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The Consolidated Standards of Reporting Trials (CONSORT) are guidelines to facilitate transparent and unbiased reporting of randomized controlled trials (RCTs). Adherence to CONSORT guidelines ensures the inclusion of key information, so that readers can properly assess the validity and generalizability of RCTs and apply it to their patient population.

CONSORT for Abstracts is a 19-item checklist specifically designed to improve the reporting of RCTs in abstracts. Key items include the trial design, methods (participants, intervention, objective, outcome, randomization, blinding) and results (including an explicit statement on harms or side effects), as well as transparency requirements by inclusion of registration and funding information.

In a recent study by Hays et al, they found a variable and inconsistent adherence to CONSORT for Abstracts among high-impact general medical journals. In our study, we conducted a post hoc analysis of the dataset to determine whether professional medical writing support (PMWS) might improve adherence.

Better reporting

The role of PMWS, as defined by the recent American Medical Writers Association (AMWA), European Medical Writers Association (EMWA), and International Society of Medical Publication Professionals (ISMPP) Joint Position Statement on the Role of Professional Medical Writers, is to help authors and sponsors disclose their research in peer-reviewed journals and at scientific congresses in an ethical, accurate, and timely manner, with the ultimate aim of advancing patient care.

This is achieved by following Good Publication Practice guidelines (GPP3) and International Committee of Medical Journal Editors (ICMJE) recommendations, and by consulting appropriate reporting guidelines, such as CONSORT for Abstracts.

The Role of Professional Medical Writers is to help authors and sponsors disclose their research in peer-reviewed journals and at scientific congresses in an ethical, accurate, and timely manner.

PMWS is not well understood by academia and lay audiences. It is critical to accumulate evidence to demonstrate the role of PMWS in adding value to medicine and to root out and shame bad practices, such as ghostwriting and nondisclosure of clinical research. PMWS, correctly acknowledged, is endorsed by GPP3 and has shown greater prevalence in recent years in industry-sponsored RCTs.

For example, in a recent study by two authors of the current study, PMWS was associated with an increased adherence to CONSORT in articles reporting RCTs. In a sample of open-access journals, they found that the number of articles that completely reported ≥50% of the studied CONSORT items was significantly higher with PMWS than without.

The role of professional medical writers

We found that the mean proportion of adherence to CONSORT for Abstracts items reported was similar with and without PMWS. PMWS improved adherence to disclosing harms/side effects and funding source. Although there was the risk of false positives in this post hoc analysis, these were found to be statistically significant. This indicates the important role of professional medical writers in promoting adherence to Medical Publishing Insights & Practices (MPIP) recommendations to improve reporting of adverse event in clinical trial publications.

There is an important role for professional medical writers to work closely with authors and journals to provide training, writing, and reviewing.

We were disappointed to find a lower adherence to the reporting of study setting with PMWS, and that PMWS was not associated with improvements in other CONSORT for Abstract items such as specification of design study in the title (Checklist item 2), confirmation that the study was randomized (Checklist item 1), and reporting of numbers randomized and analysed (Checklist items 12 and 13).

These data were potentially confounded by funding source, as PMWS is typically restricted to industry-funded studies – so the improvements we observed might have been caused by the industry review processes rather than the PMWS. In addition, although GPP3 promote transparency of PMWS, it remains possible that it was not consistently reported in this dataset.

A call to arms

Overall, we are encouraged that these findings confirm prior evidence, showing PMWS improves the reporting of safety measures and funding source, as one would expect from PMWS. On the other hand, these findings represent a “call to arms” suggesting room for improvement by PMWS in reporting type of trial, setting, and other areas.

Ensuring adherence to reporting guidelines such as the CONSORT for Abstracts is a complex task. We believe that there is an important role for professional medical writers to work closely with authors and journals to provide training, writing, and reviewing, and thereby improve the quality of RCT reporting.