How to improve the study design of clinical trials in internal medicine: recent advances in the evidence­based methodology.

Meta-research has highlighted that up to half of all clinical studies may be redundant and do not add any value. We suggest that such unnecessary studies will continue to be prepared and published unless researchers systematically and transparently identify and consider the existing evidence. This approach of identifying and utilizing the existing knowledge base before and after conducting a new trial is called Evidence-Based Research (EBR), defined as the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. This paper describes the issues that have led to the development of the EBR approach, suggests what researchers should do to avoid wasteful and unnecessary research, and outlines the benefits of conducting evidence-based research. Finally, we present the international EBR Network established to support the efforts to minimize waste in research and increase the value of clinical studies.

Evidence-Based Research Series-Paper 2 : Using an Evidence-Based Research approach before a new study is conducted to ensure value.

BACKGROUND AND OBJECTIVES: There is considerable actual and potential waste in research. The aim of this article is to describe how using an evidence-based research approach before conducting a study helps to ensure that the new study truly adds value. STUDY DESIGN AND SETTING: Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this second article of the evidence-based research series, we describe how to apply an evidence-based research approach before starting a new study. RESULTS: Before a new study is performed, researchers need to provide a solid justification for it using the available scientific knowledge as well as the perspectives of end users. The key method for both is to conduct a systematic review of earlier relevant studies. CONCLUSION: Describing the ideal process illuminates the challenges and opportunities offered through the suggested evidence-based research approach. A systematic and transparent approach is needed to provide justification for and to optimally design a relevant and necessary new study.

Evidence-Based Research Series-Paper 3: Using an Evidence-Based Research approach to place your results into context after the study is performed to ensure usefulness of the conclusion.

BACKGROUND AND OBJECTIVE: There is considerable actual and potential waste in research. Using evidence-based research (EBR) can ensure the value of a new study. The aim of this article, the third in a series, is to describe an EBR approach to putting research results into context. STUDY DESIGN AND SETTING: EBR is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this third and final article of a series, we describe how to use the context of existing evidence to reach and present a trustworthy and useful conclusion when reporting results from a new clinical study. RESULTS: We describe a method, the EBR approach, that by using a systematic and transparent consideration of earlier similar studies when interpreting and presenting results from a new original study will ensure usefulness of the conclusion. CONCLUSION: Using an EBR approach will improve the usefulness of a clinical study by providing the context to draw more valid conclusions and explicit information about new research needs.

Enhancing the uptake of systematic reviews of effects: what is the best format for health care managers and policy-makers? A mixed-methods study.

BACKGROUND: Systematic reviews are infrequently used by health care managers (HCMs) and policy-makers (PMs) in decision-making. HCMs and PMs co-developed and tested novel systematic review of effects formats to increase their use. METHODS: A three-phased approach was used to evaluate the determinants to uptake of systematic reviews of effects and the usability of an innovative and a traditional systematic review of effects format. In phase 1, survey and interviews were conducted with HCMs and PMs in four Canadian provinces to determine perceptions of a traditional systematic review format. In phase 2, systematic review format prototypes were created by HCMs and PMs via Conceptboard©. In phase 3, prototypes underwent usability testing by HCMs and PMs. RESULTS: Two hundred two participants (80 HCMs, 122 PMs) completed the phase 1 survey. Respondents reported that inadequate format (Mdn = 4; IQR = 4; range = 1-7) and content (Mdn = 4; IQR = 3; range = 1-7) influenced their use of systematic reviews. Most respondents (76%; n = 136/180) reported they would be more likely to use systematic reviews if the format was modified. Findings from 11 interviews (5 HCMs, 6 PMs) revealed that participants preferred systematic reviews of effects that were easy to access and read and provided more information on intervention effectiveness and less information on review methodology. The mean System Usability Scale (SUS) score was 55.7 (standard deviation [SD] 17.2) for the traditional format; a SUS score < 68 is below average usability. In phase 2, 14 HCMs and 20 PMs co-created prototypes, one for HCMs and one for PMs. HCMs preferred a traditional information order (i.e., methods, study flow diagram, forest plots) whereas PMs preferred an alternative order (i.e., background and key messages on one page; methods and limitations on another). In phase 3, the prototypes underwent usability testing with 5 HCMs and 7 PMs, 11 out of 12 participants co-created the prototypes (mean SUS score 86 [SD 9.3]). CONCLUSIONS: HCMs and PMs co-created prototypes for systematic review of effects formats based on their needs. The prototypes will be compared to a traditional format in a randomized trial.

The definition of acute kidney injury and its use in practice.

Acute kidney injury (AKI) is a common syndrome that is independently associated with increased mortality. A standardized definition is important to facilitate clinical care and research. The definition of AKI has evolved rapidly since 2004, with the introduction of the Risk, Injury, Failure, Loss, and End-stage renal disease (RIFLE), AKI Network (AKIN), and Kidney Disease Improving Global Outcomes (KDIGO) classifications. RIFLE was modified for pediatric use (pRIFLE). They were developed using both evidence and consensus. Small rises in serum creatinine are independently associated with increased mortality, and hence are incorporated into the current definition of AKI. The recent definition from the international KDIGO guideline merged RIFLE and AKIN. Systematic review has found that these definitions do not differ significantly in their performance. Health-care staff caring for children or adults should use standard criteria for AKI, such as the pRIFLE or KDIGO definitions, respectively. These efforts to standardize AKI definition are a substantial advance, although areas of uncertainty remain. The new definitions have enabled the use of electronic alerts to warn clinicians of possible AKI. Novel biomarkers may further refine the definition of AKI, but their use will need to produce tangible improvements in outcomes and cost effectiveness. Further developments in AKI definitions should be informed by research into their practical application across health-care providers. This review will discuss the definition of AKI and its use in practice for clinicians and laboratory scientists.