Aim

Our aim is to develop a reporting guideline for observational studies using health data collected for non-research purposes as an extension of STROBE- the REporting of studies Conducted using Observational Routinely-collected Data (RECORD) statement.

Methods

The development of the RECORD statement followed the process proposed by the EQUATOR network (1). Members of EQUATOR executive are also members of the steering and working committees of RECORD (see RECORD GROUP tab). The approach to reporting guideline development has been suggested by the EQUATOR network and involved five phases (1):

PHASE 1 Initial steps-Applications for external funding were applied for and granted.

PHASE 2 Pre-meeting activities

Open-call was conducted to recruit stakeholders. A modified-delphi exercise was developed (consisting of two surveys):

• An open-text survey was sent to stakeholders, working and steering committee members. They were asked to suggest elements which they consider essential in the reporting of database research for inclusion in the RECORD statement. They were asked to provide elements under each sub-section of STROBE ((title and abstract, introduction (background and objectives), introduction (objectives), etc.)
• A Ranking Survey was sent to stakeholders, working and steering committee members . Results from the open text survey were then analyzed and grouped into thirteen themes. Each theme was presented in each sub-section (same as that listed in STROBE), and participants were asked to rank how strongly they believe the proposed theme should be incorporated into the RECORD reporting guideline. Under each theme, example phrases of those listed from the first survey were provided, to guide the participant in their decision.

Themes which were ranked highest in each sub-section were then presented to the working and steering committee, where example phrases identified in the first survey from stakeholders were presented and helped guide the committee on phrasing of the of checklist items for the reporting guidelines.

PHASE 3 Face-to-face consensus meeting (workshop)

Steering and Working committees met face-to-face at a consensus meeting with the aim of developing a draft checklist using results from the first two surveys.

PHASE 4 Post-Meeting activities

• Set up a forum to allow stakeholders to actively comment on the draft guidelines developed by the steering and working committee.
• Finalize checklist phrasing, develop explanatory document and final publication.

PHASE 5 Post-publication activities

Knowledge translation, encouragement of uptake and post-publication evaluation.

• 1. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med. 2010 Feb;7(2):e1000217.