Development of quality indicators for the diagnosis and management of achalasia.

BACKGROUND: The management of achalasia has improved due to diagnostic and therapeutic innovations. However, variability in care delivery remains and no established measures defining quality of care for this population exist. We aimed to use formal methodology to establish quality indicators for achalasia patients. METHODS: Quality indicator concepts were identified from the literature, consensus guidelines and clinical experts. Using RAND/University of California, Los Angeles (UCLA) Appropriateness Method, experts in achalasia independently ranked proposed concepts in a two-round modified Delphi process based on 1) importance, 2) scientific acceptability, 3) usability, and 4) feasibility. Highly valid measures required strict agreement (≧ 80% of panelists) in the range of 7-9 for across all four categories. KEY RESULTS: There were 17 experts who rated 26 proposed quality indicator topics. In round one, 2 (8%) quality measures were rated valid. In round two, 19 measures were modified based on panel suggestions, and experts rated 10 (53%) of these measures as valid, resulting in a total of 12 quality indicators. Two measures pertained to patient education and five to diagnosis, including discussing treatment options with risk and benefits and using the most recent version of the Chicago Classification to define achalasia phenotypes, respectively. Other indicators pertained to treatment options, such as the use of botulinum toxin for those not considered surgical candidates and management of reflux following achalasia treatment. CONCLUSIONS & INFERENCES: Using a robust methodology, achalasia quality indicators were identified, which can form the basis for establishing quality gaps and generating fully specified quality measures.

Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0©.

Chicago Classification v4.0 (CCv4.0) is the updated classification scheme for esophageal motility disorders using metrics from high-resolution manometry (HRM). Fifty-two diverse international experts separated into seven working subgroups utilized formal validated methodologies over two-years to develop CCv4.0. Key updates in CCv.4.0 consist of a more rigorous and expansive HRM protocol that incorporates supine and upright test positions as well as provocative testing, a refined definition of esophagogastric junction (EGJ) outflow obstruction (EGJOO), more stringent diagnostic criteria for ineffective esophageal motility and description of baseline EGJ metrics. Further, the CCv4.0 sought to define motility disorder diagnoses as conclusive and inconclusive based on associated symptoms, and findings on provocative testing as well as supportive testing with barium esophagram with tablet and/or functional lumen imaging probe. These changes attempt to minimize ambiguity in prior iterations of Chicago Classification and provide more standardized and rigorous criteria for patterns of disorders of peristalsis and obstruction at the EGJ.

Assessment of the esophagogastric junction (EGJ) using the EGJ contractile integral (EGJ-CI) following per-oral endoscopic myotomy (POEM) in achalasia

Background: the esophagogastric junction contractile integral (EGJ-CI) is a novel high-resolution manometry (HRM) tool designed to assess EGJ barrier function. This study assessed whether changes in EGJ-CI values reflect a disruption of the EGJ in achalasia patients undergoing per-oral endoscopic myotomy (POEM). Methods: patients with HRM performed both before and after POEM were identified over a three year period and were compared to healthy controls. EGJ-CI was calculated using the St Louis method, where EGJ vigor is assessed independently of respiration and referenced to the gastric baseline. It is reported as mmHg.cm. Pre- and post-POEM EGJ-CI, conventional lower esophageal sphincter pressure (LESP) metrics (end expiratory LESP and mean basal LESP) and integrated relaxation pressure (IRP) were compared between groups. The correlation between EGJ-CI and conventional LESP metrics was also assessed and compared to controls. Results: fifteen achalasia patients (35.2 ± 2.5 years, 73% female) fulfilled the inclusion criteria and were compared to 20 healthy volunteers (26.6 ± 1.1 years, 50% female). The Eckardt score was significant lower after POEM (1.5 ± 0.3 vs 7.0 ± 0.5, p < 0.001). Baseline conventional LESP metrics, EGJ-CI and IRP were higher in achalasia cases compared to controls (p < 0.001). Both conventional LESP metrics and EGJ-CI decreased significantly following POEM (p < 0.001) and approximated the values recorded in controls (p ≥ 0.1). However, IRP remained higher post-POEM compared to controls (p = 0.011). EGJ-CI correlated with conventional LESP metrics at baseline (Pearson's r = 0.75-0.79; Spearman's rho = 0.84-0.85, p < 0.001) and following POEM (0.55-0.70 and 0.5-0.77, respectively; p ≤ 0.03). Conclusions: EGJ-CI complements the assessment of the EGJ barrier and may be a useful metric to follow barrier function after per-oral myotomy

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High resolution manometry patterns distinguish acid sensitivity in non-cardiac chest pain.

BACKGROUND: High resolution manometry (HRM) has demonstrated two distinct smooth muscle contraction segments in the esophageal body; changes in these segments typify certain esophageal disorders. We investigated segmental characteristics in subgroups of non-cardiac chest pain (NCCP). METHODS: 32 NCCP subjects were segregated into a GERD group (ambulatory pH testing off antisecretory therapy showing elevated total acid exposure time, AET≥4.0% and positive symptom association probability, SAP) and an acid sensitive group (normal AET and positive SAP). HRM Clouse plots were analyzed; smooth muscle segment lengths, pressure amplitude peaks were measured for segment 2 and segment 3 (proximal and distal smooth muscle segments). Pressure volumes were determined in mmHg cm(-1) s(-1) for each peristaltic segment, and ratios of segment 3:segment 2 calculated. Values were compared to a cohort of 14 normal controls. KEY RESULTS: A distinctive shift in peak contraction amplitude to segment 3 was evident in the acid sensitive group (segment 2, 100.03±11.06mmHg, segment 3, 145.23± 10.29mmHg, P=0.006). Pressure volumes were similarly shifted to segment 3 (segment 2: 855.3 ± 135.1 mmHg cm(-1) s(-1) , segment 3: 2115.2±218.6 mmHg cm(-1) s(-1) , P<0.005). In contrast, peak amplitude and pressure volume were near equal in the two segments in GERD and control groups. A threshold segment 3:segment 2 pressure volume ratio of 1.9 had the best performance characteristic for segregating acid sensitivity subjects from all GERD and control subjects. CONCLUSIONS & INFERENCES: Shift in contractile vigor to the third peristaltic segment may be seen in acid sensitive subjects. HRM characteristics of smooth muscle contraction segments are of value in making this determination.