Details

Autor(en) / Beteiligte

• Shah, Eric D.
• Pelletier, Elizabeth A.
• Greeley, Carol
• Sieglinger, Emily E.
• Sanchez, Jamie D.
• Northam, Kayla A.
• Perrone, Jessica A.
• Curley, Michael A.
• Navas, Christopher M.
• Ostler, Tracy L.
• Burnett Greeley, Aimee R.
• Martinez-Camblor, Pablo
• Baker, Jason R.
• Harris, Adrienne
• Siegel, Corey A.
• Chey, William D.

Titel

An Office-Based, Point-of-Care Test Predicts Treatment Outcomes With Community-Based Pelvic Floor Physical Therapy in Patients With Chronic Constipation

Ist Teil von

• Clinical gastroenterology and hepatology, 2023-04, Vol.21 (4), p.1082-1090

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2023

Quelle

MEDLINE

Beschreibungen/Notizen

• Rectal evacuation disorders are common among constipated patients. We aimed to evaluate the accuracy of an investigational point-of-care test (rectal expulsion device [RED]) to predict outcomes with community-based pelvic floor physical therapy. We enrolled patients meeting Rome IV criteria for functional constipation failing fiber/laxatives for more than 2 weeks. RED was inserted and self-inflated, and then time-to-expel was measured in a left lateral position. All patients underwent empiric community-based pelvic floor physical therapy in routine care with outcomes measured at 12 weeks. The primary end point was global clinical response (Patient Assessment of Constipation Symptoms score reduction, >0.75 vs baseline). Secondary end points included improvement in health-related quality-of-life (Patient Assessment of Constipation Quality of Life score reduction, >1.0) and complete spontaneous bowel movement frequency (Food and Drug Administration complete spontaneous bowel movement responder definition). Thirty-nine patients enrolled in a feasibility phase to develop the use-case protocol. Sixty patients enrolled in a blinded validation phase; 52 patients (mean, 46.9 y; 94.2% women) were included in the intention-to-treat analysis. In the left lateral position, RED predicted global clinical response (generalized area under the curve [gAUC], 0.67; 95% CI, 0.58–0.76]), health-related quality-of-life response (gAUC, 0.67; 95% CI, 0.58–0.77; P < .001), and complete spontaneous bowel movement response (gAUC, 0.63; 95% CI, 0.57–0.71; P < .001). As a screening test, a normal RED effectively rules out evacuation disorders (expected clinical response, 8.9%; P = .042). Abnormal RED in the left lateral position (defined as expulsion within 5 seconds or >120 seconds) predicted 48.9% clinical response to physical therapy. A seated maneuver enhanced the likelihood of clinical response (71.1% response with seated RED retained >13 seconds) but likely is unnecessary in most settings. RED offers an opportunity to disrupt the paradigm by offering a personalized approach to managing chronic constipation in the community (Clinicaltrials.gov: NCT04159350). [Display omitted]