Bibliographical noteFunding Information:
Funding: The work was funded by the National Institute for Health Research (Department of Health and Social Care 73514) and Medical Research Council (MRC). Additional time on the study was funded by grants from the MRC for KS (MC_UU_12017/11, MC_UU_00022/3), LMa, SAS, and LMo (MC_UU_12017/14, MC_UU_00022/1); PC (MC_UU_12017/15, MC_UU_00022/2); and MW (MC_UU_12015/6 and MC_UU_00006/7). Additional time on the study was also funded by grants from the Chief Scientist Office of the Scottish Government Health Directorates for KS (SPHSU11 and SPHSU18); LMa, SAS, and LMo (SPHSU14 and SPHSU16); and PC (SPHSU13 and SPHSU15). KS and SAS were also supported by an MRC Strategic Award (MC_ PC_13027). JMB received funding from the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol and by the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures - MR/K025643/1). DF is funded in part by the NIHR Manchester Biomedical Research Centre (IS-BRC-1215-20007) and NIHR Applied Research Collaboration - Greater Manchester (NIHR200174). MP is funded in part as director of the NIHR’s Public Health Policy Research Unit. This project was overseen by a scientific advisory group that comprised representatives of NIHR research programmes, of the MRC/NIHR Methodology Research Programme Panel, of key MRC population health research investments, and authors of the 2006 guidance. A prospectively agreed protocol, outlining the workplan, was agreed with MRC and NIHR, and signed off by the scientific advisory group. The framework was reviewed and approved by the MRC/NIHR Methodology Research Programme Advisory Group and MRC Population Health Sciences Group and completed NIHR HTA Monograph editorial and peer review processes. Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: support from the NIHR, MRC, and the funders listed above for the submitted work; KS has project grant funding from the Scottish Government Chief Scientist Office; SAS is a former member of the NIHR Health Technology Assessment Clinical Evaluation and Trials Programme Panel (November 2016 - November 2020) and member of the Chief Scientist Office Health HIPS Committee (since 2018) and NIHR Policy Research Programme (since November 2019), and has project grant funding from the Economic and Social Research Council, MRC, and NIHR; LMo is a former member of the MRC-NIHR Methodology Research Programme Panel (2015-19) and MRC Population Health Sciences Group (2015-20); JB is a member of the NIHR Public Health Research Funding Committee (since May 2019), and a core member (since 2016) and vice chairperson (since 2018) of a public health advisory committee of the National Institute for Health and Care Excellence; JMB is a former member of the NIHR Clinical Trials Unit Standing Advisory Committee (2015-19); DPF is a former member of the NIHR Public Health Research programme research funding board (2015-2019), the MRC-NIHR Methodology Research Programme panel member (2014-2018), and is a panel member of the Research Excellence Framework 2021, subpanel 2 (public health, health services, and primary care; November 2020 - February 2022), and has grant funding from the European Commission, NIHR, MRC, Natural Environment Research Council, Prevent Breast Cancer, Breast Cancer Now, Greater Sport, Manchester University NHS Foundation Trust, Christie Hospital NHS Trust, and BXS GP; EM is a member of the NIHR Public Health Research funding board; MP has grant funding from the MRC, UK Prevention Research Partnership, and NIHR; JR-M is programme director and chairperson of the NIHR’s Health Services Delivery Research Programme (since 2014) and member of the NIHR Strategy Board (since 2014); MW received a salary as director of the NIHR PHR Programme (2014-20), has grant funding from NIHR, and is a former member of the MRC’s Population Health Sciences Strategic Committee (July 2014 to June 2020). There are no other relationships or activities that could appear to have influenced the submitted work.