VivaScope® 1500 and 3000 systems for detecting and monitoring skin lesions: a systematic review and economic evaluation

Background: Skin cancer is one of the most common cancers in the UK. The main risk factor is exposure to ultraviolet radiation from sunlight or the use of sunbeds. Patients with suspicious skin lesions are first examined with a dermoscope. After examination, those with non-cancerous lesions are discharged, but lesions that are still considered clinically suspicious are surgically removed. VivaScope® is a non-invasive technology designed to be used in conjunction with dermoscopy to provide a more accurate diagnosis, leading to fewer biopsies of benign lesions or to provide more accurate presurgical margins reducing the risk of cancer recurrence. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of VivaScope® 1500 (Caliber Imaging and Diagnostics, Rochester, NY, USA; Lucid Inc., Rochester, NY, USA; or Lucid Inc., MAVIG GmbH, Munich, Germany) and VivaScope® 3000 (Caliber Imaging and Diagnostics, Rochester, NY, USA) in the diagnosis of equivocal skin lesions, and VivaScope 3000 in lesion margin delineation prior to surgical excision of lesions. Data sources: Databases (MEDLINE, EMBASE and The Cochrane Library) were searched on 14 October 2014, reference lists of included papers were assessed and clinical experts were contacted for additional information on published and unpublished studies. Methods: A systematic review was carried out to identify randomised controlled trials (RCTs) or observational studies evaluating dermoscopy plus VivaScope, or VivaScope alone, with histopathology as the reference test. A probabilistic de novo economic model was developed to synthesise the available data on costs and clinical outcomes from the UK NHS perspective. All costs were expressed as 2014 prices. Results: Sixteen studies were included in the review, but they were too heterogeneous to be combined in a meta-analysis. One of two diagnostic studies that were deemed most representative of UK clinical practice reported that dermoscopy plus VivaScope 1500 was significantly more sensitive than dermoscopy alone in the diagnosis of melanoma (97.8% vs. 94.6%; p = 0.043) and significantly more specific than dermoscopy alone in the diagnosis of non-melanoma (92.4% vs. 26.74%; p  5 mm beyond the dermoscopically identified margin. Using ‘optimistic’ diagnostic data, the economic model resulted in an incremental cost-effectiveness ratio (ICER) of £8877 per quality-adjusted life-year (QALY) (£9362 per QALY), while the ‘less favourable’ diagnostic data resulted in an ICER of £19,095 per QALY (£25,453 per QALY) in the diagnosis of suspected melanomas. VivaScope was also shown to be a dominant strategy when used for the diagnostic assessment of suspected basal cell carcinoma (BCC). Regarding margin delineation of LM, mapping with VivaScope was cost-effective, with an ICER of £10,241 per QALY (£11,651 per QALY). However, when VivaScope was used for diagnosis as well as mapping of LM, then the intervention cost was reduced and VivaScope became a dominant strategy. Limitations: There is an absence of UK data in the included studies and, therefore, generalisability of the results to the UK population is unclear. Conclusions: The use of VivaScope appears to be a cost-effective strategy in the diagnostic assessment of equivocal melanomas and BCCs, and in margin delineation of LM prior to surgical treatment. Future work: High-quality RCTs are required in a UK population to assess the diagnostic accuracy of VivaScope in people with equivocal lesions. Study registration: This study is registered as PROSPERO CRD42014014433. Funding: The National Institute for Health Research Health Technology Assessment programme

Faecal immunochemical tests to triage patients with lower abdominal symptoms for suspected colorectal cancer referrals in primary care:a systematic review and cost-effectiveness analysis

Background: Colorectal cancer (CRC) is the third most common cancer in the UK. Presenting symptoms that can be associated with CRC usually have another explanation. Faecal immunochemical tests (FITs) detect blood that is not visible to the naked eye and may help to select patients who are likely to benefit from further investigation.Objectives: To assess the effectiveness of FITs [OC-Sensor (Eiken Chemical Co./MAST Diagnostics, Tokyo, Japan), HM-JACKarc (Kyowa Medex/Alpha Laboratories Ltd, Tokyo, Japan), FOB Gold (Sentinel/Sysmex, Sentinel Diagnostics, Milan, Italy), RIDASCREEN Hb or RIDASCREEN Hb/Hp complex (R-Biopharm, Darmstadt, Germany)] for primary care triage of people with low-risk symptoms.Methods: Twenty-four resources were searched to March 2016. Review methods followed published guidelines. Summary estimates were calculated using a bivariate model or a random-effects logistic regression model. The cost-effectiveness analysis considered long-term costs and quality-adjusted life-years (QALYs) that were associated with different faecal occult blood tests and direct colonoscopy referral. Modelling comprised a diagnostic decision model, a Markov model for long-term costs and QALYs that were associated with CRC treatment and progression, and a Markov model for QALYs that were associated with no CRC.Results: We included 10 studies. Using a single sample and 10 aeg Hb/g faeces threshold, sensitivity estimates for OC-Sensor [92.1%, 95% confidence interval (CI) 86.9% to 95.3%] and HM-JACKarc (100%, 95% CI 71.5% to 100%) indicated that both may be useful to rule out CRC. Specificity estimates were 85.8% (95% CI 78.3% to 91.0%) and 76.6% (95% CI 72.6% to 80.3%). Triage using FITs could rule out CRC and avoid colonoscopy in approximately 75% of symptomatic patients. Data from our systematic review suggest that 22.5-93% of patients with a positive FIT and no CRC have other significant bowel pathologies. The results of the base-case analysis suggested minimal difference in QALYs between all of the strategies; no triage (referral straight to colonoscopy) is the most expensive. Faecal immunochemical testing was cost-effective (cheaper and more, or only slightly less, effective) compared with no triage. Faecal immunochemical testing was more effective and costly than guaiac faecal occult blood testing, but remained cost-effective at a threshold incremental cost-effectiveness ratio of pound 30,000. The results of scenario analyses did not differ substantively from the base-case. Results were better for faecal immunochemical testing when accuracy of the guaiac faecal occult blood test (gFOBT) was based on studies that were more representative of the correct population.Limitations: Only one included study evaluated faecal immunochemical testing in primary care; however, all of the other studies evaluated faecal immunochemical testing at the point of referral. Further, validation data for the Faecal haemoglobin, Age and Sex Test (FAST) score, which includes faecal immunochemical testing, showed no significant difference in performance between primary and secondary care. There were insufficient data to adequately assess FOB Gold, RIDASCREEN Hb or RIDASCREEN Hb/Hp complex. No study compared FIT assays, or FIT assays versus gFOBT; all of the data included in this assessment refer to the clinical effectiveness of individual FIT methods and not their comparative effectiveness.Conclusions: Faecal immunochemical testing is likely to be a clinically effective and cost-effective strategy for triaging people who are presenting, in primary care settings, with lower abdominal symptoms and who are at low risk for CRC. Further research is required to confirm the effectiveness of faecal immunochemical testing in primary care practice and to compare the performance of different FIT assays.</p