Standards of practice
Research Reporting Standards for Percutaneous Vertebral Augmentation

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Population Description

Accurate description of the patient population is essential for several reasons: (i) it enables a reader to determine whether a study is relevant to his or her patient population; (ii) it helps to delineate which patient subsets are likely to benefit from the intervention being described; and (iii) it facilitates meaningful comparison with other studies describing patient cohorts who were treated with the same or different medical, surgical, or interventional therapies. The main indications for

Treatment Description

Radiologic imaging has been a critical part of vertebral augmentation from its inception. Most procedures are performed with use of single-plane or biplane fluoroscopic guidance for needle placement and to monitor bone cement injection. The use of computed tomography (CT) has been described (25, 26) as well as cone-beam C-arm CT (27).

Outcomes Assessment

The goal of vertebral augmentation is to improve patients' quality of life by relieving pain and returning patients to their baseline level of activity before the onset of pain related to a vertebral compression fracture or neoplastic/tumoral destruction of a vertebral body. As a result of the differing underlying disease processes (eg, osteoporosis, malignancy, hemangioma), outcome measures will be different and the follow-up of these patients may be limited by life expectancy. To fully

Comparison Between Treatment Groups

The randomized clinical trial is the criterion standard of clinical research and is the methodology of choice for determining the safety and efficacy of vertebral augmentation treatments and for comparing them with other percutaneous, surgical, and medical therapies (55). However, it is recognized that most studies will be of lesser methodologic rigor as a result of practical reasons such as cost, patient recruitment, and/or ethical considerations. Randomized trials should be performed in

Conclusion

Published studies on vertebral augmentation have been limited by nonstandardized reporting, lack of long-term follow-up, and use of surrogate outcome measures. It is the purpose of these reporting standards to bring greater uniformity to vertebral augmentation research reported in the radiology literature. A summary of the requirements and recommendations for reporting are provided in Table 2. Some of these requirements and recommendations may be more applicable to large trials than small case

Acknowledgements

Dr. Martin G. Radvany authored the first draft of this document and served as topic leader during the subsequent revisions of the draft. Dr. Steve Millward is chair of the SIR Technology Assessment Committee and Dr. John Cardella is SIR Standards Division Councilor. Other members of the Technology Assessment Committees who participated in the development of this clinical practice guideline are (listed alphabetically): Mark Baerlocher, Filip Banovac, MD, John Dean Barr, MD, Gary J. Becker, MD,

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      Moreover, conservative therapy can lead to complications, often serious, in older or fragile patients. Currently, most authors agree on the indications and contraindications for the PVP procedure [2–9,15]. However, it is clear from the literature that many authors decline to use PVP for treating severe vertebral fractures, where the vertebral body height is reduced >70%; this condition has been considered an exclusion criteria [4], an unfavorable situation [10], or a relative contraindication [3] to PVP treatment.

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    M.J.W. received grant support from Siemens Medical Solutions. None of the other authors have identified a conflict of interest.

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