Journal of Clinical Densitometry: Assessment & Management of Musculoskeletal Health, vol. 17, no. 2, 219e224, 2014 Ó Copyright 2014 by The International Society for Clinical Densitometry 1094-6950/17:219e224/$36.00 http://dx.doi.org/10.1016/j.jocd.2014.01.007

2013 Pediatric Position Development Conference

2013 Pediatric Position Development Conference: Executive Summary and Reflections Catherine M. Gordon,*,1 Mary B. Leonard,2 and Babette S. Zemel2 1

2

Division of Adolescent Medicine, Hasbro Children’s Hospital and Brown University, Providence, RI, USA; and Department of Pediatrics, Children’s Hospital of Philadelphia and the University of Pennsylvania, Philadelphia, PA, USA

Abstract The International Society for Clinical Densitometry (ISCD) convened its second Pediatric Position Development Conference (PDC) on October 2e3, 2013 in Baltimore, MD. The conference was co-sponsored by the American Society for Bone and Mineral Research (ASBMR) and was held immediately before their annual meeting. The aim of a PDC is to make recommendations for standards in the field of bone densitometry. The recommendations address issues such as quality control, data acquisition and analysis, and the interpretation and reporting of bone densitometric results. In 2007, ISCD convened its first Pediatric PDC to address issues specific to skeletal health assessments in children and adolescents. The 2013 Pediatric PDC focused on advances in the field since that initial conference that would lead to revisions of the original positions. Topics for consideration were developed by the ISCD and its Scientific Advisory Committee. Clinically relevant questions related to each topic were assigned to task forces for a comprehensive review of the medical literature and subsequent presentation of reports to an international panel of experts. Expert panelists included representatives from both the ISCD and ASBMR. The recommendations of the PDC Expert Panel were subsequently reviewed by the ISCD Board of Directors and positions accepted by majority vote. The approved recommendations became the Official Positions of the ISCD. The positions are to be submitted to the ASBMR for its consideration for endorsement. Topics considered at the Pediatric PDC included fracture prediction and definition of osteoporosis, dual-energy X-ray absorptiometry assessment in chronic diseases that may affect the skeleton, dual-energy X-ray absorptiometry interpretation and reporting, quantitative computed tomography measurements, and densitometry in infants and young children. We discuss potential implications of the new recommendations and factors leading to a change in the wording of these positions, considering the science that has evolved over the past 6 yr. Key Word: Children; densitometry; osteoporosis; pediatrics.

as necessitated by advances in the field. The Official Positions are widely used by clinicians and technologists as a reference for quality control, acquisition, analysis, interpretation, and reporting, and form the basis for the material taught in the ISCD Bone Densitometry Courses. The Official Positions resulting from any PDC provide clinicians, technologists, and investigators with a reference standard for skeletal health assessments (1). Because the field of bone densitometry, and in particular the pediatric bone health field, is new and evolving, some clinically important issues that were addressed at the PDC are not accompanied by robust medical evidence and are based largely on expert opinion. Despite the limitations inherent in any subjective process such as a PDC, the

Introduction The Official Positions of the International Society for Densitometry (ISCD) provide official recommendations for the use of bone densitometry for both clinical care and research. Once established, Official Positions are reevaluated periodically at a Position Development Conferences (PDC), Received 01/14/14; Accepted 01/14/14. *Address correspondence to: Catherine M. Gordon, MD, MSc, Division of Adolescent Medicine, Hasbro Children’s Hospital, 593 Eddy Street, Providence, RI 02903. E-mail: catherine_gordon@ brown.edu

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220 ISCD, and the American Society for Bone and Mineral Research (ASBMR), the co-sponsors of the Pediatric PDC, believe that it is essential to provide clinicians and technologists with the best distillation of current knowledge in the discipline of bone densitometry, which is the primary aim of a PDC. The Official Positions and accompanying commentary documents also provide an important focus for the scientific community to consider further research to resolve areas of controversy and fill gaps in knowledge. As for our first Pediatric PDC in 2007, the topics addressed at the recent 2013 conference were selected by the ISCD and the Pediatric Scientific Advisory Committee. Four of the topics had been addressed previously at the initial PDC in 2007. For the first time, we explored potential uses of bone densitometry measurements in infants and young children, a topic of growing interest in the pediatric bone field (2). The topic addressed by each task force was deemed to be clinically relevant, have a perceived need for an Official Position because of lack of overwhelming medical evidence or its controversial nature, and have a reasonable likelihood of achieving a consensus by the Expert Panel (3). The 5 topic areas included: fracture prediction and definition of osteoporosis, DXA assessment in chronic diseases that may affect the skeleton, DXA interpretation and reporting, quantitative computed tomography (QCT) measurements, and densitometry in infants and young children. The procedures followed at the second Pediatric PDC were similar to those followed previously (1). The 3 co-chairs (CMG, MBL, and BSZ) oversaw the planning and conduct of the 2013 Pediatric PDC. Experts in pediatric skeletal health were identified to serve as a task force chair for each area of focus. The Task Force members were then selected by each task force chair. The Task force members performed a medical literature search relevant to their area of focus using a method modified from that used by the Cochrane reviews (4). Appropriate articles were selected from these searches for further review. Each Task Force submitted a draft of their Official Positions that were presented and discussed at the PDC in Baltimore, MD. International experts in the field of bone densitometry were invited to serve as expert panelists. Ten accepted the invitation; 7 were able to attend the PDC in Baltimore, MD. The Expert Panel included individuals from throughout the world, and representatives chosen by the ASBMR or ISCD. The role of the Expert Panel was to review the proposed Official Positions, cast a preliminary vote before the conference to identify areas of controversy, and then re-vote after hearing presentations and the discussion at the PDC. The PDC moderators experienced in the RAND (Santa Monica, California)/University of California at Los Angeles (UCLA) Appropriateness Method were selected by the co-chairs. In collaboration with clinicians at UCLA, the RAND Corporation developed this method to synthesize the scientific literature and expert opinion on health care topics. The 2 moderators (CBL and MBL) assisted the Task Force chairs in the wording and refinement of statements derived from the task forces. They

Gordon, Leonard, and Zemel also led the discussion and rating by the Expert Panel during the October 3, 2013 conference. All Official Positions for the 2013 PDC were rated by the Expert Panel with respect to the following categories: appropriateness, quality of evidence, strength of recommendation, and application. Statements that the Expert Panel rated as ‘‘appropriate without disagreement’’ according to criteria derived from the RAND/UCLA Appropriateness Method (5) were referred to the ISCD Board of Directors with a recommendation to become Official Positions. A statement was defined as ‘‘appropriate’’ when the expected health benefit exceeded the expected negative consequences such that it was worth performing (5). Recommended Official Positions that were rated by the Expert Panel were then rated according to the necessity to perform in all circumstances (i.e., whether the health benefits outweighed the risks to such an extent that it must be offered to all patients) (5). The scale for quality of evidence included: good (evidence included consistent results from well-designed, well-conducted studies in representative populations), fair (evidence is sufficient to determine effects on outcomes, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies), or poor (evidence is insufficient to assess the effects on outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information). The criteria used to define strength of recommendations included: A (strong recommendation supported by the evidence), B (supported by some evidence), and C (supported primarily by expert opinion). The application of the recommendations was either W (worldwide recommendation) or L (application of recommendation varies according to local requirements). The preliminary Official Positions were presented by each task force chair or their representative with supportive evidence in a morning session that was open to the public and attended by ISCD and ASBMR members, representatives from companies with interests in bone health and skeletal assessment, and other individuals with an interest in bone disease and densitometry. All participants were encouraged to provide comments and suggestions to the expert panelists. In the afternoon and evening closed sessions, the Expert Panel with the PDC co-chairs, task force chairs, and co-moderators determined the final wording of the Official Positions. These recommendations were then presented to the ISCD Board on December 20, 2013 for review and voting. The Board did not alter the content or wording of the proposed Official Positions. All recommendations were approved by a majority vote of the ISCD Board of Directors and became the 2013 ISCD Official Positions. At the time of press, the ASBMR had not received the final manuscript for consideration of its endorsement. Compared with the first PDC, for some task forces, the number of official positions has been reduced or the wording of the positions has been changed. For some of the positions, the quality of the evidence is rated lower (rather than higher) despite the passing of 6 yr and the expectation that new data would have been generated that would inform and enhance the strength of the recommendations. However, it is important

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Pediatric Position Development Conference to note that only 1 of the expert panelists was the same for the 2013 Pediatric PDC in Baltimore vs the initial 2007 Pediatric PDC in Montreal, Quebec, Canada. We also speculate that as more evidence has become available and our understanding of bone assessments is more refined for young children and adolescents, the Expert Panel may have viewed each position more critically compared with what transpired in 2007. Thus, the adage ‘‘less may be more’’ may have become apparent as a realization of gaps in knowledge became more readily apparent during this second Pediatric PDC. Lastly, although the RAND methodology follows a rigorous algorithm, nonetheless, the subjective nature of rating positions as part of a PDC is important to consider as one reads these new and revised Official Positions. The 5 accompanying articles from the task forces provide the detailed background, rationale, and published references, which led to the development of the Official Positions for each given topic. A text file and downloadable PDF of the ISCD Official Positions can be found at the ISCD Web site (www.ISCD.org). All 2013 Pediatric PDC participants are listed in Appendix. In conclusion, we are extremely grateful to the many individuals whose collective talents and hours of volunteer service made this second Pediatric PDC and publication of the task force documents possible. We wish to acknowledge the extraordinary efforts of the PDC Task Force Chairs and members, the moderators, and the Expert Panel, who represent a distinguished group of international experts. We are also grateful to Peter Brown from the ISCD and Ann Elderkin from the ASBMR for their gracious support of this initiative. Lastly, we wish to thank Alexion Pharmaceuticals and the Crohn’s and Colitis Foundation of America whose support made the convening of this international team of experts possible.

New ISCD Official Positions The new ISCD Official Positions resulting from the 2013 Pediatric PDC are summarized below.

Fracture Prediction and the Definition of Osteoporosis in Children and Adolescents Task Force  Evaluation of bone health should identify children and adolescents who may benefit from interventions to decrease their elevated risk of a clinical significant fracture. Grade: Fair/GooddB/CdW  The finding of 1 or more vertebral compression (crush) fractures is indicative of osteoporosis, in the absence of local disease or high energy trauma. In such children and adolescents, measuring bone mineral density (BMD) adds to the overall assessment of bone health. Grade: FairdBdW  The diagnosis of osteoporosis in children and adolescents should not be made on the basis of densitometric criteria alone. Grade: PoordCdW

221  In the absence of vertebral compression (crush) fractures, the diagnosis of osteoporosis is indicated by the presence of both a clinically significant fracture history and BMD Z-score of 2.0 or lower. A clinically significant fracture history is one or more of the following: (1) 2 or more long-bone fractures by the age of 10 yr; (2) 3 or more long-bone fractures at any age up to age 19 yr. A bone mineral content (BMC)/BMD Zscore higher than 2.0 does not preclude the possibility of skeletal fragility and increased fracture risk. Grade: PoordCdW

Dual Energy X-ray Absorptiometry Interpretation and Reporting in Children and Adolescents Task Force  DXA is the preferred method for assessing BMC and areal BMD (aBMD). Grade: GooddAdW  The posteroanterior spine and total body less head (TBLH) are the preferred skeletal sites for performed BMC and aBMD measurements in most pediatric subjects. Other sites may be useful depending on the clinic need. Grade: FairdBdW  The hip is not a preferred measurement site in growing children because of variability in skeletal development. Grade: FairdBdW  If a follow-up DXA scan is indicated, the minimum interval between scans is 6e12 mo. Grade: FairdBdW  Soft tissue measures in conjunction with whole-body scans may be helpful in evaluating patients with chronic conditions associated malnutrition or with muscle and skeletal deficits. Grade: FairdBdW  An appropriate data set must include a sample of healthy representatives of the general population sufficiently large to capture variability in bone measures that takes into consideration gender, age, and race/ethnicity. Grade: GooddAdW  When upgrading densitometer instrumentation or software, it is essential to use reference data valid for the hardware and software technological updates. Grade: GooddBdW  In children with short stature or growth delay, spine and TBLH BMC and aBMD results should be adjusted. For the spine, adjust either BMD or the height Z-score. For TBLH, adjust using the height Z-score. Grade: FairdBdW  A baseline DXA report should contain the following information: DXA manufacturer, model and software version; referring physician; patient age, gender, race/ ethnicity, weight, and height; relevant medical history including previous fractures; indication for study; Tanner stage and bone age results, if available; technical quality; BMC and aBMD; BMC and aBMD Z-score; source of

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reference data for Z-score calculation; adjustments made for growth; and interpretation. Recommendations for the necessity and timing of the next DXA study are optional. Grade: FairdCdL T-scores should not appear in pediatric DXA reports. Grade: GooddAdW The term ‘‘osteoporosis’’ should not appear in pediatric DXA reports without a clinically significant fracture history. Grade: GooddBdW The term ‘‘osteopenia’’ should not appear in pediatric DXA reports. Grade: Fair/PoordCdW ‘‘Low bone mass or bone mineral density’’ is the preferred term for pediatric DXA reports when BMC or aBMD Zscores are less than or equal to 2.0 standard deviation. Grade: PoordCdW Serial DXA reports should include the same information as for baseline testing. Additionally, indications for the follow-up scan, technical comparability of studies, changes in height and weight, and change in BMC and aBMD Z-scores should be reported. Grade: FairdCdW

Bone Health in Children and Adolescents With Chronic Diseases That May Affect the Skeleton Task Force  DXA measurement is part of a comprehensive skeletal health assessment in patients with increased risk of fracture. Grade: GooddBdW  In patients with primary bone disease or at risk for secondary bone disease, a DXA should be performed when the patient may benefit from interventions to decrease their elevated risk of a clinically significant fracture, and the DXA results will influence that management. Grade: FairdBdW  DXA should not be performed if safe and appropriate positioning of the child cannot be assured. Grade: FairdCdW

QCT in Children and Adolescents Task Force  There is no preferred method for QCT for clinical application in children and adolescents. Grade: FairdCdW  QCT, peripheral QCT, and high-resolution peripheral QCT are primarily the research techniques used to characterize bone deficits in children. They can be used clinically in children where appropriate reference data and expertise are available. Grade: FairdBdW  It is imperative that QCT protocols in children using general CT scanners use appropriate exposure factors, calibration phantoms, and software to optimize results and minimize radiation exposure. Grade: GooddBdW

Gordon, Leonard, and Zemel Bone Densitometry in Infants and Young Children  DXA is an appropriate method for clinical densitometry of infants and young children. Grade: FairdBdW  DXA lumbar spine measurements are feasible and can provide reproducible measures of BMC and aBMD for infants and young children aged 0e5 yr. Grade: FairdBdW  DXA whole body measurements are feasible and can provide reproducible measures or BMC and aBMD for children aged 3 yr or older. Grade: FairdBdW  DXA whole body BMC measurements for children aged younger than 3 yr are of limited clinical utility owing to feasibility and lack of normative data. The aBMD measurement should not be used routinely owing to difficulty in appropriate positioning. Grade: FairdCdW  Forearm and femur measurements are technically feasible in infants and young children, but there is insufficient information regarding methodology, reproducibility, and reference data for these measurement sites to be clinically useful at this time. Grade: FairdCdW  In infants and children aged younger than 5 yr, the impact of growth delay on the interpretation of the DXA results should be considered, but it is not quantifiable presently. Grade: FairdCdW

References 1. Baim S, Leonard MB, Bianchi ML, et al. 2008 Official Positions of the International Society for Clinical Densitometry and executive summary of the 2007 ISCD Pediatric Position Development Conference. J Clin Densitom 11:6e21. 2. Kalkwarf HJ, Zemel BS, Yolton K, Heubi JE. 2013 Bone mineral content and density of the lumbar spine of infants and young toddlers: influence of age, sex, race, growth, and human milk feeding. J Bone Miner Res 28:206e212. 3. The Writing Group for the ISCD Position Development Conference. 2004 Diagnosis of osteoporosis in men, premenopausal women and children. J Clin Densitom 7:17e26. 4. Anonymous. 2002 Cochrane reviews handbook, vol. 4.1.5. Oxford, UK: The Cochrane Collaboration. 5. Fitch K, Bernstein SJ, Aguilar MS, et al. 2001 The RAND/UCLA appropriateness method user’s manual. Santa Monica, CA: The RAND Corporation.

Appendix Pediatric Position Development Conference (PDC) Co-Chairs: Catherine M. Gordon, MD, MSc, Hasbro Children’s Hospital and Brown University, Providence, RI, USA Mary Leonard, MD, MSCE, The Children’s Hospital of Philadelphia and the the University of Pennsylvania, Philadelphia, PA, USA

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Pediatric Position Development Conference Babette Zemel, PhD, The Children’s Hospital of Philadelphia and the University of Pennsylvania, Philadelphia, PA, USA

Quantitative Computed Tomography in Children and Adolescents Task Force Chair: Judith Adams, MBBS, University of Manchester, Manchester, UK

Task Force Members: Professor Klaus Engelke, PhD, University of Erlangen, Erlangen, Germany Kate Ward, PhD, University of Manchester, Manchester, UK. Babette Zemel, PhD, The Children’s Hospital of Philadelphia, Philadelphia, PA, USA

Bone Health in Children and Adolescents With Chronic Diseases That May Affect the Skeleton Task Force Chair: Maria-Luisa Bianchi, MD, Istituto Auxologico Italiano IRCCS, Milano, Italy

Task Force Members: Susanne Bechtold, MD, Department of Pediatrics, Medical University Munich, Munich, Germany Wolfgang Hogler, DSc, Department of Endocrinology and Diabetes, Birmingham Children’s Hospital, Birmingham, UK Mary B. Leonard, MD, MSCE, The Children’s Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA M. Zulf Mughal, MBChB, Department of Pediatric Medicine, Royal Manchester Children’s Hospital, Manchester, UK Eckhart Sch€ onau, MD, Klinik und Poliklinik f€ur Kinderund Jugendmedizin, Universit€atsklinik K€ oln, K€ oln, Germany Francisco A. Sylvester, MD, Connecticut Children’s Medical Center, Hartford, CT, USA Maria Vogiatzi, MD, Department of Pediatric Endocrinology, Weill Medical College of Cornell University, New York, NY, USA Marry M. van den Heuvel-Eibrink, MD, PhD, Pediatric Oncology-Hematology, Erasmus MCeSophia Children’s Hospital, Rotterdam, The Netherlands Leanne Ward, MD, Children’s Hospital of Eastern Ontario, Ottawa, ON, Canada

Fracture Prediction and the Definition of Osteoporosis in Children and Adolescents Task Force Chair: Nicholas Bishop, MD, FRCPCH, Academic Unit of Child Health, Department of Human Metabolism, University of Sheffield, Sheffield, UK

Task Force Members: Paul Arundel, Sheffield Children’s Hospital, University of Sheffield, Sheffield, UK

223 Emma Clark, MD, University of Bristol, Bristol, UK Paul Dimitri, BSc, MBChB, FRCPCH, PhD, Sheffield Children’s Hospital, University of Sheffield, Sheffield, UK Joshua Farr, PhD, College of Medicine, Mayo Clinic, Rochester, MN, USA Graeme Jones, MD, Menzies Research Institute, Hobart, Australia Outi Makitie, MD, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland Craig F. Munns, MBBS, PhD, The Children’s Hospital at Westmead, Sydney, New South Wales, Australia Nick Shaw, MD, Birmingham Children’s Hospital, Birmingham, UK

Dual-Energy X-ray Absorptiometry Interpretation and Reporting in Children and Adolescents Task Force Chair: Nicola Crabtree, PhD, MSc, Birmingham Children’s Hospital, Birmingham, UK

Task Force Members: Asma Arabi, MD, MS, CCD, American University of Beirut, Lebanon, NH, USA Laura K Bachrach, MD, Stanford University, Palo Alto, CA, USA Mary Fewtrell, MD, MB, ChB, UCL Institute of Child Health, London, UK Ghada El-Hajj Fuleihan, MD, MPH, American University of Beirut, Lebanon, NH, USA Heidi H. Kecskemethy, CBDT, Nemours/A.I. duPont Hospital for Children, Wilmington, DE, USA Maciej Jaworski, PhD, The Children’s Memorial Health Institute, Warsaw, Poland Catherine M. Gordon, MD, MSc, Hasbro Children’s Hospital and Alpert Medical School of Brown University, Providence, RI, USA

Bone Densitometry in Infants and Young Children Chair: Heidi Kalkwarf, PhD, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

Task Force Members: Steven A. Abrams, MD, PhD, Baylor College of Medicine, Houston, TX, USA Linda A. DiMeglio, MD, MPH, Riley Children’s Hospital, Indiana University, Indianapolis, IN, USA Winston W. K. Koo, MD, Louisiana State University Health Sciences Center, Shreveport, LA, USA Bonny L. Specker, PhD, South Dakota State University, Brookings, SD, USA Hope Weiler, PhD, School of Dietetics and Human Nutrition, McGill University, Montreal, QC, Canada

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224 Co-Moderators: Craig L. Langman, MD, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA Mary B. Leonard, MD, MSCE, Children’s Hospital of Philadelphia, Philadelphia, PA, USA

Expert Panel Members: *Laura Tosi, MD, Children’s National Medical Center, Washington, DC, USA *Linda DiMeglio, MD, MPH, Riley Children’s Hospital, University of Indiana, Indianapolis, IN, USA Rachel Gafni, MD, National Institutes of Health, Bethesda, MD, USA *Keith J. Loud, MD, MSc, Dartmouth-Hitchcock Medical Center, Dartmouth University, Lebanon, NH, USA *Thomas Carpenter, MD, Yale University School of Medicine, New Haven, CT, USA Francis Glorieux, MD, PhD, Shriners Hospital for Children, Montreal, QC, Canada

Gordon, Leonard, and Zemel *John Pettifor, MB, BCh, Department of Pediatrics, Chris Hani Baragwanath Hospital, University of Witwatersrand, Johannesburg, South Africa. *William D. Leslie, MD, MSc, University of Manitoba, Winnipeg, Manitoba, Canada *Allison Boyce, MD, Children’s National Medical Center, Washington, DC, USA Ingrid Holm, MD, MPH, Boston Children’s Hospital, Boston, MA, USA *Attended Pediatric PDC.

American Society for Bone and Mineral Research (ABMR) and the International Society for Clinical Densitometry (ISCD) Staff: Ann Elderkin, PA, Executive Director, ASBMR Peter Brown, Executive Director & Chief Executive Officer, ISCD Mary Saier, Director of Certification, Accreditation & Financial Operations, ISCD

Journal of Clinical Densitometry: Assessment & Management of Musculoskeletal Health

Volume 17, 2014

2013 Pediatric Position Development Conference: executive summary and reflections.

The International Society for Clinical Densitometry (ISCD) convened its second Pediatric Position Development Conference (PDC) on October 2-3, 2013 in...
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