Development and Validation of a Patient-Reported Experience Measure for Gastrointestinal Endoscopy: The Comprehensive Endoscopy Satisfaction Tool (CEST).

GOALS: We aimed to develop and validate a patient-reported experience measure for gastrointestinal (GI) endoscopy, the Comprehensive Endoscopy Satisfaction Tool that captures relevant domains that influence the patient's experience and identify factors that shape satisfaction. BACKGROUND: Patient-reported experience measures are used to capture specific quality aspects of health care services. GI endoscopic services are high-volume services, and there is a lack of specific, validated instruments to capture various domains that shape the patients' experience with routine clinical endoscopic services. STUDY: After an environmental scan and structured literature review, focus groups with patients were conducted to identify relevant factors influencing the patient experience with GI endoscopic services. After an initial validation in 101 patients undergoing routine GI endoscopies, the instrument was tested in 7800 patients. In addition, the influence of sociodemographic factors on global satisfaction was explored. RESULTS: The final version included 26 specific items plus 4 global ratings for preprocedure, experience on day of procedure, postprocedure care, and infrastructure. In addition, a global rating of the overall experience was included. Patient satisfaction was significantly higher in older patients (P<0.001) but not influenced by gender, nationality, marital status, education, or employment status. Interestingly, during periods of coronavirus disease-19-related service interruptions, the Net Promoter Score was significantly reduced (P<0.0001) providing evidence for the responsiveness of the instrument. CONCLUSIONS: The Comprehensive Endoscopy Satisfaction Tool is a valid measure for the patient experience with the various components of endoscopic services, allows for the identification of domains that impact on the patient experience and is a practical tool to compare patient satisfaction over time and across facilities.

Improving the Quality of Bowel Preparation: Rewarding Patients for Success or Intensive Patient Education?

INTRODUCTION AND OBJECTIVES: The quality of the bowel preparation is a critical parameter for the outcome of colonoscopies. It is well established that the bowel preparation modality (e.g., split or larger volume preparation) significantly improves the quality of the bowel preparation. Patient compliance is another important factor impacting on the quality of bowel preparations that receives relatively little research attention. We aimed to explore if intensified education or a lottery ticket as reward for good bowel preparation could improve outcomes. METHODS: After informed consent, all patients received a standardized printed information booklet. In a randomized fashion, patients were offered (a) a lottery scratchy ticket with an opportunity to win $25,000 as "reward" for good bowel preparation, (b) an education session delivered over the phone by a trained nurse, or (c) no additional measure. RESULTS: Overall, the quality of the bowel preparation was rated good or very good in 69.1% (95% CI 61.7-75.7%) of patients. Reward intervention did not influence the quality of bowel preparation (OR 0.42, 95% CI 0.09-1.91, p = 0.260); however, bowel preparation quality decreased in patients randomized to receive the additional education (OR 0.28, 95% CI 0.08-0.96, p = 0.042). Neither intervention significantly impacted on polyp detection rates. CONCLUSIONS: Contrasting general beliefs, additional interventions (e.g., incentives or phone consultation) did not improve the quality of the bowel preparation. The unexpected result shows that utilizing extra resources must be balanced against real-world outcomes and may not always provide the expected result.

Induction of Meal-related Symptoms as a Novel Mechanism of Action of the Duodenal-Jejunal Bypass Sleeve.

BACKGROUND: Treatment with a duodenal-jejunal bypass sleeve (DJBS) induces clinically significant weight loss, but little is known about the mechanisms of action of this device. AIM: The aim of this study was to characterize the mechanisms of action of the DJBS and determine the durability of weight loss and metabolic improvements. MATERIALS AND METHODS: We studied a cohort of 19 subjects with severe obesity and type 2 diabetes (baseline body mass index: 43.7±5.3 kg/m). Anthropometry, body composition, blood pressure, biochemical measures, and dietary intake were monitored for 48 weeks after DJBS implantation, and then for 1 year after device removal. Gastric emptying and triglyceride absorption were measured at baseline, 8 weeks after implant, and within 3 weeks of device explant. Visceral sensory function was assessed at baseline, 4 weeks after implant, and within 3 weeks after explant. RESULTS: Significant weight loss (P<0.01) occurred following DJBS placement, with a mean weight reduction of 17.0±6.5% at 48 weeks. The symptom burden following a standardized nutrient challenge was increased after DJBS implantation (P<0.05), returning to baseline after DJBS removal. Neither gastric emptying nor triglyceride absorption changed with the device in situ. A significant reduction in energy intake was observed [baseline: 7703±2978 kJ (1841±712 kcal), 24 weeks: 4824±2259 kJ (1153±540 kcal), and 48 weeks: 4474±1468 kJ (1069±351 kcal)]. After 1 year, anthropometry remained significantly improved, but there was no durable impact on metabolic outcomes. CONCLUSIONS: DJBS treatment resulted in substantial weight loss. Weight loss is related to reduced caloric intake, which seems linked to an augmented upper gastrointestinal symptom response, but not altered fat absorption.

An Evidence-based Approach Towards Targeted Patient Education to Improve Bowel Preparation for Colonoscopy.

GOALS AND BACKGROUND: Quality of bowel preparation is an important factor influencing adenoma detection. Patient education is believed to improve the quality of bowel preparation but might be resource-intensive. We aimed to (a) identify risk factors for failed bowel preparations and (b) develop and test the efficacy of a screening tool that allows to prospectively identify and target patients at increased risk. STUDY: Part 1: 76 consecutive outpatients with poor bowel preparation were compared with 76 age-matched and gender-matched outpatients with good preparation from the same procedure lists. Sociodemographic and clinical data were obtained from centralized databases. Univariate analysis and multivariate logistic regression was used to identify risk factors for poor bowel preparation. Part 2: on the basis of results of part 1, a screening tool for prospectively identifying patients at high risk was developed, and targeted education tested. RESULTS: We identified the use of opioids or other constipating agents and low socioeconomic status as risk factors for poor bowel preparation [odds ratio (OR)=2.88; 95% confidence interval (CI): 1.22-6.80 and OR=2.43; 95% CI: 1.25-4.72]. Diabetes, hypothyroidism, age, and gender were found to have no effect on quality. When education was provided only to patients at increased risk, the targeted approach did not negatively affect the proportion of poor preparation (OR=6.12%; 95% CI: 4.79%-7.78% vs. OR=5.73%; 95% CI: 4.61%-7.10%). CONCLUSIONS: Poor bowel preparation is associated with specific risk factors. Identifying and specifically targeting education at patients with these risk factors appears to facilitate more efficient use of education resources in endoscopy.

An in vitro and clinical dose-finding study of antifoaming effects of simethicone during colonoscopy.

Simethicone is an antifoaming agent frequently added to endoscopic rinse solutions but has recently been implicated as a risk factor for transmission of infections due to the formation of simethicone deposits within scope channels. Since the build-up of residue is likely dose-related, the smallest effective dose of simethicone should be used but there are no data available on the effective dose. Thus, we conducted a dose-finding study in an "in vitro bubble model" to determine the appropriate simethicone dose. Six 100-mL test tubes were filled with a 1% (v/v) solution of kitchen detergent (Fairy®, Procter & Gamble, London, England) in water for irrigation (Baxter®, Sydney, Australia). One test tube served as the control, while different doses of simethicone (Infacol®, Nice Pak, Melbourne, Australia) were added to the other five tubes (0.02, 0.2, 2.0, 20, and 200 mg/100 mL). Oxygen was streamed for 30 s into the test tubes at a rate of 2 L/min. After 10 s, photographs were taken and the visible bubbles were semi-quantitatively rated by independent assessors blinded to the dosing of simethicone. Simethicone at doses of 2 mg/100 mL had no appreciable antifoaming effect, whereas concentrations ≥ 20 mg/100 mL were sufficient to suppress bubble formation. This is substantially lower compared with frequently used doses of up to 200 mg/100 mL. Subsequently, we tested the lower simethicone dose with previously used higher doses, in 1475 and 1340 patients, respectively. We found it to have no impact on polyp detection with a rate of 56.7% (54.2-59.3% [95% CI]) at the lower dose and 56.5% (53.8-59.1% [95% CI]) at the higher dose.

Correction to: An in vitro and clinical dose-finding study of antifoaming effects of simethicone during colonoscopy.

In the above article, due to probable typo error with the picture and legend, the correct Fig. 1 and the Legend to the Fig. 1 is printed here.

Influence of Simethicone Added to the Rinse Water during Colonoscopies on Polyp Detection Rates: Results of an Unintended Cohort Study.

BACKGROUND AND AIMS: Simethicone is a common antifoaming agent that is added to endoscopic rinse solutions, but data regarding its effect on polyp detection rates is lacking. In this study, we report the effect of discontinuation of this practice on polyp detection rates. METHODS: Procedure data of 4,254 consecutive colonoscopies were used. Patients underwent standard bowel preparation with polyethyleneglycol (Glycoprep®). Colonoscopies were performed utilising Olympus EVIS EXERA III, CV-190 equipment, while quality data (withdraw times, polyp detection rates, quality of bowel preparation) was assessed utilising an endoscopy reporting system (Provation®). Following an educational event that highlighted that simethicone may form deposits in the channels of endoscopes, the practice to add simethicone (InfacolR, Nice Pak) to the auxiliary channel water pump was abandoned, but endoscopists were not notified about this change. After 5 days and performing 75 colonoscopies, the change of practice was identified and addition of simethicone recommenced. RESULTS: The discontinuation of simethicone use reduced the polyp detection rate from 55% (95% CI 53-56) to 45% (95% CI 34-56, 1-sided, p = 0.028); the polyp detection rate returned to the pre-intervention levels of 55% (95% CI 52-58) upon resumption of normal practice. CONCLUSION: The addition of simethicone to the auxiliary water pump during colonoscopy results in a 10% increase in polyp detection rates.

Cyclodextrin-crosslinked poly(acrylic acid): Synthesis, physicochemical characterization and controlled release of diflunisal and fluconazole from hydrogels.

The aim of this work was to develop mucoadhesive hydrogels with variable drug delivery properties by crosslinking poly(acrylic acid) (PAA) with cyclodextrins (CDs). CD-PAA polymers with high CD content and good inter-batch reproducibility were synthesized by activating PAA with SOCl2, then reacting PAA chloride with CD in the presence of 4-dimethylaminopyridine at 50°C. Manipulation of the synthesis conditions affected the physicochemical character of the CD-PAA polymers and hydrogels in terms of CD content, the average number of ester bonds to an individual CD, viscosity, and the association and release of model drugs. Inclusion complexation of diflunisal (DIF) and fluconazole (FLZ) with CD-PAA hydrogels was assessed by (19)F NMR spectroscopy and association constants (Kas) for DIF were in the range 220-486M(-1) with ßCD-PAA and 1327-6055M(-1) with hydroxypropyl-ßCD-PAA. For FLZ the Ka range was 34-171M(-1) with hydroxypropyl-ßCD-PAA. The hydrogels were found to release both drugs by means of Fickian diffusion as the predominant mechanism. A slight trend toward negative correlation was found between the Ka and Higuchi kH values for DIF. These results highlight the potential of CD-PAA hydrogels to control the release of model drugs through inclusion complexation.

Cyclodextrin-crosslinked poly(acrylic acid): adhesion and controlled release of diflunisal and fluconazole from solid dosage forms.

The controlled release of diflunisal and fluconazole from tablets made of novel polymers, poly(acrylic acid) (PAA) crosslinked with either ß-cyclodextrin (ßCD) or hydroxypropyl-ßCD (HPßCD), was investigated and Carbopol 934P (Carbopol) was used as a highly crosslinked PAA for comparison. Diflunisal strongly associates with ßCD-PAA and HPßCD-PAA polymers (Ka of 486 and 6,055 M(-1) respectively); thus, it was physically mixed into the conjugates and also precomplexed to identify whether decomplexation has any influence on release kinetics. Fluconazole has poor complexing ability (Ka of 34 M(-1) with HPßCD-PAA); thus, it was only tested as a physical mixture. Swelling and adhesion studies were conducted on all tablet combinations and adhesivity of the CD-PAA polymer tablets was maintained. Diflunisal release was much slower from HPßCD-PAA tablets than from ßCD-PAA, suggesting that a higher degree of complexation retards release. The precomplexed diflunisal release was also slower than the physically mixed diflunisal of the corresponding conjugate. The release closely followed zero-order kinetics for HPßCD-PAA, but was more sigmoidal for ßCD-PAA and especially Carbopol. Conversely, poorly associating fluconazole released in almost exactly the same way across both polymers and Carbopol, indicating that the release kinetics of poorly associating drugs are not influenced by the presence of cyclodextrins. In view of the varying profiles and release rates shown with diflunisal for the different polymers, the fluconazole data support the concept that adequate complexation can indeed modulate the release kinetics of drugs.