Patient-reported outcomes, weight loss, and remission of type 2 diabetes 3 years after gastric bypass and sleeve gastrectomy (Oseberg); a single-centre, randomised controlled trial.

BACKGROUND: Little is known about the comparative effects of various bariatric procedures on patient-reported outcomes. We aimed to compare 3-year effects of gastric bypass and sleeve gastrectomy on patient-reported outcome measures in patients with obesity and type 2 diabetes. METHODS: The Oseberg trial was a single-centre, parallel-group, randomised trial at Vestfold Hospital Trust, a public tertiary obesity centre in Tønsberg, Norway. Eligible patients were aged 18 years or older with previously verified BMI 35·0 kg/m2 or greater. Diabetes was diagnosed if glycated haemoglobin was at least 6·5% (48 mmol/mol) or by their use of anti-diabetic medications with glycated haemoglobin at least 6·1% (43 mmol/mol). Eligible patients were randomly assigned (1:1) to gastric bypass or sleeve gastrectomy. All patients received identical preoperative and postoperative treatment. Randomisation was done with a computerised random number generator and a block size of ten. Study personnel, patients, and the primary outcome assessor were blinded to allocations for 1 year. The prespecified secondary outcomes reported here were 3-year changes in several clinically important patient-reported outcomes, weight loss, and diabetes remission. Analyses were done in the intention to treat population. This trial is ongoing, closed to recruitment and is registered with ClinicalTrials.gov, NCT01778738. FINDINGS: Between Oct 15, 2012 and Sept 1, 2017, 319 consecutive patients with type 2 diabetes scheduled for bariatric surgery were assessed for eligibility. 101 patients were not eligible (29 did not have type 2 diabetes according to inclusion criteria and 72 other exclusion criteria) and 93 declined to participate. 109 patients were enrolled and randomly assigned to sleeve gastrectomy (n=55) or gastric bypass (n=54). 72 (66%) of 109 patients were female and 37 (34%) were male. 104 (95%) of patients were White. 16 patients were lost to follow up and 93 (85%) patients completed the 3-year follow-up. Three additional patients were contacted by phone for registration of comorbidities Compared with sleeve gastrectomy, gastric bypass was associated with a greater improvement in weight-related quality of life (between group difference 9·4, 95% CI 3·3 to 15·5), less reflux symptoms (0·54, 0·17 to -0·90), greater total bodyweight loss (8% difference, 25% vs 17%), and a higher probability of diabetes remission (67% vs 33%, risk ratio 2·00; 95% CI 1·27 to 3·14). Five patients reported postprandial hypoglycaemia in the third year after gastric bypass versus none after sleeve-gastrectomy (p=0·059). Symptoms of abdominal pain, indigestion, diarrhoea, dumping syndrome, depression, binge eating, and appetitive drive did not differ between groups. INTERPRETATION: At 3 years, gastric bypass was superior to sleeve gastrectomy in patients with type 2 diabetes and obesity regarding weight related quality of life, reflux symptoms, weight loss, and remission of diabetes, while symptoms of abdominal pain, indigestion, diarrhoea, dumping, depression and binge eating did not differ between groups. This new patient-reported knowledge can be used in the shared decision-making process to inform patients about similarities and differences between expected outcomes after the two surgical procedures. FUNDING: Morbid Obesity Centre, Vestfold Hospital Trust. TRANSLATION: For the Norwegian translation of the abstract see Supplementary Materials section.

Colonoscopy quality improvement after initial training: A cross-sectional study of intensive short-term training.

Background and study aims High-quality is crucial for the effectiveness of colonoscopy and can be achieved by high-quality training and verified with assessment of key performance indicators (KPIs) for colonoscopy such as cecum intubation rate (CIR), adenoma detection rate (ADR) and adequate polyp resection. Typically, trainees achieve adequate CIR after 275 procedures, but little is known about learning curves for KPIs after initial training. Methods This cross-sectional study includes work-up colonoscopies after a positive screening test with fecal occult blood testing (FIT) or sigmoidoscopy, performed by either trainees after 300 training colonoscopies or by consultants. Outcome measures were KPIs. We assessed inter-endoscopist variation in trainees and learning curves for trainees as a group. We also compared KPIs for trainees and consultants as a group.  Results Data from 6,655 colonoscopies performed by 21 trainees and 921 colonoscopies performed by 17 consultants were included. Most trainees achieved target standards for main KPIs. With time, trainees shortened cecum intubation time and withdrawal time without decreasing their ADR, reduced the proportion of painful colonoscopies, and increased the adequate polyp resection rate (all P  < 0.01). Compared to consultants, trainees had higher CIR (97.7 % vs. 96.3 %, P  = 0.02), ADR after positive FIT (57.6 % vs. 50.3 %, P  < 0.01), and proximal ADR after sigmoidoscopy screening (41.1 % vs. 29.8 %; P  < 0.01), higher adequate polyp resection rate (94.9 % vs. 93.1 %, P  = 0.01) and fewer serious adverse events (0.65 % vs. 1.41 %, P  = 0.02). Conclusions Trainees performed high-quality colonoscopies and achieved international target standards. Several KPIs continuously improved after initial training. Trainees outperformed consultants on several KPIs.

The effect of train-the-colonoscopy-trainer course on colonoscopy quality indicators.

BACKGROUND: Systematic training in colonoscopy is highly recommended; however, we have limited knowledge of the effects of "training-the-colonoscopy-trainer" (TCT) courses. Using a national quality register on colonoscopy performance, we aimed to evaluate the effects of TCT participation on defined quality indicators. METHODS: This observational study compared quality indicators (pain, cecal intubation, and polyp detection) between centers participating versus not participating in a TCT course. Nonparticipating centers were assigned a pseudoparticipating year to match their participating counterparts. Results were compared between first year after and the year before TCT (pseudo)participation. Time trends up to 5 years after TCT (pseudo)participation were also compared. Generalized estimating equation models, adjusted for age, sex, and bowel cleansing, were used. RESULTS: 11 participating and 11 nonparticipating centers contributed 18 555 and 10 730 colonoscopies, respectively. In participating centers, there was a significant increase in detection of polyps ≥ 5 mm, from 26.4 % to 29.2 % (P = 0.035), and reduction in moderate/severe pain experienced by women, from 38.2 % to 33.6 % (P = 0.043); no significant changes were found in nonparticipating centers. Over 5 years, 20 participating and 18 nonparticipating centers contributed 85 691 and 41 569 colonoscopies, respectively. In participating centers, polyp detection rate increased linearly (P = 0.003), and pain decreased linearly in women (P = 0.004). Nonparticipating centers did not show any significant time trend during the study period. CONCLUSIONS: Participation in a TCT course improved polyp detection rates and reduced pain experienced by women. These effects were maintained during a 5-year follow-up.

Incomplete endoscopic resection of colorectal polyps: a prospective quality assurance study.

BACKGROUND: Endoscopic screening with polypectomy has been shown to reduce colorectal cancer incidence in randomized trials. Incomplete polyp removal and subsequent development of post-colonoscopy cancers may attenuate the effect of screening. This study aimed to quantify the extent of incomplete polyp removal. METHODS: We included patients aged 50-75 years with nonpedunculated polyps ≥ 5 mm removed during colonoscopy at four hospitals in Norway. To evaluate completeness of polyp removal, biopsies from the resection margins were obtained after polypectomy. Logistic regression models were fitted to identify factors explaining incomplete resection. RESULTS: 246 patients with 339 polyps underwent polypectomy between January 2015 and June 2017. A total of 12 polyps were excluded due to biopsy electrocautery damage, and 327 polyps in 246 patients (mean age 67 years [range 42-83]; 52 % male) were included in the analysis. Overall, 54 polyps (15.9 %) in 54 patients were incompletely resected. Histological diagnosis of the polyp (sessile serrated lesions vs. adenoma, odds ratio [OR] 10.9, 95 % confidence interval [CI] 3.9-30.1) and polyp location (proximal vs. distal colon, OR 2.8, 95 %CI 1.0-7.7) were independent risk factors for incomplete removal of polyps 5-19 mm. Board-certified endoscopists were not associated with lower rates of incomplete resection compared with trainees (14.0 % vs. 14.2 %), OR 1.0 (95 %CI 0.5-2.1). CONCLUSION: Incomplete polyp resection was frequent after polypectomy in routine clinical practice. Serrated histology and proximal location were independent risk factors for incomplete resection. The performance of board-certified gastroenterologists was not superior to that of trainees.

Erosive Esophagitis and Symptoms of Gastroesophageal Reflux Disease in Patients with Morbid Obesity with and without Type 2 Diabetes: a Cross-sectional Study.

BACKGROUND: Type 2 diabetes (T2DM) is associated with gastroesophageal reflux disease (GERD) in the general population, but the relationship between these conditions in candidates for bariatric surgery is uncertain. We compared the prevalence of GERD and the association between GERD symptoms and esophagitis among bariatric candidates with and without T2DM. METHODS: Cross-sectional study of baseline data from the Oseberg study in Norway. Both groups underwent gastroduodenoscopy and completed validated questionnaires: Gastrointestinal Symptom Rating Scale and Gastroesophageal Reflux Disease Questionnaire. Participants with T2DM underwent 24-h pH-metry. RESULTS: A total of 124 patients with T2DM, 81 women, mean (SD) age 48.6 (9.4) years and BMI 42.3 (5.5) kg/m2, and 64 patients without T2DM, 46 women, age 43.0 (11.0) years and BMI 43.0 (5.0) kg/m2, were included. The proportions of patients reporting GERD-symptoms were low (< 29%) and did not differ significantly between groups, while the proportions of patients with esophagitis were high both in the T2DM and non-T2DM group, 58% versus 47%, p = 0.16. The majority of patients with esophagitis did not have GERD-symptoms (68-80%). Further, 55% of the patients with T2DM had pathologic acid reflux. Among these, 71% also had erosive esophagitis, whereof 67% were asymptomatic. CONCLUSIONS: The prevalence of GERD was similar in bariatric patients with or without T2DM, and the proportion of patients with asymptomatic GERD was high independent of the presence or absence of T2DM. Accordingly, GERD may be underdiagnosed in patients not undergoing a preoperative endoscopy or acid reflux assessment. TRIAL REGISTRATION: Clinical Trials.gov number NCT01778738.

Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and ß-cell function in subjects with morbid obesity: a protocol for the Obesity surgery in Tønsberg (Oseberg) study.

INTRODUCTION: Bariatric surgery is increasingly recognised as an effective treatment option for subjects with type 2 diabetes and obesity; however, there is no conclusive evidence on the superiority of Roux-en-Y gastric bypass or sleeve gastrectomy. The Oseberg study was designed to compare the effects of gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and ß-cell function. METHODS AND ANALYSIS: Single-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway. Eligible patients with type 2 diabetes and obesity were randomly allocated in a 1:1 ratio to either gastric bypass or sleeve gastrectomy. The primary outcome measures are (1) the proportion of participants with complete remission of type 2 diabetes (HbA1c≤6.0% in the absence of blood glucose-lowering pharmacologic therapy) and (2) ß-cell function expressed by the disposition index (calculated using the frequently sampled intravenous glucose tolerance test with minimal model analysis) 1 year after surgery. ETHICS AND DISSEMINATION: The protocol of the current study was reviewed and approved by the regional ethics committee on 12 September 2012 (ref: 2012/1427/REK sør-øst B). The results will be disseminated to academic and health professional audiences and the public via publications in international peer-reviewed journals and conferences. Participants will receive a summary of the main findings. TRIAL REGISTRATION NUMBER: NCT01778738;Pre-results.

Registration bias in a clinical quality register.

Background and aims The quality of medical quality registers is poorly defined and lack of trust in data due to low completeness may be a major barrier against their use in quality improvement interventions. The aim of the current observational study was to explore how selective reporting may influence adverse events registered in the Norwegian quality register for colonoscopy (Gastronet). Materials and methods Gastronet's database includes data provided by endoscopists, nurses and patients. All outpatient colonoscopies reported to Gastronet in 2015 were included and compared to the total number of colonoscopies performed in Norway as retrieved from the National Patient Registry. Hospitals were categorized into four groups according to reporting completeness < 50 %, 50 % to 69 %, 70 % to 89 % and ≥ 90 %. The number of recorded adverse events (AEs) and procedure time were analyzed. Multivariate logistic regression models were fitted to explore independent factors for selection bias. Results A total of 22,364 colonoscopies were reported to the National Patient Register of which 15,855 (71 %) were registered in Gastronet. Feedback was received from 11,079 patients (50 %). The frequency of AEs increased from 0.6 % in completeness group < 50 % to 1.6 % in completeness group ≥ 90 % ( P  < 0.001). Long colonoscopy procedure time was associated with low reporting completeness. Patient feedback was associated with older age, cecal intubation success and sedation-free colonoscopy. Conclusion Incomplete registration in a colonoscopy quality register is associated with underreporting of AEs. Longer procedure time, a surrogate marker for time constraint, is associated with low completeness.

Endoscopy assistants influence the quality of colonoscopy.

BACKGROUND: Colonoscopy performance varies between endoscopists, but little is known about the impact of endoscopy assistants on key performance indicators. We used a large prospective colonoscopy quality database to perform an exploratory study to evaluate differences in selected quality indicators between endoscopy assistants. METHODS: All colonoscopies reported to the Norwegian colonoscopy quality assurance register Gastronet can be used to trace individual endoscopy assistants. We analyzed key quality indicators (cecum intubation rate, polyp detection rate, colonoscopies rated as severely painful, colonoscopies with sedation or analgesia, and satisfaction with information) for colonoscopies performed between 1 January 2013 and 31 December 2014. Differences between individual assistants were analyzed by fitting multivariable logistic regression models, with the best performing assistant at each participating hospital as reference. All models were adjusted for the endoscopist. RESULTS: 63 endoscopy assistants from 12 hospitals assisted in 15 365 colonoscopies. Compared with their top performing peers from the same hospital, one assistant was associated with cecum intubation failure, four with poor polyp detection, nine with painful colonoscopy, 16 with administration of sedation or analgesics during colonoscopy, and three with patient dissatisfaction about information given relating to the colonoscopy. The number of procedures during the study period or lifetime experience as an endoscopy assistant were not associated with any quality indicator. CONCLUSION: In this exploratory study, there was little variation on important colonoscopy quality indicators between endoscopy assistants. However, there were differences among assistants that may be clinically important. Endoscopy assistants should be subject to quality surveillance similarly to endoscopists.

Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative.

The European Society of Gastrointestinal Endoscopy and United European Gastroenterology present a short list of key performance measures for lower gastrointestinal endoscopy. We recommend that endoscopy services across Europe adopt the following seven key performance measures for lower gastrointestinal endoscopy for measurement and evaluation in daily practice at a center and endoscopist level: 1 rate of adequate bowel preparation (minimum standard 90%); 2 cecal intubation rate (minimum standard 90%); 3 adenoma detection rate (minimum standard 25%); 4 appropriate polypectomy technique (minimum standard 80%); 5 complication rate (minimum standard not set); 6 patient experience (minimum standard not set); 7 appropriate post-polypectomy surveillance recommendations (minimum standard not set). Other identified performance measures have been listed as less relevant based on an assessment of their importance, scientific acceptability, feasibility, usability, and comparison to competing measures.

Patient-reported adverse events after colonoscopy in Norway.

Background and aims Patient-reported outcome measures are increasingly important in healthcare. European guidelines have recommended inclusion of patient feedback to capture adverse events due to colonoscopy, but this is rarely implemented. Methods The Norwegian Quality Assurance network for endoscopy (Gastronet) collects patient-reported outcome for colonoscopies. Free-text comments on patient reports from January to December 2015 were characterized as positive or negative. All negative free-text comments were scrutinized for information that might suggest colonoscopy-related adverse events. We identified severe adverse events with and without admission to hospital. Results We included 16 552 outpatient colonoscopies performed at 21 hospitals. A total of 11 248 procedures (68 %) were accompanied by a patient feedback report, of which 2628 (23 %) had free-text comments (2196 [20 %] characterized as positive and 432 [3.8 %] as negative). These negative free texts on patient reports revealed 15 post-colonoscopy hospital admissions due to adverse events that had not been registered in the colonoscopy report. This increased the number of hospital admissions caused by adverse events from 3 (0.03 %) to 18 (0.16 %). In addition, there were 14 patient reports of severe events without hospital admission. Therefore, a total of 29 severe adverse events reported by patients were missed by conventional documentation in the colonoscopy form. Conclusion It is feasible to implement patient feedback as routine reporting to capture the full picture of colonoscopy-related adverse events. Some patients experience significant complications that are not recorded through any registries. Patient feedback forms should be tailored to capture adverse events after colonoscopy that are otherwise not easily disclosed.

Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

The European Society of Gastrointestinal Endoscopy and United European Gastroenterology present a short list of key performance measures for lower gastrointestinal endoscopy. We recommend that endoscopy services across Europe adopt the following seven key performance measures for lower gastrointestinal endoscopy for measurement and evaluation in daily practice at a center and endoscopist level: 1 Rate of adequate bowel preparation (minimum standard 90 %); 2 Cecal intubation rate (minimum standard 90 %); 3 Adenoma detection rate (minimum standard 25 %); 4 Appropriate polypectomy technique (minimum standard 80 %); 5 Complication rate (minimum standard not set); 6 Patient experience (minimum standard not set); 7 Appropriate post-polypectomy surveillance recommendations (minimum standard not set). Other identified performance measures have been listed as less relevant based on an assessment of their importance, scientific acceptability, feasibility, usability, and comparison to competing measures.

Time trends in quality indicators of colonoscopy.

BACKGROUND: There is considerable variation in the quality of colonoscopy performance. The Norwegian quality assurance programme Gastronet registers outpatient colonoscopies performed in Norwegian endoscopy centres. The aim of Gastronet is long-term improvement of endoscopist and centre performance by annual feedback of performance data. OBJECTIVE: The objective of this article is to perform an analysis of trends of quality indicators for colonoscopy in Gastronet. METHODS: This prospective cohort study included 73,522 outpatient colonoscopies from 73 endoscopists at 25 endoscopy centres from 2003 to 2012. We used multivariate logistic regression with adjustment for relevant variables to determine annual trends of three performance indicators: caecum intubation rate, pain during the procedure, and detection rate of polyps ≥5 mm. RESULTS: The proportion of severely painful colonoscopies decreased from 14.8% to 9.2% (relative risk reduction of 38%; OR = 0.92 per year in Gastronet; 95% CI 0.86-1.00; p = 0.045). Caecal intubation (OR = 0.99; 95% CI 0.94-1.04; p = 0.6) and polyp detection (OR = 1.03; 95% CI 0.99-1.07; p = 0.15) remained unchanged during the study period. CONCLUSIONS: Pain at colonoscopy showed a significant decrease during years of Gastronet participation while caecal intubation and polyp detection remained unchanged - independent of the use of sedation and/or analgesics and level of endoscopist experience. This may be due to the Gastronet audit, but effects of improved endoscopy technology cannot be excluded.

Risk stratification to predict pain during unsedated colonoscopy: results of a multicenter cohort study.

BACKGROUND AND STUDY AIMS: Colonoscopy without sedation has several advantages over sedated colonoscopy, but a considerable proportion of patients experience pain. The aim of this study was to develop a risk stratification model of pre-examination risk factors to enable targeted sedation during colonoscopy. PATIENTS AND METHODS: Between October 2011 and January 2012, consecutive outpatients who were willing to start colonoscopy without sedation at 11 Norwegian centers were prospectively recruited. Patients recorded pain on a validated 4-point scale (none, slight, moderate, or severe pain). Potential risk factors for a painful procedure (defined as moderate or severe pain) were evaluated using multivariate logistic regression analyses, and the area under the receiver operating characteristics curve (AUROC) was calculated to assess the discriminatory ability of the derived model. RESULTS: A total of 1198 patients (635 men and 563 women) were included. Seven independent, pre-procedural risk factors for patient pain were identified: female sex, age < 40 years, previous abdominal surgery, abdominal pain as indication for colonoscopy, anticipation of pain, previous painful colonoscopy, and a history of diverticulitis. In patients with 0, 1, 2, or ≥ 3 risk factors, a painful colonoscopy was experienced by 35 %, 43 %, 52 %, and 63 % of women and 18 %, 24 %, 35 %, and 63 % of men, respectively. The model showed modest discrimination abilities (AUROC = 0.69). CONCLUSION: Female sex was a strong risk factor for pain during colonoscopy, and sedation or analgesia should be considered for all women prior to colonoscopy. For male patients, the presence of multiple risk factors should encourage the endoscopist to offer sedation.

[Pain in connection with colonoscopy in Norway]. / Smerter ved koloskopi.

BACKGROUND: Colonoscopies are common examinations at Norwegian hospitals. In contrast to many other countries, the majority of colonoscopies in Norway are conducted without routine sedation or analgesia. We wanted to investigate whether current Norwegian practice offers adequate pain relief. MATERIAL AND METHOD: The material consists of prospectively recorded outpatient colonoscopies in the period January 2003-December 2011 performed at Norwegian hospitals in the quality assurance network for gastrointestinal endoscopy (Gastronet). We analysed demographic patient data and data from colonoscopies. Patients' experience of pain (none, slight, moderate or severe pain) in connection with the examination was established with the aid of a validated questionnaire. RESULTS: Data from 61,749 colonoscopies (55% on women) performed at 29 different hospitals were analysed. Colonoscopies were perceived as moderately or very painful by 33% of the patients (41% of the women, 24% of the men, p < 0.001). There were substantial differences between hospitals as to the percentage of colonoscopies that were perceived as moderately or very painful (from 9% to 43%, p < 0.001) and the use of sedatives and analgesics for the colonoscopies (from 1% to 92% of the examinations, p < 0.001). Only 23% of those who found the colonoscopy painful received analgesics. Pethidine was used in 95% of the cases in which analgesics were used during the examination. INTERPRETATION: Many patients find colonoscopies painful. Pain relief practice varies substantially between hospitals. Pethidine is an analgesic with a slow onset of action, and should perhaps be replaced with more rapidly acting opiates.

Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: a randomized study.

BACKGROUND: In sharp bends, particularly in the colonic flexures, the axial pushing force conveyed to the distal actively bending tip of the endoscope may cause impaction rather than progression. It is hypothesized that colonoscopes with a very flaccid segment immediately proximal to the distal bending tip might reduce this problem. MATERIAL AND METHODS: Two prototype colonoscopes with a flaccid passively bending segment (either progressively graded or ungraded flaccidity) positioned immediately proximal to the distal actively bending tip was evaluated in a single-blinded randomized study. The primary end-point was patients' evaluation of pain. RESULTS: Altogether, 400 patients were randomized 1:1 to examination with a prototype (60 patients to endoscope with graded flaccidity; 141 to the endoscope with ungraded flaccidity) or a standard colonoscope. The groups were similar regarding age, sex and previous abdominal surgery. Severe pain was reported by 7% of patients in the prototype and 18% in the standard group (p = 0.001). There was a trend toward shorter cecal intubation time in the prototype group (mean 14.1 min, 95% CI 12.8-15.3) compared to the standard group (mean 15.5 min, 95% CI 14.3-16.7) (p = 0.12) and similar intubation rates (89% and 85%, respectively). Results for first (ungraded flaccidity) and second (graded flaccidity) generation prototypes collectively were similar to the second generation separately. CONCLUSIONS: The concept of an endoscope with a hyper-flaccid segment may facilitate negotiation of sharp bends and reduce pain without compromising cecal intubation rate or intubation time.

Sustaining the vitality of colonoscopy quality improvement programmes over time. Experience from the Norwegian Gastronet programme.

OBJECTIVE: An important challenge of any quality assurance (QA) programme is to maintain interest among participants to ensure high data quality over time. The primary aim of this study was to identify factors associated with endoscopist compliance with the Norwegian QA programme for colonoscopies (Gastronet). MATERIAL AND METHODS: The Gastronet registration tools are an endoscopy report form to be filled in directly after the procedure by the endoscopist, and a satisfaction questionnaire to be filled in by the patient on the day after the examination. During the study period from 1 January 2004 to 31 December 2006, endoscopist compliance was measured by assessing patient report coverage, defined as the percentage of patient satisfaction questionnaires received by the Gastronet secretariat divided by the total number of colonoscopy reports registered by the individual endoscopists during the study period. Multivariate logistic regression models were applied to identify individual factors related to patient report coverage. RESULTS: Eighty-eight endoscopists from 10 hospitals contributed a total of 16,149 colonoscopies. Overall patient report coverage decreased from 87% in 2004 to 80% in 2006. A low patient report coverage was associated with time since the registrations started [odds ratio (OR) 0.98, 95% confidence interval (CI) 0.97-0.98; P < 0.001], use of sedation (OR 0.7, 95% CI 0.61-0.76; P < 0.001), and incomplete colonoscopy (OR 0.6, 95% CI 0.54-0.76; P < 0.001). CONCLUSIONS: Decreasing compliance with registration over time may compromise data quality and the validity of the results. Lower coverage of patient's reports (presumably for the most difficult examinations) may lead to erroneous conclusions regarding colonoscopy performance.

Patients' satisfaction: an important factor in quality control of gastroscopies.

OBJECTIVE: Although oesophagogastroduodenoscopies (OGDs) are associated with few medical complications, substantial pre-procedural anxiety and discomfort during the procedure have been reported. The aims of the present study were to evaluate OGD-related discomfort assessed by the patient and to identify the possibilities for improvement. MATERIAL AND METHODS: All outpatients undergoing OGDs at a single centre during 2004 were eligible for the study. On site, the endoscopy team completed a questionnaire on age of patients, gender and the use of sedation/anaesthesia. After the examination, the patients were given a questionnaire focusing on discomfort during and after the examination. The questionnaire was to be completed at home the following day and returned in a prepaid envelope. RESULTS: During the study period, 1283 examinations were registered, giving 92% coverage of OGDs. The patient response rate was 80%. Patients' mean age was 55 years, and 45% were men. The sedation rate was 7.3%. None or only slight discomfort was experienced by 68% of the patients and severe discomfort by 14%. In patients, the odds ratio (OR) for experiencing moderate or severe discomfort decreased with increasing age (OR 0.96, 95% CI 0.95-0.97, p < 0.001). There were significant differences in patient discomfort depending on the level of experience of the endoscopists. CONCLUSIONS: The majority of patients reported no or only slight discomfort during the examination, but as many as 32% did not. Increased use of sedation in selected patients is recommended. Our quality assurance program included a limited number of variables for registration, with satisfactory compliance by endoscopists and patients.

Improvement in caecal intubation rate and pain reduction by using 3-dimensional magnetic imaging for unsedated colonoscopy: a randomized trial of patients referred for colonoscopy.

OBJECTIVE: Use of magnetic endoscope imaging (MEI) during colonoscopy has the potential to ease caecal intubation and patient discomfort and to reduce dependence on sedation and/or analgesics (SAs). However, pain reduction by using MEI has not been demonstrated so far, probably because of the liberal use of SAs. The aim of the present study was to evaluate the effect of MEI on caecal intubation and patient pain during unsedated colonoscopy performed by experienced and inexperienced colonoscopists. MATERIAL AND METHODS: A consecutive series of outpatients referred for colonoscopy were randomly allocated to examination with (imager group) or without (standard group) the use of MEI. Patients agreeing to SAs being given only on demand were included in the study. End-points were caecal intubation and pain, the latter to be graded by category on a form to be completed on the day after the examination. RESULTS: The proportion of colonoscopies performed without SAs was similar when comparing imager and standard groups and experienced with inexperienced colonoscopists; altogether 367(88%) out of 419 colonoscopies. The caecal intubation rate was higher in the imager group (190/212 (90%)) than in the standard group (153/207(74%)) (p<0.001), both collectively and separately for experienced and inexperienced colonoscopists. A pain-reducing effect of MEI was shown only when performed by experienced colonoscopists, with severe pain in 10/137 patients (7.3%) in the imager group and 21/132 patients (16%) in the standard group (p=0.03). CONCLUSIONS: In colonoscopy without the routine use of SAs, MEI significantly improves the caecum intubation rate and reduces pain during the procedure.

Impact of a colonoscopic screening examination for colorectal cancer on later utilization of distal GI endoscopies.

BACKGROUND: Colonoscopic screening for colorectal cancer is being implemented in an increasing number of countries. This might lead to a demand for colonoscopies that could outstrip supply. OBJECTIVE: We wanted to investigate whether undergoing a colonoscopic examination for colorectal cancer would affect the utilization of later distal GI endoscopies for other indications than follow-up of the findings at the screening examination (usual-care endoscopies). DESIGN: Prospective case control study. PATIENTS: In 1996, a screening group of 634 individuals, aged 63 to 72 years, randomly drawn from the official population registry, was invited to a "once only" colonoscopic screening examination for colorectal cancer. A total of 451 individuals (71%) attended. An age- and sex-matched control group of 634 individuals was enrolled from the same registry. Both groups belonged to the encatchment area of a single hospital. MAIN OUTCOME MEASUREMENTS: Distal endoscopies performed in the 2 groups from January 1996 to November 2004 were registered by investigating medical records. RESULTS: A total of 1268 individuals (52.4% women) were followed for 9 years. Sixty-three individuals (9.9%) in the screening group and 110 (17.4%) individuals in the control group (odds ratio 0.53, 95% confidence interval 0.38-0.73) had had a total of 85 and 169 usual-care distal endoscopies, respectively (P < .001). CONCLUSIONS: Undergoing a colonoscopic examination for colorectal cancer seems to reduce the utilization of later usual-care endoscopic examinations. This finding could have an impact on the estimation of endoscopic resources needed for colorectal cancer screening.