Neglected impacts of patient decision-making associated with genetic testing

We highlight non-health-related impacts associated with genetic testing (GT) and knowing one’s genetic status so that health technology assessment (HTA) analysts and HTA audiences may more appropriately consider the pros and cons of GT. Whereas health-related impacts of GT (e.g., increased healthy behaviors and avoidance of harms of unnecessary treatment) are frequently assessed in HTA, some non-health-related impacts are less often considered and are more difficult to measure. This presents a challenge for accurately assessing whether a genetic test should be funded. In health systems where HTA understandably places emphasis on measurable clinical outcomes, there is a risk of creating a GT culture that is pro-testing without sufficient recognition of the burdens of GT. There is also a risk of not funding a genetic test that provides little clinical benefit but nonetheless may be seen by some as autonomy enhancing. The recent development of expanded HTA frameworks that include ethics analyses helps to address this gap in the evidence and bring awareness to non-health-related impacts of GT. The HTA analyst should be aware of these impacts, choose appropriate frameworks for assessing genetic tests, and use methods for evaluating impacts. A new reporting tool presented here may assist in such evaluations.Joanne Milverton, and Drew Carte

Microwave tissue ablation for primary and secondary liver cancer

Main issues for Medical Services Advisory Committee consideration -The clinical claims for the superiority of microwave tissue ablation (MTA) over radiofrequency ablation (RFA) made in the application are not supported by the evidence. -There is very little randomised controlled trial evidence for this intervention. -Much of the evidence included for this intervention uses historical controls; that is, institutions went from using RFA to using MTA, and then compared the experience of the MTA patients with the experience of earlier patients. This is likely to have important ramifications for the effectiveness of the intervention, as many other aspects of the treatment may also have changed in that time, such as chemotherapy, imaging, patient selection for ablation and surgery, and the equipment used to deliver the ablation. -Selection bias is also highly likely in most of the populations included in the evidence base, as most studies simply included patients seen in their institutions, and there was little discussion about who was excluded from analyses or how patients were selected for ablation. Moreover, in most studies, there was a lack of information relevant to prognosis, for example time since diagnosis, and these factors are likely to confound the results. -There does seem to be some evidence that MTA works better than RFA in more severe cases of cancer; however, given the problems with historical controls, the superior effectiveness may actually be due to improvements in other treatments, or indeed in patient selection for the treatment. -In patients with liver metastases, most of the identified evidence was excluded because patients underwent concomitant resection (meaning they were not ‘unresectable’ as described in the ‘Population’ component of the PICO criteria). It is likely that patients in this group, who have more complex disease, undergo a range of treatments, and finding evidence for just one of them in isolation will be difficult. -Despite the claims that MTA has quicker ablation time and fewer required sessions, there was little evidence available to support these claims.Joanne Milverton, Ruchi Mittal, Jacqueline Parsons, Camille Schubert and Skye Newto

Methodology to assess a predictive test for breast cancer recurrence

Poster Display #PD77Joanne Milverton, Arlene Vogan, Camille Schubert, Tracy Merli

Systematic review of the human health effects of wind farms

This independent review of the literature was commissioned by the National Health and Medical Research Council (NHMRC) to determine whether there is an association between exposure to wind farms and human health effects. The review was undertaken by independent reviewers from Adelaide Health Technology Assessment and the development of the review was guided by NHMRC’s Wind Farms and Human Health Reference Group. Direct evidence of any health effects was obtained through a systematic literature review of all the available evidence on exposure to the physical emissions produced by wind turbines. The emissions investigated were: noise, shadow flicker and the electromagnetic radiation (EMR) produced by wind turbines. A background literature review was also undertaken to establish whether there is basic biological evidence, or evidence from research into other circumstances of human exposure to the physical emissions that wind turbines produce, that makes it plausible that wind turbines cause adverse health effects. Before the review was finalised, an international expert organisation (independent from the reviewers) assessed the methodology and quality of the systematic review to ensure it was conducted in a robust and transparent manner.Tracy Merlin, Skye Newton, Benjamin Ellery, Joanne Milverton, Claude Fara

Diagnostic performance of serum cobalamin tests: a systematic review and meta-analysis

AimsSerum cobalamin (cbl, vitamin B(12)) tests are routinely ordered for investigating conditions potentially amenable to cbl supplementation. This study aimed to systematically assess the evidence of diagnostic accuracy for serum cbl tests across patient subgroups.MethodsSeven medical databases were searched (1990 to November 2009). Studies were included that compared serum cbl to a reference standard (all reference standards employed). Study quality was assessed using QUADAS. Summary estimates of test performance were determined using the bivariate model and hierarchical summary receiver operating characteristic curves (HSROC).ResultsOf 2878 identified studies, 54 were included. Studies rated poorly against QUADAS criteria. Positive (PLR) and negative likelihood ratios (NLR) were 2.72 [95% confidence interval (CI) 1.95, 3.81] and 0.59 (0.49, 0.72), respectively (studies employing methylmalonic acid as the referent). In studies employing a clinical reference standard, PLR was 3.33 (0.92, 12.10) and NLR 0.34 (0.13, 0.89). Test performance did not vary by clinical indication, test method or age.ConclusionThis review was limited by the quality of the evidence base and lack of a gold standard. From the available evidence, diagnosis of conditions amenable to cbl supplementation on the basis of serum cbl level alone cannot be considered a reliable approach to investigating suspected vitamin deficiency.Cameron D. Willis, Adam G. Elshaug, Joanne L. Milverton, Amber M. Watt, Michael P. Metz and Janet E. Hiller For The ASTUTE Health Study Grou

Cardiac MRI for myocardial stress perfusion and viability imaging in patients with known or suspected coronary artery disease

Assessment reportCardiac MRI (CMR) uses a standard MRI system, with or without specialised cardiac coils, and specialised software for quantitative analysis. The magnetic field strength used for CMR is usually either 1.5 or 3.0 teslas (T) and the images obtained are interpreted by either a qualified cardiologist or radiologist. Stress perfusion CMR (SP-CMR) detects damaged or ischaemic myocardium, which manifests as perfusion deficits or low signal areas detected during a first-pass perfusion sequence using a gadolinium-based contrast agent (Gotschy et al. 2014). These images are usually compared with perfusion images taken at rest. Viability imaging via delayed contrast-enhanced CMR, or late gadolinium enhancement (LGE), also uses gadolinium-based contrast agents to define the extent of irreversibly damaged (necrotic or scarred) myocardium (Medical Advisory Secretariat 2010e; Woodard et al. 2006). CMR for CAD is not currently covered by private health insurance and private patients who utilise CMR services are required to pay the full cost of the procedure. This contracted assessment of cardiac MRI (magnetic resonance imaging) for myocardial stress perfusion and viability imaging in patients with known or suspected coronary artery disease (CAD) addresses most of the PICO1 elements that were pre-specified in the Protocol that was ratified by the Protocol Advisory Subcommittee (PASC) or the Medical Services Advisory Committee (MSAC) Executive.Dr Judy Morona, Ms Sharon Kessels, Ms Arlene Vogan, Ms Ruchi Mittal, Ms Skye Newton, Ms Jacqueline Parsons, Ms Joanne Milverton, Mr Ben Ellery and Assoc. Prof. Tracy Merlin, Harsh Sing

High pressure atmosphere detritiation for JET and future devices

SIGLEAvailable from British Library Document Supply Centre- DSC:4672.262(JET-P--94/31) / BLDSC - British Library Document Supply CentreGBUnited Kingdo

Magnetic resonance imaging of patients with suspected (non-ischaemic) dilated cardiomyopathies

Assessment reportMagnetic resonance (CMR) imaging on the Medicare Benefits Schedule (MBS). This imaging service would be used in the diagnosis and treatment planning of patients who are suspected of having non-ischaemic dilated cardiomyopathies (NIDCM). The target population comprises: i) people with heart failure (HF) symptoms in whom echocardiography is inconclusive; ii) people with HF symptoms and a low to intermediate risk of coronary artery disease (CAD) in whom echocardiography is suggestive of dilated cardiomyopathy (DCM); iii) asymptomatic first-degree relatives of someone diagnosed with NICDM and in whom echocardiography is inconclusive; or iv) asymptomatic first-degree relatives of someone diagnosed with NIDCM, with an intermediate to high risk of CAD, and in whom echocardiography is suggestive of DCM that requires further investigation prior to treatment.Ms Sharon Kessels, Dr Ruchi Mittal, Dr Judy Morona, Ms Skye Newton, Mr Ben Ellery, Ms Joanne Milverton, Ms Jacqueline Parsons, Ms Arlene Vogan, Ms Camille Schubert and Assoc. Prof. Tracy Merlin, Dr John Younger, Assoc. Prof. John Atherton and Assoc. Prof. Andrew Taylo

High resolution tritium calorimetry based on inertial temperature control

SIGLEAvailable from British Library Document Supply Centre- DSC:4672.262(JET-P--93/38) / BLDSC - British Library Document Supply CentreGBUnited Kingdo