Composition of the coordinating centre and trial steering committee {5d}
Principal Investigator (SH) and co-Principal Investigator (SH):
- Design and conduct of the BEACON Study;
- Preparation of protocol and revisions;
- Preparation of study documentation;
- Organization of Steering Committee meetings;
- Publication of study reports; and
- Participation as members of Trial Management Committee (TMC).
Steering Committee
- Includes: Principal Investigator (SH), Co-Principal Investigator (MH), and Site Principal Investigators.
- Approval of the final protocol;
- All co-Investigators at each intervention site will be steering committee members;
- Recruitment of patients and liaising with Principal Investigator and co-Principal Investigator; and
- Reviewing progress of study and, if necessary, approval of changes to the protocol and/ to facilitate the smooth running of the study.
Trial Management Committee (TMC)
- Includes: Principal Investigator (SH), co-Principal Investigator (MH), and Clinical Research Associates (NE, SM).
- Study planning;
- Organization of Steering Committee meetings;
- Organization of Data and Safety Monitoring Committee (DSMC) meetings;
- Provide annual reporting to Research Ethics Board (REB);
- Serious Adverse Event (SAE) reporting to DSMC and REB;
- Responsible for Master Tracking Log;
- Budget administration and contractual issues with individual centres;
- Advice for lead investigators;
- Coordination of study monitoring;
- Assistance with REB applications;
- Data verification; and
- Randomization.
Composition of the data monitoring committee, its role and reporting structure {21a}
The Data and Safety Monitoring Committee (DSMC) is comprised of four members from the following fields of expertise: statistics/biostatistics, epidemiology, methodology, psychiatry and the ethics of clinical trials.
Responsibilities:
- Ensures the ongoing safety of study participants;
- Reviews the conduct of the study, including protocol violations and deviations;
- Reviews data on participant recruitment, accrual, and retention, as well as assessments of data quality, completeness, timeliness, data retention, data storage, data transmission and data access;
- Reviews Adverse Events (AEs) and Serious Adverse Events (SAEs) reported between meeting dates;
- Protects the confidentiality of the study data and the DSMC discussions; and
- Makes recommendations to continue, modify, or terminate the study.
Adverse event reporting and harms {22}
The anticipated harms in this study are minimal and do not exceed the risks associated with usual care. In this clinical trial, given that all outcome data are routinely collected population-level data through ICES and no participants will be enrolled in the study, Adverse Events (AEs) will not be collected and assessed. However, all AEs and Serious Adverse Events (SAEs) will be collected, monitored and reported as appropriate for all related sub-studies as this will involve the enrollment and follow-up of participants.
Frequency and plans for auditing trial conduct {23}
Not Applicable as this is a data linkage study, it does not include any trial conduct.
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Any subsequent modifications to the study protocol, including changes to study objectives, study design, patient population, sample sizes, study procedures, or significant administrative changes will be agreed upon by the Steering Committee and submitted to the REB for review and approval prior to implementation.
Dissemination plans {31a}
Data Analysis and Release of Results
To protect the scientific integrity of this study, data from all clusters will be analyzed and reported together. Although sub-analyses with specific groups will be conducted, no centre is expected to report data collected from their centre alone. The primary data analysis will be conducted by the Ottawa Methods Centre (OMC) at OHRI in conjunction with IC/ES. All statisticians will be blind to the allocation of the study sites. All study publications and presentations are expected to adhere to the BEACON Study objectives as detailed in this protocol.
Review Process
A Publications Committee, a subcommittee of the Steering Committee, will be established to coordinate all study publications and presentations. All presentation and publication abstracts must be submitted for review by the Publications Committee. This committee will create a running list of all potential publications, review all abstracts submitted for publication by the Investigative Team, identify a lead author for each publication, review all publication manuscripts, and submit publications to peer-reviewed journals for publication. They will also ensure that all publication guidelines and regulations are respected, including adherence to the study’s objectives and the CONSORT statement for cluster RCTs.
Each presentation or publication abstract/manuscript must be submitted to the Research Coordinator prior to each Publications Committee Meeting. The abstracts will be reviewed at the subsequent Publications Committee meeting. All members will vote on each abstract and will provide feedback. The Research Coordinator will include all feedback in the meeting minutes and, after each meeting, will circulate all feedback appropriately. Authors will be expected to review the committee’s feedback and re-submit their final abstract or manuscript for final approval by the Publications Committee.
Primary Outcome Publications
The Publications Committee will ensure that no presentation or publication undermines the dissemination of any primary outcome publications. Primary outcome publications refer to any presentation or publication that presents data on the primary outcomes as detailed in this protocol. During the review process, the Publications Committee will determine if an abstract/manuscript will undermine any primary outcome publications. If it is determined that this is the case, the author will be asked to delay publication until such a time as the primary outcome publication is released.
Other Study Papers, Abstracts and Presentations
This refers to all presentations and publications that do not report on the primary outcome of this trial, as detailed in this protocol. All presentation and publications abstracts/manuscripts must be reviewed and approved by the Publications Committee prior to submission.
Close-Out Procedures
The primary outcome publication is expected to be submitted for publication within two years of the completion of follow-up data collected (i.e. after the last study participant has completed the study). However, this may occur at an earlier or later date if the circumstances warrant. Study close-out will occur in two stages:
- Period of analysis and documentation of primary outcome results; and
- Debriefing of participants and dissemination of all other study results.
Reporting of Study Results
All study results will be released to study participants, referring clinicians, patients and the general medical community. Results will be communicated to study participants through the use of a newsletter or presentation, as per the overall preference of the participants. Other forms of dissemination include: academic publications, conference presentations and presentations to the general public.
SPIRIT guidance: Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals, the public, and other relevant groups (eg, via publication, reporting in results databases, or other data sharing arrangements), including any publication restrictions.