How to document and report orthopedic complications in clinical studies? A proposal for standardization (original) (raw)
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Complication Reporting in Orthopaedic TrialsA Systematic Review of Randomized Controlled Trials
The Journal of Bone and Joint Surgery (American), 2009
Background: The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required for the development or improvement of orthopaedic care. The goal of this systematic review was to check whether essential data regarding the assessment of the prevalence, severity, and characteristics of complications related to orthopaedic interventions are consistently provided by the authors of papers on randomized controlled trials.
Clinical Orthopaedics and Related Research®, 2014
Background Reliable classification of postoperative complications is important for quality improvement efforts. In 2014, The Knee Society proposed a grading system for complications after TKA, but to our knowledge, a relationship between complication grades and surgical outcomes has not yet been established. Questions/purposes We attempted to determine (1) whether an association exists between complication grade and early adverse outcomes after TKA and THA, and (2) what proportion of the variability in complications could be associated with the classification grade (a metric of potential predictive value of the grading schema). Methods A total of 210 primary THAs and TKAs in 201 patients performed at one center from January 1, 2011 to December 31, 2011 were reviewed; of those, 188 patients (94%; 197 procedures) had complete 90-day postoperative data and were evaluated retrospectively for postoperative complications. We defined and graded complications according to the classification system proposed by Iorio et al. and The Knee Society. Early adverse outcomes assessed included length of hospital stay and unplanned readmissions or reoperations. A total of 254 complications were documented in 135 patients (137 procedures); 53 patients (60 procedures) had no complications. Bivariate analyses were conducted to identify associations between complication grade and early adverse outcomes and patient variables; analyses considered patient variables including age, sex, status as a state prisoner (yes or no), American Society of Anesthesiologists score, BMI, and procedure (TKA or THA). Multiple regression and logistic regression analyses were conducted to determine the association between complication grade and early adverse outcomes (length of stay [LOS] and unplanned readmission or reoperations) adjusted for confounding patient variables. Alpha was set at 0.05 for two-sided tests. Results Maximum complication grade (range, from 0-4) was associated with a longer LOS (for each point increase of maximum grade, LOS increased 0.105 ± 0.024 days, p \ 0.001) and more readmissions or reoperations (odds ratio [OR], 3.79; 95% CI, 1.91-7.54; p \ 0.001). Total grade (range, 0-22) also was associated with increased LOS (for each point increase of total grade, LOS increased 0.032 ± 0.006 days, p \ 0.001) and increased readmissions or reoperations (OR, 1.34; 95% CI, 1.18-1.53; p \ 0.001). Total grade could account for 38% of the variation in LOS and readmissions or reoperations (C-statistic = 0.94; 95% CI, 0.90-0.98); whereas maximum complication grade could account for 35% of the variation in LOS and readmissions or reoperations (C-statistic = 0.35; 95% CI, 0.88-0.96). Thus, we found total grade to be a slightly better predictor of LOS and readmissions or reoperations than maximum grade. Conclusions We found that the proposed grading system is applicable to TKA and THA in terms of documentation Each author certifies that he/she has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research 1 editors and board members are on file with the publication and can be viewed on request. Each author certifies that his or her institution approved for the reporting of this investigation and that all investigations were conducted in conformity with ethical principles of research.
Short-term complication rate following orthopedic surgery in a tertiary care center in Argentina
SICOT-J
Introduction: Registration of adverse events following orthopedic surgery has a critical role in patient safety and has received increasing attention. The purpose of this study was to determine the prevalence and severity of postoperative complications in the department of orthopedic unit in a tertiary hospital. Methods: A retrospective review from the postoperative complication registry of a cohort of consecutive patients operated in the department of orthopedic surgery from May 2015 to June 2016 was performed. Short-term complications (3 months after surgery), age gender, types of surgery (elective, scheduled urgency, non-scheduled urgency, and emergency), operative time, surgical start time (morning, afternoon or evening), American Society of Anesthesiologists score and surgeon's experience were assessed. Complications were classified based on their severity according to Dindo-Clavien system: Grade I complications do not require alterations in the postoperative course or addi...
Annals of Saudi Medicine, 2019
BACKGROUND: Baseline statistical data on the current orthopedic outpatient load was needed to highlight the more frequent orthopedic problems. OBJECTIVE: Describe the frequency of orthopedic problems among patients attending the orthopedic outpatient department (OPD). DESIGN: Descriptive, retrospective medical record review. SETTINGS: Four-year data (2013-2017) was extracted from the computer records of patients attending the orthopedics OPD. PATIENTS AND METHODS: Computer entries of OPD visits were found, and after excluding incomplete and follow up data, age, gender, and diagnoses were described. MAIN OUTCOME MEASURES: Frequency of orthopedic diagnoses. SAMPLE SIZE AND CHARACTERISTICS: 23 495 patients, 19 377 (82.5%) males and 4118 (17.5%) females, majority (18 155, 77.3%) 19-50 years of age. RESULTS: Lower back pain (26%), tendinopathies and enthesopathies (18.3%), and bone fractures (11%) were the three common problems followed by arthritis (10.6%), nonspecific body ache (7.4%), and soft tissue injuries (9.9%). Others prominent diagnoses were ligamentous sprains (6.4%), neck-related problems (4.8%), joint stiffness (1.8%) and sports injuries (1%). CONCLUSION: This overview of the orthopedic problems in a secondary care hospital may aid in the formulation of better protocols and strategies to manage orthopedic disorders in a healthcare setting. LIMITATIONS: Retrospective and only included the primary diagnosis. CONFLICT OF INTEREST: None.
Healthcare processes must be improved to reduce the occurrence of orthopaedic adverse events
2010
Healthcare processes must be improved to reduce the occurrence of orthopaedic adverse events Background: Many nonhealth industries have decades of experiences working with safety systems. Similar systems are also needed in healthcare to improve patient safety. Clinical incident reporting systems in healthcare identify adverse events but seriously underestimate the incidence of adverse events. A wide range of information sources and monitoring techniques are needed to understand and mitigate healthcare risks. Aim: The purpose of this study was to identify patient safety risk factors that can lead to adverse events in adult orthopaedic inpatients. Design: A three-stage structured retrospective patient record review of consecutively admitted patients to the inpatient service of a large, urban Swedish hospital. Method: Records for all orthopaedic inpatients admitted during a 2-month period (n = 395) were screened using 12 criteria. Positive records were then reviewed in two stages by orthopaedic surgeons using a standardized protocol. Data were collected from the index admission and from subsequent visits or readmissions within 28 days of discharge. Results: Sixty patients experienced 65 healthcare associated adverse events. Affected patients had a length of hospital stay double that of patients without adverse events. Adverse events were more common in patients undergoing surgical procedures and patients with risk factors for anaesthesia. Although 59 of the adverse events occurred in patients who underwent surgery, only nine of the adverse events were due to deficiencies in surgical/anaesthesia technique. The others were related to deficiencies in healthcare processes. The most common adverse events were hospital acquired infections (n = 20) and delayed detection of urinary retention (n = 13). Six adverse drug events involved elderly patients ( ‡65 years). Conclusion: Orthopaedic care is a high risk activity for its typically elderly, often debilitated patients. Reducing adverse events in orthopaedic patients will require more multidisciplinary, interdepartmental teamwork strategies that focus on healthcare processes outside the operating room.
Lessons Regarding the Safety of Orthopaedic Patient Care
The Journal of Bone and Joint Surgery (American), 2013
Background: An orthopaedic malpractice claim alleges that the patient sustained a preventable iatrogenic injury. The analysis of a representative series of malpractice claims provides a unique view of alleged orthopaedic adverse events, revealing what can potentially go wrong across a spectrum of practice settings and anatomic locations. The goal of this study was to identify high-impact targets in order to institute measures to reduce claims through efforts focused on patient safety.
Techniques in Foot & Ankle Surgery, 2017
Patient safety is protection from adverse outcome through reduction of complications. The purpose of this study is to accurately identify the most common complications after foot and ankle (FA) and traumatic FA surgery and characterize their incidence compared with all other orthopedic procedures. The American Board of Orthopaedic Surgeons (ABOS) database was searched from 2006 to 2010 for all reported orthopedic and FA procedures. The incidence of complications was identified for the following groups: the 10 most common trauma FA procedures, and all FA procedures cumulatively. The incidence of complications for each group were then compared with all other orthopedic procedures reported during that same period. Statistical analysis was performed using a 2-tailed Student t test and χ2 with Yates. A total of 56,786 FA codes and their associated complication(s) were compared with 429,358 orthopedic codes and their complication(s). The 10 most commonly reported trauma FA procedures acco...
Outcomes in orthopedics and traumatology: translating research into practice
Acta Ortopédica Brasileira, 2014
Clinical research is focused in generating evidence that is feasible to be applicable to practitioners. However, translating research-focused evidence into practice may be challenging and often misleading. This article aims is to pinpoint these challenges and suggest some methodological safeguards, taking platelet-rich plasma therapies and knee osteochondral injuries as examples. Studies and systematic reviews involving the following concepts will be investigated: clinically relevant outcomes, systematic errors on sample calculation, internal and external validity. Relevant studies on platelet-rich plasma for muscle--tendon lesions and updates on osteochondral lesions treatment were included in this analysis. Authors and clinicians should consider these concepts for the implementation and application of dissemination of the best evidence. Research results should be challenged by a weighted analysis of its methodological soundness and applicability. Level of Evidence V, Therapeutic Studies -Investigating the Results of Treatment.