Complication Reporting in Orthopaedic TrialsA Systematic Review of Randomized Controlled Trials (original) (raw)
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Archives of Orthopaedic and Trauma Surgery, 2011
Introduction The documentation of complications is critical for the evaluation of therapeutic interventions in orthopedics. However, there is a lack of accepted methodological standardization and definitions. We propose a concept to support the consensus development of a standardized management and classification of complications in clinical research. Methods Complication events are examined regarding their clinical presentation, their timing of occurrence as well as their potential causal interrelationship for any given patient. Their clinical presentation is distinguished by their likely triggers, their therapeutic management, and their outcome. Complications are events (including relevant deviations from their expected healing process) that are harmful to patients and can be described as local to the treated injury/disease or systemic (when they affect the rest of the body). The treatment of a complication, e.g. by way of an unplanned surgical intervention, and its outcome should be carefully documented. Complication review boards with independent clinicians should be established to validate complication records. Application and relevance In this proposal, a number of complication examples are presented to illustrate the concept and demonstrate its practical use. This management and classification system has already proven valuable in the documentation and analysis of complication data from a number of published clinical studies. Because of this new standardized assessment process, it facilitates the communication of complications between clinicians and researchers, and helps to develop clear definitions for specific orthopedic complications.
Injury, 2008
There is a growing consensus that randomised controlled clinical trial (RCT) provide a secure basis for determining treatment effects. Prospective randomised clinical trials can be a powerful tool in medical science and evidence-based medicine. A well-defined study hypothesis, with a prospectively applied study design, blinded and randomised treatment allocation and assessment, with appropriate control groups can provide strong evidence in support of treatment decisions. However, the recent reviews of the medical literature indicate that the study design itself does not ensure the quality of science or useful and valid scientific data. Thus, regardless of the study design or level of evidence, it remains imperative for the physician and surgeon to critically evaluate a scientific report. Moreover, as randomisation, concealment of treatment allocation and blinding are difficult issues to resolve in orthopaedic surgery, future trials should focus on detailed and correct reporting of outcome measures.
Systematic Reviews of Nonrandomized Clinical Studies in the Orthopaedic Literature
Clinical Orthopaedics and Related Research, 2004
We systematically reviewed systematic reviews of surgical orthopaedic interventions published between 1996 and 2001 to document when and how nonrandomized studies were included. From more than 10,000 citations examined in various electronic databases, 58 orthopaedic systematic reviews were eligible for inclusion based on specific criteria. Thirty of these (52%) included nonrandomized studies, 15 of which found no randomized controlled trials. Systematic reviews were more likely to include randomized controlled trials if nondistinguishable operations were compared (if participants could be blinded). Only six of the systematic reviews that included nonrandomized studies (20%) assessed the quality of primary studies. Heterogeneity of studies was a major concern. In 21 of the systematic reviews that included nonrandomized studies (70%), data for groups treated similarly were pooled across studies, and outcomes for pooled groups were compared. The conclusions of systematic reviews that included nonrandomized studies are weakened by the limitations of nonrandomized study designs. The absence of established methods for including nonrandomized studies in systematic reviews, and consequently variability in the methods adopted, also limits the comparability of such reviews. Therefore the findings of systematic reviews that include nonrandomized studies should be interpreted with caution.
Journal of Bone and Joint Surgery, 2018
Background: The responsibility for ensuring that studies are adequately reported is primarily that of those conducting the study; however, journal policies may influence how thoroughly authors choose to report their research. The use of reporting guidelines and prospective trial registration are promising avenues for ensuring that published studies adhere to the highest methodological standards. The purpose of this study is to evaluate orthopaedic surgery journal policies regarding reporting guidelines and trial registration, and to evaluate the effects that these policies have on adherence to reporting. Methods: We conducted a cross-sectional survey of journal policies and "Instructions for Authors" to determine the journals' policies and guidance regarding use of reporting guidelines and study registration. We also examined whether trials published in journals referencing CONSORT (Consolidated Standards of Reporting Trials) had higher rates of compliance with publishing a CONSORT flow diagram and whether journals with trial registration policies were more likely to contain registered trials than journals without these requirements. Results: Of the 21 orthopaedic surgery journals, 6 (29%) did not mention a single guideline, and clinical trial registration was required by 11 (52%) orthopaedic surgery journals and recommended by 2 (10%). Of the 21 general medical journals, 3 (14%) did not mention a single guideline, and trial registration was required by 13 (62%) general medical journals and recommended by 5 (24%) others. Furthermore, journals that referenced CONSORT were more likely to publish trials with a CONSORT flow diagram. Journals with trial registration policies were more likely to publish registered trials. Conclusions: Reporting guidelines and trial registration are suboptimally required or recommended by orthopaedic surgery journals. These 2 mechanisms may improve methodology and quality, and should be considered for adoption by journal editors in orthopaedic surgery. Clinical Relevance: Because orthopaedic surgeons rely on high-quality research to direct patient care, measures must be taken to ensure that published research is of the highest quality. The use of reporting guidelines and prospective clinical trial registration may improve the quality of orthopaedic research, thereby improving patient care.
The design and assessment of prospective randomised, controlled trials in orthopaedic surgery
Journal of Bone and Joint Surgery - British Volume, 2007
Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.
Randomised Trial Support for Orthopaedic Surgical Procedures
PLoS ONE, 2014
We investigated the proportion of orthopaedic procedures supported by evidence from randomised controlled trials comparing operative procedures to a non-operative alternative. Orthopaedic procedures conducted in 2009, 2010 and 2011 across three metropolitan teaching hospitals were identified, grouped and ranked according to frequency. Searches of the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effects (DARE) were performed to identify RCTs evaluating the most commonly performed orthopaedic procedures. Included studies were categorised as ''supportive'' or ''not supportive'' of operative treatment. A risk of bias analysis was conducted for included studies using the Cochrane Collaboration's Risk of Bias tool. A total of 9,392 orthopaedic procedures were performed across the index period. 94.6% (8886 procedures) of the total volume, representing the 32 most common operative procedure categories, were used for this analysis. Of the 83 included RCTs, 22.9% (19/83) were classified as supportive of operative intervention. 36.9% (3279/8886) of the total volume of procedures performed were supported by at least one RCT showing surgery to be superior to a non-operative alternative. 19.6% (1743/8886) of the total volume of procedures performed were supported by at least one low risk of bias RCT showing surgery to be superior to a non-operative alternative. The level of RCT support for common orthopaedic procedures compares unfavourably with other fields of medicine.
Pilot randomized controlled trials in the orthopaedic surgery literature: a systematic review
BMC musculoskeletal disorders, 2018
The primary objective of this systematic review is to examine the characteristics of pilot randomized controlled trials (RCTs) in the orthopaedic surgery literature, including the proportion framed as feasibility trials and those that lead to definitive RCTs. This review aim to answer the question of whether pilot RCTs lead to definitive RCTs, whilst investigating the quality, feasibility and overall publication trends of orthopaedic pilot trials. Pilot RCTs in the orthopaedic literature were identified from three electronic databases (EMBASE, MEDLINE, and Pubmed) searched from database inception to January 2018. Search criteria included the evaluation of at least one orthopaedic surgical intervention, research on humans, and publication in English. Two reviewers independently screened the pool of pilot trials, and conducted a search for corresponding definitive trials. Screened pilot RCTs were assessed for feasibility outcomes related to efficiency, cost, and/or timeliness of a lar...
BMC Musculoskeletal Disorders, 2008
Background Evidence-based medicine posits that health care research is founded upon clinically important differences in patient centered outcomes. Statistically significant differences between two treatments may not necessarily reflect a clinically important difference. We aimed to quantify the sample sizes and magnitude of treatment effects in a review of orthopaedic randomized trials with statistically significant findings. Methods We conducted a comprehensive search (PubMed, Cochrane) for all randomized controlled trials between 1/1/95 to 12/31/04. Eligible studies include those that focused upon orthopaedic trauma. Baseline characteristics and treatment effects were abstracted by two reviewers. Briefly, for continuous outcome measures (ie functional scores), we calculated effect sizes (mean difference/standard deviation). Dichotomous variables (ie infection, nonunion) were summarized as absolute risk differences and relative risk reductions (RRR). Effect sizes >0.80 and RRRs&...
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.