Table 1 - uploaded by Philippe Ravaud
Content may be subject to copyright.
Source publication
Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts. However, no specific recommendation is related to the reporting of conflicts of interest (CoI). The objective was to compare physicians' confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubM...
Context in source publication
Citations
... Three articles described studies that assessed the effects of the strategy of conflict of interest disclosure to advisees on advisee perceptions, attitudes, or beliefs (35)(36)(37). All studies had an experimental design and simulated the effects of one or more disclosure policies by exposing health professionals to different versions of an article or abstract. ...
... Outcomes assessed included perceptions of the methodological quality of the study, confidence in the study conclusions, and reported likelihood of changing one's practice based on the study. None of the three articles reported effects of the article or abstract version on participants' perceptions, attitudes, or beliefs (35)(36)(37). ...
Background
More stringent policies for addressing conflicts of interest have been implemented around the world in recent years. Considering the value of revisiting conflict of interest quality standards set by the International Patient Decision Aid Standards (IPDAS) Collaboration, we sought to review evidence relevant to 2 questions: 1) What are the effects of different strategies for managing conflicts of interest? and 2) What are patients’ perspectives on conflicts of interest?
Methods
We conducted a narrative review of English-language articles and abstracts from 2010 to 2019 that reported relevant quantitative or qualitative research.
Results
Of 1743 articles and 118 abstracts identified, 41 articles and 2 abstracts were included. Most evidence on the effects of conflict of interest management strategies pertained only to subsequent compliance with the management strategy. This evidence highlighted substantial noncompliance with prevailing requirements. Evidence on patient perspectives on conflicts of interest offered several insights, including the existence of diverse views on the acceptability of conflicts of interest, the salience of conflict of interest type and monetary value to patients, and the possibility that conflict of interest disclosure could have unintended effects. We identified no published research on the effects of IPDAS Collaboration conflict of interest quality standards on patient decision making or outcomes.
Limitations
Because we did not conduct a systematic review, we may have missed some evidence relevant to our review questions. In addition, our team did not include patient partners.
Conclusions
The findings of this review have implications for the management of conflicts of interest not only in patient decision aid development but also in clinical practice guideline development, health and medical research reporting, and health care delivery.
... 9 Similarly, a randomised trial of French general practitioners (GPs) found no evidence of a significant impact of reporting of COIs on GP's confidence in the conclusions of trial abstracts. 10 Clinical education articles are intended to provide guidance on clinical care for clinicians, yet our understanding of the role of COIs on readers' perceptions of the credibility of such articles, rather than primary research articles, is limited. Educational articles are prone to bias as they typically use non-systematic methods of literature acquisition, and broadly rely on the interpretation of one author, or a small number of authors, on their chosen included literature. ...
Objectives
To investigate how different competing interest (COI) statements affect clinical readers’ perceptions of education articles.
Design
Randomised controlled trial.
Setting and participants
Random sample of UK doctors.
Interventions
We created four permutations of each of two clinical reviews (on gout or dyspepsia), which varied only in terms of the COI statement. Volunteers were blinded and randomised to receive one review and asked to complete a questionnaire after reading it. Blinded factorial analyses of variance and analyses of covariance were carried out to assess the influence of each review and type of COI on outcomes.
Primary and secondary outcomes
Confidence in the article’s conclusions (primary outcome), its importance, their level of interest in the article and their likelihood to change practice after reading it.
Results
Of 10 889 doctors invited to participate, 1065 (10%) volunteered. Of these, 749 (70%) completed the survey. Analysis of covariance (adjusting for age, sex, job type, years since qualification) showed no significant difference between the groups in participants’ confidence in the article (gout: p=0.32, dyspepsia: p=0.78) or their rating of its importance (gout: p=0.09, dyspepsia: p=0.79). For the gout review, participants rated articles with advisory board and consultancies COI as significantly less interesting than those with no COI (p=0.028 with Bonferroni correction). Among participants indicating that they treat the condition and that the article’s recommendations differed from their own practice, there was no significant difference in likelihood to change practice between groups (gout: p=0.59, n=59; dyspepsia: p=0.56, n=80).
Conclusions
Doctors’ confidence in educational articles was not influenced by the COI statements. Further work is required to determine if doctors do not perceive these COIs as important in educational articles or if they do not pay attention to these statements. More meaningful COI disclosure practices may be needed, which highlight context-specific potential sources of bias to readers.
Trial registration number
NCT02548312 ; Results.
... We assumed a within-group standard deviation of 2.7 points [13,14]. We used a Bonferroni correction for three pairwise comparisons resulting in an adjusted a of 0.0167. ...
Background:
Multiple features in the presentation of randomized controlled trial (RCT) results are known to influence comprehension and interpretation. We aimed to compare interpretation of cancer RCTs with time-to-event outcomes when the reported treatment effect measure is the hazard ratio (HR), difference in restricted mean survival times (RMSTD), or both (HR+RMSTD). We also assessed the prevalence of misinterpretation of the HR.
Patients and methods:
We performed a randomized experiment. We selected 15 cancer RCTs with statistically significant treatment effects for the primary outcome. We masked each abstract and created 3 versions reporting either the HR, RMSTD, or HR+RMSTD. We randomized corresponding authors of RCTs and medical residents and fellows to one of 15 abstracts and one of 3 versions. We asked how beneficial the experimental treatment was (0 to 10 Likert scale). All participants answered a multiple-choice question about interpretation of the HR. Participants were unaware of the study purpose.
Results:
We randomly allocated 160 participants to evaluate an abstract reporting the HR, 154 to the RMSTD, and 155 to both HR+RMSTD. The mean Likert score was statistically significantly lower in the RMSTD group as compared with the HR group (mean difference -0.8, 95% confidence interval, -1.3 to -0.4, p < 0.01) and as compared with the HR+RMSTD group (difference -0.6, -1.1 to -0.1, p = 0.05). In all, 47.2% (42.7% to 51.8%) of participants misinterpreted the HR, with 40% equating it with a reduction in absolute risk.
Conclusion:
Misinterpretation of the HR is common. Participants judged experimental treatments to be less beneficial when presented with RMSTD as compared with HR. We recommend that authors present RMST-based measures alongside the HR in reports of RCT results.
... It is worth noting, however, that the trial funding source or statements of con icts of interest potentially in uence readers more than the actual quality of the evidence [53,54]. While there may well be unease about industry-funded studies [55], for acute pain there is good evidence of no in uence of industry funding on study results [56]. ...
We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs) and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, n=519 ), gynaecological surgery (3 trials, n=679 ), and dysmenorrhoea (2 trials, n=711 ) conducted in 1988–1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal. Greater methodological information in CSRs contributed to lesser risk of bias than published trials. Numbers needed to treat (NNT) from CSRs for all six postoperative trials for at least 50% of maximum pain relief over 6 h were 2.2 (95% confidence interval, 1.9–2.6) and 2.1 (1.8–2.4) for 50 and 100 mg diclofenac potassium, respectively. A Cochrane review of published trial data reported NNTs of 2.1 and 1.9, and one comprehensive analysis reported NNTs of 2.2 and 2.1, respectively. All analyses had similar results for patients remedicating within 8 h. No data from dysmenorrhoea CSRs appeared in a Cochrane review. CSRs provide useful information and increase confidence. Stable efficacy estimates with standard study designs reduce the need for updating reviews.
... 17 Thus, companysponsored research should not be automatically assigned a lower quality rating without a careful evaluation, which requires full transparency of the authors' COIs. Prior studies evaluating the impact of COIs on the interpretation of study results have reported mixed findings, 4,11,13,22,23 with some studies showing that the quality of a manuscript with a commercial COI is downgraded by the physician reading the article, while other studies have shown no change. To the best of my knowledge, this type of analysis has not yet been reported for orthopaedic practitioners. ...
... Although we are unaware of any research on this specific type of disclosure, there are studies on disclosures that provide other details about the information source (i.e., conflict of interest and funding statements). Some studies find that these disclosures have an effect (Kesselheim et al., 2012;Schroter, Morris, Chaudhry, Smith, & Barratt, 2004) whereas others do not (du Vaure, Boutron, Perrodeau, & Ravaud, 2014;Silverman et al., 2010). Researchers have encouraged testing disclosures before they are implemented (Andrews, 2011;Kozup, Taylor, Capella, & Kees, 2012), thus warranting research on whether a disclosure affects individuals' ability to separate the disease awareness and prescription drug information. ...
We sought to determine whether links from branded prescription drug websites to websites containing disease information mislead participants about drug benefits and whether nonsponsorship disclosures diminish this potential effect. We randomly assigned online panelists with depression (N = 1,071) to view a fictitious prescription drug website that had (a) no link to a disease information website (control), (b) a link with no disclosure, (c) a link with a simple nonsponsorship disclosure, or (d) a link with a detailed nonsponsorship disclosure. If participants in the link conditions did not click the link, they were returned to the drug website and encouraged to click it. All participants then completed an online questionnaire assessing recall, perceptions, and intentions. Few participants (12%) clicked the link without prompting; 67% did so when prompted. Compared with control participants, participants in link conditions were more likely to confuse disease information with drug benefits and to recall fewer true drug benefits. Disclosures did not diminish these effects, and exposure to disease information did not affect other perceptions or intentions. Consumers seem to confuse information on disease websites with information on branded prescription drug websites. Disclosures may not adequately help consumers to distinguish between the 2 types of information.
... 13 Finally, a 2014 study among French general practitioners found no significant difference in their evaluation of abstracts of a randomized trial based on funding source or author conflict of interest. 3 It is easy to understand why declarations of funding source and relevant financial relationships have become a required feature of medical presentations and publications. Although a few high-profile scandals are often cited in which pharmaceutical firms have been accused of suppressing unfavorable effects of their products, 8,19 a greater concern is the possibility that financial considerations may bias the design or reporting of clinical trials. ...
... Conflicting evidence from other disciplines suggests that the presence of conflicts of interests adversely affects study quality. [10][11][12] The small number of industrysponsored RCTs did not allow statistical assessment of such an association with a low risk of type II statistical error. Four of the 14 (28.6%) ...
Measures have been taken to improve methodological quality of randomized controlled trials (RCTs). This review systematically assessed the trends in volume and methodological quality of RCTs on minimally invasive surgery within a 10-year period.
RCTs on minimally invasive surgery were searched in the 10 most cited general surgical journals and the 5 most cited journals of laparoscopic interest for the years 2002 and 2012. Bibliometric and methodological quality components were abstracted using the Scottish Intercollegiate Guidelines Network. The pooled number of RCTs from low-contribution regions demonstrated an increasing proportion of the total published RCTs, compensating for a concomitant decrease of the respective contributions from Europe and North America. International collaborations were more frequent in 2012. Acceptable or high quality RCTs accounted for 37.9% and 54.4% of RCTs published in 2002 and 2012, respectively. Components of external validity were poorly reported.
Both the volume and the reporting quality of laparoscopic RCTs have increased from 2002 to 2012, but there seems to be ample room for improvement of methodological quality.
Copyright © 2015 Elsevier Inc. All rights reserved.
Purpose:
Platelet-rich plasma (PRP) represents a highly profitable biological therapy. Platelet-rich plasma is widely used to treat musculoskeletal disorders despite mixed evidence of its efficacy. As evidenced by literature from other domains, industry funding may influence the results of clinical trials. The objective of the current study was to determine the association between industry funding and positive results for randomized controlled trials (RCTs) assessing the efficacy of PRP in musculoskeletal disorders.
Methods:
A search of four databases was conducted. Included studies were RCTs comparing PRP to any non-PRP comparator in adults (18 years old or over) with musculoskeletal disorders and had full text available in English. Studies were excluded if they were published before 2016 or were non-human trials. A multivariate binomial logistic regression model was created to explore predictors of statistically significant findings. Covariates included the presence of industry funding, sample size, and length of study follow-up. 1440 records were screened with 87 trials included in the final analysis.
Results:
Of the 87 studies, 61 (70%) reported a statistically significant primary outcome. The presence of industry funding was not predictive of a statistically significant primary outcome [OR = 0.36, 95% CI 0.096-1.36, (n.s.)]. Studies that did not state whether industry funding was present had a higher chance of reporting a statistically significant primary outcome (OR = 3.61, 95% CI 1.1-11.9, p = 0.035). Sample size and length of follow-up were not predictive of a statistically significant primary outcome.
Conclusion:
The results of the current study conclude that industry funding had no impact on the reporting of positive results for RCTs investigating PRP in musculoskeletal disorders. However, not disclosing sources of funding was associated with a higher likelihood of reporting positive results. The results of trials that fail to disclose funding sources should be interpreted with caution in the PRP literature.
Level of evidence:
I.
Publishing is simply the process of making a paper available to the public. Today there are many ways to publish and disseminate reports, but most of them would not be considered scientific. In the present era, publication in a peer-reviewed journal is really the only form of scientific publication. (Publishing a book or conference abstract would also be scientific, when peer-review is involved, but usually it is not really. Academic theses are normally also scientific, but they are only rarely published). Publications in peer-reviewed journals can be considered scientific, precisely because they have undergone a process of peer review and journal selection. This process weeds out much of the material that does not meet the prevailing standards of the scientific community for reliable knowledge. Compared to the ethical issues arising during the conduct, analysis, and write-up of medical research, the ethical issues of the publishing phase are rather minor. The ethical issues of publishing all revolve around communicating honestly and transparently with the journal Editors and peer-reviewers, so they can evaluate the manuscript appropriately. Ethical scientific publishing mainly involves four different issues: 1) avoiding redundant publications, 2) being honest about who are the authors, 3) disclosing all potential conflicts of interest and sources of funding, and 4) notifying the journal of any errors or problems discovered after publication. Despite their names, the ethical problems of “salami publication” and “non-publication” are actually a consequence of writing too much or too little about a research study, and thus arise almost entirely prior to the phase of submitting and publishing the paper. Accordingly, they were discussed in Chap. 21, “Ethics of Scientific Writing”.
