Screening for health risks: A social science perspective

Health screening promises to reduce risks to individuals via probabilistic sifting of populations for medical conditions. The categorisation and selection of 'conditions' such as cardiovascular events, dementia and depression for screening itself requires prior interpretive labour which usually remains unexamined. Screening systems can take diverse organisational forms and varying relationships to health status, as when purported disease precursors, for example 'pre-cancerous' polyps, or supposed risk factors, such as high cholesterol themselves, become targets for screening. Screening at best yields small, although not necessarily unworthwhile, net population health gains. It also creates new risks, leaving some individuals worse-off than if they had been left alone. The difficulties associated with attempting to measure small net gains through randomised controlled trials are sometimes underestimated. Despite endemic doubts about its clinical utility, bibliometric analysis of published papers shows that responses to health risks are coming to be increasingly thought about in terms of screening. This shift is superimposed on a strengthening tendency to view health through the lens of risk. It merits further scrutiny as a societal phenomenon

Moral entrepreneurship, the power‐knowledge nexus, and the Cochrane “crisis”

Background In 2018, a so‐called crisis developed in the international network of systematic reviewers known as Cochrane. It was widely depicted in terms of two competing narratives—“bad behaviour” by one member of Cochrane's Governing Board and scientific and moral decline within Cochrane. Objective Our goal was to distil insights on the structural issues underpinning the crisis, without taking a definitive position on the accuracy of either narrative. Approach and dataset In this paper, we draw on (among other theories) Becker's notion of moral entrepreneurship and Foucault's conceptualisation of power to analyse the claims and counterclaims made by different parties. Our dataset consisted of publicly available materials (blogs, journal articles, newspaper articles) to end 2018, notably those relating to the expulsion of one Governing Board member. Main findings Both narratives include strong moral claims about the science of systematic review and the governance of scientific organizations. The expelled individual and his supporters defined good systematic reviews in terms of a particular kind of methodological rigour and elimination of bias, and good governance largely in terms of measures to achieve independence from industry influence. Most of Cochrane's Governing Board and their sympathizers evaluated systematic reviews according to a broader range of criteria, incorporating factors such as attention to relationships among reviewers and reflexivity and dialogue around scientific and other judgements. They viewed governance partly in terms of accountability to an external advisory group. Power‐knowledge alignments in Cochrane have emerged from, and contributed to, a particular system of meaning which is now undergoing evolution and challenge. Conclusion Polarizing Cochrane's “crisis” into two narratives, only one of which is true, is less fruitful than viewing it in terms of a duality consisting of tensions between the two positions, each of which has some validity. Having framed the conflict as primarily philosophical and political rather than methodological and procedural, we suggest how Cochrane and its supporters and critics might harness their tensions productively

Divine intervention? A Cochrane review on intercessory prayer gone beyond science and reason

We discuss in this commentary a recent Cochrane review of 10 randomised trials aimed at testing the religious belief that praying to a god can help those who are prayed for. The review concluded that the available studies merit additional research. However, the review presented a scientifically unsound mixture of theological and scientific arguments, and two of the included trials that had a large impact on the findings had problems that were not described in the review. The review fails to live up to the high standards required for Cochrane reviews

The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials

Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurat

Recommendations by Cochrane Review Groups for assessment of the risk of bias in studies

<p>Abstract</p> <p>Background</p> <p>Assessing the risk of bias in individual studies in a systematic review can be done using individual components or by summarizing the study quality in an overall score.</p> <p>Methods</p> <p>We examined the instructions to authors of the 50 Cochrane Review Groups that focus on clinical interventions for recommendations on methodological quality assessment of studies.</p> <p>Results</p> <p>Forty-one of the review groups (82%) recommended quality assessment using components and nine using a scale. All groups recommending components recommended to assess concealment of allocation, compared to only two of the groups recommending scales (P < 0.0001). Thirty-five groups (70%) recommended assessment of sequence generation and 21 groups (42%) recommended assessment of intention-to-treat analysis. Only 28 groups (56%) had specific recommendations for using the quality assessment of studies analytically in reviews, with sensitivity analysis, quality as an inclusion threshold and subgroup analysis being the most commonly recommended methods. The scales recommended had problems in the individual items and some of the groups recommending components recommended items not related to bias in their quality assessment.</p> <p>Conclusion</p> <p>We found that recommendations by some groups were not based on empirical evidence and many groups had no recommendations on how to use the quality assessment in reviews. We suggest that all Cochrane Review Groups refer to the Cochrane Handbook for Systematic Reviews of Interventions, which is evidence-based, in their instructions to authors and that their own guidelines are kept to a minimum and describe only how methodological topics that are specific to their fields should be handled.</p

Risk management of biosimilars in oncology: each medicine is a work in progress

Drug licensing and drug safety monitoring for standard chemical entities have been established and are routinely used. These have resulted in a solid foundation of knowledge from which confident therapeutic decisions can be made. For many chemical entities, this advanced level of experience is also present for the generic products. The expertise surrounding the development of biosimilar competitor versions is increasing and progress is encouraging. To address the re-engineering and comparability complexities of biosimilars, the European Union imposed a requirement that risk management plans be included in the medications’ marketing applications. This paper summarizes and discusses the circumstances complicating the public’s view of drug safety, historical incidents during the transition from innovative to competitor products, as well as retrospective assessments of the development and post-marketing experiences thus far with two biosimilars. Through assessing the market entries and post-marketing experiences of biosimilars used in oncology, the healthcare field can better prepare for the next wave of comparator-products: biosimilar monoclonal antibodies

What Should Be Done To Tackle Ghostwriting in the Medical Literature?

Background to the debate: Ghostwriting occurs when someone makes substantial contributions to a manuscript without attribution or disclosure. It is considered bad publication practice in the medical sciences, and some argue it is scientific misconduct. At its extreme, medical ghostwriting involves pharmaceutical companies hiring professional writers to produce papers promoting their products but hiding those contributions and instead naming academic physicians or scientists as the authors. To improve transparency, many editors' associations and journals allow professional medical writers to contribute to the writing of papers without being listed as authors provided their role is acknowledged. This debate examines how best to tackle ghostwriting in the medical literature from the perspectives of a researcher, an editor, and the professional medical writer