Summary The methods and results of health research are documented in study protocols, full study reports (detailing all analyses), journal reports, and participant-level datasets. However, protocols, ...full study reports, and participant-level datasets are rarely available, and journal reports are available for only half of all studies and are plagued by selective reporting of methods and results. Furthermore, information provided in study protocols and reports varies in quality and is often incomplete. When full information about studies is inaccessible, billions of dollars in investment are wasted, bias is introduced, and research and care of patients are detrimentally affected. To help to improve this situation at a systemic level, three main actions are warranted. First, academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Second, standards for the content of protocols and full study reports and for data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should endorse and enforce policies supporting study registration and wide availability of journal reports, full study reports, and participant-level datasets.
AbstractThe SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) statement aims to improve the completeness of clinical trial protocol reporting, by providing ...evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there is a growing recognition that interventions involving artificial intelligence need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes.The SPIRIT-AI extension is a new reporting guideline for clinical trials protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI. Both guidelines were developed using a staged consensus process, involving a literature review and expert consultation to generate 26 candidate items, which were consulted on by an international multi-stakeholder group in a 2-stage Delphi survey (103 stakeholders), agreed on in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants).The SPIRIT-AI extension includes 15 new items, which were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations around the handling of input and output data, the human-AI interaction and analysis of error cases.SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.
Global biomedical and public health research involves billions of dollars and millions of people. Although this vast enterprise has led to substantial health improvements, many more gains are ...possible if the waste and inefficiency in the ways that biomedical research is chosen, designed, done, analysed, regulated, managed, disseminated, and reported can be addressed.
Systematic reviews are increasingly utilized in the medical literature to summarize available evidence on a research question. Like other studies, systematic reviews are at risk for bias from a ...number of sources. A systematic review should be based on a formal protocol developed and made publicly available before the conduct of the review; deviations from a protocol with selective presentation of data can result in reporting bias. Evidence selection bias occurs when a systematic review does not identify all available data on a topic. This can arise from publication bias, where data from statistically significant studies are more likely to be published than those that are not statistically significant. Systematic reviews are also susceptible to bias that arises in any of the included primary studies, each of which needs to be critically appraised. Finally, competing interests can lead to bias in favor of a particular intervention. Awareness of these sources of bias is important for authors and consumers of the scientific literature as they conduct and read systematic reviews and incorporate their findings into clinical practice and policy making.
Systematic reviews of clinical trials aim to include all relevant studies conducted on a particular topic and to provide an unbiased summary of their results, producing the best evidence about the ...benefits and harms of medical treatments. Relevant studies, however, may not provide the results for all measured outcomes or may selectively report only some of the analyses undertaken, leading to unnecessary waste in the production and reporting of research, and potentially biasing the conclusions to systematic reviews. In this article, Kirkham and colleagues provide a methodological approach, with an example of how to identify missing outcome data and how to assess and adjust for outcome reporting bias in systematic reviews.
Keratinocyte carcinoma is the most common malignant disease, but it is not captured in major registries. We aimed to describe differences by sex in the incidence and mortality rates of keratinocyte ...carcinoma in Ontario, Canada.
We conducted a population-based retrospective study of adults residing in Ontario between Jan. 1, 1998, and Dec. 31, 2017, using linked health administrative databases. We identified the first diagnosis of keratinocyte carcinoma using a validated algorithm of health insurance claims, and deaths related to keratinocyte carcinoma from death certificates. We calculated the incidence and mortality rates of keratinocyte carcinoma, stratified by sex, age and income quintile. We evaluated trends using the average annual percentage change (AAPC) based on joinpoint regression.
After decreasing from 1998 to 2003, the incidence rate of keratinocyte carcinoma increased by 30% to 369 per 100 000 males and 345 per 100 000 females in 2017 (AAPC 1.9%, 95% confidence interval CI 1.7 to 2.1 from 2003 to 2017). The incidence rate was higher in females younger than 55 years, but higher in males aged 55 years or older. Between 2008 and 2017, the incidence rate rose faster in females than males aged 45-54 years (AAPC 1.2% v. 0.5%,
= 0.01) and 55-64 years (1.2% v. 0.1%,
< 0.01). The incidence was higher in males than females in the higher income quintiles. Between 1998 and 2017, the mortality rate of keratinocyte carcinoma was 1.8 times higher in males than females, on average, and rose 4.8-fold overall (AAPC 8.9%, 95% CI 6.4 to 11.4 in males; 8.0%, 95% CI 5.3-10.8 in females).
The population burden of keratinocyte carcinoma is growing, and the incidence and mortality rates rose disproportionately among certain sex- and age-specific groups. This warrants further investigation into causal factors and renewed preventive public health measures.
Abbreviations: FDA, Food and Drug Administration; NDA, new drug application Provenance: Commissioned; not externally peer reviewed Although randomized trials provide key guidance for how we practice ...medicine, trust in their published results has been eroded in recent years due to several high-profile cases of alleged data suppression, misrepresentation, and manipulation 1-5, 39. ...only devices, pharmaceuticals, and biological agents require regulatory approval in the United States and other countries, meaning that trials examining other types of interventions (e.g., surgery, education)--which constitute 20% of published randomized trials 24--would be excluded from reviews of regulatory agency documents.
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Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Evidence in the medical literature suggests that trial registration may not be preventing selective reporting of results. We wondered about the place of such information in the peer-review process.
...We asked 1,503 corresponding authors of clinical trials and 1,733 reviewers to complete an online survey soliciting their views on the use of trial registry information during the peer-review process.
1,136 authors (n = 713) and reviewers (n = 423) responded (37.5%); 676 (59.5%) had reviewed an article reporting a clinical trial in the past 2 years. Among these, 232 (34.3%) examined information registered on a trial registry. If one or more items (primary outcome, eligibility criteria, etc.) differed between the registry record and the manuscript, 206 (88.8%) mentioned the discrepancy in their review comments, 46 (19.8%) advised editors not to accept the manuscript, and 8 did nothing. The reviewers' reasons for not using the trial registry information included a lack of registration number in the manuscript (n = 132; 34.2%), lack of time (n = 128; 33.2%), lack of usefulness of registered information for peer review (n = 100; 25.9%), lack of awareness about registries (n = 54; 14%), and excessive complexity of the process (n = 39; 10.1%).
This survey revealed that only one-third of the peer reviewers surveyed examined registered trial information and reported any discrepancies to journal editors.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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