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.
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.
Objective Patient-Reported Outcome Measures (PROMs) gain growing attention. The Food and Drug Administration suggested in 2009 to have PROMs for every new treatment and technology. The use of PROMs was further promoted by the Patient Protection and Affordable Care Act of 2010 in the USA. Recommendations from other national and international organizations include the OECD's Project of Patient-Reported Indicator Surveys (PaRIS) and the International Consortium for Health Outcomes Measurement (ICHOM). Our development and initiation of a Fracture Database started early in 2018. We orientated our database on the role model of the Swedish Fracture Registry. Methods REDCap (Research Electronic Data Capture) is a web interface for a SQL (Structured Query Language)-Database. We used it to program the Fracture Registry. We collect data about demographics, diagnosis, treatment, adverse events, clinical outcomes, and PROMs. The PROMS are recorded with the Software 'Heartbeat ONE' vs. 6.15.4. Inclusion criteria are all patients with fractures of the upper and lower extremity, including the pelvis and multiple injuries, treated surgically. Excluded are all patients with fractures of the hand as monotrauma and non-surgical treatment. We established questionnaire sets for each anatomical region. Every hospitalized patient is screened for inclusion criteria to get the baseline PROMs. Follow-up PROMs are collected at 3-months and 12-months in our outpatient clinic. Results In five months of collecting PROMs, we have evaluated 599 patients, 521 fulfilling the inclusion criteria. 329 (63%) questionnaire sets were completed. The mean time for answering the questions was 11-20 minutes. The input rate of 63% for PROMs accounts for the start of the process, with 22 (4%) patients being dismissed before answering the questionnaires. 93 (18%) patients denied participation. 52 (10%) patients were not able to participate (dementia, delirium). Other causes for missing data were language barriers (n = 28; 5%), medical reasons like polytraumatized patients (n = 4; 0.8%), and deceased patients (n = 15; 2.9%). Conclusion Most Orthopaedic Trauma centers publish data about PROMs from surgically treated patients. Starting in the first quarter of 2021, we will include non-surgically treated patients. We have optimized the process of including patients. Our aim is a response rate of more than 80% within this year to get representing data.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.