Abstract
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Objectives Gastric emptying scintigraphy (GES) results are known to be variable across institutions owing to lack of protocol standardization. This affects the accuracy and consistency of results as well as the reliability of reported normal values.1. Many factors including patient preparation, meal composition and technical details can influence the final interpretation.2 To address this, SNMMI published Procedure Guideline for Adult Solid-Meal Gastric-Emptying Study 3.0 in 2009, which describes a consensus-recommended, standardized and validated protocol using a large normal database.3 For valid comparisons between facilities, protocols must closely follow this standard methodology. The degree of adherence to the guidelines at a national level is unknown. The aim of our study was to assess the rate of compliance to the standardized protocol in a large cohort of laboratories from different practice settings across the US.
Methods We used the Intersocietal Accreditation Commission (IAC) database to extract detailed information from the gastric emptying protocols of 129 laboratories applying for general nuclear medicine (GNM) accreditation in 2013 - 2015. We evaluated six key elements for compliance with the consensus protocol: 1. medication withholding - prokinetic agents, opiates, and anticholinergic drugs; 2. blood glucose level - not to exceed 275 mg/dl; 3. meal - all 4 ingredients with correct quantity and preparation; 4. radiopharmaceutical dose - 蠅0.5 -≤ 1 mCi technetium-99m sulfur colloid (SC); 5. frequency/duration of imaging - minimum 0, 1, 2 and 4 hours; 6. reporting - geometric mean from anterior and posterior projections, decay corrected and expressed as % retention with normal values. We compared protocol compliance with various laboratory attributes.
Results Facility characteristics - A majority of laboratories were hospital-based (58.9%) and located in the South and Northeast US, performing a median of 1201 GNM studies annually. The median number of physicians, technologists, and cameras per laboratory was 7 (range 1-38), 5 (range 1-31), and 3 (range 1-22), respectively. Although almost all of the laboratories (96.1%) had been previously accredited at least once, accreditation was delayed for 58.9%. Variable Compliance - Only 17%% of laboratory protocols were fully compliant with all 6 consensus variables. 3.1% of protocols were not compliant with any variables, with an additional 40.3% compliant with only one. 55% of the protocols were noncompliant with 4 of the 6 variables. Patient preparation (blood glucose and medication withholding) had the lowest compliance - 23.3% and 27.1%, respectively. Full compliance with the meal elements/preparation was found in 31.0% of protocols. Radiopharmaceutical dose 蠅0.5 - ≤1 mCi Tc-99m SC had the highest compliance (67.4%). Compliance Comparisons - We found significant positive correlations in meal compliance with numbers of technologists (p< 0.001), cameras (p=0.006), and volume of GNM studies performed annually (p=0.006). We also found significant positive correlations in dose compliance with technologists (P=0.026) and cameras (p=0.042). Larger facilities with more technologists, cameras, and number of studies performed were more likely to have compliant protocols.
Conclusions Almost seven years after the publication of the SNMMI GES guideline, there is low protocol adherence among laboratories applying for IAC accreditation. This substantial degree of guideline noncompliance is concerning. The variability in GES protocols may have a significant effect on patient management, as results may be inaccurate and/or inconsistent. The low level of protocol adherence indicates a continued gap between guideline publication and implementation and points to a need for further dissemination of the consensus protocol and education efforts.
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