.e. apnea for > 30 seconds or desaturations < 85% for longer than 30 seconds) due to practitioners generally not agreeing on the duration at which an event becomes adverse and duration may not be tracked objectively in the midst of focusing on patient care. ICAPS chose, however, to use guidance from the 2009 Quebec Guideline for Pediatric Sedation Research2 and define an adverse event based on the intervention performed on its behalf. Therefore an adverse event would apply if, for example, oxygen desaturation occurred and an intervention was performed in order to improve the desaturation. This will still vary depending on provider practice differences, but some of these differences will be negated when considering that the tool is intended to capture only unplanned events/interventions.
Both tools are in a checklist format; organized into an organ systems format making them easy to use. The purpose of the clinical quality improvement tool would be to serve as a way to flag a sedation encounter for further review by the quality improvement team. The article provides an example of a paper version or a link to an online version of the data collection instrument (www.TROOPS-sedation.com). Neither version (paper or online) collects HIPPA information so the method for how to identify the record to review for sentinel events identified by the TROOPS tool would need to be worked out by individual institutions.
Many pediatric sedation services utilize the Pediatric Sedation Research Consortium (PSRC) for sedation outcome/tracking purposes. What advantage might the TROOPS tool have over the PSRC? First, if utilized in real time, it could allow for immediate identification of sentinel issues that need to be addressed in an urgent manner. Second, it limits the number of “sub-sentinel” outcomes to those most likely to have the largest potential for patient impact. Is it worth adopting if centers are already utilizing the PSRC? That depends. The breadth of the data that is collected into the PSRC includes so much more than just outcomes and therefore informs services in many more ways than just their end results. The PSRC data has been used in a multitude of publications since its inception while the TROOPS tools have yet to be trialed by actual sedation services. I do believe that the TROOPS tool could be added to the quality monitoring toolbox of a sedation service with minimal effort or change to the workflow of the team but with a chance to gain a more timely knowledge of opportunities. If multiple services adopt the use of the TROOPS quality improvement tool, outcomes could be compared easily between institutions without having to first compare definitions of what is an adverse outcome. Neither TROOPS nor the PSRC takes into account the patient or procedure characteristics and how those impact the risks for sedation outcomes. No outcome assessment tool to date has provided this Holy Grail: allowing us to compare patient and procedure adjusted outcomes between institutions.
TROOPS is the first multidisciplinary consensus based, standardized sedation-outcome monitoring tool geared for use by all sedation providers in all settings for the purpose of quality monitoring in procedural sedation. The widespread use of its research companion would allow comparison of studies side by side using identical definitions. Each tool should be easily adoptable by sedation services and researchers alike but has not yet undergone reliability or validity evaluation nor have we seen the results from centers that are using this tool.
1Roback MG, Green SM, Andolfatto G, Leroy PL and Mason KP. Tracking and Reporting Outcomes of Procedural Sedation (TROOPS): Standardized Quality Improvement and Research Tools from the International Committee for the Advancement of Procedural Sedation. Br J Anaesth. 2018 Jan;120(1):164-172.
2Bhatt M, Kennedy RM, Osmond MH. et al. Consensus based recommendations for standardizing terminology and reporting adverse events for emergency department procedural sedation and analgesia in children. Ann Emerg Med. 2009; 53: 426-35.