Impact of Clinical Practice Guideline on the Treatment of Pediatric Femoral Fractures in a Pediatric Hospital

Oetgen, Matthew E. MD; Blatz, Allison M. BA; Matthews, Allison MS

Journal of Bone & Joint Surgery - American Volume:
doi: 10.2106/JBJS.O.00161
Scientific Articles
Abstract

Background: Clinical practice guidelines are being developed for a number of topics in medicine to decrease practice variability and to improve evidenced-based care. Within orthopaedic surgery, the American Academy of Orthopaedic Surgeons (AAOS) has a dedicated committee that produces these clinical practice guidelines on a variety of issues. One such issue was the treatment of pediatric diaphyseal femoral fractures, with the clinical practice guideline being published in 2009. We performed a retrospective review of the treatment of pediatric diaphyseal femoral fractures at a single institution from 2007 to 2012 to assess the clinical impact of this clinical practice guideline on the treatment of this condition.

Methods: A retrospective review of all patients treated at a single pediatric hospital between 2007 and 2012 for a pediatric diaphyseal femoral fracture was conducted. The 2009 AAOS clinical practice guideline on the treatment of this condition was assessed and each patient record was analyzed to determine if the clinical practice guideline was followed, based on the age-specific recommendations. The percentage of treatment rendered adhering to the clinical practice guideline recommendations was compared in the pre-guideline group (prior to June 2009) and the post-guideline group (after June 2009).

Results: A total of 361 patients were treated for a diaphyseal femoral fracture during this time frame and were included in this study. Overall, little change in treatment was found following the publication of this clinical practice guideline. The only significant change noted over this time period was a decrease (p = 0.03) in the percentage of patients between the ages of five and eleven years who were treated with flexible nails, at odds with this specific clinical practice guideline recommendation.

Conclusions: We found little direct clinical impact of the recently published AAOS clinical practice guideline on the treatment of pediatric diaphyseal femoral fractures. This analysis suggests an important role for clinical assessment after guideline publication to identify areas of potentially important future clinical research and to assess the utility of this guideline.

Author Information

1Department of Orthopaedic Surgery and Sports Medicine, Children’s National Medical Center, 111 Michigan Avenue N.W., W1.5, Suite 400, Washington, DC 20010. E-mail address for M.E. Oetgen: moetgen@childrensnational.org

2The George Washington University School of Medicine, Ross Hall, 2300 Eye Street N.W., Washington, DC 20037

Article Outline

Clinical practice guidelines are increasingly becoming important in the practice of clinical medicine. In general, these practice guidelines are developed and are published by medical societies on specific topics to improve treatment based on the current best evidence available. They are developed by a collaboration of physicians who use a systematic review of published literature on a subject to assess which procedures or services are successful for an established clinical issue. These practice guidelines are not offered as absolutes on treatment, but rather serve as resources for physicians to improve quality and efficiency of care and to decrease clinical variability of care1,2.

The American Academy of Orthopaedic Surgeons (AAOS) approved one such clinical practice guideline on the treatment of pediatric diaphyseal femoral fractures on June 19, 20093. This guideline was subsequently published in the Journal of the American Academy of Orthopaedic Surgeons4 and in The Journal of Bone & Joint Surgery3. This guideline consisted of fourteen recommendations on a variety of topics related to the treatment of pediatric diaphyseal femoral fractures. Of these care options, one was recommended, one was suggested, six were listed as options of treatment, and six were considered incomplete recommendations on the basis of a lack of substantial evidence in the literature (Table I)3.

Despite the support of these clinical practice guidelines by medical societies, there are few data on the actual clinical impact of the development and publication of these guidelines in orthopaedic surgery. Given the resources used and the costs incurred in developing these guidelines, it is important to evaluate their impact. We aimed to assess the impact on clinical practice of the development and publication of a clinical practice guideline on the treatment of pediatric femoral fractures by assessing if this guideline led to a change in the treatment of pediatric diaphyseal femoral fractures in line with the recommendations.

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Materials and Methods

A retrospective chart review of all patients who presented to a single pediatric tertiary care hospital for the treatment of a diaphyseal femoral fracture between 2007 and 2012 was performed, once institutional review board approval was obtained. A total of 612 patients were identified according to billing records with a primary diagnosis of a midshaft femoral fracture. A total of 251 patients were excluded, including patients without adequate radiographs at any time point; patients with incomplete follow-up; patients with nondiaphyseal or pathologic fractures; patients with congenital, neuromuscular, genetic, or bone disease conditions; patients who initially presented to an outside hospital; and two patients with fractures secondary to gunshot wounds.

Medical records and radiographs were reviewed, and baseline, surgical, and follow-up data were abstracted for each patient. Baseline data included patient age, patient weight, type of femoral fracture (transverse, oblique, spiral), and initial shortening of the fracture (as measured on the presenting radiographs). Surgical data included type of anesthesia, type of treatment performed, and implant type used, if applicable. The follow-up period was defined as immediately postoperative to the healing of the fracture. Data from this period included perioperative consultations (work-up for non-accidental injury), postoperative fracture shortening and angulation (shortening or angulation at fracture-healing and at the time of a change of treatment plan, if applicable), use of physical therapy in the postoperative period, and ultimate removal of implants.

The AAOS guidelines for the treatment of pediatric diaphyseal femoral fractures were analyzed and recommendations lacking sufficient data for definitive clinical recommendation (incomplete recommendations) were excluded. Eight treatment recommendations remained that were assessed in this review3 (Table II). Because of age-specific recommendations, only those recommendations applicable to the age of the patient were recorded for each patient. Additionally, a lack of documentation in the medical records made it impossible to accurately assess for the use of waterproof cast liners with the application of spica casts; thus, this recommendation was excluded from analysis.

The patients were divided into a pre-guideline group (patients treated before June 2009) and a post-guideline group (patients treated after June 2009). The treatment of each patient was compared with the clinical practice guideline to determine if the treatment recommendations had been followed, and the groups were compared for each recommendation with use of the chi-square test or the Fisher exact test to determine if a significant change in treatment approach was found after the clinical practice guideline was published (p < 0.05). Additionally, implementation rates of the guideline were compared between the pre-guideline publication period and the post-guideline publication period, generating a risk ratio indicating the estimated relative effect of each guideline as well as the 95% confidence interval around that estimate.

A post hoc analysis of sample size was performed, indicating that the current study has 80% power to detect a change in compliance of ≥20% between the periods before and after publication of the guideline, as 180 total patients [ninety patients preoperatively compared with ninety patients postoperatively] were needed to detect a 20% difference.

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Source of Funding

No external funding was used to support this work.

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Results

A total of 361 patients were treated for a diaphyseal femoral fracture during this time frame and were included in this study, 143 patients (40%) in the pre-guideline group and 218 patients (60%) in the post-guideline group. Treatment was provided by twelve different fellowship-trained pediatric orthopaedic surgeons. The overall patient cohort consisted of 107 female patients and 254 male patients with a mean age of 5.3 years (range, zero to 16.1 years). The distribution of the patient ages is shown in Figures 1 and 2.

The results for each recommendation are shown in Table III. When looking at the use of a non-accidental trauma evaluation in children younger than thirty-six months, there was a slight decrease after the clinical practice guideline was introduced, although this was not significant (p = 0.40). The use of a Pavlik harness or spica cast for children younger than six months also did not change significantly (p = 0.36), with one patient in the pre-guideline group being treated with a long leg cast (nine of ten patients according to the guideline) and all patients in the post-guideline group being treated according to the guideline.

A slight, nonsignificant decrease in the use of spica casts was noted for patients who were six months to five years of age (p = 0.07). In the pre-guideline group, two patients were treated with a Pavlik harness and one was treated with a long leg cast, and in the post-guideline group, seven patients were treated with long leg casts, four were treated with flexible nails, one was treated with a Pavlik harness, and two were treated with external fixators. A small, nonsignificant increase in treatment alteration for those children with >2-cm fracture shortening in a spica cast was observed after the clinical practice guideline was introduced (p = 0.09). A significant decrease in the adherence to the clinical practice guideline suggesting use of flexible nails for the patients who were five to eleven years of age was found (p = 0.03). In the pre-guideline group, ten patients were treated with spica casts and four patients were treated with submuscular plates, and in the post-guideline group, there were eleven patients treated with rigid nails, ten patients treated with submuscular plates, four patients treated with spica casts, and two patients treated with an external fixator and percutaneous pinning.

Little difference was observed in the treatment of patients older than eleven years of age between the groups (p = 0.63) and in the use of regional anesthesia between the groups (p = 0.40).

The risk ratios provided in Table III describe the estimated relative effect of the guidelines between the pre-guideline publication period and the post-guideline publication period. For example, looking at the guideline for non-accidental trauma evaluation in children younger than thirty-six months, the risk ratio of 0.86 indicated that the post-guideline period was associated with 86% of the compliance of the pre-guideline period, with a nonsignificant p value (p = 0.40). However, for the guideline for flexible nails for patients who were five to eleven years of age, the risk ratio was 0.65, with a p value of 0.03, indicating that the post-guideline period was associated with only 65% of the compliance of the pre-guideline period. The risk ratios for the treatment of patients older than eleven years, use of regional anesthesia, and treatment alteration for those children with >2-cm fracture shortening in a spica cast could not be calculated because of low compliance or lack of difference between the groups in the two time periods.

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Discussion

Our assessment of the effects of the AAOS clinical practice guideline on the treatment of pediatric diaphyseal femoral fractures demonstrated little significant change of practice. There appeared to be variable influence of this clinical practice guideline, but little overall change from before to after the guideline was published. In general, there appeared to be a divide between those recommendations in which we found a high percentage of pre-guideline publication adherence (Pavlik harness or spica cast for patients who were younger than six months of age and nail or plate for patients who were older than eleven years of age) and those recommendations that were typically not followed prior to the guideline publication (evaluation for non-accidental trauma for patients who were younger than thirty-six months of age, alteration of treatment for >2-cm shortening in a spica cast, and use of flexible nails for patients who were five to eleven years of age). In those guideline recommendations that demonstrated high pre-guideline publication adherence, we generally observed a high degree of guideline adherence after the clinical practice guideline was released as well. Guideline recommendations that demonstrated low pre-publication adherence generally were found to have low post-publication adherence. One exception appeared to be the recommendation for use of a spica cast in patients who were six months to five years of age. This recommendation had a 95% adherence in the pre-guideline publication period, but the adherence dropped to 84% in the post-guideline publication period. The guidelines that were found to have a low or lower percentage of adherence after guideline publication seemed to involve guideline recommendations for broader patient age ranges and more specific recommendations in which alternative treatments used after the guideline publication accounted for the care inconsistencies.

Evaluation after guideline development has been performed for other topics5-14. A review of the clinical practice patterns for nonsurgical treatment of osteoarthritis of the knee was performed to assess the similarities between clinical practice and clinical practice guidelines for this issue. Dhawan et al. found gaps between AAOS-recommended treatment and actual pre-guideline treatment patterns5. Other medical and surgical specialties have performed various analyses of clinical practice guidelines. Many of these reviews used physician surveys to assess adherence to the guidelines10,13, literature reviews to assess validity or robustness of guidelines6,12, assessment of the potential cost-effectiveness of clinical practice guidelines8,14, or comparisons of hospitals with and without clinical practice guidelines to assess clinical impact9. Although these studies generally found improvements in care standardization with clinical practice guidelines9,11, many of these methodologies lacked the ability to assess areas in which the clinical practice guidelines could be improved for greater impact.

Overall, one reason for the apparent modest clinical effect of this clinical practice guideline in the present study could be the lack of higher-level evidence on which this guideline was based. Sanders et al. suggested that “the quality and usefulness of CPGs [clinical practice guidelines] are determined primarily by the strength and clarity of the underlying evidence.”2 Clearly, there is overall weak evidence to support the pediatric diaphyseal fracture guideline, with 43% (six) of the fourteen recommendations lacking enough data for support and only one of the clinical options supported by enough evidence for a firm recommendation. Another possibility is that this guideline is based on outdated evidence, with routine clinical practice already having moved beyond these data. This is possible when evaluating the significant decrease in the percentage of patients treated according to the guideline on the use of flexible nails for children who were five to eleven years of age. After the guideline was published, fewer children were treated with flexible nails and more were treated with rigid nails and submuscular plates than prior to the publication of the guideline. Newer technology (better plates or nails) or different physician training may have led to these alternative treatments, despite the lack of clinical data in the literature to support the inclusion of these techniques in the guideline.

Although clinical practice guidelines address the question of which procedures work successfully and although there is evidence that they improve the process of care, an assessment of the clinical applicability of individual guidelines is appropriate2. One role of these guidelines is to assess the current literature and to highlight fertile areas for future research in a particular area; however, this clinical evaluation of these guidelines may have suggested more focused or clinically important areas of future research2. Combining the clinical practice guidelines and their effects on clinical practice, it may become evident that there are areas of clinical practice that are diverging from the guidelines, such as is seen in the decreasing rate of non-accidental trauma evaluations, the decreasing use of spica casts for patients who are six months to five years of age, and the decreasing rates of use of flexible nails in patients who are five to eleven years of age. These trends may suggest better areas of study to determine how real clinical practice is changing, rather than just where previous research deficiencies lie. Additionally, data documenting the actual clinical impact of clinical practice guidelines may temper the chance of clinical practice guidelines being used as de facto standards of care in legal and reimbursement situations.

Although the poor clinical performance of some of these clinical practice guidelines on the treatment of pediatric femoral fractures may be due to poor data and weak recommendations, the AAOS committees that develop clinical practice guidelines have already realized this issue, and new processes are in place to avoid this situation in the future2. Better selection of topics for clinical practice guidelines (those with data to support recommendations) and required revisions of clinical practice guidelines already published will help in the future.

There were a number of weaknesses of our study. This is a single-center study, which may have introduced bias regarding the treatment of these femoral fractures. Additionally, bias against the clinical practice guideline, the authors of this clinical practice guideline, or the AAOS clinical practice guideline process, or conflicts of interest related to the clinical practice guideline may have determined fracture treatments other than those recommended by the clinical practice guideline.

Overall, we found that the clinical practice guideline on pediatric diaphyseal femoral fractures produced little change in the clinical practice of treating these fractures at our center. In most of the studied recommendations, there was less agreement with the clinical practice guideline after it was introduced, suggesting a change of clinical practice not addressed in the clinical practice guideline. Clinical assessment of clinical practice guidelines after they are published appears to be an important step in the continued evaluation and evolution of clinical practice guidelines, providing important information with regard to treatment patterns and clinically impactful areas of future research and suggesting potential weaknesses of the guidelines. The current clinical assessment of the pediatric femoral fracture clinical practice guideline points to new areas of potential research in this field, including why there was such a low use of non-accidental trauma assessments in children younger than thirty-six months of age and why there was a significantly lower use of flexible nails in patients who were five to eleven years of age after the introduction of this guideline.

Investigation performed at the Department of Orthopaedic Surgery and Sports Medicine, Children’s National Medical Center, Washington, District of Columbia

Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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