Ethics approval and consent to participate
Ethics approval was received from West of Scotland REC2 on the 15th August 2017.
R&D approval was given to allow SSS staff to pass information to the TCC if the client gives verbal permission. Those who consent to take part in the trial will be sent a written copy of their consent form. In addition, potential participants receive an Information sheet which communicates data confidentiality procedures, the fact that participation is entirely voluntary, and the possibility of leaving the study at any time and without justification.
Substantial Amendments:
AM02 08/11/2017 Changes to main consent form, main PIS and protocol. REC approved 20/11/2017.
AM06 10/07/2018 New procedures: Poster and summary PIS for antennal trial information. Permission for trial staff to contact participants to further explain the trial prior to consent.
Process evaluation - £25 voucher to women taking part in interviews and other changes. REC approved 04/09/2018.
Current protocol V3.1 27/09/2018
The annual report dated 08/08/2018 informed the ethics committee that new sites were to be involved and that Salisbury had agreed to take part. ‘On the 26th of July 2018 Salisbury site confirmed that they would like to be a site and could use their own research network staff for local research nurse input required by the trial.’ Four other sites in the Wessex area have also agreed to take part—Poole, Isle of Wight, Dorchester, Portsmouth. The sponsor designated addition of these sites as minor amendments AM08 and AM09. The ethics committee has been informed regarding these new sites in the annual report dated 13/09/2019.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Funding
Funding for this trial has been provided by: Cancer Research UK, the Chief Scientist Office, Scottish Government; HSC Public Health Agency Northern Ireland; Chest Heart and Stroke Northern Ireland, The Lullaby Trust, Public Health Agency Northern Ireland and the Scottish Cot Death Trust.
Authors’ contributions
DT and LB conceived the study. DT, LB, DTorg, FK, MU, KB, PH, FH, and JM were applicants for the funding. All authors were involved in designing the study and drafting the protocol. KB and NM designed the health economic aspects of the study. JM, PH and FH designed the qualitative aspects of the study. All authors read and approved the final protocol.
Trial organisation
Trial Steering Committee
The overall scientific aspects of the project will be overseen by a Steering Committee. The Steering Committee includes an independent chairperson, the chief investigator, main statistician, trial management support, representatives from the major funding bodies—Cancer Research UK and the Chief Scientist Office, a patient representative and an international scientist with research interests in smoking cessation during pregnancy.
The responsibility of the Steering Committee is to ensure the scientific integrity and quality of the project. To achieve this, the specific responsibilities of the Steering Committee include: maintaining adherence to the study protocol; approving changes to study protocol if required; reviewing quality assurance indicators; monitoring study recruitment and the overall study timetable; advising, as required, on specific scientific items that may arise; compliance with legislation; adherence to research governance; reporting to funders; approving publication and dissemination strategies.
The Steering Committee will meet every 6 months.
Trial Management Group
The Trial Management Group comprises the principal investigators, trial manager and trial management support, trial administrator, senior managers from smoking cessation services, data manager, statisticians, health economists and qualitative researchers and supports the running of the trial by the Trial Management Working Group. Review meetings are being held quarterly.
Trial Management Working Group
The responsibilities of the Trial Management Working Group include: establishing and monitoring recruitment of participants; distributing and supplying appropriate documentation for the trial; data collection and management; data entry and cleaning; data analysis; organising and providing information for the Trial Steering Committee.
Data Monitoring Committee
An independent Data Monitoring Committee will not be established as adverse events related to the financial incentives intervention are not envisaged and are not being systematically collected.
ECHO Managed Services Ltd
ECHO and the trial team have developed the trial database which sits behind secure firewalls. The database is accessed by trial staff over a secure password protected internet portal. Data extracts are provided to York Trials Unit who manage the data output. This database serves as the data coordinating centre and is overseen by York Trials Unit in terms of data management.
ECHO also provide a call centre facility where trained staff conduct trial consent and perform initial data collection for both the primary and secondary outcome assessment of self-reported smoking status near the end of pregnancy and at six months after birth.
ECHO subcontract to Latcham Direct for provision of a secure document fulfillment service to the trial. Latcham dispatch trial PIS’ to potential participants, paper copies of verbally obtained consent, GP letters and financial voucher incentive payments by recorded delivery.
NHS Research and Development Greater Glasgow & Clyde
NHS R&D Glasgow is the sponsor for the trial. NHS R&D offices provide accommodation for the main trial team in Glasgow, Scotland.
York Trials Unit, University of York
York Trials Unit provide trial management support and data management including data monitoring, statistical analysis and reporting for the study.
Stop Smoking Services
SSS staff are discussing the trial with potential participants and passing details of those who give permission to the TCC. SSS are providing cost data for the economic analysis and a sample of SSS staff will be interviewed as part of the mixed methods process evaluation.
Publication policy
The primary results of the trial will be published with authorship in relation to specific participation in the study, with the name order to be presented by the principal investigators for consideration by the TSC. Suggested revisions in order of authors should meet with the approval of the principal investigators. Publications in specific areas of the study or on methodological aspects can be led by co-investigators in their area of expertise subject to approval by the TSC and the principal investigators. The requirements for authorship will follow recommended practice in journal guidelines.
Confidentiality
Encryption defined by NHS GG&C security management is in place to pass data for potential participants from SSS to the ECHO managed trial database and call centre. ECHO has a long history of managing government-related services and is able to demonstrate their commitment to data security and quality management through their ISO27001 and ISO9001 accreditations and recent GDPR legislation. Their ISO27001 accredited Information Security Management Systems demand that all of their systems and processes are maintained with confidentiality, integrity and availability of data at the core. In addition ECHO is ISO9001 accredited, the internationally recognized standard for Quality Management Systems. Data is passed via SFTP encrypted in transit. Regular external audits ensure adherence to ISO9001 and ISO27001 standards.
Data will be analysed by staff at York Trials Unit. During and after data analysis participants will be identified by their trial number to ensure confidentiality.
Site confidentiality will be maintained by anonymising sites. This will allow the process evaluation to provide important insights regarding barriers and facilitators to future implementation without causing difficulties at trial sites.
Acknowledgements
Authors’ information
Lesley Sinclair (Trial Manager): Has experience of data management and the management of clinical trials including an MSc in Clinical Trials from London School of Hygiene and Tropical Medicine. She runs the trial on a day to day basis. Lesley managed the CPIT II feasibility trial in Glasgow UK. She has led on development of the trial database in conjunction with ECHO. She assisted with protocol development for this trial and supported by Helen Tilbrook at York Trial Unit is managing all operational aspects of this trial. Lesley Sinclair and David Tappin wrote this paper with input from all the authors above.
Margaret McFadden (Lead Trial Research Nurse) was Lead Research Nurse on CPIT II. She is a very experienced research nurse who has undertaken many trial related roles as research nurse. Margaret is acting as research nurse for one site. She is also leading the research nurses for all sites and has trained the nurses in data and sample collection for the trial. She has been closely involved in development of the trial database.
Helen Tilbrook is Research Fellow at York Trials Unit, University of York. Helen has an MSc in Health Services Research and extensive experience of managing clinical trials. She is responsible for providing trial management support including data monitoring. She also supports Lesley Sinclair in her trial management role particularly regarding organisation of the Trial Steering Committee and the Trial Management Group. Helen has been closely involved in development of the trial protocol and submission to regulatory bodies as well as supporting development of the trial database. Helen is supervised by Judith Watson.
Alex Mitchell is the Trial Statistician and Trainee Statistician at, York Trials Unit, University of York. Alex is responsible for providing day-to-day statistical support for the study including statistical aspects of data management and monitoring. Alex runs the statistical aspects of the trial supported by Ada Keding.
Ada Keding provides supervision to Alex Mitchell at York Trials Unit and will plan and support Alex to undertake statistical analysis for the trial.
Judith Watson supervises Helen Tilbrook at York Trials Unit including the data management and data monitoring aspects of the trial.
Linda Bauld is Co-Principal Investigator for the trial and is the Bruce and John Usher Chair in Public Health, Usher Institute, University of Edinburgh. Linda has extensive experience of quantitative and particularly qualitative work related to smoking cessation. She supports the trial on a regular basis and will be involved in writing and dissemination of results.
Frank Kee is Professor of Public Health at Queens University Belfast and is co-applicant responsible for one of the trial sites. Frank administers grant funding for staff at this site. He has helped with protocol development and in many other aspects of support for the trial.
David Torgerson is a co-applicant and is Director of York Trial Unit, University of York. He supported the study team during grant application for the trial including direction on trial design (cluster or individual randomisation). He has overseen design of data collection in relation to statistical analysis. Through York Trials Unit he has supported the running of the trial so that it is safe for the funders regarding their investment.
Catherine Hewitt is co-applicant and Deputy Director of York Trials Unit. Catherine has assessed and designed the support required from York Trials Unit to reduce the risk to the funders regarding their investment. Catherine has supported the data management design for the trial.
Jennifer McKell is a Research Fellow in the Institute for Social Marketing at the University of Stirling. She is a qualitative researcher with extensive experience of carrying out research in relation to tobacco use and smoking in pregnancy, including the qualitative element of the CPIT II feasibility trial. She is the main researcher working on the trial’s embedded process evaluation for this trial.
Pat Hoddinott holds a Chair in Primary Care, in the Nursing Midwifery and Health Professionals Research Unit at the University of Stirling. She has clinical and trial expertise in maternal and child health, preventative medicine, behaviour change and financial incentives. She is advising on all aspects of the trial and oversees the process evaluation.
Fiona Harris is an Associate Professor in Medical Anthropology and Health Services Research, Nursing, Midwifery and Allied Health Professions Research Unit at the University of Stirling. She has extensive experience of conducting mixed methods process evaluations within trials and will support the conduct, analysis and reporting of the process evaluation component of the study.
Isabelle Uny is social scientist by training and a researcher at the Institute for Social Marketing (ISM), University of Stirling. Her expertise is in global policy making and policy implementation analysis. She also specialises in qualitative health research (methods/ analysis/ frameworks) and qualitative evidence synthesis (particularly meta-ethnography). Her work focuses primarily on non-communicable diseases (NCDs) and maternal health. She will support the data collection, analysis and reporting of the process evaluation.
Kathleen Boyd isSenior Lecturer in Health Economics at Glasgow University with extensive experience of decision modelling and designing and analysing trial based economic evaluations, particularly in SSS. She designed and will undertake the health economic evaluation.
Nicola McMeekin is a Research Assistant in health economics and has experience of designing and undertaking economic evaluations alongside clinical trials. She helped design the health economic evaluation and will carry out the analysis in conjunction with KB.
Shirley Mitchell leads the SSS at one of the sites and is Principal Investigator on this trial for that site. Shirley has supported research nurses and NHS staff in set-up and to enroll and collect data from trial participants.
Joanna Dover leads the SSS at one of the sites and is Principal Investigator on this trial for that site. Joanna has supported research nurses and NHS staff in set-up and to enroll and collect data from trial participants.
Michael Ussher is Professor of Behavioural Medicine at the St George’s, University of London and at the University of Stirling. Michael has extensive experience of trials of smoking cessation in pregnancy and advises on all aspects of the study and especially on issues related to health psychology.
Amanda Pattie is Assistant Portfolio Manager for one of the study areas. Amanda has supported the trial to allow five sites in one area to engage with the trial including providing research nurse network support and oversight of recruitment targets.
David Tappin is Co-Principal Investigator and Senior Research Fellow at Glasgow University based at the Scottish Cot Death Trust, in Glasgow. David has experience of the management of clinical trials including an MSc in Clinical Trials from London School of Hygiene and Tropical Medicine. He wrote all the grant applications for this trial and writes all the funding reports. He co-ordinates and manages the overall running of the trial and will be closely involved in data analysis and paper writing and dissemination of results.