Towards standardised definitions of shoulder arthroplasty complications: a systematic review of terms and definitions

Jacxsens, Matthijs; Walz, Theodor; Durchholz, Holger; Müller, A; Flury, Manuel; Schwyzer, Hans‐Kaspar; Audigé, Laurent

doi:10.1007/s00402-017-2635-9

Cited by 11 publications

(5 citation statements)

References 58 publications

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“…The number of reviewed articles may be considered limited and reflective of only a small proportion of the published PHF literature. However, based on previous experience [20,21], our strategy of focusing on the most recent publications to source the most relevant and common event terms and definitions can be considered sufficient and most effective. The review of textbooks was restricted to a limited time period for the same reason.…”

Section: Discussionmentioning

confidence: 99%

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

Alispahic

Brorson

Bahrs

et al. 2020

BMC Musculoskelet Disord

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Background: The most frequently used surgical procedures for treating a proximal humeral fracture (PHF) are plate osteosynthesis, nail osteosynthesis and arthroplasty. Evidence-based recommendations for an appropriate surgical procedure after PHF requires transparent and valid safety data. We performed a systematic review to examine reported terms and definitions of complications after surgically-treated PHFs. Methods: A literature search was conducted on PubMed, Cochrane Library, EMBASE, Scopus and WorldCat to identify clinical articles and book chapters on complications of PHF published from 2010 to 2017. Complication terms and definitions were extracted from each selected article independently by two reviewers and grouped according to a predefined scheme. Results: From 1376 initial references, we selected 470 articles, of which 103 were reviewed in reverse chronological order until no further information was gained. Twelve book chapters were reviewed. We found 667 local event terms associated with complications after surgical treatment of PHFs. The most frequently used event terms were infection (52 references), nonunion (n = 42), malunion (n = 35), avascular necrosis (n = 27) and pain (n = 25). Overall, 345, 177, 257 and 102 local event terms were related to plating, nailing, arthroplasty and other surgical techniques, respectively. Radiological assessment was the basis for the majority of event terms and complication definitions. Thirty-six event definitions were extracted, mostly defining the terms "secondary fracture displacement", "screw perforation/cutout", "malunion", "delayed healing" and "notching". Conclusion: Scientific literature on surgically-managed PHF uses different terms to describe complications and without approved definitions, which highlights a lack of agreement on adverse event terminology for PHFs. Defined event terms are mostly based on radiological observations. Consensus among shoulder surgeons on a core event set is indispensable to support the standardization of safety reporting for surgically-treated PHFs.

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Section: Discussionmentioning

confidence: 99%

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

Alispahic

Brorson

Bahrs

et al. 2020

BMC Musculoskelet Disord

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“…fairly straightforward and required minimal changes, which further demonstrates the relevance of the current proposal for SA, as well as any future CES development for other indications or treatments in orthopedics. Previous reports on complications after SA were largely based on retrospective case series, and about one-fifth of examined articles in our previous literature review 20 were narrative reviews. Without international consensus, the authors of these reports were left to judge which events were most relevant to them or their patients.…”

Section: Discussionmentioning

confidence: 99%

“…We applied a well-accepted methodologic process 37 for the development of the SA CES, which was similar to that for ARCR. 1 A systematic literature review was implemented comprising 495 original articles published between 2010 and 2014, 20 which gave rise to a total of 1399 event terms grouped according to 8 of 9 previously defined event groups: device, osteochondral, pain, surgical-site infection, peripheral neurologic, vascular, superficial soft tissue, and deep soft tissue. 1 Another group of terms related to impaired function was also established to examine the possibility of using a similar structured list.…”

Section: General Methodologymentioning

confidence: 99%

“…Valid and consistent reporting of AEs in SA is essential to foster adequate decision-making processes, but much of the quantitative information stems from reviews of published data 4,5,7,16,23,38 and retrospective series that are highly inconsistent. 20 Further reports of large administrative databases 13,21,36 only include events that were not defined by consensus and may not be considered unfavorable events relevant to surgeons and their patients. Mandated registration of device failures with health authorities more likely provides valid safety implant data 33 yet also excludes further relevant events.…”

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confidence: 99%

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

Audigé

Schwyzer

Panel

et al. 2019

Journal of Shoulder and Elbow Surgery

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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.

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“…Despite this bias towards surgical literature we find it important to focus on complications after non-surgical management. A systematic reporting of complications and adverse events is needed for evidence-based suggestions and balanced decision-making [46].…”

Section: Discussionmentioning

confidence: 99%

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

Brorson

Alispahic

Bahrs

et al. 2019

BMC Musculoskelet Disord

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Background A majority of proximal humeral fractures can be managed without surgery. Recent randomized clinical trials and meta-analyses even question the benefit of surgical treatment for displaced 3-, and 4-part fractures. However, evidence-based treatment recommendations, balancing benefits and harms, presuppose a common reporting of complications and adverse events, which at the moment is largely missing. Therefore we systematically reviewed the use of terms and definitions of complications after nonsurgical management of proximal humeral fractures. Methods We searched PubMed, EMBASE, Cochrane Library, Scopus and WorldCat (2010–2017) and included articles and book chapters containing complication terms or definitions. Two reviewers independently extracted and grouped terms and definitions according to a predefined scheme. Terms and definitions concerning non-surgical management were tabulated, grouped and analyzed qualitatively. Results The initial search identified 1376 references from which 470 articles were selected for full-text retrieval. Data-extraction included first articles published in 2017, was then performed iteratively in batches of 20 articles, and terminated after retrieval of 91 articles when no additional definitions or terms was found. In addition, 12 book chapters were reviewed from an initial list of 100. No general definition of a complication was found. A total of 69 terms for complications after non-surgical management were identified from 19 articles. Sixty-seven terms regarded local events. The most commonly reported event terms regarded osteonecrosis, malunion, secondary displacement and rotator cuff problems. Seven individual terms were accompanied by some kind of definition. Most terms and definitions were based on radiographical assessments. Conclusions We found no consensus in the use of terms and definitions of complications after nonsurgical management of proximal humeral fractures. Multiple terms, some synonymous, some partly synonymous, some distinct, were used. Few complication terms were explicitly defined. Development and validation of an internationally consensus-based core event set for complications after proximal humeral fractures managed non-surgically is needed. Electronic supplementary material The online version of this article (10.1186/s12891-019-2459-6) contains supplementary material, which is available to authorized users.

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Towards standardised definitions of shoulder arthroplasty complications: a systematic review of terms and definitions

Cited by 11 publications

References 58 publications

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

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

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

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

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