Recent advances in medical and information technologies, the availability of new types of medical data, the requirement of increasing numbers of study participants, as well as difficulties in recruitment and retention, all present serious problems for traditional models of specific and informed consent to medical research. However, these advances also enable novel ways to securely share and analyse data. This paper introduces one of these advances—blockchain technologies—and argues that they can be used to share medical data in a secure and (...) auditable fashion. In addition, some aspects of consent and data collection, as well as data access management and analysis, can be automated using blockchain-based smart contracts. This paper demonstrates how blockchain technologies can be used to further all three of the bioethical principles underlying consent requirements: the autonomy of patients, by giving them much greater control over their data; beneficence, by greatly facilitating medical research efficiency and by reducing biases and opportunities for errors; and justice, by enabling patients with rare or under-researched conditions to pseudonymously aggregate their data for analysis. Finally, we coin and describe the novel concept of prosent, by which we mean the blockchain-enabled ability of all stakeholders in the research process to pseudonymously and proactively consent to data release or exchange under specific conditions, such as trial completion. (shrink)

Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient (...) subjects based on this questionnaire.Results: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good , and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators. (shrink)

BackgroundNew metrics have been developed to assess the impact of research and provide an indication of online media attention and data dissemination. We aimed to describe online media attention of articles evaluating cancer treatments and identify the factors associated with high online media attention.MethodsWe systematically searched MEDLINE via PubMed on March 1, 2015 for articles published during the first 6 months of 2014 in oncology and medical journals with a diverse range of impact factors, from 3.9 to 54.4, and selected (...) a sample of articles evaluating a cancer treatment regardless of study design. Altmetric Explorer was used to identify online media attention of selected articles. The primary outcome was media attention an article received online as measured by Altmetric score (i.e., number of mentions in online news outlets, science blogs and social media). Regression analysis was performed to investigate the factors associated with high media attention, and regression coefficients represent the logarithm of ratio of mean (RoM) values of Altmetric score per unit change in the covariate.ResultsAmong 792 articles, 218 (27.5%) received no online media attention (Altmetric score = 0). The median [Q1–Q3] Altmetric score was 2.0 [0.0–8.0], range 0.0–428.0. On multivariate analysis, factors associated with high Altmetric score were presence of a press release (RoM = 10.14, 95%CI [4.91–20.96]), open access to the article (RoM = 1.48, 95%CI [1.02–2.16]), and journal impact factor (RoM = 1.10, 95%CI [1.07–1.12]. As compared with observational studies, systematic reviews were not associated with high Altmetric score (RoM = 1.46, 95%CI [0.74–2.86]; P = 0.27), nor were RCTs (RoM = 0.65, 95%CI [0.41–1.02]; P = 0.059) and phase I/ii non-RCTs (RoM = 0.58, 95%CI [0.33–1.05]; P = 0.07). The articles with abstract conclusions favouring study treatments were not associated with high Altmetric score (RoM = 0.97, 95%CI [0.60–1.58]; P = 0.91).ConclusionsMost important factors associated with high online media attention were the presence of a press release and the journal impact factor. There was no evidence that study design with high level of evidence and type of abstract conclusion were associated with high online media attention. (shrink)

BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in (...) a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data. (shrink)