Abstract
BackgroundThe number of hip, knee and shoulder arthroplasties continues to rise worldwide. The Organization for Economic Cooperation and Development has launched an initiative (called PaRIS Initiative) for the systematic collection of Patient Reported Outcome Measures (PROMs) in patients undergoing elective hip and knee arthroplasty. The Rizzoli Orthopedic Institute (IOR) was selected as a pilot center for the launch of the Initiative in Italy given that IOR hosts the Registry of Orthopedic Prosthetic Implants (RIPO), a region-wide registry which collects joint implant data from all the hospitals in the Emilia-Romagna Region. In this specific geographic area information related to PROMs after joint replacement is unknown. This paper describes the protocol of a study (PaRIS-IOR) that aims to implement the collection of a set of PROMs within an existing implant registry in Italy. The study will also investigate the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention.MethodsThe PaRIS-IOR study is a prospective, single site, cohort study that consists of the administration of PROMs questionnaires to patients on the list for elective arthroplasty. The questionnaires will be administered to the study population within 30 days before surgery, and then at 6 and 12 months following surgery. The study population will consist of consecutive adult patients undergoing either hip, knee or shoulder arthroplasty. The collected data will be linked with those routinely collected by the RIPO in order to assess the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention.DiscussionThe PaRIS-IOR study could have important implications in targeting the factors influencing functional outcomes and quality of life reported by patients after hip, knee and shoulder arthroplasty, and will also represent the first systematic collection of PROMs related to arthroplasty in Italy.Trial registrationProtocol version (1.0) and trial registration data are available on the platform www.clinicaltrial.gov with the identifier NCT03790267, first posted on December 31, 2018.
Highlights
The number of hip, knee and shoulder arthroplasties continues to rise worldwide
Patient centeredness can be improved through the collection and analysis of functional outcomes and quality of life reported by patients, the so-called Patient-Reported Outcome Measures (PROMs)
This paper described the protocol of the PaRIS-IOR study
Summary
Design and setting of the study The PaRIS-IOR study is a prospective, single site, cohort study that will be conducted at the IOR, a third-level mono-specialty hospital in Bologna, Italy. According to the surgical procedure, patients will be administered with a joint-specific questionnaire: the Hip disability and Osteoarthritis Outcome Score – Physical function Short-form (HOOS-PS) for patients undergoing hip replacement [22]; the Knee injury and Osteoarthritis Outcome Score – Physical function Short-form (KOOSPS) for patients undergoing knee replacement [23]; the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants This last questionnaire will be administered in a modified version that does not include the assessments performed by the orthopedic surgeon [24]. Sample size The study will include all patients undergoing elective hip, knee and shoulder arthroplasty in the 6 Operative Units, who will meet the inclusion criteria. These costs will be incurred within the RIPO and IOR funds, respectively
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