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Transcranial doppler re-screening of subjects who participated in STOP and STOP II
Robert J Adams1, Dan T Lackland1, Lynette Brown2
1Neurology, Medical University of South Carolina, Charleston, South Carolina.
Insights
The STOP Protocol for stroke prevention in children with Sickle Cell Disease (SCD) shows inconsistent implementation, with only 57% receiving recommended Transcranial Doppler Ultrasound (TCD) rescreening. Site variation highlights potential for system improvements to reduce ischemic stroke risk.
Area of Science:
- Pediatric Hematology
- Neurology
- Public Health
Background:
- Stroke is a major complication in children with Sickle Cell Disease (SCD).
- The STOP Protocol, combining Transcranial Doppler Ultrasound (TCD) and chronic red cell transfusion (CRCT), is a proven stroke prevention strategy.
- The extent of STOP Protocol implementation post-clinical trials is not well understood.
Purpose of the Study:
- To assess the real-world implementation of the STOP Protocol in children with SCD.
- To evaluate the rates of TCD rescreening and CRCT maintenance in the Post STOP era.
- To identify factors associated with protocol adherence and variations in implementation across sites.
Main Methods:
- A retrospective medical records review of children participating in the STOP and STOP II trials.
- Analysis of data from 19 sites that conducted the pivotal trials, covering the 10-15 years following their conclusion.
- Inclusion of 2,851 medical records from children eligible for TCD rescreening.
Main Results:
- Only 57% (1,090 of 1,896) of eligible children received TCD rescreening in the Post STOP era.
- Significant variation in TCD rescreening rates observed across sites (18% to 91%).
- Younger age and conditional TCD results during prior trials were linked to higher rescreening likelihood; 68 new high-risk cases were identified.
Conclusions:
- The STOP Protocol for stroke prevention in children with SCD is not fully implemented, even at experienced centers.
- Wide site variation suggests systemic barriers to implementation exist.
- Improving implementation could further reduce ischemic stroke incidence in pediatric SCD patients.
Abstract:
In children with Sickle Cell Disease, the combination of risk stratification with Transcranial Doppler Ultrasound (TCD) and selective chronic red cell transfusion (CRCT-the STOP Protocol) is one of the most effective stroke prevention strategies in medicine. How fully it is being implemented is unclear. Nineteen of 26 sites that conducted the two pivotal clinical trials (STOP and STOP II) participated in Post STOP, a comprehensive medical records review assessing protocol implementation in the 10-15 years since the trials ended. Professional abstractors identified medical records in the Post STOP era in 2851 (74%) of the 3,840 children who took part in STOP and/or STOP II, and documented TCD rescreening, maintenance of CRCT in those at risk, and stroke. Among 1,896 children eligible for TCD rescreening (target group), evidence of any rescreening was found in 1,090 (57%). There was wide site variation in TCD rescreening ranging from 18% to 91% of eligible children. Both younger age and having a conditional TCD during STOP/II were associated with a higher likelihood of having a TCD in Post STOP. Sixty eight new abnormal, high risk cases were identified. Despite clear evidence of benefit the STOP protocol is not fully implemented even at experienced sites. Site variation suggests that system improvements might remove barriers to implementation and result in even greater reduction of ischemic stroke in children with SCD. Am. J. Hematol. 91:1191-1194, 2016. © 2016 Wiley Periodicals, Inc.
