Refining the usability and acceptability of reporting guidelines: a sequential feasibility study and parallel process evaluation.

Background: Reporting guidelines are recommendations to help medical researchers write up their research completely and transparently.

Most leading medical journals and funders endorse them, and they are recognised as an important line of defence against incomplete or misleading reporting and are fundamental for reproducibility. Yet few guidelines have undergone meaningful user testing. Consequently, their effectiveness is limited, poor reporting continues, and patients suffer.

Our previous systematic review identified 32 problems authors face when trying to find, understand, and use reporting guidelines.

We used a behaviour change framework to address these by creating a design blueprint that could be applied across all reporting guidelines hosted on our EQUATOR Network website.

The blueprint presents the content of reporting guidelines in three parts: a guidance document with explanations and examples, a checklist, and a template for a journal publication. We have applied the blueprint to the 10 most accessed reporting guidelines.

Aim and objectives: Our aim is to refine the blueprint to make reporting guidelines as easy to use as possible, and to ensure the blueprint is acceptable to authors, publishers, and guideline developers. Our objectives are to identify and address parts of our blueprint that could be more acceptable or easier to use.

Methods: Our project has three work packages.

First we will run workshops with guideline developers and publishers to ensure our blueprint is sufficiently acceptable for them to adopt.

Our second work package is a process evaluation to understand how authors submitting to a journal behave when they encounter our redesigned reporting guidelines.

Journals including PLOS Medicine, PLOS Biology, and The BMJ will begin referring authors to our resources and we will use analytics software to anonymously track submitting authors as they navigate from submission platforms to our resources. We will then look at journal submissions to see how many authors submit a reporting checklist and adhere to guidance.

The results will influence the interview schedule and sampling strategy for our third work package, where we will interview 50 authors to identify acceptability and usability deficiencies.

We will recruit authors who did submit a reporting checklist as well as those that did not, and our purposive sampling will seek variation in research experience, subject areas, and first languages.

We will use think aloud and semi-structured interviews to explore the acceptability and usability of the guidelines, checklist, and templates.

We will thematically analyse transcripts from our workshops and interviews using well established frameworks for acceptability and usability that are commonly used alongside behaviour change frameworks. We will make iterative improvements to our designs after each workshop and after every 15 author interviews.

Anticipated Impact and Dissemination: Once refined, we will add our redesigned reporting guidelines to the EQUATOR Network website which is visited by 1 million authors each year. Where EQUATOR currently refers authors to hard-to-use publications, it will instead direct them to our resources.

We will then develop a protocol for a future evaluation study to explore whether our redesigned reporting guidelines increase the quality of reporting in medical research.