Patient Registry of Upper Limb Outcomes (PRULO) A Protocol for an orthopaedic clinical quality registry to monitor treatment outcomes

Abstract

ABSTRACTIntroductionRegistries have been widely utilised to track clinical results in observational cohorts for quality improvement. They have been very successful in orthopaedics, particularly in the context of arthroplasties where they have guided and optimised implant choice, patient safety and identified underperforming implants. However, equivalent systems to monitor outcomes in soft-tissue disorders are lacking. This manuscript describes the protocols around design, ethics and implementation of a regional registry focusing on upper limb soft tissue orthopaedic conditions.Methods and analysisPRULO (Patient Registry of Upper Limb pathology Outcomes) is a multi-cohort, prospective observational, clinical quality registry collating clinical data and patient-reported outcomes for patients presenting to a specialist orthopaedic clinic with upper limb pathology. PRULO is currently a single-centre study involving three clinician investigators, which aims to determine what patient characteristics, pathology factors and treatment strategies are associated with treatment success within 2 years of surgical or non-surgical treatment of targeted pathology. PRULO captures patient reported outcomes (VAS, EQ5D-5L, QuickDASH, MODEMS-Expectations and Satisfaction, WORC, WOSI), clinical and radiological data. Data points are recorded at initial practice registration, after initial consultation, intraoperatively, as well as 3, 6, 12 and 24 months. Inclusion criteria are patients aged 16 and above offered treatment by speciality trained surgeons, for upper limb orthopaedic pathology. Patient subgroups (cohorts) will include shoulder conditions: conditions affecting predominantly the rotator cuff (tear, tendinopathy), conditions associated with glenohumeral instability, as well as all other conditions presenting in the shoulder elbow, hand and wrist, according to the surgeon-generated diagnosis.Ethics and disseminationEthical approval was obtained by the Barwon Health Research Ethics Committee (approval number 19/70).Trial RegistrationThe project was added as a trial to the Australia and New Zealand Clinical Trials Registry (ACTRN12619000770167) 23-May-2019.