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BackgroundInitial treatment for early breast cancer is usually either breast-conserving surgery (BCS) or mastectomy. After BCS, whole-breast external beam radiotherapy (WB-EBRT) is the standard of care. A potential alternative to post-operative WB-EBRT is intraoperative radiation therapy delivered by the INTRABEAM®Photon Radiotherapy System (Carl Zeiss, Oberkochen, Germany) to the tissue adjacent to the resection cavity at the time of surgery.ObjectiveTo assess the clinical effectiveness and cost-effectiveness of INTRABEAM for the adjuvant treatment of early breast cancer during surgical removal of the tumour.Data sourcesElectronic bibliographic databases, including MEDLINE, EMBASE and The Cochrane Library, were searched from inception to March 2014 for English-language articles. Bibliographies of articles, systematic reviews, clinical guidelines and the manufacturer’s submission were also searched. The advisory group was contacted to identify additional evidence.MethodsSystematic reviews of clinical effectiveness, health-related quality of life and cost-effectiveness were conducted. Two reviewers independently screened titles and abstracts for eligibility. Inclusion criteria were applied to full texts of retrieved papers by one reviewer and checked by a second reviewer. Data extraction and quality assessment were undertaken by one reviewer and checked by a second reviewer, and differences in opinion were resolved through discussion at each stage. Clinical effectiveness studies were included if they were carried out in patients with early operable breast cancer. The intervention was the INTRABEAM system, which was compared with WB-EBRT, and study designs were randomised controlled trials (RCTs). Controlled clinical trials could be considered if data from available RCTs were incomplete (e.g. absence of data on outcomes of interest). A cost–utility decision-analytic model was developed to estimate the costs, benefits and cost-effectiveness of INTRABEAM compared with WB-EBRT for early operable breast cancer.ResultsOne non-inferiority RCT, TARGeted Intraoperative radioTherapy Alone (TARGIT-A), met the inclusion criteria for the review. The review found that local recurrence was slightly higher following INTRABEAM than WB-EBRT, but the difference did not exceed the 2.5% non-inferiority margin providing INTRABEAM was given at the same time as BCS. Overall survival was similar with both treatments. Statistically significant differences in complications were found for the occurrence of wound seroma requiring more than three aspirations (more frequent in the INTRABEAM group) and for a Radiation Therapy Oncology Group toxicity score of grade 3 or 4 (less frequent in the INTRABEAM group). Cost-effectiveness base-case analysis indicates that INTRABEAM is less expensive but also less effective than WB-EBRT because it is associated with lower total costs but fewer total quality-adjusted life-years gained. However, sensitivity analyses identified four model parameters that can cause a switch in the treatment option that is considered cost-effective.LimitationsThe base-case result from the model is subject to uncertainty because the disease progression parameters are largely drawn from the single available RCT. The RCT median follow-up of 2 years 5 months may be inadequate, particularly as the number of participants with local recurrence is low. The model is particularly sensitive to this parameter.Conclusions and implicationsA significant investment in INTRABEAM equipment and staff training (clinical and non-clinical) would be required to make this technology available across the NHS. Longer-term follow-up data from the TARGIT-A trial and analysis of registry data are required as results are currently based on a small number of events and economic modelling results are uncertain.Study registrationThis study is registered as PROSPERO CRD42013006720.FundingThe National Institute for Health Research Health Technology Assessment programme. Note that the economic model associated with this document is protected by intellectual property rights, which are owned by the University of Southampton. Anyone wishing to modify, adapt, translate, reverse engineer, decompile, dismantle or create derivative work based on the economic model must first seek the agreement of the property owners.

ObjectiveTo assess costs, health outcomes and cost-effectiveness of interventions that aim to improve quality of diet and level of physical activity in adolescents.DesignA Markov model was developed to assess four potential benefits of healthy behaviour for adolescents: better mental health (episodes of depression and generalised anxiety disorder), higher earnings and reduced incidence of type 2 diabetes and adverse pregnancy outcomes (in terms of preterm delivery). The model parameters were informed by published literature. The analysis took a societal perspective over a 20-year period. One-way and probabilistic sensitivity analyses for 10 000 simulations were conducted.ParticipantsA hypothetical cohort of 100 adolescents with a mean age of 13 years.InterventionsAn exemplar school-based, multicomponent intervention that was developed by the Engaging Adolescents for Changing Behaviour programme, compared with usual schooling.Outcome measureIncremental cost-effectiveness ratio (ICER) as measured by cost per quality-adjusted life-year (QALY) gained.ResultsThe exemplar dietary and physical activity intervention was associated with an incremental cost of £123 per adolescent and better health outcomes with a mean QALY gain of 0.0085 compared with usual schooling, resulting in an ICER of £14 367 per QALY. The key model drivers are the intervention effect on levels of physical activity, quality-of-life gain for high levels of physical activity, the duration of the intervention effects and the period over which effects wane.ConclusionsThe results suggested that such an intervention has the potential to offer a cost-effective use of healthcare-resources for adolescents in the UK at a willingness-to-pay threshold of £20 000 per QALY. The model focused on short-term to medium-term benefits of healthy eating and physical activity exploiting the strong evidence base that exists for this age group. Other benefits in later life, such as reduced cardiovascular risk, are more sensitive to assumptions about the persistence of behavioural change and discounting.Trail registration numberISRCTN74109264.

We conducted a systematic review of the accuracy of fundus autofluorescence (FAF) imaging for diagnosing and monitoring retinal conditions. Searches in November 2014 identified English language references. Sources included MEDLINE, EMBASE, the Cochrane Library, Web of Science, and MEDION databases; reference lists of retrieved studies; and internet pages of relevant organisations, meetings, and trial registries. For inclusion, studies had to report FAF imaging accuracy quantitatively. Studies were critically appraised using QUADAS risk of bias criteria. Two reviewers conducted all review steps. From 2240 unique references identified, eight primary research studies met the inclusion criteria. These investigated diagnostic accuracy of FAF imaging for choroidal neovascularisation (one study), reticular pseudodrusen (three studies), cystoid macular oedema (two studies), and diabetic macular oedema (two studies). Diagnostic sensitivity of FAF imaging ranged from 32 to 100% and specificity from 34 to 100%. However, owing to methodological limitations, including high and/or unclear risks of bias, none of these studies provides conclusive evidence of the diagnostic accuracy of FAF imaging. Study heterogeneity precluded meta-analysis. In most studies, the patient spectrum was not reflective of those who would present in clinical practice and no studies adequately reported whether FAF images were interpreted consistently. No studies of monitoring accuracy were identified. An update in October 2016, based on MEDLINE and internet searches, identified four new studies but did not alter our conclusions. Robust quantitative evidence on the accuracy of FAF imaging and how FAF images are interpreted is lacking. We provide recommendations to address this.