Muireann Quigley

The assessment of the quality of reporting of meta-analyses in diagnostic research: a systematic review

BackgroundOver the last decade there have been a number of guidelines published, aimed at improving the quality of reporting in published studies and reviews. In systematic reviews this may be measured by their compliance with the PRISMA statement. This review aims to evaluate the quality of reporting in published meta-analyses of diagnostic tests, using the PRISMA statement and establish whether there has been a measurable improvement over time.MethodsEight databases were searched for reviews published prior to 31st December 2008. Studies were selected if they evaluated a diagnostic test, measured performance, searched two or more databases, stated the search terms and inclusion criteria, and used a statistical method to summarise a tests performance. Data were extracted on the review characteristics and items of the PRISMA statement. To measure the change in the quality of reporting over time, PRISMA items for two periods of equal duration were compared.ResultsCompliance with the PRISMA statement was generally poor: none of the reviews completely adhered to all 27 checklist items. Of the 236 meta-analyses included following selection: only 2(1%) reported the study protocol; 59(25%) reported the searches used; 76(32%) reported the results of a risk of bias assessment; and 82(35%) reported the abstract as a structured summary. Only 11 studies were published before 2000. Thus, the impact of QUOROM on the quality of reporting was not evaluated. However, the periods 2001-2004 and 2005-2008 (covering 93% of studies) were compared using relative risks (RR). There was an increase in the proportion of reviews reporting on five PRISMA items: eligibility criteria (RR 1.13, 95% CI 1.00 - 1.27); risk of bias across studies (methods) (RR 1.81, 95% CI 1.34 - 2.44); study selection results (RR 1.48, 95% CI 1.05 - 2.09); results of individual studies (RR 1.37, 95% CI 1.09 - 1.72); risk of bias across studies (results) (RR 1.65, 95% CI 1.20 - 2.25).ConclusionAlthough there has been an improvement in the quality of meta-analyses in diagnostic research, there are still many deficiencies in the reporting which future reviewers need to address if readers are to trust the validity of the reported findings.

Organ donation and transplantation

This article examines key ethical issues involved in organ donation and transplantation. A brief initial overview is provided of general ethical issues that arise in relation to deceased and living organ donation, as well as xenotransplantation. Thereafter, the role played by the gift of life metaphor in underpinning the system of organ donation as well as ethical dilemmas that are raised by markets in organs are examined. Finally, specific issues that have given rise to particularly contentious ethical debate in recent years are addressed, including the use of opt-out systems of organ donation, organ donor exchange, and conditional organ donation.

Uptake of newer methodological developments and the deployment of meta-analysis in diagnostic test research: a systematic review

BackgroundThe last decade has seen a number of methodological developments in meta-analysis of diagnostic test studies. However, it is unclear whether such developments have permeated the wider research community and on which applications they are being deployed. The objective was to assess the uptake and deployment of the main methodological developments in the meta-analysis of diagnostic tests, and identify the tests and target disorders most commonly evaluated by meta-analysis.MethodsDesign - systematic review. Data Sources - Medline, EMBASE, CINAHL, Cochrane, PsychInfo, Global health, HMIC, and AMED were searched for studies published before 31st December 2008. Selection criteria - studies were included if they satisfied all of the following: evaluated a diagnostic test; measured test performance; searched two or more databases; stated search terms and inclusion criteria; used a statistical method to summarise performance. Data extraction - included the following data items: year; test; reference standard; target disorder; setting; statistical and quality methods.Results236 studies were included. Over the last 5 years the number of meta-analyses published has increased, but the uptake of new statistical methods lags behind. Pooling the sensitivity and specificity and using the SROC remain the preferred methods for analysis in 70% of studies, with the bivariate random effects and HSROC model being used in only 22% and 5% of studies respectively. In contrast, between 2006 and 2008 the QUADAS tool was used in 40% of studies. Broadly, radiological imaging was the most frequent category of tests analysed (36%), with cancer (22%) and infection (21%) being the most common categories of target disorder. Nearly 80% of tests analysed were those normally used in specialist settings.ConclusionAlthough quality assessment in meta-analyses has improved with the introduction of QUADAS, uptake of the newer statistical methods is still lagging behind. Furthermore, the focus of secondary research seems to be in evaluating specialist tests in specialist settings, in contrast to the more routine tests and settings encountered in the majority of clinical practice.

NUDGING FOR HEALTH: ON PUBLIC POLICY AND DESIGNING CHOICE ARCHITECTURE

There have been recent policy moves aimed at encouraging individuals to lead healthier lives. The Cabinet Office has set up a ‘nudge unit’ with health as one of its priorities and behavioural approaches have started to be integrated into health-related domestic policy in a number of areas. Behavioural research has shown that that the way the environment is constructed can shape a persons choices within it. Thus, it is hoped that, by using insights from such research, people can be nudged towards making decisions which are better for their health. This article outlines how nudges can be conceived of as part of an expanding arsenal of health-affecting regulatory tools being used by the Government and addresses some concerns which have been expressed regarding behavioural research-driven regulation and policy. In particular, it makes the case that, regardless of new regulatory and policy strategies, we cannot escape the myriad of influences which surround us. As such, we can view our health-affecting decisions as already being in some sense shaped and constructed. Further, it argues we may in fact have reason to prefer sets of health-affecting options which have been intentionally designed by the state, rather than those that stem from other sources or result from random processes. Even so, in closing, this article draws attention to the largely unanswered questions about how behavioural research translates into policy and regulatory initiatives.

The organs crisis and the Spanish model: theoretical versus pragmatic considerations

In the United Kingdom, the debate about how best to meet the shortfall of organs for transplantation has persisted on and off for many years. It is often presumed that the answer is simply to alter the law to a system of presumed consent. Acting perhaps on that presumption in his annual report launched in July, the Chief Medical Officer, Sir Liam Donaldson, advocated a system of organ donation based on presumed consent, the so-called “opt-out” system.1 He is calling for a change in the law in England and Wales whereby consent to organ donation is presumed, making a person’s organs automatically available for transplantation after death, unless they registered objections to this while alive. Subsequently, the British Medical Association (BMA) lent its support to the introduction of such a system.2 The BMA contends that “the practice of presumed consent legislation has had a significant effect on the number of cadaveric donors per million population.”2 It is often taken for granted that there must be a correlation between the enactment of legislation on presumed consent and an increase in organ donation and procurement. However, the correlation is not as straightforward as it might seem. It may be that other practical measures to encourage organ donation could be implemented without changing the Human Tissue Act 2004, an Act which has been in force for barely a year. An analysis by Abadie and Gay demonstrated that “presumed consent legislation has a positive and sizeable effect on organ donation rates”(p599),3 but they themselves admitted that the correlation between rates of donation and presumed consent legislation is “not completely unequivocal”(p606).3 It is true that among the most successful cases in procurement rates are countries with presumed consent legislation (Spain, Austria, Belgium, France and Italy). However, since some of the …

Organ donation and priority points in Israel: an ethical analysis.

Israel’s rates of organ donation have been one of the lowest among developed countries. An attempt to change this has led to the introduction of a pioneering new law, the Organ Transplant Act 2008, which came into effect in January 2010 and sets out principles underlying a new policy in relation to the allocation of organs for transplantation. According to this policy, a person can gain priority points by signing a donor card, making a nondirected organ donation during their lifetime, or as a result of a first-degree relative signing a donor card, or consenting to procurement of organs after death. In this opinion piece, we argue that although this approach merits attention for its innovative aspects and its potential benefits, it raises some ethical difficulties. In particular, we discuss some problems of justice and fairness inherent in the system, focusing on inequalities because of the (a) number of relatives one might have, (b) the type of living donation one makes, (c) the potential for strategic behavior, and (d) problems regarding the consent of family members.

Best interests and potential organ donors

Many potential donor organs are currently lost because of misunderstanding of the law. John Coggon and colleagues clarify what is permissible in non-heart-beating donation

Non‐human primates: the appropriate subjects of biomedical research?

Following the publication of the Weatherall report on the use of non-human primates in research, this paper reflects on how to provide appropriate and ethical models for research beneficial to humankind. Two of the main justifications for the use of non-human primates in biomedical research are analysed. These are the “least-harm/greatest-good” argument and the “capacity” argument. This paper argues that these are equally applicable when considering whether humans are appropriate subjects of biomedical research.

Property and the body: Applying Honoré

This paper argues that the new commercial and quasi-commercial activities of medicine, scientists, pharmaceutical companies and industry with regard to human tissue has given rise to a whole new way of valuing our bodies. It is argued that a property framework may be an effective and constructive method of exploring issues arising from this. The paper refers to A M Honoré’s theory of ownership and aims to show that we have full liberal ownership of our own bodies and as such can be considered to be self-owners.

Opt-out organ donation: on evidence and public policy.

Deceased organ donation in the United Kingdom (UK) is governed by the Human Tissue Act 2004 and the Human Tissue Act (Scotland) 2006 and operates under an opt-in system of donation. Despite its rejection by the Organ Donation Taskforce in 2008, there have been continued calls to move to an opt-out system (sometimes, perhaps incorrectly, termed presumed consent). For example, the British Medical Association has long supported such a move and there have been sustained attempts from some academic commentators who argue for legislative change. Recently, the National Assembly for Wales voted in favour of a draft Human Transplantation (Wales) Bill, which will enable the creation of an opt-out system. This follows a referendum held in early 2011 which resulted in the Assembly gaining further law-making powers, including in relation to health and health services. The new law is slated to be on the statute books by 2015. In addition, earlier this year, the Northern Irish Executive announced plans to consult on organ donation including a possible move to an opt-out system. It has been widely assumed that the evidence available makes credible the suggestion that opt-out systems yield significantly higher rates of organ donation, something that a recent review commissioned by the Welsh Assembly supposedly reaffirms. In this essay piece, we take issue with the way in which the evidence has been used to make inferences and reach conclusions not necessarily (strongly) supported by the evidence. The available evidence is weaker than sometimes assumed, yet it is being used to support ideological, ethical and political commitments. In the absence of strong evidence, time and effort spent on legislative change misses the opportunity to focus on non-legislative action, which could have greater impact. Measuring the potential impact of legislative change