Fay Karpouzis


Background: Despite the introduction of the CONSORT checklist, the quality of reporting of randomized controlled trials (RCTs) within the biomedical literature has been described as suboptimal, with a need for improvement, while that of chiropractic trials remains unexamined.

Aims: The aim of this protocol is to develop a tool to assess the overall reporting quality of published chiropractic RCTs using standardised guidelines (i.e. CONSORT), to identify key methodological items that safeguard against biases and to identify predictors of better reporting quality.

Methods/Design: A search of RCTs published in English from 2005 - 2014 will be performed in the international clinical trial registers, PubMed and the Cochrane library using keywords and Medical Subject Headings (MeSH). Trials will be included if they involve high-velocity low-amplitude spinal or extremity manipulation and are conducted by a chiropractor or within a chiropractic department/institution. RCTs meeting inclusion criteria will be assessed using a customised 39-point rating tool, designed by the authors. The customised tool will be based on the CONSORT 2010 and CONSORT for Non-Pharmacological Treatments statements. Furthermore, each RCT will be assessed according to 4 key methodological items (KMIS); allocation concealment; blinding of participants; blinding of assessors; and the use of intention-to-treat analysis (ITT). Predictors that will be chosen for the study, will be identified in the medical literature as influencing the reporting quality of RCTs such as: industry funding, positive findings, sample size, year of publication and journal type. A multiple regression analyses will be used to explore associations between the outcome, overall quality of reporting score (OQRS) and the predictor variables.

Discussion: The results of this study will provide an OQRS in chiropractic RCTs over the last decade. It will provide an individual score for each item of the CONSORT 2010 and CONSORT for Non-Pharmacological Treatments checklists, as well as key methodological items. Furthermore, the study will provide a list of predictors for improved overall quality of reporting of chiropractic RCTs.