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AbstractObjectiveTo assess the effect of disclosing authors’ conflict of interest declarations to peer reviewers at a medical journal.DesignRandomized controlled trial.SettingManuscript review process at the Annals of Emergency Medicine.ParticipantsReviewers (n=838) who reviewed manuscripts submitted between 2 June 2014 and 23 January 2018 inclusive (n=1480 manuscripts).InterventionReviewers were randomized to either receive (treatment) or not receive (control) authors’ full International Committee of Medical Journal Editors format conflict of interest disclosures before reviewing manuscripts. Reviewers rated the manuscripts as usual on eight quality ratings and were then surveyed to obtain “counterfactual scores”—that is, the scores they believed they would have given had they been assigned to the opposite arm—as well as attitudes toward conflicts of interest.Main outcome measureOverall quality score that reviewers assigned to the manuscript on submitting their review (1 to 5 scale). Secondary outcomes were scores the reviewers submitted for the seven more specific quality ratings and counterfactual scores elicited in the follow-up survey.ResultsProviding authors’ conflict of interest disclosures did not affect reviewers’ mean ratings of manuscript quality (Mcontrol=2.70 (SD 1.11) out of 5; Mtreatment=2.74 (1.13) out of 5; mean difference 0.04, 95% confidence interval –0.05 to 0.14), even for manuscripts with disclosed conflicts (Mcontrol= 2.85 (1.12) out of 5; Mtreatment=2.96 (1.16) out of 5; mean difference 0.11, –0.05 to 0.26). Similarly, no effect of the treatment was seen on any of the other seven quality ratings that the reviewers assigned. Reviewers acknowledged conflicts of interest as an important matter and believed that they could correct for them when they were disclosed. However, their counterfactual scores did not differ from actual scores (Mactual=2.69; Mcounterfactual=2.67; difference in means 0.02, 0.01 to 0.02). When conflicts were reported, a comparison of different source types (for example, government, for-profit corporation) found no difference in effect.ConclusionsCurrent ethical standards require disclosure of conflicts of interest for all scientific reports. As currently implemented, this practice had no effect on any quality ratings of real manuscripts being evaluated for publication by real peer reviewers.

Background Implementing the treatment arm of a clinical trial often requires changes to healthcare practices. Barriers to such changes may undermine the delivery of the treatment making it more likely that the trial will demonstrate no treatment effect. The ‘Major outcomes with personalized dialysate temperature’ (MyTEMP) is a cluster-randomised trial to be conducted in 84 haemodialysis centres across Ontario, Canada to investigate whether there is a difference in major outcomes with an individualized dialysis temperature (IDT) of 0.5 °C below a patient’s body temperature measured at the beginning of each haemodialysis session, compared to a standard dialysis temperature of 36.5 °C. To inform how to deploy the IDT across many haemodialysis centres, we assessed haemodialysis physicians’ and nurses’ perceived barriers and enablers to IDT use. Methods We developed two topic guides using the Theoretical Domains Framework (TDF) to assess perceived barriers and enablers to IDT ordering and IDT setting (physician and nurse behaviours, respectively). We recruited a purposive sample of haemodialysis physicians and nurses from across Ontario and conducted in-person or telephone interviews. We used directed content analysis to double-code transcribed utterances into TDF domains, and inductive thematic analysis to develop themes. Results We interviewed nine physicians and nine nurses from 11 Ontario haemodialysis centres. We identified seven themes of potential barriers and facilitators to implementing IDTs: (1) awareness of clinical guidelines and how IDT fits with local policies (knowledge; goals), (2) benefits and motivation to use IDT (beliefs about consequences; optimism; reinforcement; intention; goals), (3) alignment of IDTs with usual practice and roles (social/professional role and identity; nature of the behaviour; beliefs about capabilities), (4) thermometer availability/accuracy and dialysis machine characteristics (environmental context and resources), (5) impact on workload (beliefs about consequences; beliefs about capabilities), (6) patient comfort (behavioural regulation; beliefs about consequences; emotion), and (7) forgetting to prescribe or set IDT (memory, attention, decision making processes; emotion). Conclusions There are anticipatable barriers to changing healthcare professionals’ behaviours to effectively deliver an intervention within a randomised clinical trial. A behaviour change framework can help to systematically identify such barriers to inform better delivery and evaluation of the treatment, therefore potentially increasing the fidelity of the intervention to increase the internal validity of the trial. These findings will be used to optimise the delivery of IDT in the MyTEMP trial and demonstrate how this approach can be used to plan intervention delivery in other clinical trials. Trial registration ClinicalTrials.gov NCT02628366 . Registered November 16 2015.

Purpose Patient-reported outcome (PRO) results from clinical trials can inform clinical care, but PRO interpretation is challenging. We evaluated the interpretation accuracy and perceived clarity of various strategies for displaying clinical trial PRO findings. Methods We conducted an e-survey of oncology clinicians and PRO researchers (supplemented by one-on-one clinician interviews) that randomized respondents to view one of the three line-graph formats (average scores over time for two treatments on four domains): (1) higher scores consistently indicating \"better\" patient status; (2) higher scores indicating \"more\" of what was being measured (better for function, worse for symptoms); or (3) normed scores. Two formats displayed proportions changed (pie/bar charts). Multivariate modeling was used to analyze interpretation accuracy and clarity ratings. Results Two hundred and thirty-three clinicians and 248 researchers responded; ten clinicians were interviewed. Line graphs with \"better\" directionality were more likely to be interpreted accurately than \"normed\" line graphs (OR 1.55; 95% CI 1.01-2.38;P = 0.04). No significant differences were found between \"better\" and \"more\" formats. \"Better\" formatted graphs were also more likely to be rated \"very clear\" versus \"normed\" formatted graphs (OR 1.91; 95% CI 1.44-2.54; P< 0.001). For proportions changed, respondents were less likely to make an interpretation error with pie versus bar charts (OR 0.35; 95% CI 0.2-0.6; P< 0.001); clarity ratings did not differ between formats. Qualitative findings informed the interpretation of the survey findings. Conclusions Graphic formats for presenting PRO data differ in how accurately they are interpreted and how clear they are perceived to be. These findings will inform the development of best practices for optimally reporting PRO findings.

Randomized clinical trials (RCTs) are an essential method of evaluating health care interventions and a cornerstone for evidence-based health care. However, RCTs have become increasingly complex and costly, which is particularly challenging for independent investigator-initiated clinical trials (IICTs). IICTs have an essential role in clinical research, and it is important that efforts are made to ensure IICTs are adequately funded and are conducted cost-effectively. To examine the practices and attitudes of Swiss stakeholders regarding IICT funding acquisition and cost management. For this qualitative study, interviews were conducted in Switzerland between February and August 2020. The purposive sample comprised 48 stakeholders from 4 different groups: primary investigators (n = 27), funders and sponsors (n = 9), clinical trial support organizations (n = 6), and ethics committee members (n = 6). Practices and attitudes of stakeholders regarding IICT funding acquisition and cost management were assessed using individual semistructured qualitative interviews. Interviews were analyzed using conventional content analysis. After interviews with 48 IICT stakeholders (75% male presenting), these participants identified a systemic problem of IICTs being underfunded, which can lead to compromises being made regarding the quality and conduct of IICTs. Participants identified 2 overarching and interconnected groups of reasons why IICTs in Switzerland are regularly underfunded. First, it was reported that IICT budget estimations are often inaccurate because of poor planning and preparation, unforeseeable events, investigators intentionally underestimating budgets, and limited budget assessment and oversight. Second, with the exception of a specific IICT funding program by the Swiss National Science Foundation, it was reported that limited funding sources and unrealistic expectation of funders led to underlying challenges in getting IICTs fully funded. A number of measures that could help reduce the underfunding of IICTs were identified, including improving the support of investigators and IICTs, strengthening networking and guidance, harmonizing and simplifying bureaucracy, and increasing public funding of IICTs. This study highlights the inadequate expertise of Swiss stakeholders to correctly, systematically, and reproducibly calculate RCT budgets and the need for transparency on trial costs as well as training in budgeting practices. Limited financial resources for academic clinical research and issues regarding the professional planning and conduct of IICTs are persistent issues that many other countries also face.

PurposeWe aimed to assess the agreement between study investigators and the core laboratory (core lab) of a thrombectomy trial for imaging scores.MethodsThe Alberta Stroke Program Early CT Score (ASPECTS), the European Collaborative Acute Stroke Study (ECASS) hemorrhagic transformation (HT) classification, and the Thrombolysis In Cerebral Infarction (TICI) scores as recorded by study investigators were compared with the core lab scores in order to assess interrater agreement, using Cohen’s unweighted and weighted kappa statistics.ResultsThere were frequent discrepancies between study sites and core lab for all the scores. Agreement for ASPECTS and ECASS HT classification was less than substantial, with disagreement occurring in more than one-third of cases. Agreement was higher on MRI-based scores than on CT, and was improved after dichotomization on both CT and MRI. Agreement for TICI scores was moderate (with disagreement occurring in more than 25% of patients), and went above the substantial level (less than 10% disagreement) after dichotomization (TICI 0/1/2a vs 2b/3).ConclusionDiscrepancies between scores assessed by the imaging core lab and those reported by study sites occurred in a significant proportion of patients. Disagreement in the assessment of ASPECTS and day 1 HT scores was more frequent on CT than on MRI. The agreement for the dichotomized TICI score (the trial’s primary outcome) was substantial, with less than 10% of disagreement between study sites and core lab.Trial registration number NCT02523261, Post-results.

Scientists are enthusiastically imagining ways in which artificial intelligence (AI) tools might improve research. Why are AI tools so attractive and what are the risks of implementing them across the research pipeline? Here we develop a taxonomy of scientists’ visions for AI, observing that their appeal comes from promises to improve productivity and objectivity by overcoming human shortcomings. But proposed AI solutions can also exploit our cognitive limitations, making us vulnerable to illusions of understanding in which we believe we understand more about the world than we actually do. Such illusions obscure the scientific community’s ability to see the formation of scientific monocultures, in which some types of methods, questions and viewpoints come to dominate alternative approaches, making science less innovative and more vulnerable to errors. The proliferation of AI tools in science risks introducing a phase of scientific enquiry in which we produce more but understand less. By analysing the appeal of these tools, we provide a framework for advancing discussions of responsible knowledge production in the age of AI. The proliferation of artificial intelligence tools in scientific research risks creating illusions of understanding, where scientists believe they understand more about the world than they actually do.

Predatory journals have shoddy reporting and include papers from wealthy nations, find David Moher, Larissa Shamseer, Kelly Cobey and colleagues.

Use these ten principles to guide research evaluation, urge Diana Hicks, Paul Wouters and colleagues.

Mandates to include women and minority populations in research have heightened the need to identify successful recruitment strategies. This paper describes the recruitment and retention strategies used as part of a randomized controlled trial (RCT) of a physical activity and dietary intervention targeting low-income, predominantly Latino patients in a primary health care clinic. Data on the recruitment and retention rates and the representativeness of participants are presented. Strategies included hiring bilingual staff, translating and culturally adapting intervention materials and soliciting ongoing consultation from patients, clinicians and organizations providing services to the Latino community. The primary recruitment procedure involved letters from physicians followed by phone calls from project staff to patients identified from electronic medical records. Two hundred patients were recruited into the RCT (78% of those reached and eligible), with 69 and 81% reached for the 6-week and 6-month follow-ups, respectively. Women were more likely to both participate and remain in the trial, and there was a trend toward greater recruitment and retention of Spanish speakers. By engaging the community, clinicians and patients, this study was able to successfully recruit and retain a large proportion of this often difficult to reach Latino sub-population of patients with multiple chronic conditions.

Reviewing and accepting study plans before results are known can counter perverse incentives. Chris Chambers sets out three ways to improve the approach. Reviewing and accepting study plans before results are known can counter perverse incentives. Chris Chambers sets out three ways to improve the approach.