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lists of included papers were assessed and clinical experts were contacted for additional information on published and unpublished studies.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 < 0.000001). The results of another study suggest 100% [95% confidence interval (CI) 86.16% to 100%] sensitivity for dermoscopy plus VivaScope 1500 versus 100% (95% CI 91.51% to 100%) for dermoscopy alone. Specificity varied from 51.77% to 80.2% depending on the analysis set used. In terms of margin delineation with VivaScope, one study found that 17 out of 29 patients with visible lentigo maligna (LM) had subclinical disease of > 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.

The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms.

BACKGROUND: Fibrin sealants are used in different types of surgery to prevent the accumulation of post-operative fluid (seroma) or blood (haematoma) or to arrest haemorrhage (bleeding). However, there is uncertainty around the benefits and harms of fibrin sealant use. OBJECTIVES: To systematically review the evidence on the benefits and harms of fibrin sealants in non-emergency surgery in adults. DATA SOURCES: Electronic databases [MEDLINE, EMBASE and The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and the Cochrane Central Register of Controlled Trials)] were searched from inception to May 2015. The websites of regulatory bodies (the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency and the Food and Drug Administration) were also searched to identify evidence of harms. REVIEW METHODS: This review included randomised controlled trials (RCTs) and observational studies using any type of fibrin sealant compared with standard care in non-emergency surgery in adults. The primary outcome was risk of developing seroma and haematoma. Only RCTs were used to inform clinical effectiveness and both RCTs and observational studies were used for the assessment of harms related to the use of fibrin sealant. Two reviewers independently screened all titles and abstracts to identify potentially relevant studies. Data extraction was undertaken by one reviewer and validated by a second. The quality of included studies was assessed independently by two reviewers using the Cochrane Collaboration risk-of-bias tool for RCTs and the Centre for Reviews and Dissemination guidance for adverse events for observational studies. A fixed-effects model was used for meta-analysis. RESULTS: We included 186 RCTs and eight observational studies across 14 surgical specialties and five reports from the regulatory bodies. Most RCTs were judged to be at an unclear risk of bias. Adverse events were inappropriately reported in observational studies. Meta-analysis across non-emergency surgical specialties did not show a statistically significant difference in the risk of seroma for fibrin sealants versus standard care in 32 RCTs analysed [n = 3472, odds ratio (OR) 0.84, 95% confidence interval (CI) 0.68 to 1.04; p = 0.13; I2 = 12.7%], but a statistically significant benefit was found on haematoma development in 24 RCTs (n = 2403, OR 0.62, 95% CI 0.44 to 0.86; p = 0.01; I2 = 0%). Adverse events related to fibrin sealant use were reported in 10 RCTs and eight observational studies across surgical specialties, and 22 RCTs explicitly stated that there were no adverse events. One RCT reported a single death but no other study reported mortality or any serious adverse events. Five regulatory body reports noted death from air emboli associated with fibrin sprays. LIMITATIONS: It was not possible to provide a detailed evaluation of individual RCTs in their specific contexts because of the limited resources that were available for this research. In addition, the number of RCTs that were identified made it impractical to conduct independent data extraction by two reviewers in the time available. CONCLUSIONS: The effectiveness of fibrin sealants does not appear to vary according to surgical procedures with regard to reducing the risk of seroma or haematoma. Surgeons should note the potential risk of gas embolism if spray application of fibrin sealants is used and not to exceed the recommended pressure and spraying distance. Future research should be carried out in surgery specialties for which only limited data were found, including neurological, gynaecological, oral and maxillofacial, urology, colorectal and orthopaedics surgery (for any outcome); breast surgery and upper gastrointestinal (development of haematoma); and cardiothoracic heart or lung surgery (reoperation rates). In addition, studies need to use adequate sample sizes, to blind participants and outcome assessors, and to follow reporting guidelines. STUDY REGISTRATION: This study is registered as PROSPERO CRD42015020710. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Impact of weight change on quality of life in adults with overweight/obesity in the United States: a systematic review.

OBJECTIVE: To review published evidence on the impact of weight/BMI change on health-related quality of life (HRQoL) in adults from the US with overweight/obesity. METHODS: The systematic review was conducted in accordance with PRISMA guidelines. MEDLINE, Embase, EconLit, and Cochrane Library databases were reviewed using pre-defined eligibility criteria to identify relevant US studies in adults with overweight/obesity, with ≥1 year follow-up, quantified weight change, and measured HRQoL. This manuscript focuses on HRQoL derived using the Short-Form 36 (SF-36) and Impact of Weight on Quality of Life-Lite (IWQOL-Lite) instruments. RESULTS: In total, 32 of 6793 identified publications reported HRQoL according to SF-36 or IWQOL-Lite; 20 provided adequate data for inclusion in this review. Although study design and outcomes were heterogeneous, improvements in HRQoL were generally observed with weight loss. Bariatric surgery studies provided the most evidence (12 publications) and demonstrated dramatic (≥20%) weight loss and associated HRQoL improvements. Sustained weight loss was associated with maintenance of HRQoL improvements out to 6 years in some studies. In lifestyle and pharmaceutical intervention studies showing weight loss of 5%-10%, some aspects of HRQoL improved, although the association with weight was not typically explored. Across the 20 publications, physical versus mental HRQoL improvements were more commonly statistically significant. CONCLUSION: Overweight/obesity is typically associated with poorer HRQoL than normal weight (BMI 18.5-24.9 kg/m(2)). This systematic review of US literature demonstrated that significant weight loss after bariatric surgery may be associated with improvements in HRQoL. In non-bariatric studies with weight loss of ≥5%, improvements in some aspects of HRQoL were noted, although the causal nature of the relationship is uncertain. Although many SF-36 and IWQOL-Lite domain scores increased, improvements were typically only significant for physical, rather than mental, HRQoL. This systematic review provides evidence supporting that weight loss may improve HRQoL in people with overweight/obesity.

The influence of the food environment on overweight and obesity in young children: a systematic review.

BACKGROUND AND OBJECTIVE: The increasing prevalence of childhood obesity has led to interest in its prevention, particularly through school-based and family-based interventions in the early years. Most evidence reviews, to date, have focused on individual behaviour change rather than the 'obesogenic environment'. OBJECTIVE: This paper reviews the evidence on the influence of the food environment on overweight and obesity in children up to 8 years. DATA SOURCES: Electronic databases (including MEDLINE, EMBASE, Cochrane Controlled Trials Register (CCTR), DARE, CINAHL and Psycho-Info) and reference lists of original studies and reviews were searched for all papers published up to 31 August 2011. STUDY SELECTION: Study designs included were either population-based intervention studies or a longitudinal study. Studies were included if the majority of the children studied were under 9 years, if they related to diet and if they focused on prevention rather than treatment in clinical settings. DATA EXTRACTION: Data included in the tables were characteristics of participants, aim, and key outcome results. Quality assessment of the selected studies was carried out to identify potential bias and an evidence ranking exercise carried out to prioritise areas for future public health interventions. DATA SYNTHESIS: Thirty-five studies (twenty-five intervention studies and ten longitudinal studies) were selected for the review. There was moderately strong evidence to support interventions on food promotion, large portion sizes and sugar-sweetened soft drinks. CONCLUSIONS: Reducing food promotion to young children, increasing the availability of smaller portions and providing alternatives to sugar-sweetened soft drinks should be considered in obesity prevention programmes aimed at younger children. These environment-level interventions would support individual and family-level behaviour change.