@article{Kwakkenbos:2018:10.1186/s41073-018-0053-3,
author = {Kwakkenbos, L and Juszczak, E and Hemkens, LG and Sampson, M and Fröbert, O and Relton, C and Gale, C and Zwarenstein, M and Langan, SM and Moher, D and Boutron, I and Ravaud, P and Campbell, MK and Mc, Cord KA and van, Staa TP and Thabane, L and Uher, R and Verkooijen, HM and Benchimol, EI and Erlinge, D and Sauvé, M and Torgerson, D and Thombs, BD},
doi = {10.1186/s41073-018-0053-3},
journal = {Research Integrity and Peer Review},
title = {Protocol for the development of a CONSORT extension for RCTs using cohort and routinely collected health data},
url = {http://dx.doi.org/10.1186/s41073-018-0053-3},
volume = {3},
year = {2018}
}

Download

TY  - JOUR
AB  - 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 i
AU  - Kwakkenbos,L
AU  - Juszczak,E
AU  - Hemkens,LG
AU  - Sampson,M
AU  - Fröbert,O
AU  - Relton,C
AU  - Gale,C
AU  - Zwarenstein,M
AU  - Langan,SM
AU  - Moher,D
AU  - Boutron,I
AU  - Ravaud,P
AU  - Campbell,MK
AU  - Mc,Cord KA
AU  - van,Staa TP
AU  - Thabane,L
AU  - Uher,R
AU  - Verkooijen,HM
AU  - Benchimol,EI
AU  - Erlinge,D
AU  - Sauvé,M
AU  - Torgerson,D
AU  - Thombs,BD
DO  - 10.1186/s41073-018-0053-3
PY  - 2018///
SN  - 2058-8615
TI  - Protocol for the development of a CONSORT extension for RCTs using cohort and routinely collected health data
T2  - Research Integrity and Peer Review
UR  - http://dx.doi.org/10.1186/s41073-018-0053-3
UR  - http://hdl.handle.net/10044/1/64672
VL  - 3
ER  - 

Download