Randomized Controlled Trials, Article Critique Example

Introduction

Augestad, Bernsten, Lassen, Belika, Wooton, & Lindsetmo (2012) created a large scale systematic search to analyze the overall reporting quality of randomized clinical trials (RCT-s), mostly performed in primary care. The main aim of the research was to provide guidelines for researchers and practitioners to improve data quality of RCT-s.

The authors (Augestad et al., 2012) used 32 randomized clinical trial papers for the final review from the pool of total 3784. The most common research topics covered by trials were asthma, diabetes, and hyperlipidemia. The authors used the Consolidated Standards for Reporting Trials (CONSORT) as a benchmarking criteria when assessing the data quality of papers.

The study of the selected RCT papers resulted in the finding that overall data quality is low. This finding implies that there is a need for creating further quality improvement and benchmarking frameworks and standards to improve the reporting accuracy of randomized clinical trials. Only forty percent of the trials researched were found to be of superior quality, according to the Jadad score benchmarking system.

Main Findings of the Research

One of the most significant findings of the research was that the CONSORT adherence of trials was generally low. This indicates that researchers and trial administrators are either not fully aware of the CONSORT benchmarking criteria, or do not fully understand the methods. Some of the most important development areas that the research highlighted were related to data selection and methodology. As Augestad et al. (2012, p. 17) state: “there is considerable room for improving methodology in areas such as the description of specific research objectives, randomization methods, sample size calculations, reporting of adverse events, and a general focus on CONSORT”.

Apart from research methodology and benchmarking problems, Augestad et al. (2012) also found that the documentation of research and definition of intervention was also of low quality. One worrying finding is that “none of the trials defined the intervention as complex or discussed the definition of a complex intervention” (p. 15).

The authors of the study (Augestad et al., 2012) also attempted to explain the reasons behind poor data and report quality of randomized clinical trials. The main research challenges identified, based on literature review were the complexity of intervention methods, the interaction of different treatments, over-standardization, dealing with data variation, sample size selection dilemmas, and the lack of standards for selecting outcome measures. The choice between randomized and clustered design can also create data variations.

Conclusion and Future Implications

The above article was selected in order to highlight issues that today’s health informatics professionals face. It has been found that there is indeed a need for creating standards and setting strict criteria for RCT-s, as well as other research.  While research designs are flexible, there is a need for introducing benchmarking criteria, used by Augestad et al. (2012) to evaluate data quality.  The low adherence to CONSORT standards indicate that the methods used by different trial administrators vary significantly, therefore, study outcomes can be influenced by the difference in research design. Future studies should focus on overcoming obstacles and challenges related to researching the effectiveness of complex clinical intervention methods. Introducing standards for comparing complex intervention outcomes and avoiding over-standardization that can result in unreliable data, reduce the quality of newly developed evidence-based treatment plans. Creating a consensus statement for research design and quality benchmark within the medical informatics community is a potential solution to the problem identified in the article.

References

Augestad, K. M., Berntsen, G., Lassen, K., Bellika, J. G., Wootton, R., & Lindsetmo, R. O. (2012). Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support. Journal of the American Medical Informatics Association, 19(1), 13-21.