General

Guideline Title

The official positions of the International Society for Clinical Densitometry: body composition analysis reporting.

Bibliographic Source(s)

  • Petak S, Barbu CG, Yu EW, Fielding R, Mulligan K, Sabowitz B, Wu CH, Shepherd JA. The official positions of the International Society for Clinical Densitometry: body composition analysis reporting. J Clin Densitom. 2013 Oct-Dec;16(4):508-19. [92 references] PubMed

Guideline Status

This is the current release of the guideline.

Recommendations

Major Recommendations

The definitions for quality of evidence ( Good, Fair, Poor ), strength of recommendations ( A–C ), and application of recommendations ( W, L ) are provided at the end of the “Major Recommendations” field.

What Measures Should Appear on All Reports?

International Society for Clinical Densitometry (ISCD) Official Position

  • For adults total body (with head) values of body mass index (BMI), bone mineral density (BMD), bone mineral content (BMC), total mass, total lean mass, total fat mass, and percent fat mass should appear on all reports. Grade: Fair-C-W

What Additional Measures and Indices May Be Helpful during Evaluation of Lean Mass and Adiposity?

ISCD Official Position

  • Dual-energy x-ray absorptiometry (DXA) measures of adiposity and lean mass include visceral adipose tissue (VAT), appendicular lean mass index (ALMI: appendicular lean mass/height 2 [ht 2 ]), android/gynoid ratio (A/G ratio), trunk to leg fat mass ratio, lean mass index (LMI: total lean mass/ht 2 ), and fat mass index (FMI: fat mass/ht 2 ). The clinical utility of these measures is currently uncertain. Grade: Fair-C-W

What Reference Database Should Be Used to Represent the General Healthy Population According to Age, Health Status, Race, and Physical Activity?

ISCD Official Position

  • When comparing to the US population, the National Health and Nutrition Examination Survey (NHANES) 1999–2004 body composition (BC) data are most appropriate for different races, both sexes, and for ages 8 to 85 years. ( Note : reference to a population does not imply health status.) Grade: Fair-C-L

What Reference Database Should Be Used to Report DXA BMC for 4-Compartment BC Analyses?

ISCD Official Position

  • Total body BMC as represented in the NHANES 1999–2004 reference data should be used when incorporating DXA in 4-compartment models. Grade: Fair-B-W

How Should Reference Data Be Used in Reporting DXA BC?

  1. Should T-scores be used in reporting BC measures?
  2. Should Z-scores be used in reporting BC measures?
  3. Should percentile values be used in reporting BC values?

ISCD Official Position

  • Both Z-scores and percentiles are appropriate to report if derived using methods to adjust for non-normality. Grade: Fair-C-W

How Are DXA BC Values Used for Risk Stratification and Diagnosis of Obesity?

ISCD Official Position

  • The use of DXA adiposity measures (percent fat mass or FMI) may be useful in risk-stratifying patients for cardiometabolic outcomes. Specific thresholds to define obesity have not been established. Grade: Fair-C-W

How Are DXA BC Values Used for Risk Stratification and Diagnosis of Sarcopenia?

ISCD Official Position

  • “Low lean mass” could be defined using appendicular lean mass divided by height squared (ALM/height 2 ) with Z-scores derived from a young adult, race, and gender-matched population. Thresholds for low lean mass from consensus guidelines for sarcopenia await confirmation. Grade: Fair-C-W

ISCD Official Position

  • No position could be agreed upon at this time.

Definitions:

Quality of Evidence

Good : Evidence includes 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.

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.

Strength of Recommendations

A : Strong recommendation supported by the evidence

B : Recommendation supported by the evidence

C : Recommendation supported primarily by expert opinion

Application of Recommendations

W : Worldwide recommendation

L : Application of recommendation may vary according to local requirements

Clinical Algorithm(s)

None provided

Scope

Disease/Condition(s)

  • Sarcopenia
  • Obesity
  • Human immunodeficiency virus (HIV) complications such as lipodystrophy and lipoatrophy

Guideline Category

  • Diagnosis
  • Evaluation
  • Risk Assessment
  • Technology Assessment

Clinical Specialty

  • Endocrinology
  • Family Practice
  • Geriatrics
  • Internal Medicine
  • Obstetrics and Gynecology
  • Radiology
  • Rheumatology

Intended Users

  • Physicians

Guideline Objective(s)

  • To outline the new 2013 International Society for Clinical Densitometry Official Positions regarding analysis and reporting of body composition (BC) analysis studies using dual energy x-ray absorptiometry (DXA)
  • To provide evidence-based standards for the reporting and clinical application of DXA-based measures of BC

Target Population

Individuals at risk of very low lean body mass, very low fat mass, or very high fat mass (either regionally or systemically)

Interventions and Practices Considered

  1. Dual-energy x-ray absorptiometry (DXA) measurements of body composition (BC)
  2. Parameters for inclusion in DXA BC reports * Body mass index (BMI) * Bone mineral density (BMD) * Body mineral content (BMC) * Total mass * Total lean mass * Total fat mass * Percent fat mass
  3. Additional measures and indices * Visceral adipose tissue (VAT) * Appendicular lean mass index (ALMI: appendicular lean mass/height2 [ht2]) * Android/gynoid ratio (A/G ratio) * Trunk to leg fat mass ratio * Lean mass index (LMI: total lean mass/ht2) * Fat mass index (FMI: fat mass/ht2)
  4. Use of the National Health and Nutrition Examination Survey (NHANES) 1999-2004 BC dataset as an age-, gender-, and race-specific reference and to calibrate BMC in 4-compartment models
  5. Use of Z-scores and percentiles of BC measures
  6. Use of DXA measures for risk stratification and diagnosis of obesity and sarcopenia

Major Outcomes Considered

Accuracy, precision, and predictive value of dual-energy x-ray absorptiometry (DXA) measures of body composition (BC)

Methodology

Methods Used to Collect/Select the Evidence

  • Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

Task Force members performed a medical literature search relevant to the clinical and/or technical questions using a method modified from that utilized by the Cochrane reviews. The literature searches were conducted using the electronic database PubMed. Appropriate articles were selected from the searches for further review.

Literature searches were performed in PubMed from 1/1/1990 through 12/31/2012, by the use of keywords used in the body composition (BC) literature to help define what parameters are useful in clinical application (see the Appendix in the original guideline document for specific search strategies). The search results were distributed to the task force for review and assessment in relation to the questions posed.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

  • Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Quality of Evidence

Good: Evidence includes 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.

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.

Methods Used to Analyze the Evidence

  • Review of Published Meta-Analyses
  • Systematic Review

Description of the Methods Used to Analyze the Evidence

The development of the International Society for Clinical Densitometry (ISCD) Official Positions was undertaken according to the RAND/University of California, Los Angeles (UCLA) Appropriateness Method (RAM). This is a mechanism to determine whether procedures or indications are expected to provide a specific health benefit, designated as “appropriate,” that exceeds the potential negative consequences by such a wide margin that the procedure or indication is worth doing, exclusive of cost. The rationale for use of the RAM for the Position Development Conference (PDC) is based on its ability to combine the best available scientific evidence with the collective judgment of worldwide experts in the bone field, to yield appropriate recommendations that are patient- and technology-specific.

Methods Used to Formulate the Recommendations

  • Expert Consensus (Consensus Development Conference)

Description of Methods Used to Formulate the Recommendations

Position Development Conference (PDC) Expert Panel

Concurrent with Task Force work, international experts in the field of bone densitometry and societies specific to skeletal health were contacted by the PDC Steering Committee to serve as member panelists. Twelve experts agreed to participate on the PDC Expert Panel. In addition to individuals representing many regions of the world, one official representative from each of the following professional societies were participants on the expert panel: The American Society for Bone and Mineral Research (ASBMR), the North American Menopause Society (NAMS), and the National Osteoporosis Foundation (NOF). The role of the Expert Panel was to review the proposed Official Positions and supportive documents developed by the task forces and make final recommendations to the International Society for Clinical Densitometry Board of Directors (ISCD BOD).

PDC Moderators

PDC panel Moderators with experience in the RAND/University of California, Los Angeles (UCLA) Appropriateness Method (RAM) were selected by the Steering Committee. Two moderators assisted the Chair of the PDC in the development and refinement of statements derived from the initial Task Forces questions and sub-questions and, along with the Chair of the PDC, lead the discussion and the rating by the Expert Panel during the PDC in Tampa, Florida, USA.

Grading of the Official Positions

All Official Positions for the 2013 PDC were rated by the Expert Panel in the following categories: appropriateness, necessity, quality of evidence, strength of recommendations and application of recommendations (see the “Rating Scheme for the Strength of the Evidence” and the “Rating Scheme for the Strength of the Recommendations” fields).

Proposed ratings in all cases, except the RAM ratings for appropriateness and necessity for each of the above categories, were included in the preliminary Official Positions crafted by each Task Force. Final ratings were determined by the on site meeting, convened Expert Panel that included appropriateness and necessity.

A rating of “appropriate” was required in order for a statement to be sent to the BOD for selection as an ISCD Official Position. Ratings of each Official Position from the 2013 PDC are expressed in the form of four characters representing quality of the evidence, strength of the recommendation, application of the recommendation, and whether it is necessary as previously described. For example, a rating “Good-A-W-Necessary” indicates that the evidence includes consistent results from well-designed, well-conducted studies in representative populations, a strong recommendation supported by the evidence, worldwide recommendation, and is necessary to perform in all instances. Since PDC topics are often selected because strong medical evidence is unavailable, it is the nature of the process that Official Positions are not always supported by the highest possible level of evidence. Nevertheless, the ISCD Official Positions encourage consistent approaches in the clinical practice of bone densitometry, and focus attention on issues that require further study.

PDC Procedures

After the initial selection of topics by the Board of Directors and Scientific Advisory Committee, the PDC Steering Committee selected three Task Force chairpersons, one for each of the three major PDC topics. Thereafter, the PDC Steering Committee and Task Force chairpersons worked collectively to select international experts as members of their respective Task Forces with the knowledge required to evaluate their assigned PDC topic. All topic questions and sub-questions that were generated by each Task Force were thoroughly researched in the scientific medical literature.

Prior to the PDC meeting in Tampa, Florida, USA, topic questions and sub-questions were converted into recommendation statements that were sent to the Expert Panel for an initial “appropriateness” rating. The PDC required a median “appropriateness” rating in either the upper third or lower third of the rating continuum (continuum was 1 to 9 with clusters 7 to 9 representing the upper third and clusters 1 to 3 representing the lower third) without “disagreement.” “Disagreement” was defined as lack of consensus being predetermined to be four or more Expert Panelists rating in extreme clusters 1 to 3 and 7 to 9. In circumstances where the median “appropriateness” rating was less than 7, no Official Position was developed.

In making its decisions, the Expert Panel considered the level of the medical evidence, expert opinion, and the clinical need for a recommendation. In some instances, regulatory issues received consideration. The statements rated as “appropriate” with a median score of 7 or higher without “disagreement” by the Expert Panel were designated Official Positions. The statements rated as “uncertain” with a median score between four and six or any median score with “disagreement” were further discussed at the PDC. After the initial rating the documents supporting all Task Forces’ recommendations were sent to the Expert Panelists for review. In brief, Task Force chairs presented reports on their topics supporting the “uncertain” statements to the Expert Panelists in closed session on the first day of the conference. These statements were then edited by Task Force chairs, if necessary, reflecting suggestions made by the Expert Panelists. Re-rating of “uncertain” statements occurred during each Task Force chairpersons’ presentation when the PDC Moderators felt there was a significant likelihood of change in the opinions of the Expert Panel.

After all statements rated as “appropriate without disagreement” had been selected and all supporting evidence presented, the Expert Panel performed a final rating for necessity, quality of the evidence, strength of the recommendation, and application of the recommendation. The proposed Official Positions with supportive evidence were presented by the Task Force chairs at a meeting open to the public (in conjunction with the ISCD Annual Meeting) and attended by ISCD members, representatives from companies with interests in bone health and skeletal assessment, and other individuals with interest in bone disease and densitometry. All participants were encouraged to provide comments and suggestions to the expert panelists. On the next day, the Expert Panelists, in closed session, determined final wording of the proposed Official Positions.

Rating Scheme for the Strength of the Recommendations

All Official Positions for the 2013 Position Development Conference were rated by the Expert Panel in the following categories:

Appropriateness : Statements that the Expert Panel rated as “appropriate without disagreement” according to predefined criteria derived from the RAND/University of California, Los Angeles (UCLA) Appropriateness Method (RAM) were referred to the International Society for Clinical Densitometry Board of Directors (ISCD BOD) with a recommendation to become ISCD Official Positions. A statement was defined as “appropriate” when the expected health benefit exceeded the expected negative consequences by a significant margin such that it was worth performing.

Necessity : Recommended Official Positions that were rated by the Expert Panel were then rated according to 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. Necessity rating was conducted in a similar fashion as the appropriateness rating, in that each Official Position had to be rated as necessary without disagreement using similar predefined RAM criteria.

Strength of Recommendations

A : Strong recommendation supported by the evidence

B : Recommendation supported by the evidence

C : Recommendation supported primarily by expert opinion

Application of Recommendations

W : Worldwide recommendation

L : Application of recommendation may vary according to local requirements

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

  • External Peer Review
  • Internal Peer Review

Description of Method of Guideline Validation

The proposed Official Positions with supportive evidence were presented by the Task Force chairs at a meeting open to the public and attended by International Society for Clinical Densitometry (ISCD) members, representatives from companies with interests in bone health and skeletal assessment, and other individuals with interest in bone disease and densitometry. All participants were encouraged to provide comments and suggestions to the expert panelists. On the final day, the Expert Panelists, in closed session, determined final wording of the proposed Official Positions.

Following completion of the Position Development Conference, the Steering Committee finalized recommendation wording without changing content. These recommendations were then presented to the International Society for Clinical Densitometry Board of Directors (ISCD BOD) for review and voting. The BOD did not alter the content or wording of the proposed Official Positions. Recommendations approved by a majority vote of the ISCD BOD became ISCD Official Positions.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is specifically stated for each recommendation (see the “Major Recommendations” field).

Since the field of bone densitometry is new and evolving, some clinically important issues that are addressed at the Position Development Conferences are not associated with robust medical evidence. Accordingly some Official Positions are based largely on expert opinion.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

  • Identification of those with localized or systemic loss of lean body mass warranting intervention
  • Identification of those with localized fat atrophy warranting intervention
  • Specification, among those with a high body mass index (BMI), of the proportions of body mass that are lean tissue and adipose tissue

Potential Harms

Low radiation exposure

Qualifying Statements

Qualifying Statements

Since Position Development Conference topics are often selected because strong medical evidence is unavailable, it is the nature of the process that Official Positions are not always supported by the highest possible level of evidence. Nevertheless, the International Society for Clinical Densitometry (ISCD) Official Positions encourage consistent approaches in the clinical practice of bone densitometry, and focus attention on issues that require further study.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy included publication of the International Society for Clinical Densitometry (ISCD) Official Positions in international journals that directly or indirectly pertain to skeletal diseases and the measurement of skeletal health.

Formal presentation of the ISCD Official Positions occurs at ISCD Annual Scientific Meetings, all ISCD Adult and Pediatric Bone Density Educational Courses, and ISCD Vertebral Fracture Assessment Educational courses. The Official Positions have been published in the society’s official journal, Journal of Clinical Densitometry and Assessment of Skeletal Health.

Implementation Tools

  • Foreign Language Translations
  • Quick Reference Guides/Physician Guides
  • Staff Training/Competency Material

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need

  • Living with Illness
  • Staying Healthy

IOM Domain

  • Effectiveness

Identifying Information and Availability

Bibliographic Source(s)

  • Petak S, Barbu CG, Yu EW, Fielding R, Mulligan K, Sabowitz B, Wu CH, Shepherd JA. The official positions of the International Society for Clinical Densitometry: body composition analysis reporting. J Clin Densitom. 2013 Oct-Dec;16(4):508-19. [92 references] PubMed

Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released

2013 Oct-Dec

Guideline Developer(s)

  • International Society for Clinical Densitometry - Nonprofit Organization

Source(s) of Funding

International Society for Clinical Densitometry

Guideline Committee

Analysis and Reporting of Body Composition Analysis Studies Using DXA Task Force 3

Composition of Group That Authored the Guideline

Task Force Members : Steven Petak, MD, JD, CCD ( Chair ), Department of Medicine, Houston Methodist Hospital, Houston, TX, USA; Carmen G. Barbu, MD, PhD, CCD, Carol Davila University, Elias Hospital Endocrinology Department, Bucharest, Romania; Elaine W. Yu, CCD, Department of Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA; Roger A. Fielding, PhD, Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA; Kathleen Mulligan, PhD, University of California San Francisco, San Francisco, CA, USA; Brian Sabowitz, MD, FACP, CCD, Department of Endocrinology, Diabetes, and Metabolism, University of Texas Health Sciences Center, San Antonio, TX, USA; Chih-Hsing Wu, MD, CCD, Department of Family Medicine, National Cheng Kung University Hospital, Tainan, Taiwan; John A. Shepherd, PhD, CCD, University of California San Francisco, San Francisco, CA, USA

Financial Disclosures/Conflicts of Interest

None disclosed

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available to subscribers from the Journal of Clinical Densitometry Web site.

Print copies: Available from the International Society for Clinical Densitometry, 101 Centerpoint Drive, Suite 208, Middletown, CT 06457; Phone: (860) 259-1000; Fax: (860) 259-1030; Web site: www.iscd.org.

Availability of Companion Documents

The following are available:

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on August 21, 2014. The information was verified by the guideline developer on September 30, 2014.

This summary is based on the original guideline, which is subject to the guideline developer’s copyright restrictions.

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