Gautam, Misha

ABSTRACT Background Treatment options for medically‐refractory faecal incontinence ( FI )—including anorectal biofeedback, dextranomer injection, and sacral nerve stimulation—are limited and outcomes are often suboptimal. Anal or vaginal insert devices are infrequently used. Aims We evaluated the safety and effectiveness of a new anal insert device (StaySure) in patients with FI. Methods Patients with FI for ≥ 6 months and ≥ 4 moderate or large FI episodes during a 4‐week baseline entered a 2–4 week fitting/run‐in period to individualise device size (10 or 13 mm) followed by a 4‐week treatment period. Outcomes included effectiveness, safety, and quality of life (QoL). The primary outcome was the proportion achieving a ≥ 50% reduction in FI frequency. Results Of 124 enrolled patients, 98, 71, and 61 progressed through the baseline, fitting/run‐in, and treatment phases respectively, with few exclusions due to device intolerance. In the intent‐to‐treat cohort of 59 participants (93% women), mean ( SD ) number of days with FI declined from 13.2 (7.0) to 6.3 (6.9), and FI weekly episodes declined from 5.4 (6.9) to 2.1 (5.1) (69% reduction; p < 0.001) with similar results for both device sizes. The primary endpoint was achieved in 76.3% of participants; 54.2% achieved ≥ 75% reduction. The FIQoL overall score increased from a mean ( SD ) of 1.9 (0.6) to 2.3 (0.6) ( p < 0.001), indicating improved QoL . Improvements in FI frequency, FIQoL exceeded minimal clinically important difference thresholds, confirming clear clinical benefit. No treatment‐related serious adverse events were reported. Conclusions The StaySure anal insert device is safe, well tolerated, and effective in reducing FI in patients with moderate to severe symptoms refractory to conservative therapies. Trial Registration ClinicalTrials.gov identifier: NCT03898778

e13683 Background: Access to specialized cancer care varies by place of residence, partly due to differences in geographic proximity to designated cancer centers. Telehealth services can help alleviate some of these geographic disparities. In response to the COVID-19 pandemic, Medicare telehealth services were expanded rapidly. In this study, we sought to describe the geographic variations in Medicare telehealth utilization and their relationship with locations of designated cancer centers in the United States. We hypothesized that differences in telehealth utilization might be reflective of barriers to telehealth access for Medicare beneficiaries in these regions. Methods: We used the Medicare Telehealth Trends data file and calculated the proportion of Medicare users who used a telehealth service (% Telehealth Users) across all quarters of 2021. To obtain % Telehealth Users in a state, the number of telehealth users were divided by the total number of telehealth-eligible users. Then, using % Telehealth Users as a metric of telehealth utilization, we ranked all US states by overall % Telehealth Users, and % Telehealth Users in rural and urban locations. Finally, we correlated these ranks with the presence of an NCI (National Cancer Institute) Designated Cancer Center within the states. Results: The % Telehealth Users ranged from 15%-53% overall, 16%-54% for rural locations, and 14%-54% for urban locations, across lowest ranked to highest ranked states. The 5 lowest ranking states and their respective % Telehealth Users overall were- Wyoming (20%), Montana (20%), Iowa (20%), South Dakota (18%), Nebraska (17%), and North Dakota (15%). The lowest ranking states in terms of rural % Telehealth Users were Montana, Kansas, Iowa, Tennessee, Wyoming (19% each), and South Dakota and Nebraska (16% each). The lowest ranking states in terms of urban % Telehealth Users were Montana (20%), Wyoming (20%), Nebraska (19%), South Dakota (16%), and North Dakota (14%). 4 out of 6 states overall, 3 out of 7 in the rural category, and 4 out of 5 states in the urban category that were ranked the lowest in telehealth utilization did not have an in-state NCI designated cancer center. Conclusions: Telehealth services can bridge gaps in access to specialty cancer care for patients that do not live in geographic proximity of cancer centers. However, regions lacking geographic proximity to cancer centers were also regions with poorest telehealth utilization. Advocacy and policy efforts directed towards increasing access to telehealth can ensure equitable and timely access to specialized cancer care in these regions of need.

AbstractBackground and objectivesChronic constipation (CC) may be caused by defecatory disorders (DDs) and associated with reduced rectal sensation. Among patients with type 1 diabetes (T1D) and CC (T1DCC patients), the prevalence of DDs and reduced rectal sensation is unknown. We sought to compare complications of T1D, anorectal dysfunction, and CC symptoms, among T1DCC patients with versus without a DD.MethodsAnorectal pressures at rest and during squeeze and evacuation, as well as rectal sensation and rectal balloon expulsion time (BET) were measured with high‐resolution anorectal manometry in 114 consecutive T1DCC patients.ResultsThirty‐seven patients (32%) had prolonged BET, suggestive of a DD. Complications of T1D included peripheral neuropathy (n = 67, 59%), retinopathy (n = 42, 37%), and nephropathy (n = 26, 23%). Among these complications, only retinopathy was associated with, that is, more prevalent in patients with normal (45%) than prolonged BET (19%). Compared with patients with normal BET, patients with prolonged BET had a lower rectal pressure (mean [SD], 32 [23] mm Hg vs. 23 [19] mm Hg,p = 0.03), greater anal pressure (91 [23] mm Hg vs. 68 [36] mm Hg,p < 0.001), and lower rectoanal gradient (−67 [30] mm Hg vs. −36 [32] mm Hg,p < 0.0001) during evacuation. Anal resting pressure and anal squeeze increment were below normal in 14 (13%) and 32 (29%) of patients and one or more rectal sensory thresholds were above normal in 34 (30%) patients; these abnormalities affected similar proportions in the normal and prolonged BET cohorts.ConclusionsAmong T1DCC patients, 37 (32%) had prolonged BET, which was associated with anorectal pressures indicative of a DD but was not associated with reduced rectal sensation, suggesting that DDs are more likely explained by abdomino‐anal dyscoordination than visceral disturbance.

AbstractBackground and AimsAlthough high‐resolution manometry (HR_ARM) is commonly used to diagnose defecatory disorders, its intraindividual day‐to‐day reproducibility is unknown. Since these measurements entail voluntary effort, this study aimed to evaluate the intraindividual day‐to‐day reproducibility of HR_ARM.MethodsIn 22 healthy women (35 years [14] mean [SD]) and 53 constipated patients (42 years [13], 46 women), the rectal balloon expulsion time (BET), and anorectal pressures were measured with HR_ARM on 2 days separated by a median (interquartile range) of 15 days (11–53) in healthy and 40 days (8–75) in constipated patients. Anorectal pressures were evaluated at rest (20 s), during squeeze, and during evacuation. Rectal sensation was also evaluated in constipated patients. The agreement between both measurements was evaluated with Lin's concordance correlation coefficient (CCC) and other tests.ResultsAmong constipated patients, the anal resting (mean CCC [95%CI] 0.62 [0.43–0.76]) and squeeze pressures (CCC 0.65 [0.47–0.79]), rectoanal gradient during evacuation (CCC 0.42 [0.17–0.62]), and rectal sensory thresholds (CCC for urgency 0.72 [0.52–0.84]) were concordant. Between days 1 and 2, one or more outcomes, characterized as normal or abnormal, differed in 79% of constipated patients, i.e., anal resting and squeeze pressures, the gradient, and the rectal BET differed in, respectively, 25%, 19%, 36%, and 10% of constipated patients. The rectal BET was prolonged in three healthy persons (both days) and either on 1 day (six patients) or 2 days (33 patients) in constipated patients.ConclusionsWhile HR_ARM variables and the BET are reproducible within healthy and constipated persons, the outcome on repeat testing differed in 79% of constipated patients.

AbstractBackgroundDuring high‐resolution anorectal manometry (HR_ARM), the raw data are converted into software‐derived summary variables (e.g., rectoanal gradient during evacuation) that capture only a snapshot of the data collected during HR_ARM and are less useful than newer indices, which are also derived from the raw data, for diagnosing defecatory disorders (DD). However, it is cumbersome and time‐consuming to extract raw data from the program and calculate such indices. This study aimed to devise a user‐friendly approach to extract anorectal pressures measured with HR_ARM.MethodsAnorectal pressures at rest, during anal squeeze, and evacuation were measured with HR_ARM in 180 women, among whom 60 each were healthy, had DD, or fecal incontinence. A reverse engineering approach extracted pressure values from color images in HR_ARM reports. The summary variables generated by the software and a reverse engineering approach were compared with Lin's concordance correlation coefficient (CCC), pairedt‐tests, and Bland–Altman's tests.ResultsAnorectal pressures summarized by the software and a reverse engineering method were highly concordant for anal resting (CCC [95% CI], 0.98 [0.97, 0.99]) and squeeze pressures (0.99 [0.99, 0.99) and the rectoanal gradient during evacuation with an empty (0.98 [0.97, 0.98]) and a filled balloon (0.99 [0.99, 0.99]). For most variables, the paired t and Bland–Altman comparisons were not significant.ConclusionsAnorectal pressures can be accurately determined from pressure topography images in HR_ARM reports. In future, this reverse engineering approach can be harnessed to compile large HR_ARM datasets across centers and to uncover newer, potentially more useful summary rectoanal pressure variables.