— By Brian Boyle, Journal Development Manager, Frontiers in Pharmacology
The issue of reproducibility – the ability of an experiment or study to be duplicated either by the same researcher or by someone else working independently – and over adequacy of methodology and reliable reporting of results, is becoming more prominent across all sciences, not least in life sciences.
Where studies relate, or directly apply, to current or prospective medical applications, the issue takes on a whole new impetus, moving from academic abstraction to potential human cost. This is exemplified by research in medical sciences and clinical research but also environmental research.
In recognition of this critical issue, the CONSORT (Consolidated Standards of Reporting Trials) statement was first published in 1996 (Begg et al, 1996) laying out a rigorous set of criteria to standardize the reporting of clinical trials, and today remains the ‘gold standard’ to fulfil, with the integrity of a trial assessed accordingly (Schulz et al, 2010).
Now, Prof Michael Heinrich, co-Specialty Chief Editor of the Frontiers in Pharmacology Specialty Section `Ethnopharmacology`, and colleagues in the ConsETPFS Working Group, have used the CONSORT framework as a basis to develop a set of draft standards for the reporting of ethnopharmacological field studies – specifically focusing on studies concerning medicinal and health food plants. Such studies report on the local and traditional use of such natural substances and their importance within a society.
Though representing a wider spectrum of scientific goals when compared to the direct study of clinical interventions in a randomized controlled trial, through this framework document Prof Heinrich and colleagues seek to develop criteria for best practice for such field studies and to lay the foundations for a more evidence-based use of such natural substances, with the research acting as a credible reference point also for health care practitioners and policy makers.
Seeking as much input into the final version of the document as possible, Prof Heinrich and colleagues are inviting the comments from the community on the draft by the end of February hosted at the Journal of Ethnopharmacology at the following link –
We spoke to Prof Heinrich to gain some insight into the development of the document:
- How did the ConsETPFS Working Group come together?
We – the members of the steering group – have worked together for many years on joint projects and had become increasingly concerned about what is reported about local and traditional uses of medicinal and food plants. After initiating the steering group, we approached colleagues on all continents and now have an advisory board which represents a wide range of academic interests globally
- The CONSORT guidelines have previously been extended, for example to non-pharmacological interventions. Can you elaborate on the process of adapting the guidelines to field studies and building the draft document?
We cannot really adapt them, since the CONSORT guidelines relate to clinical and other medical research. Here we are working in community settings and thus in a very different scientific context. Therefore, while we have taken some elements with regards to general scientific and reporting practice from the CONSORT guidelines, we have added many novel elements. Importantly, a key question in the current debate about these guidelines for best practice relates to the question ‘what is a meaningful content of ethnopharmacological field studies’?
- What is the estimated timeframe for the publication of the final version of the document?
During the first six months of 2017, the draft ConsETPFS guidelines will be discussed at scientific meetings (e.g. of the International Society, for Ethnopharmacology, the European Society for Integrative Medicine and the Society for Economic Botany) and we hope to have the guidelines finalized and published by the end of this year.
- In your opinion, what effect will increasing the evidence based utilization of such field studies have on health care systems?
First it is about best practice in science and only on the basis of such best practice can appropriate advice be developed. There can be no doubt that far more than half of the world’s population rely on local and traditional medical practices. Far too little is known about it and very often it is a hidden practice not known to mainstream practitioners. ConsETPFS can lay the foundation for a better understanding of the uses of plants and other natural substances and how they can contribute to better healthcare, especially in regions which continue to have poor access to good national healthcare.
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276(8):637-639
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar23;340:c332