Publication in peer-reviewed journals is an essential step in the scientific process. However, publication is not simply the reporting of facts arising from a straightforward analysis thereof. ...Authors have broad latitude when writing their reports and may be tempted to consciously or unconsciously “spin” their study findings. Spin has been defined as a specific intentional or unintentional reporting that fails to faithfully reflect the nature and range of findings and that could affect the impression the results produce in readers. This article, based on a literature review, reports the various practices of spin from misreporting by “beautification” of methods to misreporting by misinterpreting the results. It provides data on the prevalence of some forms of spin in specific fields and the possible effects of some types of spin on readers’ interpretation and research dissemination. We also discuss why researchers would spin their reports and possible ways to avoid it.
Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, ...may be a key to addressing these challenges and should draw the attention of the whole clinical research community.Blockchain brings the Internet to its definitive decentralisation goal. The core principle of Blockchain is that any service relying on trusted third parties can be built in a transparent, decentralised, secure "trustless" manner at the top of the Blockchain (in fact, there is trust, but it is hardcoded in the Blockchain protocol via a complex cryptographic algorithm). Therefore, users have a high degree of control over and autonomy and trust of the data and its integrity. Blockchain allows for reaching a substantial level of historicity and inviolability of data for the whole document flow in a clinical trial. Hence, it ensures traceability, prevents a posteriori reconstruction and allows for securely automating the clinical trial through what are called Smart Contracts. At the same time, the technology ensures fine-grained control of the data, its security and its shareable parameters, for a single patient or group of patients or clinical trial stakeholders.In this commentary article, we explore the core functionalities of Blockchain applied to clinical trials and we illustrate concretely its general principle in the context of consent to a trial protocol. Trying to figure out the potential impact of Blockchain implementations in the setting of clinical trials will shed new light on how modern clinical trial methods could evolve and benefit from Blockchain technologies in order to tackle the aforementioned challenges.
About 10% of people infected by severe acute respiratory syndrome coronavirus 2 experience post COVID-19 disease. We analysed data from 968 adult patients (5350 person-months) with a confirmed ...infection enroled in the ComPaRe long COVID cohort, a disease prevalent prospective e-cohort of such patients in France. Day-by-day prevalence of post COVID-19 symptoms was determined from patients' responses to the Long COVID Symptom Tool, a validated self-reported questionnaire assessing 53 symptoms. Among patients symptomatic after 2 months, 85% still reported symptoms one year after their symptom onset. Evolution of symptoms showed a decreasing prevalence over time for 27/53 symptoms (e.g., loss of taste/smell); a stable prevalence over time for 18/53 symptoms (e.g., dyspnoea), and an increasing prevalence over time for 8/53 symptoms (e.g., paraesthesia). The disease impact on patients' lives began increasing 6 months after onset. Our results are of importance to understand the natural history of post COVID-19 disease.
The growth in scientific production may threaten the capacity for the scientific community to handle the ever-increasing demand for peer review of scientific publications. There is little evidence ...regarding the sustainability of the peer-review system and how the scientific community copes with the burden it poses. We used mathematical modeling to estimate the overall quantitative annual demand for peer review and the supply in biomedical research. The modeling was informed by empirical data from various sources in the biomedical domain, including all articles indexed at MEDLINE. We found that for 2015, across a range of scenarios, the supply exceeded by 15% to 249% the demand for reviewers and reviews. However, 20% of the researchers performed 69% to 94% of the reviews. Among researchers actually contributing to peer review, 70% dedicated 1% or less of their research work-time to peer review while 5% dedicated 13% or more of it. An estimated 63.4 million hours were devoted to peer review in 2015, among which 18.9 million hours were provided by the top 5% contributing reviewers. Our results support that the system is sustainable in terms of volume but emphasizes a considerable imbalance in the distribution of the peer-review effort across the scientific community. Finally, various individual interactions between authors, editors and reviewers may reduce to some extent the number of reviewers who are available to editors at any point.
Summary The biomedical research complex has been estimated to consume almost a quarter of a trillion US dollars every year. Unfortunately, evidence suggests that a high proportion of this sum is ...avoidably wasted. In 2014, The Lancet published a series of five reviews showing how dividends from the investment in research might be increased from the relevance and priorities of the questions being asked, to how the research is designed, conducted, and reported. 17 recommendations were addressed to five main stakeholders—funders, regulators, journals, academic institutions, and researchers. This Review provides some initial observations on the possible effects of the Series, which seems to have provoked several important discussions and is on the agendas of several key players. Some examples of individual initiatives show ways to reduce waste and increase value in biomedical research. This momentum will probably move strongly across stakeholder groups, if collaborative relationships evolve between key players; further important work is needed to increase research value. A forthcoming meeting in Edinburgh, UK, will provide an initial forum within which to foster the collaboration needed.
Despite the burden of rheumatic and musculoskeletal diseases (RMDs), these conditions probably deserve more attention from public health authorities in several countries including developed ones. We ...assessed their contribution to disability.
Data on disabilities associated with RMDs were extracted from the national 2008-2009 Disability-Health Survey of 29,931 subjects representative of the population in France. We used the core set of disability categories for RMDs of the World Health Organization's International Classification of Functioning, Disability and Health for analysis. Diagnosis and disabilities were self-reported. We assessed the risk of disability associated with RMDs using odds ratios (ORs) and the societal impact of RMDs using the average attributable fraction (AAF).
Overall 27.7% (about 17.3 million people) (95% CI 26.9-28.4%) of the population reported having RMDs. The most prevalent RMDs were low back pain (12.5%, 12.1-13.1) and osteoarthritis (12.3%, 11.8-12.7). People reporting osteoarthritis were more disabled in walking (adjusted OR 1.9, 1.7-2.2) than those without. People reporting inflammatory arthritis were more limited in activities of daily living (from 1.4, 1.2-1.8 for walking to 2.1, 1.5-2.9 for moving around). From a societal perspective, osteoarthritis was the main contributor to activity limitations (AAF 22% for walking difficulties). Changing jobs was mainly attributed to neck pain (AAF 13%) and low back pain (11.5%).
RMDs are highly prevalent and significantly affect activity limitations and participation restrictions. More effort is needed to improve care and research in this field.
In this randomized trial, patients with vasculitides who were in complete remission after initial induction therapy received either rituximab at intervals or daily azathioprine. More patients had ...sustained remission with rituximab than with azathioprine.
Granulomatosis with polyangiitis (formerly called Wegener’s granulomatosis), microscopic polyangiitis, and renal-limited antineutrophil cytoplasm antibody (ANCA)–associated vasculitides are the main ANCA-associated vasculitis variants.
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Although these entities differ in their pathogenesis, genetics, and serotypes, severe forms of ANCA-associated vasculitis share several clinical features and currently have similar treatments.
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A staged therapeutic strategy that combines glucocorticoids and cyclophosphamide to induce remission has dramatically improved survival over the past few decades, but with frequent early and late side effects. The results of two trials (RAVE and RITUXVAS) showed that rituximab was not inferior to daily oral or pulse intravenous cyclophosphamide for the induction . . .
Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research. The CONSORT (Consolidated Standards of Reporting Trials) Statement is an evidence-based reporting ...guideline that aims to improve research transparency and reduce waste. In 2008, the CONSORT Group developed an extension to the original statement that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy. This article describes an update of that extension and presents an extension for reporting abstracts of NPT trials. To develop these materials, the authors reviewed pertinent literature published up to July 2016; surveyed authors of NPT trials; and conducted a consensus meeting with editors, trialists, and methodologists. Changes to the CONSORT Statement extension for NPT trials include wording modifications to improve readers' understanding and the addition of 3 new items. These items address whether and how adherence of participants to interventions is assessed or enhanced, description of attempts to limit bias if blinding is not possible, and specification of the delay between randomization and initiation of the intervention. The CONSORT extension for abstracts of NPT trials includes 2 new items that were not specified in the original CONSORT Statement for abstracts. The first addresses reporting of eligibility criteria for centers where the intervention is performed and for care providers. The second addresses reporting of important changes to the intervention versus what was planned. Both the updated CONSORT extension for NPT trials and the CONSORT extension for NPT trial abstracts should help authors, editors, and peer reviewers improve the transparency of NPT trial reports.
To avoid a surge of demand on the healthcare system due to the COVID-19 pandemic, we must reduce transmission to individuals with chronic conditions who are at risk of severe illness with COVID-19. ...We aimed at understanding the perceptions, context and attitudes of individuals with chronic conditions during the COVID-19 pandemic to clarify their potential risk of infection.
A cross-sectional survey was nested in ComPaRe, an e-cohort of adults with chronic conditions, in France. It assessed participants' perception of their risk of severe illness with COVID-19; their context (i.e., work, household, contacts with external people); and their attitudes in situations involving frequent or occasional contacts with symptomatic or asymptomatic people. Data were collected from March 23 to April 2, 2020, during the lockdown in France. Analyses were weighted to represent the demographic characteristics of French patients with chronic conditions. The subgroup of participants at high risk according to the recommendations of the French High Council for Public Health was examined.
Among the 7169 recruited participants, 63% patients felt at risk because of severe illness. About one quarter (23.7%) were at risk of infection because they worked outside home, had a household member working outside home or had regular visits from external contacts. Less than 20% participants refused contact with symptomatic people and <20% used masks when in contact with asymptomatic people. Among patients considered at high risk according to the recommendations of the French High Council for Public Health, 20% did not feel at risk, which led to incautious attitudes.
Individuals with chronic conditions have distorted perceptions of their risk of severe illness with COVID-19. In addition, they are exposed to COVID-19 due to their context or attitudes.
We aimed to assess the impact of spin (ie, reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results) on the interpretation of ...results of abstracts of randomized controlled trials (RCTs) in the field of cancer.
We performed a two-arm, parallel-group RCT. We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion. Two versions of these abstracts were used-the original with spin and a rewritten version without spin. Participants were clinician corresponding authors of articles reporting RCTs, investigators of trials, and reviewers of French national grants. The primary outcome was clinicians' interpretation of the beneficial effect of the experimental treatment (0 to 10 scale). Participants were blinded to study hypothesis.
Three hundred clinicians were randomly assigned using a Web-based system; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin. For abstracts with spin, the experimental treatment was rated as being more beneficial (mean difference, 0.71; 95% CI, 0.07 to 1.35; P = .030), the trial was rated as being less rigorous (mean difference, -0.59; 95% CI, -1.13 to 0.05; P = .034), and clinicians were more interested in reading the full-text article (mean difference, 0.77; 95% CI, 0.08 to 1.47; P = .029). There was no statistically significant difference in the clinicians' rating of the importance of the study or the need to run another trial.
Spin in abstracts can have an impact on clinicians' interpretation of the trial results.
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