Improving the Reporting of Interventions in Clinical Trials of Acupuncture: The Updated and Revised STRICTA

Abstract

The revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) are being published with free online access to all users and prospective authors. The original STRICTA were co-published in five journals and also translated and published in Chinese, Korean and Japanese. STRICTA were written in response to published reports of acupuncture trials that reported insufficient information on the interventions themselves, compromising the interpretation of trial results and any possible replications. The aim of STRICTA is to provide precise guidelines for prospective authors of clinical trials to report clearly the specific components of acupuncture interventions used within an acupuncture trial, so as to enable other researchers to to reproduce the reported research protocol accurately and reliably or to appraise the findings critically. Poor reporting of interventions within trials is not confined to the field of acupuncture or complementary medicine. In the conventional medical field, approximately onehalf of trials scrutinized in one study were found to describe interventions inadequately. The whole subject of the quality of reporting in clinical trials has been addressed by the CONSORT (CONsolidated Standards Of Reporting Trials) Group. First published in 1996, and then revised in 2001 and 2010, the CONSORT Statement set out guidelines designed to improve the reporting of parallel-group randomized controlled trials. The CONSORT 2010 Statement consists of a 25-item checklist and a flow diagram, along with a set of explanations and examples of good reporting. When first developed in 2001, the STRICTA guidelines were designed to replace the one item in the CONSORT checklist related to interventions, which is Item 5 in the current version of CONSORT. STRICTA expanded this item with an additional 6 sub-items. The intention from the outset was that authors reporting acupuncture trials should follow CONSORT for all items except the one related to interventions, and, for this item, the STRICTA checklist with six subitems should be followed. In parallel with the updating of CONSORT, the STRICTA Group has also revised and updated the STRICTA guidelines. The details of this 2-year revision process, which included an extensive literature review a survey of authors of previous trials, the collation of opinions elicited from a group of 47 experts, and a consensus meeting in Freiburg, in Germany in 2008, have been set out elsewhere. The newly revised STRICTA criteria will be published online in this journal as an official extension to CONSORT. The revised STRICTA has retained the six sub-items as before, but has refined the criteria, removing those details identified by the international group of collaborators as redundant, ambiguous, lacking in clarity, and needing reworking to achieve improvement. These guidelines now comprise not only a sixitem checklist, but also explanatory text with examples of good reporting. All the the Editorial team of the Journal exhort all authors reporting trials of acupuncture to use both STRICTA and CONSORT when writing up studies for publication, and, equally, to use these guidelines as Gold Standards for the evaluation of published work. This will facilitate higherquality reporting, which, in turn, will enhance the impact of research conducted in the field. We believe that the online publication of the revised version of STRICTA will prove extremely useful not only to researchers worldwide, but also to millions of patients the world over who should be the beneficiaries of such improved research.