Comparison of Quality Measures for Detection of Neoplasia at Screening Colonoscopy.

BACKGROUND & AIMS: The proportion of colonoscopies with at least one adenoma (adenoma detection rate [ADR]) is inversely associated with colorectal cancer (CRC) risk and death. The aim of this study was to examine whether such associations exist for colonoscopy quality measures other than ADR. METHODS: We used data from the Polish Colorectal Cancer Screening Program collected in 2000-2011. For all endoscopists who performed ≥100 colonoscopies we calculated detection rates of adenomas (ADR), polyps (PDR), and advanced adenomas (≥10 mm/villous component/high-grade dysplasia [AADR]); and number of adenomas per colonoscopy (APC) and per colonoscopy with ≥1 adenoma (APPC). We followed patients until CRC diagnosed before recommended surveillance, death, or December 31, 2019. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) using Cox proportional-hazard models. We used Harrell's C statistic to compare the predictive power of the quality measures. RESULTS: Data on 173,287 patients (median age, 56 years; 37.8% male) and 262 endoscopists were used. During a median follow-up of 10 years and 1,490,683 person-years, we identified 395 CRCs. All quality measures were significantly associated with CRC risk and death. The relative reductions in CRC risk were as follows: for ADR ≥24.9% (reference <12.1%; HR, 0.41; 95% CI, 0.25-0.66), PDR ≥42.7% (reference <19.9%; HR, 0.35; 95% CI, 0.24-0.51), AADR ≥9.1% (reference <4.1%; HR, 0.69; 95% CI, 0.49-0.96), APC ≥0.37 (reference <0.15; HR, 0.35; 95% CI, 0.21-0.58), and APPC ≥1.54 (reference <1.19; HR, 0.54; 95% CI, 0.35-0.83). AADR was the only quality measure with significantly lower predictive power than ADR (Harrell's C, 59.7 vs 63.4; P = .001). Similar relative reductions were observed for CRC death. CONCLUSIONS: This large observational study confirmed the inverse association between ADR and CRC risk and death. The PDR and APC quality measures appear to be comparable with ADR.

Participation in Competing Strategies for Colorectal Cancer Screening: A Randomized Health Services Study (PICCOLINO Study).

BACKGROUND & AIMS: Primary colonoscopy and fecal immunochemical testing (FIT) are considered first-tier tests for colorectal cancer (CRC) screening. Although colonoscopy is considered the most efficacious test, FIT might achieve higher participation rates. It is uncertain what the best strategy is for offering population-wide CRC screening. METHODS: This was a multicenter randomized health services study performed within the framework of the Polish Colonoscopy Screening Program between January 2019 and March 2020 on screening-naïve individuals. Eligible candidates were randomly assigned in a 1:1:1 ratio to participate in 1 of 3 competing invitation strategies: control (invitation to screening colonoscopy only); sequential (invitation to primary colonoscopy and invitation for FIT for initial nonresponders); or choice (invitation offering a choice of colonoscopy or FIT). The primary outcome was participation in CRC screening within 18 weeks after enrollment into the study. The secondary outcome was diagnostic yield for advanced neoplasia. RESULTS: Overall, 12,485 individuals were randomized into the 3 study groups. The participation rate in the control group (17.5%) was significantly lower compared with the sequential (25.8%) and choice strategy (26.5%) groups (P < .001 for both comparisons). The colonoscopy rates for participants with positive FITs were 70.0% for the sequential group and 73.3% for the choice group, despite active call-recall efforts. In the intention-to-screen analysis, advanced neoplasia detection rates were comparable among the control (1.1%), sequential (1.0%), and choice groups (1.1%). CONCLUSIONS: Offering a combination of FIT and colonoscopy as a sequential or active choice strategy increases participation in CRC screening. Increased participation in strategies with FIT do not translate into higher detection of advanced neoplasia. ClinicalTrials.gov, Number NCT03790475.

Long-Term Colorectal Cancer Incidence and Mortality After a Single Negative Screening Colonoscopy.

BACKGROUND: Current guidelines recommend a 10-year interval between screening colonoscopies, but evidence is limited. OBJECTIVE: To assess the long-term risk for colorectal cancer (CRC) and death from CRC after a high- and low-quality single negative screening colonoscopy. DESIGN: Observational study. SETTING: Polish Colonoscopy Screening Program. PARTICIPANTS: Average-risk individuals aged 50 to 66 years who had a single negative colonoscopy (no neoplastic findings). MEASUREMENTS: Standardized incidence ratios (SIRs) and standardized mortality ratios (SMRs) of CRC after high- and low-quality single negative screening colonoscopy. High-quality colonoscopy included a complete examination, with adequate bowel preparation, performed by endoscopists with an adenoma detection rate of 20% or greater. RESULTS: Among 165 887 individuals followed for up to 17.4 years, CRC incidence (0.28 [95% CI, 0.25 to 0.30]) and mortality (0.19 [CI, 0.16 to 0.21]) were 72% and 81% lower, respectively, than in the general population. High-quality examination resulted in 2-fold lower CRC incidence (SIR, 0.16 [CI, 0.13 to 0.20]) and mortality (SMR, 0.10 [CI, 0.06 to 0.14]) than low-quality examination (SIR, 0.32 [CI, 0.29 to 0.35]; SMR, 0.22 [CI, 0.18 to 0.25]). In multivariable analysis, the hazard ratios for CRC incidence after high-quality versus low-quality colonoscopy were 0.55 (CI, 0.35 to 0.86) for 0 to 5 years, 0.54 (CI, 0.38 to 0.77) for 5.1 to 10 years, and 0.46 (CI, 0.25 to 0.86) for 10 to 17.4 years. Only after high-quality colonoscopy did the SIR and SMR for 10.1 to 17.4 years of follow-up not differ compared with earlier observation periods. LIMITATION: The general population was used as the comparison group. CONCLUSION: A single negative screening colonoscopy was associated with reduced CRC incidence and mortality for up to 17.4 years. Only high-quality colonoscopy yielded profound and stable reductions in CRC incidence and mortality throughout the entire follow-up. PRIMARY FUNDING SOURCE: Polish Ministry of Health.

Mortality and Rate of Hospitalization in a Colonoscopy Screening Program From a Randomized Health Services Study.

BACKGROUND & AIMS: It is difficult to quantify adverse events related to screening colonoscopy due to lack of valid and adequately powered comparison groups. We compared mortality and rate of unplanned hospitalizations among subjects who underwent screening colonoscopies within the Polish Colonoscopy Screening Program (PCSP) vs unscreened matched controls in Poland. METHODS: Persons 55-64 years old living in the area covered by the PCSP from 2012 through 2015 were assigned in a (1:1) to a group invited for screening colonoscopy (n = 338,477) or a matched group that would be invited 5 years later (controls, n = 338,557). All subjects in the screening group were assigned proposed screening colonoscopy dates (actual dates when invitees confirmed or rescheduled colonoscopy) and those in the control group were assigned virtual dates corresponding to the matched individuals from the screening group. In the screening group, 55,390 subjects (16.4%) underwent screening colonoscopy. Mortality and hospitalization data were obtained from National Registries. We compared mortality and rate of hospitalization between the groups for defined intervals before and after colonoscopy date. Hospitalizations were divided into related and unrelated to colonoscopy based on ICD codes by 3 specialists. Our primary aim was to compare mortality and hospitalization 6 weeks before and 30 days following the actual or virtual date of colonoscopy in the screening or control group. RESULTS: In the intent to treat analysis, overall there were no significant differences in mortality between the colonoscopy group and control group (0.22% vs 0.22%; risk difference less than .01%; 95% CI, decrease of 0.02% to 0.02%; P = .913). The overall rate of unplanned hospitalization was significantly higher for the colonoscopy group (2.39% vs 2.31% for the control group; risk difference, 0.08%; 95% CI, 0.01%-0.15%; P=.026) for the entire observation period. This was due to the higher rate of hospitalizations after screening (1.10% vs 1.01% for the control group; risk difference, 0.09%; 95% CI, 0.04%-0.14%; P < .001) including higher proportion of hospitalizations that were assessed as related to colonoscopy (0.24% vs 0.22% for the control group; risk difference, 0.02%; 95% CI, 0.00%-0.05%; P = .046). In the per-protocol analysis, the overall rate of hospitalizations did not differ significantly between control and screening colonoscopy groups (1.87% vs 1.90%; P=.709). However, screening colonoscopy did increase rates of related hospitalizations after the date of screening (from 0.14% to 0.31%; P < .001). CONCLUSIONS: In an analysis of data from the PCSP, we found high-quality evidence that colonoscopy as a screening intervention does not increase mortality before or after colonoscopy. However, it may be associated with a small but significant increase in unplanned hospitalizations, especially after the colonoscopy is completed.

Key performance measures for colonoscopy in the Polish Colonoscopy Screening Program.

BACKGROUND: The European Society of Gastrointestinal Endoscopy (ESGE) has published guidelines on key performance measures for colonoscopy. We analyzed whether those standards were met in the Polish Colonoscopy Screening Program (PCSP) and whether the monitoring was feasible. METHODS: We analyzed database records for 43 277 PCSP participants (25 PCSP centers) for the years 2014 - 2015. We used the guideline definitions to calculate values for all key performance measures and compared these with the proposed standards at individual, center, and program level. All data were acquired from the PCSP database, apart from complication data which was assessed from external registries. RESULTS: At the program level, four of five minimum standards and one of two target standards (no set minimum standard) were met. Adequate bowel preparation rate was 91.3 % for the whole program (range among individual centers 79.2 % - 99.2 %). Cecal intubation rate was 97.4 % (93.4 % - 99.4 %). Adenoma detection rate was 29.8 % (19.1 % - 39.1 %). An appropriate polypectomy technique was applied in 62.7 % of cases (0.4 % - 97.8 %). Regarding complications, 7-day hospitalization rate after screening colonoscopy was 0.3 % (n = 127), and 30-day all-cause mortality was 0.02 % (n = 9). Patient feedback was assessed in 66.2 % of colonoscopies (7.6 % - 81.8 %). Appropriate post-polypectomy surveillance was proposed in 95.4 % of cases (range 84.9 % - -99.7 %). It was easy to monitor 6 of 7 key performance measures within the PCSP database, but monitoring complications required the additional effort of data extraction from external registries. CONCLUSIONS: The PCSP meets most proposed minimum standards at program level. Some centers need additional interventions to meet the complete set of quality standards. Use of ESGE performance measures for monitoring colonoscopy is generally feasible in the setting of the colonoscopy screening program.

The impact of low- versus standard-volume bowel preparation on participation in primary screening colonoscopy: a randomized health services study.

BACKGROUND: The aim of this study was to evaluate the impact of low-volume vs. standard-volume bowel preparation on participation in screening colonoscopy, bowel preparation quality, and lesion detection rates. METHODS: This was a multicenter, randomized, health services study within the population-based primary colonoscopy screening program in Poland. Individuals aged 55 - 62 years were randomized in a 1:1 ratio to bowel preparation with a low-volume (0.3 L sodium picosulfate with magnesium citrate) or standard-volume (4 L polyethylene glycol) regimen and then invited to participate in screening colonoscopy. The primary outcome measure was the rate of participation in screening colonoscopy. Compliance with the assigned bowel preparation, bowel preparation quality, and lesion detection rates were also evaluated. RESULTS: A total of 13 621 individuals were randomized and 13 497 were analyzed (6752 in the low-volume group and 6745 in the standard-volume group). The participation rate (16.6 % vs. 15.5 %; P = 0.08) and compliance rate (93.3 % vs. 94.1 %; P = 0.39) did not differ significantly between the groups. In the low-volume group, fewer participants had adequate bowel preparation compared with the standard-volume group (whole colon 79.0 % vs. 86.4 %, P < 0.001; proximal colon 80.1 % vs. 87.3 %, P < 0.001). Detection rates of advanced adenoma (AADR) and advanced serrated polyps (ASPDR) were lower in the low-volume group than in the standard-volume group (AADR in the proximal colon 2.6 % vs. 4.3 %, P = 0.02; ASPDR in the whole colon 2.0 % vs. 3.3 %, P = 0.04; ASPDR in the proximal colon 1.0 % vs. 1.9 %, P = 0.048). CONCLUSION: When compared with a standard-volume bowel preparation with polyethylene glycol, low-volume bowel preparation with sodium picosulfate/magnesium citrate did not improve participation rate or lesion detection rates, and negatively affected bowel preparation quality.

Cost-effectiveness of colonoscopy in an organized screening program.

INTRODUCTION: Colorectal cancer (CRC) is a serious health problem, and various screening programs to reduce CRC have been introduced worldwide. However, the cost­effectiveness of a program based on once­in­a­lifetime colonoscopy in Poland is unknown. OBJECTIVES: The main aim of this study was to assess the cost­effectiveness of Polish Colonoscopy Screening Platform (PCSP), the colonoscopy screening program in Poland. PATIENTS AND METHODS: A Markov model was constructed to compare the strategy of colonoscopy screening as compared with no screening in 100 000 subjects. The model was based on data collected from the nationwide Polish CRC screening program whenever possible. The incremental cost­effectiveness ratio (ICER) was calculated and compared with the willingness­to­pay thresholds. A sensitivity analysis was also performed using the Monte Carlo simulation. RESULTS: Colonoscopy screening within PCSP resulted in a 18.9% reduction in CRC incidence and 19.8% reduction in CRC mortality. The strategy allowed a gain of 2317 life­years saved (1959 after discount­ ing). The cost of colonoscopy screening per participant examined was estimated at 267.70 USD (95% CI, 263.08-272.32 USD). The ICER was less than 6500 USD, which was much lower than the accepted willingness­to­pay thresholds, indicating that the screening was cost­effective. CONCLUSIONS: Colonoscopy screening within the PCSP is cost­effective and may have a substantial impact on the Polish society due to life­years saved. The results have good informative value not only for health policy makers and medical practitioners, but also for health technology assessment.

Reinvitation to screening colonoscopy: a randomized-controlled trial of reminding letter and invitation to educational meeting on attendance in nonresponders to initial invitation to screening colonoscopy (REINVITE).

OBJECTIVES: The response rate to initial invitation to population-based primary screening colonoscopy within the NordICC trial (NCT 00883792) in Poland is around 50%. The aim of this study was to compare the effect of a reinvitation letter and invitation to an educational intervention on participation in screening colonoscopy in nonresponders to initial invitation. METHODS: Within the NordICC trial framework, individuals living in the region of Warsaw, who were drawn from Population Registries and assigned randomly to the screening group, received an invitation letter and a reminder with a prespecified screening colonoscopy appointment date. One thousand individuals, aged 55 to 64 years, who did not respond to both the invitation and the reminding letter were assigned randomly in a 1:1 ratio to the reinvitation group (REI) and the educational meeting group (MEET). The REI group was sent a reinvitation letter and reminder 6 and 3 weeks before the new colonoscopy appointment date, respectively. The MEET group was sent an invitation 6 weeks before an educational meeting date. Outcome measures were participation in screening colonoscopy within 6 months and response rate within 3 months from the date of reinvitation or invitation to an educational meeting. RESULTS: The response rate and the participation rate in colonoscopy were statistically significantly higher in the REI group compared with the MEET group (16.5 vs. 4.3%; P<0.001 and 5.2 vs. 2.1%; P=0.008, respectively). CONCLUSION: A simple reinvitation letter results in a higher response rate and participation rate to screening colonoscopy than invitation to tailored educational meeting in nonresponders to previous invitations. (NCT01183156).