NHS Digital Data Release Register - reformatted
Beyond Compliance projects
1 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
Opt outs honoured: N (Reasonable Expectation)
Legal basis: Health and Social Care Act 2012 – s261(7)
Sensitive: Non Sensitive
When:2018.06 — 2018.09.
Access method: Ongoing
- Patient Reported Outcome Measures (Linkable to HES)
The purpose of collecting the data is service evaluation. Northgate Public Services (NPS) are the data controller in this application. They specialise in integration of IT and network technologies that can be used to benefit people and businesses worldwide, including health and social care. NPS have designed the data collection platform and the reports that will be disseminated. It is NPS that collate, aggregate, analyse and disseminate data needed during the assessment process. Access to the platform is offered by Northgate to the implant manufacturers who have products registered with the Beyond Compliance Service on an annual subscription-basis.
Beyond Compliance was introduced in 2012, by the Association of British Healthcare Industries (ABHI), the British Orthopaedic Association (BOA) and the Medicines & Healthcare products Regulatory Agency (MHRA), as a service available to manufacturers of implants used for joint replacements, such as total hip or total knee replacements, which supports their safe introduction. NPS collects information about patients who receive these implants and then tracks their post-surgical progress and provide reports to Beyond Compliance that illustrate whether each new design or design modification is performing as required. Northgate Public Services (NPS) is a commercial entity, providing a technology platform for the provision of the Beyond Compliance service. The Beyond Compliance service is a service available to implant manufacturers (themselves commercial entities) wishing to enhance the safety and vigilance of the entry of a new or modified CE (European Conformity) marked product into the UK market. CE Marking is a declaration that a product complies with the essential requirements of the relevant legislation so that it may be marketed in Europe. A modified CE product is one which is an existing product that has been substantially modified so as to be considered "new". The service provides analysis of on-market implant performance to implanting surgeons, independent expert advisors, and the implant manufacturer who collectively monitor the implant.
Beyond Compliance (BC) is governed by a Steering Committee, chaired by the National Clinical Director for Musculoskeletal Services, NHS England. The BC Steering Committtee has responsibility for ensuring buy-in and involvement of representatives of all stakeholder groups. Membership of the BC Steering Committee is made up of an independent group of orthopaedic experts, including representatives from: Department of Health, Patient representative, Lay representative, Notified Bodies, Association of British Healthcare Industries, British Hip Society, National Joint Registry, British Orthopaedic Association, NHS Supply Chain, British Association for Surgery of the Knee, Medicines and Healthcare products Regulatory Agency (MHRA) who are the Secretariat for the BC Steering Committee. The Steering Committee has responsibility for ensuring representatives of all the stakeholders are involved.
Implant risk assessment and on-going safety monitoring is undertaken by the Beyond Compliance Advisory Group. http://www.beyondcompliance.org.uk/About/Committees/TheAdvisoryGroup.aspx.
The role of the Advisory Group is:
• To offer advice to industry on a voluntary basis.
• To act as an independent data monitoring committee for clinical follow-up data on new or modified products within the Beyond Compliance Service.
The Beyond Compliance Advisory Group reports to the Steering Committee.
Surgeons who decide to use an implant that is registered with Beyond Compliance are authorised by the manufacturer for the specific implant. To be accepted as an implant within Beyond Compliance, the manufacturer and the Beyond Compliance Advisory Group agree and sign a Risk Assessment which includes a commitment by the manufacturer that: "The manufacturer understands that surgeons who use a device registered with Beyond Compliance will have to obtain specific consent from each patient for the use of personal data held within Beyond Compliance. This is in addition to the consent for operation and consent for the National Joint Registry."
To support and enable the monitoring of Beyond Compliance implants, NPS has developed a Beyond Compliance platform for the secure collation, aggregation, analysis and dissemination of data needed during the assessment process. Access to this platform is offered by NPS to implant manufacturers with products in the Beyond Compliance Service on an annual subscription-basis, to support their monitoring of implant performance.
The objective of processing is for Northgate Public Services to provide the Beyond Compliance Advisory Committee and the implant manufacturer with the mechanism to assess the patient reported outcomes of patients receiving an implant (within the Beyond Compliance service) in comparison to the national average procedure-specific scores to monitor implant performance, and to flag any areas where patient outcomes report to be statistically significantly worse than the expected.
All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).
PROMS terms and Conditions will be adhered to.
The close monitoring of new or modified implants has significant benefits to patients and to the health and social care system. It is the objective of Beyond Compliance to support the responsible and safe introduction of new or modified orthopaedic implants into the UK market, and to provide an additional level of scrutiny to these products during the early stages of product introduction. Beyond Compliance aims to identify implant-related failures as early as possible, and to work collaboratively with the implant supplier to scrutinise implant performance data, taking swift action to investigate and remedy issues highlighted through the data collected. Such remedies may ultimately result in implants being withdrawn from the market prior to wide-scale adoption.
In summary, the benefits gained from Beyond Compliance are: -
• Enhanced and objective monitoring of orthopaedic implant performance that provides greater safety to patients
and assurance to health professionals in order to:
o detect potential issues sooner, to implement solutions earlier and
o expose fewer patients to any unnecessary risk,
• Supporting innovation of new implant technology coupled to increased patient protection, guided by expert
• Independent assessment of the relative risk of new implants and the recommended rate at which they should be introduced to the NHS through ongoing service evaluation,
• Supporting and encouraging peer governance over orthopaedic advances
• Building confidence in, and adoption of, improved orthopaedic implants that benefit patients, healthcare providers and the national economy.
Northgate Public Services will provide Implant Summary Reports on a monthly basis about specific Beyond Compliance Implants. The reports will detail implant performance and outcome and inform authorised stakeholders of this. A certain section of the reports will contain data that is derived from PROMs, however it will only take the form of aggregated data with all small numbers suppressed in line with the HES Analysis Guide. The first report containing the PROMs data is expected for release in April 2018.
The Implant Summary Reports are made accessible to
• Designated independent assessors who are responsible, as members of the Beyond Compliance Advisory Group, for leading the safety monitoring process for each implants
• Surgeons who use the implant and are registered with Beyond Compliance by the implant manufacturer
• Nominated personnel within each implant manufacturer.
The section containing the PROMs data will report on the following information:
a) Overall PROMs
- Mean pre-operative and six month Oxford Hip/Knee, EQ-5D, and EQ-VAS scores for the Beyond Compliance implant and
comparator group, together with mean Health Gain (six month minus pre-operative score), and the percentage of patients with an improved vs. unchanged/worsened score are tabulated.
b) Success and Satisfaction
- The proportion of patients giving each of the five possible responses is plotted for both the Beyond Compliance implant and for all other implants in that product category is plotted for the following questions:
o Success: "Overall, how are your problems now, compared to before your operation?"
o Satisfaction: "How would you describe the results of your operation?"
The Implant Summary report is distributed to those authorised users listed above via the Beyond Compliance system.
These authorised users may only download the reports when they are logged in to their secure account on the Beyond Compliance platform.
The implant summary reports are the basis for the ongoing assessment of the implant’s safety performance
Data that is disseminated under this agreement will only be used for the purposes stated. The data will only be linked to data as stated in this agreement.
Any proposed change in the use of the data would require a new application.
Where a patient has provided consent to share their PROMs data with NPS for the purpose of delivering the Beyond Compliance implant monitoring service, NPS will, request associated PROMs data for the patient from NHS Digital.
To identify patients who have given consent to Beyond Compliance, for each consented patient, NPS will provide NHS Digital with the following data:
• BC Index Number (Study ID)
• NHS number
• Date of birth
• Post code
Where NHS Digital finds a matching PROMs record for this patient, they are requested to provide back to NPS the following data:
• BC Index Number (Study ID)
• All orthopaedic (Hip & Knee) PROMs data
• All EQ-5D and EQ-VAS scores (contained within PROMs)
• All Oxford Hip or Knee scores (contained within PROMs)
Upon receipt of this data from NHS Digital, NPS will link the PROMs data with the corresponding patient record and store this data within the Beyond Compliance system. The linking is completed at the patient level in order to ensure that the correct PROMs scores are analysed and reported upon. For example, the pre-operative and post-operative reports relate to the same patient and implant. The analysis will then summarise the PROMs data and outputs will be aggregated with small numbers suppressed inline with the HES analysis guide. It will not be possible to identify any individual patients from the outputs made using the data provided by NHS Digital.
Beyond Compliance currently collects data from England, Wales and Northern Ireland - however for the purposes of linkage it will be ensured that only Beyond Compliance identifiers for patients with postcodes in England will be sent to NHS Digital. No further PROMs data from outside England is being requested and no separate linkages will be taking place.
All processing of the data will take place at Northgate Public Services. All those processing the data are substantive employees of Northgate Public Services.
Northgate Public Services will process the PROMs data provided by NHS Digital to report comparisons, for each available PROMs measure, between the specific implant and the national average procedure, specific scores to show:
- Mean scores reported,
- Health Gain achieved,
- Percentage patients who are improved, unchanged or worsened
- Success rates,
- Satisfaction rates.
Beyond Compliance is only available to authorised users. Each person has an individual account that is set up by Northgate Public Services that can be accessed only by a secure password that is confidential to themselves.
Sunguard Availability Services (SAS) are the storage location for the data. SAS provide the data centre facility, namely the location, building/data centre fabric and selected "hands on" services. The NPS data centre is located within the SAS facilities. NPS provides and wholly manages its infrastructure to deliver services to NPS clients. SAS have no access to NPS systems for management purposes. SAS is ISO-IEC 27001:2013 certified. SAS is not a data processor, it just provides NPS with racks, power and cooling and all of the site security. SAS don't have access to any data. The tapes that SAS handle on behalf of NPS cannot be read by SAS so cannot be construed as processing any data.
The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed - this will apply to all PROMs data provided by NHS Digital.