Mannitol for bowel preparation: Efficacy and safety results from the SATISFACTION randomised clinical trial

Background: Bowel preparation represents a significant issue to high-quality colonoscopy. Oral mannitol requires a single dose, is of low volume, and has a pleasant taste and rapid action. Aims: This SATISFACTION study compared single-dose (same day) oral mannitol 100 g/750 mL with standard split-dose PEG-ASC2 L (MoviPrep®). Methods: The primary endpoint was the proportion of patients with adequate bowel cleansing. Secondary endpoints included efficacy (adenoma detection rate, caecal intubation rate, time of evacuation), safety (intestinal gases concentration, haemato-chemical parameters, adverse events), and patient satisfaction. Results: The study included 703 patients (352 treated with mannitol and 351 with PEG-ASC). Mannitol was not inferior to PEG-ASC for the primary endpoint (91.1 % and 95.5 %, respectively; p-value for the non-inferiority =0.0131). There was no significant difference for secondary efficacy endpoints. The acceptability profile was significantly better in the mannitol group for ease of use, taste, and willingness to reuse (p < 0.0001 for all). The concentration of intestinal gases (H2, CH4) was similar between groups and well below those potentially critical. Conclusions: The SATISFACTION study indicated that low-volume, single-dose mannitol may satisfy an unmet clinical need since it was more acceptable to the patient and not inferior to the split-dose PEG-ASC for bowel cleansing efficacy

Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study

This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II–III study investigated this issue. The phase II dose-finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18)

Physician, Practice, and Patient Characteristics Related to Primary Care Physician Physical and Mental Health: Results from the Physician Worklife Study

OBJECTIVE: To study the impact that physician, practice, and patient characteristics have on physician stress, satisfaction, mental, and physical health. DATA SOURCES: Based on a survey of over 5,000 physicians nationwide. Four waves of surveys resulted in 2,325 complete responses. Elimination of ineligibles yielded a 52 percent response rate; 1,411 responses from primary care physicians were used. STUDY DESIGN: A conceptual model was tested by structural equation modeling. Physician job satisfaction and stress mediated the relationship between physician, practice, and patient characteristics as independent variables and physician physical and mental health as dependent variables. PRINCIPLE FINDINGS: The conceptual model was generally supported. Practice and, to a lesser extent, physician characteristics influenced job satisfaction, whereas only practice characteristics influenced job stress. Patient characteristics exerted little influence. Job stress powerfully influenced job satisfaction and physical and mental health among physicians. CONCLUSIONS: These findings support the notion that workplace conditions are a major determinant of physician well-being. Poor practice conditions can result in poor outcomes, which can erode quality of care and prove costly to the physician and health care organization. Fortunately, these conditions are manageable. Organizational settings that are both “physician friendly” and “family friendly” seem to result in greater well-being. These findings are particularly important as physicians are more tightly integrated into the health care system that may be less clearly under their exclusive control