Background Discrepancies between pre-specified and reported outcomes are an important source of bias in trials. Despite legislation, guidelines and public commitments on correct reporting from journals, outcome misreporting continues to be prevalent. We aimed to document the extent of misreporting, establish whether it was possible to publish correction letters on all misreported trials as they were published, and monitor responses from editors and trialists to understand why outcome misreporting persists despite public commitments to address it. Methods We identified five high-impact journals endorsing Consolidated Standards of Reporting Trials (CONSORT) ( New England Journal of Medicine , The Lancet , Journal of the American Medical Association , British Medical Journal , and Annals of Internal Medicine ) and assessed all trials over a six-week period to identify every correctly and incorrectly reported outcome, comparing published reports against published protocols or registry entries, using CONSORT as the gold standard. A correction letter describing all discrepancies was submitted to the journal for all misreported trials, and detailed coding sheets were shared publicly. The proportion of letters published and delay to publication were assessed over 12 months of follow-up. Correspondence received from journals and authors was documented and themes were extracted. Results Sixty-seven trials were assessed in total. Outcome reporting was poor overall and there was wide variation between journals on pre-specified primary outcomes (mean 76% correctly reported, journal range 25–96%), secondary outcomes (mean 55%, range 31–72%), and number of undeclared additional outcomes per trial (mean 5.4, range 2.9–8.3). Fifty-eight trials had discrepancies requiring a correction letter (87%, journal range 67–100%). Twenty-three letters were published (40%) with extensive variation between journals (range 0–100%). Where letters were published, there were delays (median 99 days, range 0–257 days). Twenty-nine studies had a pre-trial protocol publicly available (43%, range 0–86%). Qualitative analysis demonstrated extensive misunderstandings among journal editors about correct outcome reporting and CONSORT. Some journals did not engage positively when provided correspondence that identified misreporting; we identified possible breaches of ethics and publishing guidelines. Conclusions All five journals were listed as endorsing CONSORT, but all exhibited extensive breaches of this guidance, and most rejected correction letters documenting shortcomings. Readers are likely to be misled by this discrepancy. We discuss the advantages of prospective methodology research sharing all data openly and pro-actively in real time as feedback on critiqued studies. This is the first empirical study of major ...
Background Discrepancies between pre-specified and reported outcomes are an important and prevalent source of bias in clinical trials. COMPare (Centre for Evidence-Based Medicine Outcome Monitoring Project) monitored all trials in five leading journals for correct outcome reporting, submitted correction letters on all misreported trials in real time, and then monitored responses from editors and trialists. From the trialists’ responses, we aimed to answer two related questions. First, what can trialists’ responses to corrections on their own misreported trials tell us about trialists’ knowledge of correct outcome reporting? Second, what can a cohort of responses to a standardised correction letter tell us about how researchers respond to systematic critical post-publication peer review? Methods All correspondence from trialists, published by journals in response to a correction letter from COMPare, was filed and indexed. We analysed the letters qualitatively and identified key themes in researchers’ errors about correct outcome reporting, and approaches taken by researchers when their work was criticised. Results Trialists frequently expressed views that contradicted the CONSORT (Consolidated Standards of Reporting Trials) guidelines or made inaccurate statements about correct outcome reporting. Common themes were: stating that pre-specification after trial commencement is acceptable; incorrect statements about registries; incorrect statements around the handling of multiple time points; and failure to recognise the need to report changes to pre-specified outcomes in the trial report. We identified additional themes in the approaches taken by researchers when responding to critical correspondence, including the following: ad hominem criticism; arguing that trialists should be trusted, rather than follow guidelines for trial reporting; appealing to the existence of a novel category of outcomes whose results need not necessarily be reported; incorrect statements by researchers about their own paper; and statements undermining transparency infrastructure, such as trial registers. Conclusions Researchers commonly make incorrect statements about correct trial reporting. There are recurring themes in researchers’ responses when their work is criticised, some of which fall short of the scientific ideal. Research on methodological shortcomings is now common, typically in the form of retrospective cohort studies describing the overall prevalence of a problem. We argue that prospective cohort studies which additionally issue correction letters in real time on each individual flawed study—and then follow-up responses from trialists and journals—are more impactful, more informative for those consuming the studies critiqued, more informative on the causes of shortcomings in research, and a better use of research resources. Electronic supplementary material The online v...
Conditional quantum optical processes enable a wide range of technologies from generation of highly non-classical states to implementation of quantum logic operations. The process fidelity that can be achieved in a realistic implementation depends on a number of system parameters. Here we experimentally examine Fock state filtration, a canonical example of a broad class of conditional quantum operations acting on a single optical field mode. This operation is based upon interference of the mode to be manipulated with an auxiliary single-photon state at a beam splitter, resulting in the entanglement of the two output modes. A conditional projective measurement onto a single photon state at one output mode heralds the success of the process. This operation, which implements a measurement-induced nonlinearity, is capable of suppressing particular photon-number probability amplitudes of an arbitrary quantum state. We employ coherent-state process tomography to determine the precise operation realized in our experiment, which is mathematically represented by a process tensor. To identify the key sources of experimental imperfection, we develop a realistic model of the process and identify three main contributions that significantly hamper its efficacy. The experimentally reconstructed process tensor is compared with the model, yielding a fidelity better than 0.95. This enables us to identify three key challenges to overcome in realizing a filter with optimal performance-namely the single-photon nature of the auxiliary state, high mode overlap of the optical fields involved, and the need for photon-number-resolving detection when heralding. The results show that the filter does indeed exhibit a non-linear response as a function of input photon number and preserves the phase relation between Fock layers of the output state, providing promise for future applications.
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