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Complication Reporting in Orthopaedic TrialsA Systematic Review of Randomized Controlled Trials
S. Goldhahn, MD1; T. Sawaguchi, MD2; L. Audigé, PhD, DVM1; R. Mundi, BHSc3; B. Hanson, MD, MPH1; M. Bhandari, MD, MSc4; J. Goldhahn, MD, MAS5
1 AO Clinical Investigation and Documentation, Stettbachstrasse 6, 8600 Dübendorf, Switzerland. E-mail address for S. Goldhahn: sabine.goldhahn@aofoundation.org
2 Department of Orthopaedic Surgery, Toyama Municipal Hospital, Imaizumihokubu 2-1, 939-8282 Toyama, Japan
3 Division of Orthopaedic Surgery, McMaster University, 1280 Main Street West, Hamilton, ON L8S 4L8, Canada
4 Department of Clinical Epidemiology and Biostatistics, McMaster University Medical Center, 1200 Main Street West, Room 2C3, Hamilton, ON L8N 3Z5, Canada
5 Musculoskeletal Research, Schulthess Clinic Zürich, Lengghalde 2, 8008 Zürich, Switzerland
View Disclosures and Other Information
Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.
Investigation performed at AO Clinical Investigation and Documentation, Dübendorf, Switzerland, and the Department of Clinical Epidemiology and Biostatistics, McMaster University Medical Center, Hamilton, Ontario, Canada

The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2009 Aug 01;91(8):1847-1853. doi: 10.2106/JBJS.H.01455
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Abstract

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.

Methods: Five major peer-reviewed orthopaedic journals were screened for randomized controlled trials published between January 2006 and July 2007. All relevant papers were obtained, anonymized, and evaluated by two external reviewers. A checklist consisting of three main parts (definition, evaluation, and reporting) was developed and applied for the assessment of complication reporting. The results were stratified into surgical and nonsurgical categories.

Results: One hundred and twelve randomized controlled trials were identified. Although complications were included as trial outcomes in two-thirds of the studies, clear definitions of anticipated complications were provided in only eight trials. In 83% of the trials, the person or group assessing the complications was not identified. No trial involved a data safety review board for assessment and classification of complications.

Conclusions: The lack of homogeneity among the published studies that we reviewed indicates that improvement in the reporting of complications in orthopaedic clinical trials is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and, most importantly, by clinical investigators.

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    References

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Sabine Goldhahn, MD
    Posted on September 07, 2009
    Dr. Goldhahn and colleagues respond to Drs. Cheng and Zhang
    AO Clinical Investigation and Documentation, Dübendorf, Switzerland

    Thank you very much for your interest and helpful comments. We totally agree that the use of a validated questionnaire is always the best choice in evidence-based medicine. In fact, we use only validated instruments in our multicenter studies. However, this study was a first attempt to quantify the size of the problem related to complication reporting in orthopaedic surgery. We were surprised by the magnitude of the problem and agree that further evaluations should include validated assessment tools. We focused in this study on orthopaedic studies only. This was the reason for not citing your quoted references. The references show one more time the tremendous need to establish uniform criteria for complication reporting in the field of orthopaedic surgery. While in some cases it is not clear what is considered a complication, your concerns about measuring them goes much farther. This has to be addressed in the next project.

    Tao Cheng, MD, PhD
    Posted on August 23, 2009
    Concern Regarding Complications Reporting in Orthopaedic Trials
    Sixth Affiliated People's Hospital, Shanghai Jiao Tong University, China

    To the Editor:

    We read with interest the paper by Goldhahn et al. (1) which elucidated the disparity in the quality of complication reporting in the orthopaedic literature and we wish to bring attention to three important issues.

    First, Goldhahn et al. asserted that two external reviewers used a nonstandardized, nonvalidated checklist for the assessment of complication reporting in the randomized controlled trials. As we know, a checklist tool must be reliable in order to be useful in clinical or research practice. In fact, there are a wide variety of techniques available, such as the kappa coefficient, to measure agreement or reliability including intraobserver and interobserver reliability.

    Second, the authors stated in the discussion section that a validated checklist is unavailable given the novelty of the field of complication reporting. However, ten standard criteria for reporting outcomes in surgery have been established (2,3) that, in our opinion, can be applied directly to the field of orthopaedics. They include the following : Method of accruing data defined; Duration of follow-up indicated; Outpatient information included; Definitions of complications provided; Mortality rate and causes of death listed; Morbidity rate and total complications indicated; Procedure-specific complications included; Severity grade utilized; Length-of-stay data; and Risk factors included in the analysis (2).

    Third, based on the fact that the modality used to detect complications is unclear in many studies, it is difficult to assess the true frequency of their occurrence or compare interventions. For example, it is possible that the disagreement in results regarding deep vein thrombosis is due to the difference between the methods of thrombus detection (4). Frequently, authors of the reviewed trials suggested that "no complications" occurred during the study period. In fact, the lack of an appropriate diagnostic modality makes it impossible to determine some asymptomatic complications such as low-grade infection and subclinical deep vein thrombosis. Recognizing the problems, we strongly recommend reporting the diagnostic modality and threshold value for complications, especially "implant-related" complications.

    The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

    References

    1. Goldhahn S, Sawaguchi T, Audigé L, Mundi R, Hanson B, Bhandari M, Goldhahn J. Complication reporting in orthopaedic trials. A systematic review of randomized controlled trials. J Bone Joint Surg Am. 2009;91:1847-53.

    2. Martin RC 2nd, Brennan MF, Jaques DP. Quality of complication reporting in the surgical literature. Ann Surg. 2002;235:803-13.

    3. Khuri SF. The NSQIP: a new frontier in surgery. Surgery. 2005;138:837-43.

    4. Wheeler HB, Anderson FA Jr. Diagnostic methods for deep vein thrombosis. Haemostasis. 1995;25:6-26.

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