Cost-effectiveness of colorectal cancer screening programmes using sigmoidoscopy and immunochemical faecal occult blood test.

OBJECTIVE: Several European countries are implementing organized colorectal cancer (CRC) screening programmes using faecal immunochemical test (FIT) and/or flexible sigmoidoscopy (FS), but the cost-effectiveness of these programmes is not yet available. We aimed to assess cost-effectiveness, based on data from the established Piedmont screening programme. METHODS: Using the Piedmont programme data, a Markov model was constructed comparing three strategies in a simulated cohort of 100,000 subjects: single FS, biennial FIT, or sequential strategy (FS + FIT offered to FS non-responders). Estimates for CRC incidence and mortality prevention were derived from studies of organized screening. Cost analysis for FS and FIT was based on data from organized programmes. Incremental cost-effectiveness ratios (ICER) between the different strategies were calculated. Sensitivity and probabilistic analyses were performed. RESULTS: Direct costs for FS, and for FIT at first and subsequent rounds, were estimated as €160, €33, and €21, respectively. All the simulated strategies were effective (10-17% CRC incidence reduction) and cost-effective vs. no screening (ICER <€1000 per life-year saved). FS and FS + FIT were the only cost-saving strategies, with FS least expensive (€15 saving per person invited). FS + FIT and FS were the only non-dominated strategies. FS + FIT were more effective and cost-effective than FS (ICER €1217 per life-year saved). The residual marginal uncertainty was mainly related to parameters inherent to FIT effectiveness and adherence. CONCLUSIONS: Organized CRC screening programmes are highly cost-effective, irrespective of the test selected. A sequential approach with FS and FIT appears the most cost-effective option. A single FS is the least expensive, but convenient, approach.

Computer-based self-training for CT colonography with and without CAD.

OBJECTIVES: To determine whether (1) computer-based self-training for CT colonography (CTC) improves interpretation performance of novice readers; (2) computer-aided detection (CAD) use during training affects learning. METHODS: Institutional review board approval and patients' informed consent were obtained for all cases included in this study. Twenty readers (17 radiology residents, 3 radiologists) with no experience in CTC interpretation were recruited in three centres. After an introductory course, readers performed a baseline assessment test (37 cases) using CAD as second reader. Then they were randomized (1:1) to perform either a computer-based self-training (150 cases verified at colonoscopy) with CAD as second reader or the same training without CAD. The same assessment test was repeated after completion of the training programs. Main outcome was per lesion sensitivity (≥ 6 mm). A generalized estimating equation model was applied to evaluate readers' performance and the impact of CAD use during training. RESULTS: After training, there was a significant improvement in average per lesion sensitivity in the unassisted phase, from 74% (356/480) to 83% (396/480) (p < 0.001), and in the CAD-assisted phase, from 83% (399/480) to 87% (417/480) (p = 0.021), but not in average per patient sensitivity, from 93% (390/420) to 94% (395/420) (p = 0.41), and specificity, from 81% (260/320) to 86% (276/320) (p = 0.15). No significant effect of CAD use during training was observed on per patient sensitivity and specificity, nor on per lesion sensitivity. CONCLUSIONS: A computer-based self-training program for CTC improves readers' per lesion sensitivity. CAD as second reader does not have a significant impact on learning if used during training. KEY POINTS: • Computer-based self-training for CT colonography improves per lesion sensitivity of novice readers. • Self-training program does not increase per patient specificity of novice readers. • CAD used during training does not have significant impact on learning.

Flexible Sigmoidoscopy and CT Colonography Screening: Patients' Experience with and Factors for Undergoing Screening-Insight from the Proteus Colon Trial.

Purpose To compare the acceptability of computed tomographic (CT) colonography and flexible sigmoidoscopy (FS) screening and the factors predicting CT colonographic screening participation, targeting participants in a randomized screening trial. Materials and Methods Eligible individuals aged 58 years (n = 1984) living in Turin, Italy, were randomly assigned to be invited to screening for colorectal cancer with FS or CT colonography. After individuals who had died or moved away (n = 28) were excluded, 264 of 976 (27.0%) underwent screening with FS and 298 of 980 (30.4%) underwent CT colonography. All attendees and a sample of CT colonography nonattendees (n = 299) were contacted for a telephone interview 3-6 months after invitation for screening, and screening experience and factors affecting participation were investigated. Odds ratios (ORs) were computed by means of multivariable logistic regression. Results For the telephone interviews, 239 of 264 (90.6%) FS attendees, 237 of 298 (79.5%) CT colonography attendees, and 182 of 299 (60.9%) CT colonography nonattendees responded. The percentage of attendees who would recommend the test to friends or relatives was 99.1% among FS and 93.3% among CT colonography attendees. Discomfort associated with bowel preparation was higher among CT colonography than FS attendees (OR, 2.77; 95% confidence interval [CI]: 1.47, 5.24). CT colonography nonattendees were less likely to be men (OR, 0.36; 95% CI: 0.18, 0.71), retired (OR, 0.31; 95% CI: 0.13, 0.75), to report regular physical activity (OR, 0.37; 95% CI: 0.20, 0.70), or to have read the information leaflet (OR, 0.18; 95% CI: 0.08, 0.41). They were more likely to mention screening-related anxiety (mild: OR, 6.30; 95% CI: 2.48, 15.97; moderate or severe: OR, 3.63; 95% CI: 1.87, 7.04), erroneous beliefs about screening (OR, 32.15; 95% CI: 6.26, 165.19), or having undergone a recent fecal occult blood test (OR, 13.69; 95% CI: 3.66, 51.29). Conclusion CT colonography and FS screening are well accepted, but further reducing the discomfort from bowel preparation may increase CT colonography screening acceptability. Negative attitudes, erroneous beliefs about screening, and organizational barriers are limiting screening uptake; all these factors are modifiable and therefore potentially susceptible to interventions. © RSNA, 2017 Online supplemental material is available for this article.

Comparing CT colonography and flexible sigmoidoscopy: a randomised trial within a population-based screening programme.

IMPORTANCE AND AIMS: The role of CT colonography (CTC) as a colorectal cancer (CRC) screening test is uncertain. The aim of our trial was to compare participation and detection rate (DR) with sigmoidoscopy (flexible sigmoidoscopy (FS)) and CTC in a screening setting. DESIGN SETTING AND PARTICIPANTS: We conducted two randomised clinical trials (RCTs). (1) Participation RCT: individuals, aged 58 years, living in Turin (Italy), were randomly assigned to be invited to FS or CTC screening; (2) detection RCT: residents in northern Italy, aged 58-60, giving their consent to recruitment, were randomly allocated to CTC or FS. Polyps ≥6 mm at CTC, or 'high-risk' distal lesions at FS, were referred for colonoscopy (TC). MAIN OUTCOME MEASURES: Participation rate (proportion of invitees examined); DR of advanced adenomas or CRC (advanced neoplasia (AN)). RESULTS: Participation was 30.4% (298/980) for CTC and 27.4% (267/976) for FS (relative risk (RR) 1.1; 95% CI 0.98 to 1.29). Among men, participation was higher with CTC than with FS (34.1% vs 26.5%, p=0.011). In the detection RCT, 2673 subjects had FS and 2595 had CTC: the AN DR was 4.8% (127/2673, including 9 CRCs) with FS and 5.1% (133/2595, including 10 CRCs) with CTC (RR 1.08; 95% CI 0.85 to 1.37). Distal AN DR was 3.9% (109/2673) with FS and 2.9% (76/2595) with CTC (RR 0.72; 95% CI 0.54 to 0.96); proximal AN DR was 1.2% (34/2595) for FS vs 2.7% (69/2595) for CTC (RR 2.06; 95% CI 1.37 to 3.10). CONCLUSIONS AND RELEVANCE: Participation and DR for FS and CTC were comparable. AN DR was twice as high in the proximal colon and lower in the distal colon with CTC than with FS. Men were more likely to participate in CTC screening. TRIAL REGISTRATION NUMBER: NCT01739608; Pre-results.

Risk of nephrogenic systemic fibrosis is low in patients with chronic liver disease exposed to gadolinium-based contrast agents.

PURPOSE: To determine the risk of nephrogenic systemic fibrosis (NSF) in a cohort of patients with chronic liver disease. MATERIALS AND METHODS: This retrospective, Institutional Review Board (IRB)-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant study was performed at a single tertiary liver center. The study cohort comprised 1167 patients with chronic liver disease followed in a liver clinic and exposed to gadolinium-based contrast agents (GBCAs) between February 2004 and October 2007. A retrospective review of medical records was performed. For each patient, data were collected on demographics, history of GBCA exposure, presence of purported risk factors for NSF, and histopathological evidence of NSF. RESULTS: Of the 1167 patients with chronic liver disease, 58% (n = 678) had cirrhosis. The patients had a total of 2421 separate GBCA exposures. Fifty-five percent (n = 646) had a single exposure, 19% (n = 218) had two exposures, and 26% (n = 303) had three or more exposures. Seventy-two percent (n = 843) of patients had renal insufficiency, 25 patients (2.1%) had hepatorenal syndrome, 80 patients (6.8%) were in the perioperative liver transplant period, and 49 patients (4.2%) had one or more additional risk factors for NSF. None of the 1167 patients developed NSF. CONCLUSION: Chronic liver disease does not appear to be a significant risk factor for NSF.

Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial.

BACKGROUND: Colorectal cancer (CRC) is the second most prevalent type of cancer in Europe. A single flexible sigmoidoscopy (FS) screening at around the age of 60 years prevents about one-third of CRC cases. However, FS screens only the distal colon, and thus mortality from proximal CRC is unaffected. Computed tomography colonography (CTC) is a highly accurate examination that allows assessment of the entire colon. However, the benefit of CTC testing as a CRC screening test is uncertain. We designed a randomized trial to compare participation rate, detection rates, and costs between CTC (with computer-aided detection) and FS as primary tests for population-based screening. METHODS/DESIGN: An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years, living in the Piedmont region and the Verona district of Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, or recent colonoscopy, or with two first-degree relatives with CRC will be excluded from the study by their general practitioners. Individuals responding positively to the invitation letter will be then randomized to the intervention group (CTC) or control group (FS), and scheduled for the screening procedure. The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests. Secondary outcomes are cost-effectiveness analysis, referral rates for colonoscopy induced by CTC versus FS, and the expected and perceived burden of the procedures. To compare participation rates for CTC versus FS, 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders will be offered fecal occult blood test (FOBT) as alternative screening test, while in the FS arm, non-responders will receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected. DISCUSSION: This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS. The trial will also evaluate the role of computer-aided detection in a screening setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01739608.

Computer-aided detection for computed tomographic colonography screening: a prospective comparison of a double-reading paradigm with first-reader computer-aided detection against second-reader computer-aided detection.

OBJECTIVES: The objective of this study was to prospectively compare diagnostic performance and time efficiency of a double-reading paradigm in which a first-reader computer-aided detection (CAD) is followed by a fast 2-dimensional review (DR FR-CAD) with those of a double reading with second-reader CAD (SR CAD). MATERIALS AND METHODS: The local ethical committee approved this study. Consecutive immunological patients who have positive results for fecal immunological test who were scheduled for colonoscopy were enrolled for a 10-month period. Computed tomographic colonography studies were read with CAD (CAD COLON-1.20; im3D, Turin, Italy) by using both SR CAD (applied after unassisted interpretation primary 2-dimensional) and DR FR-CAD (CAD-prompts evaluation followed by a fast 2-dimensional review) in randomized order with the radiologist for each reading paradigm masked to the other reader's results.Per-patient sensitivity and specificity of unassisted and CAD-assisted readings for detecting 6-mm adenomas or larger were calculated by using unblinding colonoscopy as reference standard. Reporting times were also calculated. Pairwise comparisons were performed. RESULTS: A total of 182 participants (median age, 65 years; range, 58-76) were included in the final analysis. Of these, 93 (51%) had at least 1 cancer or a 6-mm adenoma or larger. At the 6-mm threshold, sensitivity of unassisted reading (79.6%; 95% confidence interval [CI], 69.9-87.2) increased significantly with the use of both SR CAD (86.0%; 95% CI, 77.3%-92.3%) and DR FR-CAD (89.2%; 95% CI, 81.1%-94.7%), without differences between CAD readings (P = 0.500). No significant differences in specificity among the 3 paradigms were observed. Double reading with first-reader CAD required less reading time than that for SR CAD (378 vs 496; Δ118 seconds; P < 0.001) and was 59 seconds longer than the unassisted reading (P = 0.058). CONCLUSIONS: When compared with unassisted reading, a double-reading paradigm in which first-reader CAD is followed by a fast 2-dimensional review improves the adenoma detection rate to the same level achieved by a second-reader CAD while decreasing reporting times.

CT colonography: preliminary assessment of a double-read paradigm that uses computer-aided detection as the first reader.

PURPOSE: To compare diagnostic performance and time efficiency of double-reading first-reader computer-aided detection (CAD) (DR FR CAD) followed by radiologist interpretation with that of an unassisted read using segmentally unblinded colonoscopy as reference standard. MATERIALS AND METHODS: The local ethical committee approved this study. Written consent to use examinations was obtained from patients. Three experienced radiologists searched for polyps 6 mm or larger in 155 computed tomographic (CT) colonographic studies (57 containing 10 masses and 79 polyps ≥ 6 mm). Reading was randomized to either unassisted read or DR FR CAD. Data sets were reread 6 weeks later by using the opposite paradigm. DR FR CAD consists of evaluation of CAD prompts, followed by fast two-dimensional review for mass detection. CAD sensitivity was calculated. Readers' diagnoses and reviewing times with and without CAD were compared by using McNemar and Student t tests, respectively. Association between missed polyps and lesion characteristics was explored with multiple regression analysis. RESULTS: With mean rate of 19 (standard deviation, 14; median, 15; range, 4-127) false-positive results per patient, CAD sensitivity was 90% for lesions 6 mm or larger. Readers' sensitivity and specificity for lesions 6 mm or larger were 74% (95% confidence interval [CI]: 65%, 84%) and 93% (95% CI: 89%, 97%), respectively, for the unassisted read and 77% (95% CI: 67%, 85%) and 90% (95% CI: 85%, 95%), respectively, for DR FR CAD (P = .343 and P = .189, respectively). Overall unassisted and DR FR CAD reviewing times were similar (243 vs 239 seconds; P = .623); DR FR CAD was faster when the number of CAD marks per patient was 20 or fewer (187 vs 220 seconds, P <01). Odds ratio of missing a polyp with CAD decreased as polyp size increased (0.6) and for polyps visible on both prone and supine scans (0.12); it increased for flat lesions (9.1). CONCLUSION: DR FR CAD paradigm had similar performance compared with unassisted interpretation but better time efficiency when 20 or fewer CAD prompts per patient were generated.

Adverse events of computed tomography colonography: an Italian National Survey.

AIM: To retrospectively study the frequency and magnitude of complications associated with computed tomography (CT) colonography in clinical practice. METHODS: A questionnaire on complications of CT colonography was sent to Italian public radiology departments identified as practicing CT colonography with a reasonable level of training. The frequency of complications and possible risk factors were retrospectively determined. Responses were collated and row frequencies determined. A multivariate analysis of the factors causing adverse events was also performed. RESULTS: 40,121 examinations were performed in13 centers during the study period. No deaths were reported. Bowel perforations occurred in 0.02% (7 exams). All perforations were asymptomatic and occurred in patients undergoing manual insufflation. Five perforations (71%) occurred in procedures performed following a recent colonoscopy. There was no significant difference between perforations associated with rectal balloon (0.017%) and those that were not (0.02%). Complications related to vasovagal reaction (either with or without spasmolytic) occurred in 0.16% (63 exams). All vasovagal reactions resolved in less than 3h, without any sequelae. CONCLUSIONS: Perforation rate at CT colonography in Italy is comparable with elsewhere in the world, occurring regardless of the experience of radiology centers. Although the risk is very small, it may not be negligible when compared with the risk of diagnostic colonoscopy.

Efficacy of computer-aided detection as a second reader for 6-9-mm lesions at CT colonography: multicenter prospective trial.

PURPOSE: To assess the effect of computer-aided detection (CAD) as a second reader on the sensitivity and specificity of computed tomographic (CT) colonography in detecting 6-9-mm colorectal cancer (CRC) lesions. MATERIALS AND METHODS: Individuals with clinical indications for colonoscopy--either for symptoms or as part of participating in a surveillance program or CRC screening--were prospectively enrolled at one of 10 academic centers between July 2007 and May 2009. Institutional review board approval was obtained at each clinical site, and all participants provided written informed consent. All participants underwent CT colonography and colonoscopy on the same day. Experienced readers interpreted the CT colonography images unassisted and then reviewed all colorectal lesion-like structures pinpointed by the CAD algorithm. Segmental unblinding of CT colonoscopy findings at colonoscopy was utilized. The sensitivity and specificity of unassisted and CAD-assisted reading in identifying individuals with 6-9-mm lesions were calculated and compared by means of pairwise analysis. RESULTS: A total of 618 participants (mean age, 57.9 years; 54.5% male) were included in the final analysis. Of these participants, 464 (75.1%) had no lesions 6 mm or larger, and 52 (8.4%) had 6-9-mm lesions. The sensitivity of CT colonography with unassisted reading and that with CAD-assisted reading in identifying individuals with 6-9-mm lesions was 65.4% (95% confidence interval [CI]: 50.9%, 78.0%) and 76.9% (95% CI: 63.2%, 87.5%; P = .016), respectively. No significant change in specificity was observed: The specificity of CT colonography with unassisted and that with CAD-assisted reading was 91.8% (95% CI: 88.9%, 94.1%) and 90.9% (95% CI: 88.0%, 93.4%; P = .063), respectively. Evaluation of CAD candidates required an additional 1.6 minutes (25th-75th percentile: 1.0 minute to 3.4 minutes). CONCLUSION: The addition of CAD to reading performed by experienced readers resulted in a significant benefit in the detection of 6-9-mm polyps at CT colonography in this cohort. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.12120376/-/DC1.

Percutaneous vertebroplasty in multiple myeloma: prospective long-term follow-up in 106 consecutive patients.

PURPOSE: Percutaneous vertebroplasty (PV) is a minimally invasive procedure involving the injection of bone cement within a collapsed vertebral body. Although this procedure was demonstrated to be effective in osteoporosis and metastases, few studies have been reported in cases of multiple myeloma (MM). We prospectively evaluated the safety and efficacy of PV in the treatment of vertebral compression fractures (VCFs) resulting from MM. MATERIALS AND METHODS: PV was performed in 106 consecutive MM patients who had back pain due to VCFs, the treatment of which had failed conservative therapies. Follow-up (28.2 ± 12.1 months) was evaluated at 7 and 15 days as well as at 1, 3, 6, 12, 18, and every 6 months after PV. Visual analog scale (VAS) pain score, opioid use, external brace support, and Oswestry Disability Index (ODI) score were recorded. RESULTS: The median pretreatment VAS score of 9 (range 4-10) significantly (P < 0.001) decreased to 1 (range 0-9) after PV. Median pre-ODI values of 82% (range 36-89%) significantly improved to 7% (range 0-82%) (P < 0.001). Differences in pretreatment and posttreatment use of analgesic drug were statistically significant (P < 0.001). The majority of patients (70 of 81; 86%) did not use an external brace after PV (P < 0.001). CONCLUSION: PV is a safe, effective, and long-lasting procedure for the treatment of vertebral compression pain resulting from MM.

Percutaneous vertebroplasty in osteoporotic patients: an institutional experience of 1,634 patients with long-term follow-up.

PURPOSE: To assess long-term clinical outcome of percutaneous vertebroplasty (PV). MATERIALS AND METHODS: PV was performed in 1,634 patients (1,387 women; median age 73 years ± 9.3) with painful osteoporotic vertebral compression fractures (VCFs). All patients had back pain that persisted for ≥ 2 months with a concordant magnetic resonance imaging study. After PV, medical therapy for osteoporosis was continued, and patients were prospectively evaluated (follow-up 11.8-44.9 months, mean 25.0 months). Visual analog scale (VAS), Oswestry Disability Index (ODI), analgesic drug use, and use of external brace support were recorded at baseline and during follow-up. New occurrences of symptomatic vertebral fractures were recorded. RESULTS: The mean VAS score of 7.94 significantly improved to 1.12 at the primary endpoint (P < .001). Differences in patterns of analgesic usage compared with baseline values were highly statistically significant (marginal homogeneity test, P < .001). Median ODI values of 82% before treatment significantly decreased to 6% (P < .001). Before intervention, 1,279 patients wore a brace; 1,167 (91.2%) patients did not wear a brace after PV (χ(2) = 31.005, P < .0001). A new painful fracture with a significant higher proportion of contiguous vertebrae (63.6%) occurred in 214 (13.1%) patients (z = 7.59, P = .025). CONCLUSIONS: PV can provide durable pain relief and improvement in ambulation in patients with VCFs.

Painful pathologic fracture of the humerus: percutaneous osteoplasty with bone marrow nails under hybrid computed tomography and fluoroscopic guidance.

A case of a 75-year-old patient with a painful pathologic humeral shaft fracture, with unacceptably high surgical risk and unsatisfactory analgesia is reported. In this case, impaired arm function and persistent pain with conservative management resulted in a poor quality of life. Palliation with image-guided percutaneous osteoplasty was considered. Because of potential cement leakage, inadequate fracture reduction, the site of the fracture, and the mobility of the joints in that area, image-guided percutaneous delivery of metallic bone marrow nails implanted together with polymethyl methacrylate (PMMA) osteoplasty was performed. This procedure achieved humeral shaft stabilization, bone fragment alignment, fracture reduction, and pain relief.