A matter of standards in reporting medical outcomes

A matter of standards in reporting medical outcomes

Anyone who has read a paper published in a biomedical journal before, say, the 1960s would initially be surprised not only by the less formal, more conversational style of the text but also by the rather vague and ambiguous presentation of the findings. The Introduction, Methods, Results, and Discussion (IMRAD) format medical writers and researchers use today is so familiar that we take it for granted, but it is worth remembering that it was introduced only around 30 years ago.

IMRAD, which is part of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals Recommended by the International Committee of Medical Journal Editors, is designed to help medical writers and researchers present their information in an easy-to-understand way, and reviewers to assess the quality of the data and conclusions. More specifically, the Uniform Requirements help papers to deliver “the maximum amount of understandable information and viable scientific contribution in the minimum space”.[1] As these guidelines for writing, publishing and editing papers have been accepted by over 500 biomedical journals, they have, in all their various interpretations, become the basic standard that all manuscripts should meet before they are accepted for publication.

In addition, there are a number of other guidelines and statements for specific types of investigations, such as randomised controlled trials (RCTs), observational studies and systematic reviews, that aim to raise standards and help medical writers to present study data. For example, the Consolidated Standards of Reporting Trials (CONSORT) statement provides guidance for reporting all RCTs, but focuses on the most common design: individually randomised, two-group, parallel trials. The latest CONSORT statement, published in 2010, consists of a 25-item checklist of what information to include when reporting an RCT, and a flow diagram of the passage of participants through the trial.[2]

For observational research, the Strengthening the Reporting Observational Studies in Epidemiology (STROBE) Statement sets out recommendations for medical writers and researchers on what should be included in an accurate and complete report. Covering cohort, case-control and cross-sectional studies, the Statement includes a checklist of 22 items relating to the title, abstract, introduction, methods, results and discussion section of articles, and aims to improve the quality of reporting observational studies.[3]

The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement recognises that, “as with all research, the value of a systematic review depends on what was done, what was found, and the clarity of reporting”.[4] The Statement includes a 27-item checklist of items to include when reporting a systematic review or meta-analysis, as well as a flow diagram for information in the different phases of a review. Although the focus is on systematic reviews and meta-analyses of randomised trials, the Statement notes that it can be used as a basis for reviews of other types of research, particularly the evaluation of interventions.

Finally, a guideline for the reporting of economic evaluations of health interventions was published earlier this year. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is a response to a survey of medical journal editors, which indicated a need for new reporting guidance. The resulting 24-item checklist is intended to improve the reporting of health economic evaluations and, ultimately, lead to better healthcare decisions.[5]

Our medical writers keep up-to-date with all the latest initiatives to improve the reporting of medical studies, and make sure that they meet the highest possible standards, and so help your findings reach the widest possible audience.

 

References

1.      Barron JP. The Uniform Requirements for Manuscripts Submitted to Biomedical Journals Recommended by the International Committee of Medical Journal Editors*. Chest 2006;129:1089-99.

2.      Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. Ann Intern Med 2010;152:726-32.

3.      von E, E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies. PLoS Med PLoS Med 2007;4:e296.

4.      Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med PLoS Med 2009;6:e1000097.

5.      Husereau D, Drummond M, Petrou S, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ 2013;346:f1049.

 

About Frank Waaga

Frank has a passion for medical communications and over 12 years of experience providing professional and reliable support to product teams in the pharmaceutical, biotech and medical device industry.
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