Effectiveness of digital feedback on patient experience and 30-day complications after screening colonoscopy: a randomized health services study.

Background and study aims European guidelines (ESGE) recommend measuring patient experience and 30-day complication rate after colonoscopy. We compared digital and paper-based feedback on patients' experience and 30-day complications after screening colonoscopy. Patients and methods Screenees attending for primary screening colonoscopies in two centers from September 2015 to December 2016 were randomized (1:1) to an intervention arm (choice of feedback method) or control arm (routine paper-based feedback). Participants in the intervention arm could choose preferred feedback method (paper-based, automated telephone or online survey) and were contacted by automated telephone 30 days after colonoscopy to assess complications. Control group participants self-reported complications. Primary and secondary endpoints were response rates to feedback and complications questionnaire, respectively. Results There were 1,281 and 1,260 participants in the intervention and control arms, respectively. There was no significant difference in response rate between study groups (64.8 % vs 61.5 %; P  = 0.08). Free choice of feedback improved response for participants identified as poor responders: younger than 60 years (60.8 % vs 54.7 %; P  = 0.031), male (64.0 % vs 58.6 %; P  = 0.045) and in small non-public center (56.2 % vs 42.5 %; P  = 0.043). In the intervention arm, 1,168 participants (91.2 %) answered the phone call concerning complications. A total of 79 participants (6.2 %) reported complications, of which two (0.2 %) were verified by telephone as clinically relevant. No complications were self-reported in the control group. Conclusion The overall response rate was not significantly improved with digital feedback, yet the technology yielded significant improvement in participants defined as poor responders. Our study demonstrated feasibility and efficacy of digital patient feedback about complications after colonoscopy.

Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial.

BACKGROUND AND OBJECTIVES: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures. METHODS: Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis. RESULTS: Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases. CONCLUSION: The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.

Withdrawal time as a quality indicator for colonoscopy - a nationwide analysis.

BACKGROUND AND STUDY AIMS: A withdrawal time of at least 6 min has been recommended as a quality indicator for colonoscopy. One drawback of many of the studies that have investigated withdrawal time and produced conflicting results has been their single-center design involving few endoscopists. Therefore, the validity of withdrawal time as a quality measure remains unclear. This study explores the value of individual withdrawal time in a nationwide analysis. PATIENTS AND METHODS: This prospective cohort study comprised data from outpatient colonoscopies performed at 19 Norwegian centers from January to September 2009 and registered in the Norwegian Gastronet Quality Assurance (QA) program. The participating endoscopists were characterized by their median withdrawal time for visual colonoscopies (diagnostic colonoscopies without biopsy or therapy) and categorized into two visual withdrawal time (VWT) groups (< 6 min or ≥ 6 min) to analyze the predictive value of VWT for detection of one or more polyps ≥ 5 mm in diameter using multiple logistic regression models. RESULTS: The study included 4429 consecutive colonoscopies performed by 67 endoscopists. The adjusted odds ratio for the detection of polyps ≥ 5 mm was 1.21 (95 %CI 0.94 - 1.56, P = 0.14) for endoscopists with a median VWT ≥ 6 min compared with endoscopists with a median VWT < 6 min. CONCLUSION: Withdrawal time using 6 min as the threshold is not a strong predictor of the likelihood of finding a polyp during colonoscopy and should not be used as a quality indicator.

Patient satisfaction with on-demand sedation for outpatient colonoscopy.

BACKGROUND AND STUDY AIM: To reduce the costs of colonoscopy the feasibility of unsedated procedures has been explored. The aims of our study were to assess patient satisfaction with on-demand sedation and identify factors related to painful colonoscopy. PATIENTS AND METHODS: The Norwegian Gastronet quality assurance documentation tools consist of endoscopy reports (completed on site) and a patient satisfaction questionnaire (completed by the patient on the day after colonoscopy). Data were collected from January 1 2004 to December 31 2006. Colonoscopies reported to be moderately or severely painful were defined as "painful colonoscopy." RESULTS: Nine endoscopy centers representing 86 endoscopists reported 14 915 examinations and 12 354 patient reports were returned (83 % response rate). Patient satisfaction with service and information given was greater than 95 % for all centers. Mean rate of painful colonoscopy was 34 % and mean sedation rate 34 %. Odds ratio (OR) for painful colonoscopy was 2.2 ( P < 0.001) when sedation was given. The ORs for painful colonoscopy were similar for all but one center (no. 4) with OR 1.6 ( P = 0.04), while the OR for giving sedation was higher for all but one center (no. 1) compared with the reference center (ORs 2.2 to 7.5, all P-values < 0.001). CONCLUSION: A surprisingly high rate of painful colonoscopy was found. High sedation rates were not associated with low rates of painful colonoscopy. Recommending increased sedation rates as the only intervention to improve suboptimal performance might not lead to lower rates of painful colonoscopy.

Evaluation of a novel colonoscope designed for easier passage through flexures: a randomized study.

BACKGROUND AND STUDY AIMS: A new colonoscope (XCF-Q160AW prototype, Olympus, Tokyo, Japan) has been developed, designed with an additional passive bending function to ease intubation through the left colonic flexure. In this study we investigated whether this function could be included in a standard colonoscope without jeopardizing general performance, particularly passage through the sigmoid colon. PATIENTS AND METHODS: 280 outpatients referred for routine colonoscopy at Telemark Hospital were randomly allocated to colonoscopy with a standard colonoscope (Olympus 140 series) or the XCF-Q160AW prototype. Sedation was given on demand. End points were cecal intubation and the patients' grading of pain in a questionnaire. RESULTS: Cecal intubation rates were 85% and 87% for standard and prototype endoscopes, respectively (P = 0.57). On-demand sedation was given to nine (7%) and 15 (11%) of the patients, respectively (P = 0.17). Of the patients, 256 (85%) returned their questionnaire, with 87 (63%) in the standard group and 109 (77%) in the prototype group reporting that they had experienced 'no pain/slight pain' (P < 0.001). In a multiple logistic regression analysis, this difference in experienced pain remained statistically significant after adjustment for interendoscopist variation and the use of the endoscope-stiffening function. Two patients in the study, in whom there had previously been several unsuccessful attempts at negotiating the splenic flexure, were successfully examined with the prototype colonoscope. CONCLUSION: Examination with the Olympus XCF-Q160AW prototype with a passive bending function caused less pain than use of a standard Olympus 140 series colonoscope, without compromising other endoscope functions for colonic intubation.

Polyethylene glycol versus sodium phosphate in bowel cleansing for colonoscopy: a randomized trial.

BACKGROUND AND STUDY AIMS: There have been conflicting results regarding the adverse effects of established bowel cleansing regimens. The aim of the present study was to compare the effects of three bowel cleansing regimens on subjective well-being, electrolyte balance, cardiac arrhythmia, and the microscopic post-cleansing appearance of the colonic mucosa. PATIENTS AND METHODS: A total of 231 consecutive outpatients were randomly assigned to receive bowel preparation for colonoscopy with either 4 l polyethylene glycol (PEG; group I, n = 76); 2 l PEG plus 10 mg Bisacodyl (group II, n = 71); or 90 ml sodium phosphate (group III, n = 84). After bowel preparation, the participants completed a questionnaire on symptoms. Endoscopists blinded to the regimen used gave scores for the quality of cleansing at endoscopy, ranging from poor (0) to very good (5). Blood samples were taken before and after bowel cleansing, electrocardiographic monitoring was used during colonoscopy, and mucosal biopsy samples were taken in the sigmoid colon. RESULTS: Bowel preparation in group II was poorer (mean score 3.26) than in groups I (3.88) and III (4.01); P < 0.001 (II vs. III), P < 0.001 (I vs. II). The frequency of arrhythmias and post-cleansing mucosal inflammation was similar in all three groups. Lower serum potassium and higher serum phosphate concentrations were found in group III in comparison with the other groups ( P < 0.001). CONCLUSIONS: No differences were detected regarding the effectiveness and safety of bowel preparation with PEG alone and sodium phosphate in individuals without cardiac, renal, or hepatic failure, despite a significantly stronger alteration of the electrolyte balance with sodium phosphate.

Inter-endoscopist variation in polyp and neoplasia pick-up rates in flexible sigmoidoscopy screening for colorectal cancer.

BACKGROUND: The Norwegian Colorectal Cancer Prevention study is an ongoing flexible sigmoidoscopy (FS) screening trial for colorectal cancer. Twenty-one thousand average-risk individuals, aged 50-64 years, living in two separate areas in Norway were randomly drawn from the Population Registry and invited to once-only screening flexible sigmoidoscopy. Examinations were performed over 3 years, at 2 centres, by 8 different endoscopists, using the same type of equipment. The aim of the present study was to investigate possible differences between endoscopists in detecting individuals with polyps, adenomas and advanced lesions (adenomas with severe dysplasia and/or villous components and/or size larger than 9 mm and carcinoma) in flexible sigmoidoscopy screening. METHODS: The present trial comprises data from 8822 individuals, aged 55-64 years, who have undergone a flexible sigmoidoscopy. In the study period, all lesions detected by the different endoscopists were registered. Tissue samples were taken from all lesions detected. RESULTS: Detection rates varied significantly between endoscopists, ranging from 36.4% to 65.5% for individuals with any polyp, from 12.7% to 21.2% for any adenoma and from 2.9% to 5.0% for advanced lesions. In a multiple logistic regression model, the performing endoscopist was a strong independent predictor for detection of individuals with polyps (P < 0.001 ), adenomas (P < 0.001) and advanced lesions (P = 0.01). CONCLUSION: Detection rates for colorectal lesions vary significantly between endoscopists in colorectal cancer screening. Establishing systems for monitoring performance in screening programmes is important. Supervised training and re-certification for endoscopists with poor performance should be considered.

Continuous evaluation of patient satisfaction in endoscopy centres.

BACKGROUND: A randomized sample of 14,000 men and women, aged 55-64 years, resident in the City of Oslo and Telemark County, were drawn from the population registry to be offered a flexible sigmoidoscopy (FS) screening examination. A questionnaire was designed to modify routines and evaluate patient satisfaction. METHODS: Consecutive participants (4956) were given a questionnaire immediately after the FS to be filled in and returned by mail on the following day. Participants were asked questions about service, practical issues, and the level of pain during the FS and post-examination discomfort. They were also encouraged to give their comments in free text. RESULTS: Questionnaire replies were received from 4574 (92%) out of 4956 participants. The vast majority reported to have experienced no (70%) or slight (21%) pain during the examination. Women reported pain and post-examination discomfort more often than men. Pain was also associated with age of the patient and length of bowel examined, but not with total examination time. The proportion of painless examinations varied between endoscopists from 62% to 81%. For all endoscopists collectively, this improved during the study period, irrespective of past experience, but trainees seemed to adopt the score of their masters. CONCLUSIONS: The study demonstrated that the use of feedback information in an endoscopy screening unit may be useful in improving standards, including the performance of endoscopists. It is possible that the introduction of similar feedback systems in routine endoscopy laboratories may in the long run improve the reputation of gastrointestinal endoscopy.

NORCCAP (Norwegian colorectal cancer prevention): a randomised trial to assess the safety and efficacy of carbon dioxide versus air insufflation in colonoscopy.

BACKGROUND: To eliminate the risk of combustion during electrosurgical procedures and to reduce patient discomfort, carbon dioxide (CO2) insufflation has been recommended during colonoscopy. However, air insufflation is still the standard method, perhaps due to the lack of suitable equipment and shortage of randomised studies. AIMS: This randomised controlled trial was conducted to assess patient tolerance and safety when using CO2 insufflation during colonoscopy. PATIENTS: Over an eight month period a successive series of patients referred for a baseline colonoscopy due to findings in a flexible sigmoidoscopy screening trial were randomly assigned to the use of either air or CO2 insufflation during colonoscopy. METHODS: End tidal CO2 (ETCO2), a non-invasive parameter of arterial pCO2, was registered before and repeatedly during and after the examination. The patient's experience of pain during and after the examination was registered using a visual analogue scale (VAS). Sedation was not used routinely. RESULTS: CO2 insufflation was used in 121 patients (51%) and air in 119 patients (49%). The groups were similar in age, sex, and caecal intubation rate. No rise in ETCO2 was registered. There were statistically significant differences in VAS scores between the groups with less pain reported when using CO2. CONCLUSIONS: This randomised study of unsedated patients shows that CO2 insufflation is safe during colonoscopy with no rise in ETCO2 level. CO2 was found to be superior to air in terms of pain experienced after the examination.