The benefits of screening–and its harms

The benefits of screening–and its harms

Correspondence I declare no competing interests. Hamidreza Mani [email protected] Diabetes Research centre, University of Leicester, Univ...

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Correspondence

I declare no competing interests.

Hamidreza Mani [email protected] Diabetes Research centre, University of Leicester, University Hospital of Leicester NHS Trust, Leicester, UK 1

Haug CJ. Peer-review fraud—hacking the scientific publication process. N Engl J Med 2015; 373: 2393–95.

Academic apartheid in Italy Favouritism and elitism have been common features of any competitive environment, including academic medicine, for a long time, but interest the media in only a minority of cases. However, their burden could become staggering as witnessed in historical and current Italian academia. To my, possibly naive, eyes and the eyes of numerous disenchanted colleagues, the present Università is run by a few very senior academics who foster a power system based on a frequent disregard of widely accepted values of merit. These senior academics have produced a pyramidal structure in academia encompassing favourite professionals and less-fortunate professionals, who remain neglected, particularly in schools of medicine. The two exclusive options of favouring some fortunate professionals or rejecting others have created a sense of feeble justice among Italian clinicians working in academia where there are no national filters to recruit or promote professionals, and where neither a research excellence framework nor national student surveys exist to stimulate the quality of educational activity. Several efforts have been made in the past to limit this power system, but their failure has been a result of the absence of accountability in the recruitment and promotion choices and by the arbitrary component left to the assessment panels by all political reforms. The most recent example dates back to 2008, when the Gelmini reform www.thelancet.com Vol 388 August 6, 2016

should have warranted transparence of academic careers in Italy by establishing objective bibliometric eligibility criteria. In particular, the new laws1–3 affirmed that only candidates reaching two of three bibliometric thresholds should have become eligible for associate or full professorship after assessment by committees of Italian commissaries. Discussing the limits of bibliometric indices is beyond the aims of this statement, but I believe that most Italian academics were surprised by the substantial change from no rules to some strict rules (albeit not perfect). Unfortunately, the reform did not impair the two major limitations we have in Italy—ie, the arbitrary assessment of the committees and the absence of accountability for the quality of eligibilities allowed. Indeed, criticisms and even scandals arose when these laws were actually adopted in our country, from evidence that kinship, affinity, or acquaintance between candidates and commissaries, senior directors, and senior academics of medicine affected the probability of an academic promotion and qualification. Although legal appeals are still pending with good probability of success, many Italian academics that were judged ineligible for promotion, despite easily fulfilling all objective criteria because of commissaries’ blindness, were obliged to remain at the margins of academia. Ultimately, this isolation has meant that an academic boycott is underway— an extreme situation unjustified in the medical community, but pretty frequent in many Italian universities, mostly in schools of medicine. There are good professionals legitimately deserving an academic promotion who cannot obtain official recognition, only because they do not share any congeniality with the senior academics. I am truly afraid of the idea of getting older, relinquishing my honesty to any university director, and I feel humiliated at roadblocks, as I have been denied the opportunity of securing an educational role in my university and taking a fully active part in its academic life. The

global scientific community should take note of these issues in academia. I declare no competing interests.

Donato Rigante [email protected] Institute of Pediatrics, Fondazione Policlinico Universitario A Gemelli, Università Cattolica Sacro Cuore, Rome, Italy 1 2 3

Legge n. 169 30 ottobre 2008. Legge n. 240 30 dicembre 2010. Decreto Direttoriale del Ministero dell’Istruzione, dell’Università e della Ricerca n. 222 del 20 Luglio 2012.

The benefits of screening–and its harms In response to our Viewpoint (Jan 16, pp 308–10) about screening for abdominal aortic aneurysms,1 Kosmas Paraskevas and colleagues (April 16, pp 1617–18)2 mention only the benefit (a diagnosis-specific mortality reduction) and ignore its harms. This is insufficient when one considers and compares screening programmes, which is indeed the central message of our Viewpoint. 1 The research community commonly exhibit a strong focus on benefits of interventions, including screening, whereas important harms are not quantified— ie, in randomised trials.3 Additionally, lower disease-specific incidence and mortality caused by reduced risk factors and improved treatment are often not taken into account when considering the continued justification for established screening programmes.1 The observed 70% drop in the incidence of abdominal aortic aneurysms,4 largely due to reduced smoking, makes such considerations essential for screening. There is convincing evidence of considerable harm with abdominal aortic aneurysm screening due to overdiagnosis of indolent aneurysms, which leads to overtreatment and psychosocial harms.1 The screening programmes for rare serious diseases in children that Paraskevas and colleagues2 refer to do not have similar harms and their comparison, which focused only on the benefit, is therefore severely misrepresentative. Overdiagnosis and

AlexRaths

Measures need to be taken to improve transparancy in publications.

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Correspondence

its consequences were not adequately considered before the introduction of abdominal aortic aneurysm screening.1 The letter by Paraskevas and others illustrates that such unidirectional focus on benefits is still a problem. We declare no competing interests.

For more on the COMPare project see http://www.COMPare-Trials.org

*Minna Johansson, Karsten Juhl Jørgensen, John Brodersen [email protected] Department of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (MJ); Research Unit and Section for General Practice, FoUU-centrum Fyrbodal, Vänersborg, Sweden (MJ); The Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark (KJJ); and Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark (JB) 1

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Johansson M, Jørgensen KJ, Brodersen J. Harms of screening for abdominal aortic aneurysm: is there more to life than a 0·46% disease-specific mortality reduction? Lancet 2016; 387: 308–10. Paraskevas KI, Briana DD, Malamitsi-Puchner A. The benefits of screening programmes. Lancet 2016; 387: 1617–18. Heleno B, Thomsen MF, Rodrigues DS, Jørgensen KJ, Brodersen J. Quantification of harms in cancer screening trials: literature review. BMJ 2013; 347: f5334. Darwood R, Earnshaw JJ, Turton G, et al. Twenty-year review of abdominal aortic aneurym screening in men in the county of Gloucestershire, United Kingdom. J Vasc Surg 2012; 56: 8–14.

The CHAMPION trial outcomes were not adequately prespecified The publication from William Abraham and colleagues (Jan 30, p 453) 1 reports eight outcomes that were not appropriately prespecified in the trial registry (NCT00531661) or in the Article reporting the study design.2 Trial recruitment began in September, 2007, and ended in October, 2009. There was a randomised study period that finished in August, 2010, followed by an open access period that finished in April, 2012.1 In December, 2008, one primary efficacy outcome was specified in the trial registry, followed by the addition of two primary safety outcomes and four secondary outcomes in April, 2013. A trial 564

protocol was published in October, 2010, almost 1 year after the end of the randomisation period.2 From this it can be concluded that no outcomes for this trial were adequately prespecified before the commencement, or indeed completion, of the trial. We declare no competing interests.

Aaron Dale, Henry Drysdale, *Carl Heneghan on behalf of the COMPare project team [email protected] Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK 1

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Abraham WT, Stevenson LW, Bourge RC, et al. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet 2016; 387: 453–61. Adamson PB, Abraham WT, Aaron M, et al. CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system. J Card Fail 2011; 17: 3–10.

Department of Error Ong K-T, Perdu J, De Backer J, et al. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet 2010; 376: 1476–84. In this Article, the maximum dose of celiprolol is ambiguous and could lead to a dosing error. In the Summary, the description of celiprolol dosing should read “celiprolol was administered twice daily and uptritated every 6 months by steps of 100 mg to a maximum of 400 mg per day”. In the Methods, the description of celiprolol dosing should read “celiprolol was administered twice daily and uptritrated by 100 mg steps every 6 months to a maximum of 400 mg per day”. In figure 1, the 25 patients in the intervention group were allocated to “100 mg celiprolol, titrated to 200 mg, 300 mg, and 400 mg per day”. In the Discussion, the target dose should be “400 mg per day”. These corrections have been made to the online version as of August 4, 2016.

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