William C. Black

Addressing overdiagnosis and overtreatment in cancer: a prescription for change

A vast range of disorders--from indolent to fast-growing lesions--are labelled as cancer. Therefore, we believe that several changes should be made to the approach to cancer screening and care, such as use of new terminology for indolent and precancerous disorders. We propose the term indolent lesion of epithelial origin, or IDLE, for those lesions (currently labelled as cancers) and their precursors that are unlikely to cause harm if they are left untreated. Furthermore, precursors of cancer or high-risk disorders should not have the term cancer in them. The rationale for this change in approach is that indolent lesions with low malignant potential are common, and screening brings indolent lesions and their precursors to clinical attention, which leads to overdiagnosis and, if unrecognised, possible overtreatment. To minimise that potential, new strategies should be adopted to better define and manage IDLEs. Screening guidelines should be revised to lower the chance of detection of minimal-risk IDLEs and inconsequential cancers with the same energy traditionally used to increase the sensitivity of screening tests. Changing the terminology for some of the lesions currently referred to as cancer will allow physicians to shift medicolegal notions and perceived risk to reflect the evolving understanding of biology, be more judicious about when a biopsy should be done, and organise studies and registries that offer observation or less invasive approaches for indolent disease. Emphasis on avoidance of harm while assuring benefit will improve screening and treatment of patients and will be equally effective in the prevention of death from cancer.

Pleural fluid volume estimation: A chest radiograph prediction rule

RATIONALE AND OBJECTIVESnWe devised a prediction rule for estimating pleural effusion volume on the basis of posteroanterior and lateral chest radiographs.nnnMETHODSnA prediction rule was devised for estimating pleural effusion volume on the basis of the presence or absence of a meniscus on chest radiographs. The rule was tested and validated using separate data sets obtained from a retrospective review of patients having both a chest radiograph and computed tomography (CT) scan (the gold standard) within 24 hr of each other. The accuracy of the prediction rule and the degree of interobserver agreement between the two independent readers were determined.nnnRESULTSnFor the test and validation sets, the weighted accuracies of the prediction rule were 86% and 85%, respectively. The respective weighted interobserver agreements were 97% and 88%. Pleural effusions became visible as a meniscus on the lateral chest radiograph at a volume of approximately 50 ml; at a volume of 200 ml, the meniscus could be identified on the posteroanterior radiograph. At a volume of about 500 ml, the meniscus obscured the hemidiaphragm.nnnCONCLUSIONnThe volume of a pleural effusion can be estimated from the chest radiograph appearance with a reasonable degree of accuracy.

A critical synopsis of the diagnostic and screening radiology outcomes literature

In summary, the radiology outcomes research literature is both extensive and broad. The methodologic quality, however, is quite variable. Overall, this quality could be improved by intervention in two areas: methodologic dissemination and development. The number of researchers investigating radiology-related outcomes is high, and presently there are over 20 journals devoted exclusively to radiology research. Even with a relatively narrow definition of outcomes, we identified over 200 radiology outcomes studies, most from the past few years. However, the methodologic quality of most of these articles was relatively low, with important design flaws and biases. Nonetheless, a substantial number of radiology publications do employ state-of-the-art research methods and innovative approaches to methodologic challenges. The quality of radiology outcomes research overall would benefit tremendously from dissemination of such research methods. Instruction in outcomes research methods is accessible to radiologists. For example, there have been several recent articles and series of articles on outcomes research methods in JAMA, including guidelines for the performance and reporting of cost-effectiveness analyses (38-40) and for developing clinical prediction rules (57). Within radiology, several recent articles have appeared on, among other things, cost-effectiveness analysis (34,59,60), assessing quality of life (43), screening for disease (53), and defining the study population (61). The research compendium compiled for the GERRAF (General Electric-Association of University Radiologists Radiology Research Academic Fellowships) program remains a comprehensive methodologic source for many of the issues in radiology outcomes research, and outcomes research methods courses are offered every year at the Society for Health Services Research in Radiology and Society for Medical Decision Making meetings, as well as at the meeting of the Radiological Society of North America. Even so, awareness of the need for such research techniques remains limited. Dissemination of sound research methods is limited at least in part by the current incentives in radiology research. At many institutions, the number of research publications produced, rather than their quality, determines promotion or academic success. Unfortunately, more rigorous study designs often require more time and resources. Further, because peer reviewers are often as uninformed about research methods as the bulk of those who are submitting manuscripts, it may actually be more difficult to publish articles with more advanced methodologic designs. The standard in radiology is the uncontrolled case series, and deviation from the standard may make acceptance for publication more difficult. On a more optimistic note, recent publication of a number of methodology articles suggests that at least some journals are promoting improved research in methodology (43,53,59-61). We hope that time will be available for manuscript reviewers to learn to understand the strengths and weaknesses of various research approaches. If more rigorous study designs were required for publication, radiology outcomes research would probably improve drastically. Nevertheless, the current peer-review system does not effectively promote sound research design. The other great incentive in research is funding. Clearly, if advanced research design is required for funding, then there is incentive for improvement in research quality. Traditionally, National Cancer Institute and other National Institutes of Health and public sector funding has been predicated on a high level of research sophistication. Undoubtedly, availability of grants for diagnostic and screening imaging clinical trials and other research will go far to improve radiology research methods. The other traditional source of research funding is industry.

Advances in radiology and the real versus apparent effects of early diagnosis

Over the last two decades, technological advances in radiology have revolutionized the practice of medicine. Although the potential benefits of these advances are well recognized, the potential harms are not. This paper describes how early diagnosis can cause overestimations of disease prevalence and the effectiveness of intervention. The paper begins by demonstrating how the observed prevalence of disease increases with the sensitivity of the test and by explaining the concept of pseudodisease. Next, the paper explains how lead time bias, length bias and overdiagnosis bias cause overestimations of the effectiveness of earlier diagnosis and associated treatments. These biases pertain to both the detection and staging of disease. In addition, the paper explains how these overestimations of disease prevalence and the effectiveness of intervention can initiate a cycle of increasing testing and treatment, which may eventually cause more harm than benefit. Finally, randomized clinical trials and decision analysis are discussed in the context of evaluating new testing strategies.

Rationale and design of the Randomized Evaluation of patients with Stable angina Comparing Utilization of noninvasive Examinations (RESCUE) trial

RESCUE is a phase III, randomized, controlled, multicenter, comparative efficacy study, designed to compare two diagnostic imaging/treatment paradigms that use coronary computed tomography angiography (CCTA) or single photon emission computed tomography myocardial perfusion imaging (SPECT MPI) for assisting in the diagnosis of ischemic heart disease in patients with stable angina symptoms, and guiding subsequent treatment. The study is based on the hypothesis that CCTA as a diagnostic tool is associated with no increase in cardiac risk, decreased cost, and reduced radiation exposure compared with SPECT MPI. The RESCUE trial was funded by the Agency for Healthcare Research and Quality (AHRQ) and the American College of Radiology Imaging Network (ACRIN) Fund for Imaging Innovation, began in 2011, and completed in 2014.