The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce reduced this to 56 items, which were considered by 138 international stakeholders and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed by the consensus meeting participants (n=29) and reviewed by external stakeholders during a consultation period. Eleven extensions and five elaborations to the SPIRIT 2013 checklist are recommended for inclusion in clinical trial protocols where PROs are a primary or key secondary outcome. The final guidance is currently under peer review for publication. A link to the final guidance will be provided once published.
Systematic Review and Reduction of Items
- A systematic review of existing PRO-specific guidance for trial and health related research protocol writers identified 162 unique PRO-specific recommendations (Calvert et al., 2014).
- An International Society for Quality of Life Research (ISOQOL) expert taskforce was convened to review these 162 items. Redundant items were removed and where possible similar items were merged, as a result the number of recommendations was reduced to 56 (Kyte et al., 2014).
Stakeholder survey and Delphi Panel Exercise
These 56 items formed the basis of Stakeholder and Delphi Panel surveys, an invitation to complete the survey was sent to members of the Stakeholder groups and the Delphi panel members:
- Stakeholders and Delphi panel members included: Clinical trialists, Academics, Researchers, Clinicians, Health Economists, Methodologists, Trial personnel, Patient user representatives and advocates, PRO experts, Psychometricians, Funders, Industry Representatives, Journal Editors, Policy Makers, Ethicists and Researchers.
- The Stakeholder and Delphi panel surveys allowed us to gain a broad range of opinions on the perceived suitability of each of the remaining 56 items for inclusion in the final SPIRIT-PRO extension guidance and checklist.
The Delphi Exercise
In total 99 international experts were included in the Delphi panel, they reviewed the 56 items and completed their first survey. They then reviewed the stakeholder survey results completed by 138 stakeholders. A report was then sent to the Delphi panellists including the results from the stakeholder survey, the first Delphi exercise alongside their own results. They were then given the opportunity to amend their own survey if they felt it was necessary. The aim of the Delphi exercise was to decide which of the 56 items should be taken forward to the international consensus meeting.
The Consensus Meeting
The international consensus meeting took place on the 11th and 12th May at the University of Birmingham. Following the Delphi exercise, 29 members of the Delphi panel plus the SPIRIT PRO executive were present at the consensus meeting where panellists were given copies of the final results of the Delphi exercise and options on which items should be considered for inclusion. These were discussed and participants voted anonymously on which of the final items should be included or not into the final SPIRIT-PRO guidelines.
Results of the Consensus Meeting
11 SPIRIT PRO item Extensions and 5 Elaborations were identified for reporting in randomised control trials where PROs are a primary or secondary outcome. These are currently being written up for publication and we will include links to the publications once they have been accepted.
If you would like to help disseminate the research please contact us: CPROR@contacts.bham.ac.uk