Table 3.
The Research Integrity in Guidelines and evIDence synthesis (RIGID) checklist.
| Item | Description | Page |
|---|---|---|
| Step0. Integrity committee | ||
| a. | Assembled a multidisciplinary integrity committee (identified in publication(s) and/or supporting documents), comprising a minimum of five members including an impartial chair | |
| b. | Nominated two independent reviewers from the committee (identified in publication(s) and/or supporting documents) to conduct initial integrity assessments for each eligible study | |
| Step 1: Review | ||
| 1a. | For the clinical question at hand, conducted a systematic search and screening per standard review guidelines (e.g., Cochrane).
|
NA |
| 1b. | Compiled a list of all eligible studies following full text screening | |
| Step 2. Exclude | ||
| 2a. | Checked all studies for retraction notices and/or on the Retraction Watch Database to identify retracted studies | |
| 2b. | Clearly noted studies that are under investigation or have expressions of concern for further assessment | NA |
| 2c. | All retracted studies were identified and recorded as excluded, with the reason listed as ‘Retracted' | |
| Step 3. Assess | ||
| 3a. | Specified the tool used (e.g., TRACT or RIA) by two nominated reviewers to conduct independent integrity assessments for each study and reconcile their ratings through discussion and consensus | |
| 3b. | Clearly documented assessments against each domain and an initial rating for each study as low, moderate or high risk of integrity concerns (with notes/justifications where relevant) | |
| Step 4. Discuss | ||
| 4a. | Integrity checklist assessments and risk ratings were circulated to the committee members with appended publications for review prior to the committee meeting. | NA |
| 4b. | A meeting was convened with all committee members to discuss allocations and record votes and final risk rating after discussion. Studies may be shifted from one risk rating to another following discussion All studies with a final rating of ‘low risk’ are included in the evidence synthesis Where a majority cannot be reached, the Chair decides the final study allocation and this is recorded, with reasons |
|
| Step 5. Establish contact | ||
| 5a. | Sourced contact details and sent a generic email to all corresponding authors of ‘moderate risk’ and ‘high risk’ studies to obtain an ‘intention to respond’ to concerns raised. | |
| 5b. | Recorded a log with all authors contacted, noting those who responded (with relevant details of responses), allowing a minimum of two weeks. | |
| Step 6. Re-assess | ||
| 6a. | Re-assessed studies following responses (using the RIGID reassessment algorithm) and recorded final allocation as ‘Included’, ‘Not Included’ or ‘Awaiting Classification’. If authors are able to satisfy concerns within a reasonable timeframe, studies may be shifted to low risk and included following consultation and agreement by the integrity committee. |
|
| 6b. | Continued with subsequent systematic review steps including data extraction and quality appraisal using the final list of those studies which are ‘Included’ | NA |
N.B. Any members of the integrity committee may be tasked with any of the steps listed above (e.g., the two independent reviewers may conduct integrity assessments, and a more senior member may contact authors regarding integrity concerns). For transparency, the assessment record should be provided with the guideline and/or supporting documents, outlining each domain, initial risk rating, committee votes, final risk rating after discussion, and final allocation after author contact.
NA, not applicable (no page number needed for this item); RIA, research integrity assessment; RIGID, Research Integrity in Guidelines and evIDence synthesis; TRACT, Trustworthiness of Randomised Controlled Trials.