Characterising surgery for wrist arthritis and its outcomes

Study type
Protocol
Date of Approval
Study reference ID
21_000590
Lay Summary

This study aims to identify and describe the nature of wrist arthritis and treatments undertaken for patients with this condition. It aims to identify the rates of wrist arthritis due to different potential causes (such as inflammatory arthritis, or after injury), and to look at the variety of treatments currently used. If possible, the study also aims to identify complications that can occur after treatments for wrist arthritis, particularly if people undergo surgery. The proposed study uses primary care (GP) data as part of a global collaboration using existing healthcare data. The study aims to use global collaboration in order to compare the patients presenting with wrist arthritis in different countries, and to better understand what treatments are used for different patients presenting with the same condition.

Technical Summary

Objectives:
The primary objective of this study is to describe the baseline demographic and clinical characteristics of individuals presenting with wrist arthritis, in addition to the occurrence of surgical treatment for this condition and the serious adverse outcomes following surgery. This will be explored overall and if sufficiently sampling exists, to also examine treatments and outcomes by sex, age and surgical subtype.

Design:
Cohort study Cohort study using non-identifiable CPRD data mapped to the OHDSI Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) to evaluate the characteristics of patients with wrist arthritis and the treatments used.
3 cohorts will be generated, namely:
1. All patients with wrist arthritis
2. Patients with wrist arthritis who have undergone surgical management
3. Subgroups based upon of type of surgery undertaken (proximal row carpectomy, arthrodesis, denervation, arthroplasty, arthroscopy)
3. Subgroups based upon aetiology of wrist arthritis (osteoarthritis secondary to trauma, rheumatoid arthritis, crystalline deposition, idiopathic)

Participants
All adult patients with an incident diagnosis of wrist arthritis will be included.

Variables and Measurements
Treatment will be determined from the first recorded procedure; outcomes defined as the first incident event for each individual outcome (based upon those generated in protocol, using the OHDSI CDM Atlas tool). This study focusses upon characterising the populations rather than proceeding to further risk factor association studies at this stage.

Expected Results
Incidence of patients presenting with wrist arthritis; incidence of treatments undertaken for wrist arthritis; incidence of serious adverse outcomes following intervention for wrist arthritis.

Health Outcomes to be Measured

Medical outcomes following surgery (within 30 or 90 days- where available in CPRD; full list given here for use in federated network analysis):
Acute kidney injury; Acute myocardial infarction events;Bleeding; Bradycardia or heart block; Cardiac arrhythmia;Cardiovascular-related mortality; Death; Renal/Dialysis; Heart failure; Hemorrhagic stroke (intracerebral bleeding); Ischemic stroke events;Mechanical ventilation;chest pain or angina; Pneumonia; Sepsis; Venous thromboembolic (pulmonary embolism and deep vein thrombosis) events

Surgical outcomes (within 30, 90 days - where available in CPRD; full list given here for use in federated network analysis):
Wound infection requiring antibiotics; Wound infection requiring surgical management; Deep surgical site infection including septic arthritis; Neurovascular injury; Tendon injury

Surgical outcomes (within 30, 90 days, 365 days and during all follow up - where available in CPRD; full list given here for use in federated network analysis): Fracture; Prominent metalwork requiring removal; Reoperation; Non-union

Outcome cohorts will be identified using OMOP CDM codes for diagnoses, based upon some codes that have been previously validated in datasets included in OHDSI, but also using the ATLAS diagnostics tool to investigate orphan codes.Cohort entry and exit is defined as per the time at risk window: entry is at the index date, exit at date of death or migration, date of outcome, loss to follow up or where possible, 1825 and 3650 days after the index date.

Collaborators

Jennifer Lane - Chief Investigator - University of Oxford
Jennifer Lane - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford