1.1 Structure

1.1.1 Design

This is a consecutive observational cohort, clinical registry collating clinical data and patient outcomes for patient presenting to a private clinic with upper limb pathology. This is a single centre study, with three investigators consulting from multiple sites. The clinical outcomes of patients that require revision surgery will also be collected. Primary and post revision surgery follow up will reflect standard of care procedures within the investigators' practice. Due to the standard of care cohort design, all patient data will be analysed together. Registry data will be structured to contribute to future case-control analyses.

1.1.2 Participating Surgeons

Mr Kevin Eng

Mr Richard Page

Mr Graeme Brown

1.1.3 Governance and steering

The participating surgeons will meet quarterly (every 3 months) to discuss the governance and performance of the registry with a representative from:

• Clinic staff
  • Practice managers
  • Clinical nurses
• IT (Adam Galle)
• Registry Custodian (EBM Analytics)
• Other external providers as required.
  • Sally Beattie
  • Stephen Gill

Each quarterly meeting will discuss:

• Alignment of the registry with Principles of clinical quality registries set out by the Australian Commission on Safety and Quality in Health Care
• Registry data security has not been breached and arrangements to mitigate risks to the data held in the registry are implemented
• The infrastructure and technical standards of the registry remain in line with national guidelines, and aligned with the mission of the research program
• Performance review of the registry with respect to patient capture rate (%) validated against the clinical flow documented in the practice management system and as set out in the registry protocols.

1.1.4 Custodianship and access

Custodianship of the registry will be provided in line with the Operating Principles of Clinical Quality Registries as defined by the Australian Commission for Safety and Quality of Health Care (Operating-Principles-for-Australian-C...). EBMA will provide this functionality in coordination with the participating surgeon in the first instance. EBMA will be the point of contact for internal and external access to the database as per the Registry Data Access Policy below.

1. Requester to review the Data Access Policy and complete the Request for Registry Data form,
   1. Select “VIC0519” from the drop-down list under the question “For which registry is data being requested?”
2. Request to be confirmed and approved by key stakeholders via written communication
3. View or edit access to be provided to applicant depending on the type of request.

1.1.5 Registry sites and data sources

Participants will be sourced from the participating clinic and hospital locations of the registry (Figure 1.1.5) for treatment of upper limb orthopaedic disorders. Clinical information will be collected from patients by electronic and paper forms . Electronic notes will also be recorded during the surgeon consultation period and transferred by the practice manager from primary referrer notes, imaging reports, pathology reports and surgeon-generated information from the clinic and hospital. Medical imaging will be collected from secure links to picture archiving and communication systems (PACS) hosted by private radiology practices nearby to the clinic and within the hospitals attended by the participating surgeon. Biomechanical and functional data will be collected by direct data entry into the database interface by the participating surgeon from measurements performed during clinical consultation and intra-operatively.

1.1.6 Multi-site research logistics plan

Data entry will be conducted electronically and coordinated by the database software (Socrates v3.5, Ortholink Pty Ltd, Aus). Each user will have access to a laptop to: i) enter/import clinical details into the database, or ii) provide to patients for responses to patient-reported outcome scores. Each mobile device will communicate to the database via a virtual private network and a Terminal Server. Where patient-reported outcomes are returned in paper form, they will be collated and returned by the clinic staff for entering into the database. External databases existing at the private and public hospitals to track specific patient groups will not be fully integrated with the registry at Geelong Orthopaedics. Instead data will be requested from these on an as-needed basis matching patients by name, DoB and treatment. Radiology and physiotherapy practices will similarly be contacted for requests for patient information as needed and allowed by current ethics. Standard operating procedures for data entry will be available to all sites via a web browser interface.