Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

Abstract

BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data.

Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

“…At recruitment into GenV, parents provide consent for GenV to follow themselves and their child. As per the CONSORT Extension [ 30 ] for RCTs Using Cohorts and Routinely Collected Health Data, this includes consent to use their data for research purposes, with ongoing mechanisms to enable change in consent status (such as partial or full withdrawal or re-entry) any time after that. GenV’s full Parent Information & Consent Statement (PICF) is available for review [ 19 ]; its explicit trial-relevant wording is shown in Table 1 (a).…”

Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials

“…Very few trial teams described any assessments of data quality from RCHDs in the protocol. Work is ongoing that should determine whether such information should be reported in the trial publication ( Kwakkenbos et al , 2018 ). An extension to the SPIRIT guidelines for trials using RCHD is soon to be initiated, and will determine whether this information should be included in the trial protocol.…”

Statements, Recommendations, Proposals, Guidelines, Checklists and Scales Available for Reporting Results in Biomedical Research and Quality of Conduct. A Systematic Review

“…It consists of 10 items and 5 sub-elements, which are evaluated as: Yes, No, Not clear (Boutron et al, 2017). CONSORT-PRO, whose objective was to determine the results reported by the patients (PRO), which are usually inadequately reported, thus limiting the value of the data (Calvert et al, 2013); CONSORT-SPI, published in 2013 (Montgomery et al, 2013), and updated in 2018, for reporting randomized clinical trials (RCTs) of social and psychological interventions, extends 9 of the 25 items from CONSORT 2010 (CONSORT 2010), added a new item related to stakeholder involvement, and modified aspects of the flow diagram (Montgomery et al, 2018); IMPRINT, which seeks to improve CT information of infertility treatments (Harbin Consensus Conference Workshop Group et al, 2014); TIDIER checklist, for the report of interventions in evaluative studies, including CT (Hoffmann et al, 2014); adaptation to CT in orthodontics (Pandis et al, 2015); the "n-de-1", to evaluate the effectiveness of an intervention in a single patient (Vohra et al, 2016); PAFS, for the report of randomized pilot and feasibility trials, added 11 items grouped in 7 domains ; KCONSORT (2009) renamed STORK standards (2016), to generate a standard for reporting results in intervention studies where they were going to be used Kampo Products (Motoo et al, 2017); protocol for a scoping review to support development of a CONSORT extension for RCTs using cohorts and routinely collected health data, published in 2018 (Kwakkenbos et al, 2018); SW-CRT, published in 2018, for reporting of stepped wedge cluster RCT consist in 40 items grouped in 26 domains (Hemming et al, 2018); ADs, published in 2018, extension for adaptive design RCT, adjusting 24 items of 16 domains of the CONSORT 2010 (Dimairo et al, 2018); MAPGRT for reporting of Multi-Arm Parallel-Group RCT, expanding on 10 items of the CONSORT 2010 (Juszczak et al, 2019); PRT for reporting within person RCT, it extends 16 items of the CONSORT 2010 checklist and introduces a modified flowchart and baseline table (Pandis et al, 2019). None of them considers score allocation.…”