Variability in the Reporting Terminology of Adverse Events and Complications in Ankle Fracture Fixation: A Systematic Review

2019 ◽  
Vol 41 (2) ◽  
pp. 170-176
Author(s):  
Stefan A. St George ◽  
Hooman Sadr ◽  
Chayanin Angthong ◽  
Murray Penner ◽  
Peter Salat ◽  
...  

Background: Classification systems for the reporting of surgical complications have been developed and adapted for many surgical subspecialties. The purpose of this systematic review was to examine the variability and frequency of reporting terms used to describe adverse events and complications in ankle fracture fixation. We hypothesized that the terminology used would be highly variable and inconsistent, corroborating previous results that have suggested a need for standardized reporting terminology in orthopedics. Methods: Ankle fracture outcome studies meeting predetermined inclusion and exclusion criteria were selected for analysis by 2 independent observers. Terms used to define adverse events and complications were identified and recorded. Discrepancies were resolved by consensus with the aid of a third observer. All terms were then compiled and assessed for variability and frequency of use throughout the studies involved. Reporting terminology was subsequently grouped into 10 categories. Results: In the 48 studies analyzed, 301 distinct terms were utilized to describe complications or adverse events. Of these terms, 74.4% (224/301) were found in a single study each. Only 1 term, “infection,” was present in 50% of studies, and only 19 of 301 terms (6.3%) were used in at least 10% of papers. The category that was most frequently reported was “infection,” with 89.6% of studies reporting on this type of adverse event using 25 distinct terms. Other categories were “wound healing complications” (72.9% of papers, 38 terms), “bone/joint complications” (66.7% of papers, 35 terms), “hardware/implant complications” (56.3% of papers, 47 terms), “revision” (56.3% of papers, 35 terms), “cartilage/soft tissue injuries” (45.8% of papers, 31 terms), “reduction/alignment issues” (45.8% of papers, 29 terms), “medical complications” (43.8% of papers, 32 terms), “pain” (29.2% of papers, 16 terms), and “other complications” (20.8% of papers, 13 terms). There was a 78.6% interobserver agreement in the identification of terms across the 48 studies included. Conclusion: The reporting terminology utilized to describe complications and adverse events in ankle fracture fixation was found to be highly variable and inconsistent. This variability prevents accurate reporting of complications and adverse events and makes the analysis of potential outcomes difficult. The development of standardized reporting terminology in orthopedics would be instrumental in addressing these challenges and allow for more accurate and consistent outcome reporting. Level of Evidence: Level III; systematic review of Level III studies and above.

2020 ◽  
Vol 12 (6) ◽  
pp. 521-527
Author(s):  
Timothy R. Jelsema ◽  
Anthony C. Tam ◽  
James L. Moeller

Context: The use of injectable medications to help athletes quickly return to the field of play after injury is common. Understanding the effects and risks of these medications will help providers make informed decisions regarding their use in this patient population. Objective: To evaluate the utilization, efficacy, and adverse effects of injectable ketorolac and corticosteroids in athletes. Data Sources: This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A systematic search of the literature was performed using multiple databases (PubMed, Embase, Cochrane, Web of Science, and ClinicalTrials.gov). Secondary references were appraised for relevant articles. No randomized controlled trials or other prospective studies were identified. Articles included retrospective database reviews and physician survey studies. Study Selection: A total of 6 studies met the inclusion and exclusion criteria and were reviewed by 2 independent reviewers with a third consulted in the case of disagreement, which was not needed. Study Design: Systematic review. Level of Evidence: Level 5. Data Extraction: Two reviewers recorded rate of use, effectiveness of treatment, and reported side effect data. Results: Most studies centered around the football athlete, either professional or collegiate. Professional football game day use of intramuscular ketorolac declined from 93.3% (28/30) in 2002 to 48% in 2016. Collegiate football game day use of intramuscular ketorolac declined from 62% in 2008 to 26% in 2016. Game day corticosteroid injection was far lower than ketorolac usage. Both medications were reported to be effective with few adverse events. Conclusion: Use of injectable ketorolac is common but declining in professional and college football. Pain control efficacy is good, and risk of adverse events is low. The incidence of injectable corticosteroid use in athletes is unknown. Use of injectable corticosteroids in athletes allows for early return to sport activities with no reported complications.


2005 ◽  
Vol 33 (4) ◽  
pp. 515-523 ◽  
Author(s):  
Bernard Mazières ◽  
Stéphanie Rouanet ◽  
Joanne Velicy ◽  
Claudia Scarsi ◽  
Valentina Reiner

Background Topical nonsteroidal anti-inflammatory drugs offer the advantage of enhanced drug delivery to local affected tissues with low plasma levels and an expected reduced incidence of systemic adverse events (mainly peptic ulcer disease and gastrointestinal hemorrhage). Hypothesis To test the efficacy and tolerability of a 100-mg patch of ketoprofen applied once a day. Study Design Randomized controlled clinical trial; Level of evidence, 1. Methods The 2-week trial included patients suffering painful (spontaneous pain ≥50 mm on a 0- to 100-mm visual analog scale), benign (grade I or II), recent (<2 days) ankle sprains as a model of general traumatic soft tissue injuries. The primary efficacy criterion was spontaneous pain change after 7 days of treatment in the intention-to-treat population. One hundred sixty-three patients were randomized (ketoprofen, 81; placebo, 82). Results After 1 week of treatment, the decrease in spontaneous pain was -50 ± 20 mm for ketoprofen and -38 ± 24 mm for the placebo, showing a statistically significant intergroup difference (P =. 0007). The majority of the secondary criteria were also statistically significant in favor of the ketoprofen patch. Tolerance was good in both groups, adverse events being mostly local. Conclusion This trial suggested that a 7-day course of treatment with a ketoprofen patch is useful in benign ankle sprain, without revealing unexpected adverse events.


2021 ◽  
pp. 107110072110030
Author(s):  
Han Hong Chong ◽  
Melinda Y.T. Hau ◽  
Pranav Mishra ◽  
Paul Rai ◽  
Jitendra Mangwani

Background: Several studies have reported on potential negative predictive factors of functional outcomes after ankle fracture fixation. However, there is minimal patient-reported data on long-term outcomes. This study aimed to evaluate potential risk factors leading to a poor patient-reported functional outcome at 2 and 5 years following ankle fracture fixation. Methods: We conducted a prospective cohort study over a 5-year period on patients undergoing open reduction and internal fixation for unstable ankle fractures. Patient demographics, medical comorbidities, fracture pattern, and fixation quality were recorded and analyzed. Patients were followed up at 2 and 5 years. Data collected include the Olerud-Molander Ankle Score (OMAS), Lower Extremity Functional Scale (LEFS), ongoing issues, and the need for further intervention. A P value <.05 was considered statistically significant. Results: Out of 180 patients, follow-up data were available for 82 (46%) patients at 2 years and 94 (52%) patients at 5 years. At 2 years, age ≥60 years was a predictor of worse LEFS, while a body mass index ≥30 was a predictor of worse OMAS. Severely deformed ankle at presentation showed worse OMAS and LEFS score. However, these predictive factors were not significant at 5 years. An anatomically reduced ankle fracture fixation was more likely to have a better functional outcome at the 2- and 5-year follow-ups. A reduction in OMAS at 2 years was predictive of possible ongoing issues following surgery, which in turn increased the odds of worsening OMAS at 5 years. Conclusion: Achieving adequate fracture reduction during fixation is crucial for better ankle functional recovery postinjury. In this cohort, we found that patients who undergo ankle fracture fixation will have an ongoing negative impact on their functional and physical capacity at both 2 and 5 years postoperatively. Appropriate patient counseling is necessary to prepare them for the expected functional outcomes. Level of Evidence: Level II, prognostic.


Author(s):  
Maxime Robitaille-Fortin ◽  
Sharon Norman ◽  
Thomas Archer ◽  
Eric Mercier

Abstract Introduction: Pneumothorax remains an important cause of preventable trauma death. The aim of this systematic review is to synthesize the recent evidence on the efficacy, patient outcomes, and adverse events of different chest decompression approaches relevant to the out-of-hospital setting. Methods: A comprehensive literature search was performed using five databases (from January 1, 2014 through June 15, 2020). To be considered eligible, studies required to report original data on decompression of suspected or proven traumatic pneumothorax and be considered relevant to the prehospital context. They also required to be conducted mostly on an adult population (expected more than ≥80% of the population ≥16 years old) of patients. Needle chest decompression (NCD), finger thoracostomy (FT), and tube thoracostomy were considered. No meta-analysis was performed. Level of evidence was assigned using the Harbour and Miller system. Results: A total of 1,420 citations were obtained by the search strategy, of which 20 studies were included. Overall, the level of evidence was low. Eleven studies reported on the efficacy and patient outcomes following chest decompression. The most studied technique was NCD (n = 7), followed by FT (n = 5). Definitions of a successful chest decompression were heterogeneous. Subjective improvement following NCD ranged between 18% and 86% (n = 6). Successful FT was reported for between 9.7% and 32.0% of interventions following a traumatic cardiac arrest. Adverse events were infrequently reported. Nine studies presented only on anatomical measures with predicted failure and success. The mean anterior chest wall thickness (CWT) was larger than the lateral CWT in all studies except one. The predicted success rate of NCD ranged between 90% and 100% when using needle >7cm (n = 7) both for the lateral and anterior approaches. The reported risk of iatrogenic injuries was higher for the lateral approach, mostly on the left side because of the proximity with the heart. Conclusions: Based on observational studies with a low level of evidence, prehospital NCD should be performed using a needle >7cm length with either a lateral or anterior approach. While FT is an interesting diagnostic and therapeutic approach, evidence on the success rates and complications is limited. High-quality studies are required to determine the optimal chest decompression approach applicable in the out-of-hospital setting.


2018 ◽  
Vol 35 (7) ◽  
pp. 449-457 ◽  
Author(s):  
Adam J Boulton ◽  
Christopher T Lewis ◽  
David N Naumann ◽  
Mark J Midwinter

BackgroundHaemorrhage is a major cause of mortality and morbidity following both military and civilian trauma. Haemostatic dressings may offer effective haemorrhage control as part of prehospital treatment.AimTo conduct a systematic review of the clinical literature to assess the prehospital use of haemostatic dressings in controlling traumatic haemorrhage, and determine whether any haemostatic dressings are clinically superior.MethodsMEDLINE and EMBASE databases were searched using predetermined criteria. The reference lists of all returned review articles were screened for eligible studies. Two authors independently undertook the search, performed data extraction, and risk of bias and Grading of Recommendations, Assessment, Development and Evaluation quality assessments. Meta-analysis could not be undertaken due to study and clinical heterogeneity.ResultsOur search yielded 470 studies, of which 17 met eligibility criteria, and included 809 patients (469 military and 340 civilian). There were 15 observational studies, 1 case report and 1 randomised controlled trial. Indications for prehospital haemostatic dressing use, wound location, mechanism of injury, and source of bleeding were variable. Seven different haemostatic dressings were reported with QuikClot Combat Gauze being the most frequently applied (420 applications). Cessation of bleeding ranged from 67% to 100%, with a median of 90.5%. Adverse events were only reported with QuikClot granules, resulting in burns. No adverse events were reported with QuikClot Combat Gauze use in three studies. Seven of the 17 studies did not report safety data. All studies were at risk of bias and assessed of ‘very low’ to ‘moderate’ quality.ConclusionsHaemostatic dressings offer effective prehospital treatment for traumatic haemorrhage. QuikClot Combat Gauze may be justified as the optimal agent due to the volume of clinical data and its safety profile, but there is a lack of high-quality clinical evidence, and randomised controlled trials are warranted.Level of evidenceSystematic review, level IV.


2020 ◽  
Vol 163 (6) ◽  
pp. 1097-1108
Author(s):  
Angela M. Donaldson ◽  
Garret Choby ◽  
Daniel H. Kim ◽  
Lisa A. Marks ◽  
Devyani Lal

Objectives To address concerns related to the safety profile of both Food and Drug Administration (FDA)–approved and non–FDA-approved intranasal corticosteroid (INCS) use in the adult population. Data Source Systematic review of MEDLINE, PubMed, and EMBASE databases using a comprehensive search strategy including all INCS formulations and adverse events. The study design was developed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Additional sources were identified from study references of relevant articles. Review Methods A structured literature search was conducted. Each study was graded for level of evidence using the Oxford Centre for Evidence-Based Medicine. Extracted data included population size, study design, drug (dosage, route, and frequency), presence of hypothalamus pituitary axis suppression, ocular symptoms, and treatment-related adverse events. Results A total of 60 studies met inclusion criteria. The studies included use of INCS as metered nasal sprays, drops, injections, aerosols, and irrigations. There were no persistent abnormalities in cortisol level or intraocular pressure change. Meta-analysis of epistaxis showed a significantly increased risk in the FDA-approved treatment group in comparison with control (risk ratio 1.56; 95% confidence interval, 1.13-2.14; P = .007). Conclusions Overall, it appears that the use of both FDA and published non-FDA application of INCS are safe in the adult population. Meta-analysis demonstrated an increased risk of epistaxis in patients using INCS compared with placebo. Otherwise, there was no significant difference between in adults in the treatment group and placebo group. As an important caveat, the interpretation of safety of nonstandard INCS is restricted to delivery methods and dosages published in the literature.


2019 ◽  
Vol 161 (1) ◽  
pp. 36-45
Author(s):  
Gregory L. Barinsky ◽  
David Buziashvili ◽  
Peter F. Svider ◽  
Michael A. Carron ◽  
Adam J. Folbe ◽  
...  

ObjectiveDesmopressin (DDAVP) is a hemostatic agent used to manage bleeding in patients with hemostatic disorders, and there is a lack of published data to guide its use during otolaryngology procedures. The objective of this study was to conduct an evidence-based systematic review of the reported uses, efficacy, and adverse effects of DDAVP in the otolaryngology surgical setting.Data SourcesPubMed, MEDLINE, and EmBase were searched for articles on the use of DDAVP in otolaryngology.Review MethodsThe Methodological Index for Non-Randomized Studies criteria and Cochrane bias tool were used to assess study quality. Patient demographics, DDAVP dosing and route, and outcomes such as bleeding and adverse events were collected. A summary of evidence table was created specifying levels of evidence, benefits, and harm.ResultsNineteen studies encompassing 440 patients were included. Sixteen studies discussed DDAVP for prophylaxis, and 3 discussed postoperative use. DDAVP effectively prevented bleeding in high-risk patients and successfully facilitated a dry surgical field when necessary. DDAVP had a 100% success rate when used symptomatically. Five studies described adverse effects, including hyponatremia (12.3%), nausea (2.0%), emesis (0.9%), and seizure (0.2%). The aggregate level of evidence for its use was Level B for adenotonsillectomy, septoplasty, and turbinate procedures and Level C for rhinoplasty.ConclusionCurrent literature supports the use of DDAVP in otolaryngology surgical procedures as both a perioperative prophylactic agent and a postoperative symptomatic intervention for bleeding. Both modalities are effective with minimal adverse events. Further well-designed randomized trials are necessary to conclusively formulate guidelines for DDAVP use in otolaryngology.


2020 ◽  
Vol 41 (7) ◽  
pp. 866-869 ◽  
Author(s):  
Charles Cogan ◽  
Tiffany Liu ◽  
Paul Toogood

Background: Intraoperative identification of syndesmotic malreduction during ankle fracture fixation can be challenging. Prior studies describe the normal tibiofibular relationship on anteroposterior and mortise views to aid assessment, but the normal anatomic variation on the lateral view has not been well defined. The aim of this study was to describe the normal anatomy of the lateral radiographic view of the ankle, focusing on the relative position of the fibula and tibial plafond. Methods: We retrospectively identified consecutive adults undergoing ankle fracture open reduction internal fixation in 2011-2018. Two independent observers assessed the tibiofibular relationship on perfect lateral images of the uninjured side. Measurements were made in pixels, converted into millimeters using published parameters, and averaged for analysis. Reliability was calculated using Pearson correlation coefficients. Results: Of 751 cases of adult ankle fracture fixation identified, 50 patients had perfect lateral images of the contralateral side. In 11 patients (22%), the posterior border of the fibula intersected precisely at the posterior edge of the tibial plafond. Ten patients (20%) had anterior intersections, whereas 29 (58%) had posterior intersections. The intersection was within ±2 mm of the plafond edge in 27 patients (54%). Intrarater reliability was 0.86 and 0.93. Interrater reliability was 0.88. Conclusion: In most ankles, the posterior border of the fibula intersects the posterior extent of the tibial plafond within 2 mm. If more than 2 mm away, one should query malreduction, especially if anterior. This method of intraoperative assessment may decrease the occurrence of syndesmotic malreduction. Level of Evidence: Level III, comparative series.


2020 ◽  
Vol 14 (3) ◽  
pp. 274-277
Author(s):  
Renê Hobi ◽  
Rodolfo Galera ◽  
José Campos Filho ◽  
Leonardo Mugnol

Objective: To evaluate the clinical and radiographic results of suprasyndesmotic ankle fracture fixation with a minimally invasive technique. Methods: Retrospective study of 11 patients with suprasyndesmotic fractures of the lateral malleolus who underwent surgery between 2016 and 2018. Retrospective analysis of medical records considered the following: radiographic assessments (preoperative, immediate postoperative, six weeks postoperative), clinical evaluation, and strength scale and movement test results. Results: Of the 18 patients qualified for inclusion, 7 failed to appear at the follow-up appointment and were excluded. The patients’ age varied from 20 to 53 years, and 72.7% were male. The trauma mechanisms included torsion (46% of the cases), automobile accidents (36.4%) and direct trauma (17.6%). The mean time between trauma and definitive surgery was 3.27 days. The mean talocrural angle in the preoperative period was 83.13º, ranging from 80.63º in the immediate postoperative period to 81.27º at 6 months postoperatively. Approximately 90% of the patients did not lose strength. Regarding the range of motion, the mean dorsiflexion and plantar flexion 6 months postoperatively were 10.72º and 34.4º, respectively. Conclusion: The minimally invasive technique had excellent technical results in patients treated surgically for ankle fractures and required smaller incisions than conventional surgery. Osteolysis or fatigue of the osteosynthesis material is a possibility with this technique, which generally occurred between three and four months postoperatively. Level of Evidence IV; Therapeutic Studies; Case series.


Author(s):  
Yonas Abebe ◽  
Fredrik Hetmann ◽  
Kacper Sumera ◽  
Matt Holland ◽  
Trine Staff

Abstract Background Clinically meaningful pain reduction with respect to severity and the adverse events of drugs used in prehospital pain management for children are areas that have not received sufficient attention. The present systematic review therefore aims to perform a comprehensive search of databases to examine the preferable drugs for prehospital pain relief in paediatric patients with acute pain, irrespective of aetiology. Methods The systematic review includes studies from 2000 and up to 2020 that focus on children’s prehospital pain management. The study protocol is registered in PROSPERO with registration no. CRD42019126699. Pharmacological pain management using any type of analgesic drug and in all routes of administration was included. The main outcomes were (1) measurable pain reduction (effectiveness) and (2) no occurrence of any serious adverse events. Searches were conducted in PubMed, Medline, Embase, CINAHL, Epistemonikos and Cochrane library. Finally, the risk of bias was assessed using the Joanna Briggs Institute (JBI) checklist and a textual narrative analysis was performed due to the heterogeneity of the results. Results The present systematic review on the effectiveness and safety of analgesic drugs in prehospital pain relief in children identified a total of eight articles. Most of the articles reviewed identified analgesic drugs such as fentanyl (intranasal/IV), morphine (IV), methoxyflurane (inhalational) and ketamine (IV/IM). The effects of fentanyl, morphine and methoxyflurane were examined and all of the included analgesic drugs were evaluated as effective. Adverse events of fentanyl, methoxyflurane and ketamine were also reported, although none of these were considered serious. Conclusion The systematic review revealed that fentanyl, morphine, methoxyflurane and combination drugs are effective analgesic drugs for children in prehospital settings. No serious adverse events were reported following the administration of fentanyl, methoxyflurane and ketamine. Intranasal fentanyl and inhalational methoxyflurane seem to be the preferred drugs for children in pre-hospital settings due to their ease of administration, similar effect and safety profile when compared to other analgesic drugs. However, the level of evidence (LOE) in the included studies was only three or four, and further studies are therefore necessary.


Sign in / Sign up

Export Citation Format

Share Document