Leading multi-disciplinary teams towards consensus
The team at HQIP is highly skilled at convening groups of multi-professional experts across fields and disciplines to work through challenges and arrive at consensus decisions that lead to improved patient care.
In 2020, a landmark review concluded that hundreds of women suffered avoidable, life-changing harm as a result of the use of unsafe implants and devices. The Cumberlege report, First Do No Harm, called for widespread changes to the regulation of medical devices. We had been invited to give evidence to the review and both NCAPOP and the National Joint Registry (NJR) presented.
We led on two influential pieces of work in 2019 that were cited in the review report:
- We were commissioned by the Department for Health and Social Care (DHSC) to facilitate discussions amongst experts on how to develop a single data solution that could capture data and eventually report outcomes on surgical mesh implant procedures. Urogynaecological surgical mesh is used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Our feasibility report made 10 recommendations for the establishment of an interim database pending the creation of a full clinical national registry. These focused on data collection and sharing, data reporting and governance. The report recommended that further patient engagement would be required to ensure the information collected takes important patient outcomes into consideration.
- In June 2019, we held a think-tank meeting of industry experts to explore the need for a national devices registry. The subsequent report made 33 recommendations in support of the development and implementation of a national implantable medical devices registry, alongside 10 guiding principles which included the need for patient involvement in its development.
This work is indicative of our experience in convening groups of multi-professional experts across fields and disciplines to work through challenges and arrive at consensus decisions that lead to improved patient care.
The feasibility study in greater detail
We were tasked with exploring the current sources of mesh, SUI or POP data maintained by three professional societies- the British Association of Urological Surgeons (BAUS), the British Society of Urogynaecology (BSUG) and the Pelvic Floor Society (TPFS) – and whether these current data collections could address the recommendations from the Baroness Cumberlege review as an interim measure before a full clinical national registry could be established.
We delivered the project via a series of technical and stakeholder workshops involving experts from the professional societies and across the healthcare system as well as patients and charities. The aims of the work were to:
- explore the current sources of available data for SUI and POP procedures involving surgical mesh
- discuss the recommendations of the Independent Medicine and Medical Devices Safety (IMMDS)
- review and agree the requirements of an interim database(s) to meet those recommendations
- discuss the data and reporting requirements of an interim database(s)
- agree the scope of the interim database(s) and explore a minimum mesh dataset for collection
- outline the practicalities and explore the possible solutions to develop a feasible outcome data collection solution
- consider the longer term requirements of a SUI and POP registry
- listen to views about patient outcomes and agree what is important for women
- undertake an option appraisal of the potential models available and develop recommendations of modifications required to existing data sources to achieve an interim database solution to meet requirements
What the team found
We published a feasibility report in July 2019 (available to download here).
We made 10 recommendations for the establishment of an interim database, including:
- establishment of an oversight governance group
- scope (geographical and clinical), inclusion criteria and rationalised minimum dataset
- participation requirements
- data flows and linkage to other national datasets
- information governance requirements
Other recommendations focus on aims and objectives, data quality, patient outcome measures and outputs.
We also proposed that further patient engagement is required during the establishment of an interim database to ensure the information collected is appropriate and takes important patient outcomes into consideration; this should include wide representation from patient groups.
Impact of the work
We are proud to have lent our expertise to the Cumberlege review and hope our contribution will help to achieve safer care for patients. We continue to make our expertise available to help implement the recommendations and actions. DHSC is expected to publish next steps in due course.
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