Core set of unfavorable events of shoulder arthroplasty: an international Delphi consensus process

Abstract

Background: Shoulder arthroplasty (SA) complications require standardization of definitions and are not limited to events leading to revision operations. We aimed to define an international consensus core set of clinically relevant unfavorable events of SA to be documented in clinical routine practice and studies. Methods: A Delphi exercise was implemented with an international panel of experienced shoulder surgeons selected by nomination through professional societies. On the basis of a systematic review of terms and definitions and previous experience in establishing an arthroscopic rotator cuff repair core set, an organized list of SA events was developed and reviewed by panel members. After each survey, all comments and suggestions were considered to revise the proposed core set including local event groups, along with definitions, specifications, and timing of occurrence. Consensus was reached with at least twothirds agreement. Results: Two online surveys were required to reach consensus within a panel involving 96 surgeons. Between 88% and 100% agreement was achieved separately for local event groups including 3 intraoperative (device, osteochondral, and soft tissue) and 9 postoperative event groups. Experts agreed on a documentation period that ranged from 3 to 24 months after SA for 4 event groups (peripheral neurologic, vascular, surgical-site infection, and superficial soft tissue) and that was lifelong until implant revision for other groups (device, osteochondral, shoulder instability, pain, late hematogenous infection, and deep soft tissue). Conclusion:A structured core set of local unfavorable events of SA was developed by international consensus to support the standardization of SA safety reporting. Clinical application and scientific evaluation are needed.

Complications after surgical management of proximal humeral fractures: a systematic review of event terms and definitions

“…In order to arrange the event terms, we used a classification system that was recently developed by consensus in shoulder surgery with a high level of agreement [11,17]. All event terms could be categorized, which provided a good overview of the various events mentioned in the clinical PHF literature.…”

“…All event terms could be categorized, which provided a good overview of the various events mentioned in the clinical PHF literature. The process of classifying the terms into local and non-local events was straightforward, especially when local events such as nonunion, avascular Event groups were considered from a previous international consensus process for arthroscopic rotator cuff repair [10] and shoulder arthroplasty [11] necrosis, loss of reduction or implant failure were defined based on radiographic assessments. Further differentiation of local events into event groups was sometimes challenging, and our suggestion should serve as a basis to develop an international consensus.…”

“…Data were managed in REDCap [16] (Version 6.16.5,© 2018 Vanderbilt University, USA) and exported into Stata Intercooled (Version 14, Stata Corp SA, Texas, USA) for descriptive analyses and event listing. For this report, we focused on all events that were extracted and defined as exclusively related to operative management; the event terms were listed and organized according to preassigned event groups adapted from existing consensus on rotator cuff repair [10] and shoulder arthroplasty [11]. In short, events were distinguished between those considered as local / regional to the injured shoulder and non-local (i.e.…”

“…In orthopedic surgery, approaches for the standardization of complication definitions have been proposed for several indications including distal radius fractures [7], knee arthroplasty [8], spine surgery [9], arthroscopic rotator cuff repair [10] and shoulder arthroplasty [11,12]. While complication reporting is essential to evaluate the quality of health care [13], current guidelines provide neither support for reporting complication events nor consensus definitions for these events [3].…”

The Schulthess local Shoulder Arthroplasty Registry (SAR): cohort profile

“…AEs and complications are assessed according to the published international core set of unfavourable events of shoulder arthroplasty. 26 Timeframe of occurrence (intraoperative or postoperative), site (local or systemic), whether the event is a Serious AE, the affected tissues or physiological systems, possible relation to implant and the AE treatment and AE outcome are all documented. 27 Revision operations are documented in detail 28 including reasons (infection, glenoid periprosthetic fracture, humeral periprosthetic fracture, dislocation/instability, glenoid component loosening, humeral component loosening, rotator-cuff problems, prosthesis failure, other reasons).…”