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

Abstract

Introduction Registries 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 analysis PRULO (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 dissemination Ethical approval was obtained by the Barwon Health Research Ethics Committee (approval number 19/70).

Competing Interest Statement

The investigators have entered into a funding agreement with DePuy Synthes Mitek Sports Medicine to support the ongoing collection of data, and management of data by EBM Analytics. Kevin Eng, Richard Page, and Graeme Brown also report institutional education support and speaker fees from DePuy Synthes. Kevin Eng also reports consultancy fees from Medacta Medical.

Funding Statement

The investigators have entered into a funding agreement with DePuy Synthes Mitek Sports Medicine to support the ongoing collection of data, and management of data by EBMA. The contract equates to approximately 40-50% of the estimated running costs over the 36 months from the start date. Geelong Orthopaedics will cover the remainder via the surgeon's private funds and other future funding sources as appropriate. Johnson & Johnson will not be providing staff, materials or facilities under this agreement, and will not have access to the registry database or any identifying information from it. Industry sponsors had no role in the design, collection, management, analysis or interpretation of the data or writing of the report. A copy of the manuscript was provided to Johnson & Johnson Medical Pty Ltd prior to submission for peer-review, but the sponsor had no role in the decision to submit.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Barwon Health Human Research Ethics Committee (approval number 19/70)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript. Registry data may be available from the investigators on request, subject to institutional approvals.

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