Rapid tests that give near instant results, without the need of a laboratory, offer much promise. But, to ensure value for public money we need rigorous evaluation of test performance in real life settings, and empirical assessment of the consequences—intended and unintended—when mass testing and intervention are applied within a population.1 Evolution in technology, in the condition being tested for, and other changes in context mean that regular reappraisal of policy is important. Yet commercial and political incentives to promote tests irrespective of evidence can be irresistible. The popularity of testing for asymptomatic people among the public has seldom borne much relationship to actual utility of the test.2

We disagree that criticism of the United Kingdom Government’s approach to testing represents a ‘falling out’ amongst academics, apparently due to a narrow focus on the Wilson and Jungner criteria, and on test performance. Concerns are based on (i) the persisting scientific uncertainty about the real-life performance of lateral flow devices when delivered by untrained hands and (ii) the consequences of widespread idiosyncratic testing without systematic quality assurance for all steps in the pathway. The decision to spend well over £1 billion of public money on the Innova Biotime test was based on partial evidence, following a limited test validation process. Emergency regulatory approval, and repackaging of all the tests as though the Department of Health and Social Care was the actual manufacturer, then had to be secured in order to ‘retrofit’ the test to allow use outside the real manufacturer’s license. We still have no published evidence about how it performs when put to its current uses as an unsupervised self-test or in children. The focus of concerns has been on the outcomes of the whole programme, not only on a single crucial element, the actual test, although the biases and flaws in evidence relating to test performance have been voiced by those with international expertise in this sphere, an expertise vital to good health policy decision making. Other countries are deploying LFDs, but none has adopted the Innova Biotime test. For example, the basis of Germany’s LFD regulatory and evaluative approach is transparently and publicly set out. In the UK, this information is not disclosed by the Medicines and Healthcare products Regulatory Agency, even under Freedom of Information requests. The author asserts that those who advocate for sound evidence and best value policy making processes for mass testing are misguided because they base their thinking on Wilson and Jungner. It seems to us the reverse is true, with this article ignoring the contemporary world of screening and relying instead on the 1968 publication as defense against suggestions that population-wide infectious disease testing should be informed by the standards and ethics required for screening programmes.

A misguided policy, unlikely to reduce transmission

Background: In their landmark report on the “Principles and Practice Open Peer Review

Should be modelled on successful screening programmes

unknown value, but is being introduced nationwide Concerns this will see demolition of hard won frameworks for protecting the public from ineffective, poorly delivered, and unethically practised screening

BACKGROUND AND OBJECTIVES:This article examines a cervical screening incident from the 1960s and draws lessons for screening policy.STUDY DESIGN AND SETTING:Concern about harmful overtreatment of symptomless lesions prompted university gynecologist Herbert Green to study, between 1965 and 1970, a 'special series' of 33 women with carcinoma in situ (CIS) who were managed with only limited punch or wedge biopsy. These women were carefully followed up but not treated unless they showed evidence of progression to invasive cancer. This paper examines source documents and subsequent publications in order to ascertain lessons from this incident.RESULTS:In keeping with the 1964 Helsinki Declaration, written consent was not sought. Green published the outcomes for his patients with CIS including the 'special series.' A Judicial inquiry (the Cartwright Inquiry) in 1987 concluded that some women had suffered harm and some had died, but numbers and evidence were not clearly stated. Medical case review for the Inquiry identified 25 women with only punch or wedge biopsy; in 21 of these, there were reasons why no further treatment was given; two had developed cervical cancer, and none were recorded as having died. The case review found eight patients, not necessarily in the 'special series,' who 'in retrospect and by 1987 standards' might have benefited from earlier conisation or hysterectomy.CONCLUSION:Subsequent claims relating to Green's practice have wrongly stated that as many as one hundred women or more had treatment withheld and over 30 died as a result. These claims are inaccurate.

Background: In their landmark report on the “Principles and Practice Open Peer Review

Lateral flow tests cannot rule out SARS

Abstract Muir Gray, Anne Mackie and Angela Raffle have been at the forefront of achieving improvements in UK screening over recent years, and they bring a wealth of experience to this non-technical introductory guide covering all aspects of screening. As USA expert Gilbert Welch describes it, this book is “A readable yet encyclopaedic guide to screening: its history, its key design elements, its implementation and policy challenges… A must read for clinicians, managers, and policy makers who would like to assist Raffle Mackie and Gray in achieving their goal: ‘to sort out the mess’.” The first four chapters deal with concepts, methods and evidence, explaining what screening is and how it is evaluated. Chapters five to eight describe practical aspects, for example how to make policy, and how to deliver screening to a high standard. The book includes numerous examples and real-life case histories, giving important reminders of the need to be vigilant for the hidden influence of commercial incentives and ‘bad science’ if we are to achieve best value health and healthcare. A comprehensive glossary makes medical terms accessible to all, and each chapter concludes with a summary and self-test questions. Reference is made to the UK National Health Service, a leader in screening, but the book is internationally relevant because the principles of good screening apply in any setting. The controversies, paradoxes, uncertainties, and ethical dilemmas of screening are explained in a balanced way.

This chapter explains how health screening began, how the aims have evolved, how evidence and organisation influenced matters, and how challenges in the future will give rise to continuing change. It begins with Gould’s address in 1900 to the American Medical Association and charts events that led, almost by accident, to the institution of comprehensive annual testing of healthy adults in the USA, and to 5 day hospital-based ‘Human Dry Dock’ screening for Japanese executives. Scientific challenge then came from two randomised control trials, which failed to find benefit, but by then screening had become an important commercial activity. Using the UK cervical screening programme as a case study, the chapter explores how the optimism of the 1960s led through disillusionment, then to programme organisation and, by the 1990s, an era of realism. Evolution of the Wilson and Jungner criteria as an aid for policy making is covered. A key challenge now is to ensure best value policy, high quality systematic programme delivery and informed choice in the face of commercial forces that lead to the glossing over of screening’s complexities and far reaching consequences.

Abstract This chapter gives understanding of measuring evidence about consequences of screening programmes, at a level needed by public health practitioners interpreting evidence for setting screening policy, or for ensuring high quality programme delivery. It takes a practical approach, illustrating with real-life case histories and examples, ranging from infant neuroblastoma to abdominal aortic aneurysm screening. The issues covered are Three Main Biases (healthy screenee effect, length time effect including overdiagnosis, lead time effect); Three Main Evaluation Methods (randomised control trials, time trend analyses, case control studies, and mention of rare conditions); Test Performance (sensitivity and specificity, positive and negative predictive value, receiver operator characteristic curves); Two Additional Sources of Information (pilot or demonstration projects, modelling); Summarising Information on all Outcomes (the numbers in the flow diagram, and decision aids) and finishing with A Note on Sound Science. Careful use of terminology is emphasised, and pitfalls with use of jargon terms (true and false, positive and negative) and misleading labels (early, late, pre-symptomatic, carcinoma in situ) are explained. The issue of overdiagnosis of inconsequential conditions is explained.

This chapter explains why quality assurance is essential if screening is to do more good than harm. It describes some of the history and thinking that has shaped approaches to quality in industry and in healthcare, starting with an example from the American car industry and focusing on two founding fathers of quality - W Edwards Deming, and Avedis Donabedian. It outlines Donabedian’s seven components of quality, and shows how these encompass the notion of best value in healthcare so that efforts are devoted to improving health and social justice. It then goes on to explain some of the ways of measuring screening quality, setting standards and ensuring standards are met. It uses case histories and practical examples so that the reader can easily apply the lessons in their day to day work.

Abstract This chapter gives the reader an understanding of the essential tasks involved in setting up a good quality screening programme. Newborn hearing screening is used as a case study. There is an old saying that all you have to do to create an effective service is choose the right things to do, then do them right. Choosing the right screening involves assessing the evidence and making policy. Doing screening right means setting up a well ordered programme for screening that is of value, ensuring that the service is always of high quality, dealing effectively with problems. It also means making sure that when there is no evidence that benefits would outweigh harms, then screening is vest avoided. Different health care systems have very different ways of planning, delivering, and funding their screening programmes. The chapter focuses on matters that are essential if screening is to achieve public health improvement - irrespective of where, and in what type of health system, it is being delivered.

Abstract This chapter shows how resources, values, beliefs, and commercial factors all influence screening policy, and gives clear insight into some of the ethical dilemmas involved. Case histories include celebrity selling of HPV testing, the USA ‘Mammography Wars’ incident, the Cartwright Inquiry into events at National Women’s Hospital in Auckland in the 1960s and genetic testing. The chapter strongly emphasises the value of following robust and explicit processes when making screening policy, and argues that this is best done at national level. The reasons why screening policy-making can be difficult are explored in detail, and clear lessons are drawn from the case examples. The chapter addresses the technical aspects of using evidence, and also explains the power of the cultural belief that all screening must automatically be a good thing and of commercial, professional and institutional interests, often enacted through invisible lobbying using ‘third party’ techniques. The ethical conflicts inherent within screening are described and explored.