Letters

Additional Contributions: David Mackay, BVetMed, MSc, PhD, MRCVS, of the European Medicines Agency, reviewed the manuscript for accuracy and clarified the EMA's policy. Dr Mackay received no compensation for his assistance. Additional Information: Dr Doshi is personally acquainted with some European regulators who share an interest in this topic.

Author Affiliations: Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts (Jena); Department of Anesthesia, Stanford University Hospitals, Stanford, California (Sun); Medical Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland (Prasad).

1. Doshi P, Jefferson T. The first 2 years of the European Medicines Agency’s policy on access to documents: secret no longer. JAMA Intern Med. 2013;173(5):380-382.

Corresponding Author: Anupam B. Jena, MD, PhD, Department of Health Care Policy, Harvard Medical School, 180 Longwood Ave, Boston, MA 02115 ( jena @hcp.med.harvard.edu).

2. Jaeger M. Interim decision of the president of the general court in case T-44/13, AbbVie v European Medicines Agency (EMA). (General Court of the European Union 2013.) http://curia.europa.eu/juris/document/document.jsf ?text=&docid=137241&pageIndex=0&doclang=en&mode=lst&dir=&occ=first &part=1&cid=3667720. Accessed June 8, 2013.

Conflict of Interest Disclosures: None reported.

3. Jaeger M. Interim decision of the president of the general court in case T-73/13, InterMune v European Medicines Agency (EMA). (General Court of the European Union 2013.) http://curia.europa.eu/juris/document/document.jsf ?text=&docid=137242&pageIndex=0&doclang=en&mode=lst&dir=&occ=first &part=1&cid=937960. Accessed June 8, 2013. 4. Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G. Open clinical trial data for all? a view from regulators. PLoS Med. 2012;9(4):e1001202. 5. Dyer C. European drug agency’s attempts to improve transparency stalled by legal action from two US drug companies. BMJ. 2013;346:f3588. 6. European Medicines Agency. European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information. 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news _and_events/news/2013/04/news_detail_001779.jsp&mid =WC0b01ac058004d5c1. Accessed April 30, 2013. 7. European Medicines Agency. Publication and access to clinical-trial data. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013 /06/WC500144730.pdf. Accessed June 24, 2013. 8. GlaxoSmithKline. Data transparency. 2013. http://www.gsk.com/explore-gsk /how-we-do-r-and-d/data-transparency.html. Accessed June 19, 2013. 9. F. Hoffmann-La Roche Ltd. Roche Global Policy on Sharing of Clinical Trials Data. 2013. http://roche-trials.com/dataSharingPolicy.action. Accessed June 19, 2013.

1. Fleegler EW, Lee LK, Monuteaux MC, Hemenway D, Mannix R. Firearm legislation and firearm-related fatalities in the United States. JAMA Intern Med. 2013;173(9):732-740. 2. Centers for Disease Control and Prevention (CDC). Injury Prevention & Control: Data & Statistics (WISQARS). www.cdc.gov/injury/wisqars/index.html. Accessed May 24, 201.

To the Editor In the empirical model set up by Fleegler et al,1 rates with a common denominator are used on both sides of the regression equation. Such ratio variables are known to produce spurious results in linear regression models.2 This is also applic able to generalized linear models, eg, Poisson regression.2(p380) This potential problem can be avoided by applying the Poisson model for the analysis of rates.3 Do the findings reported by Fleegler et al1 change if the Poisson model for the analysis of ratios is used? Christian Westphal, Dipl-Vw Author Affiliation: Department of Statistics, University of Marburg, Marburg, Germany. Corresponding Author: Christian Westphal, Dipl-Vw, Department of Statistics, Faculty of Business Administration and Economics, University of Marburg, Universitaetsstrasse 25, Marburg 35037, Germany ([email protected] -marburg.de). Conflict of Interest Disclosures: None reported.

Firearm Legislation and Gun-Related Fatalities To the Editor With regard to the study by Fleegler et al,1 critics of stronger gun control policies argue that there is no rational impetus to strengthen the laws. They note that gun-related deaths have remained constant over the last 10 years; 10.4 gunrelated deaths per 100 000 in the United States in 2002 and 10.3 per 100 000 in 2011.2 Focusing on trends in gun-related deaths rather than totalgunshot injuries misrepresents the situation. In 2002, the incidence of nonfatal gunshot injuries in the United States was 20.5 per 100 000; in 2011 it was 23.7 per 100 000.2 The likely explanation is improvements in the management of trauma, such as prompt field stabilization and improved endovascular repair. The improvements have reduced the lethality of gunshot injuries, despite the proliferation of assaultstyle weapons. The declining lethality of gunshot injuries has been offset by increases in the rate of shootings, leaving the rate of gunrelated deaths relatively stable. In fact, gun violence in the United States has increased. Anupam B. Jena, MD, PhD Eric C. Sun, MD, PhD Vinay Prasad, MD jamainternalmedicine.com

1. Fleegler EW, Lee LK, Monuteaux MC, Hemenway D, Mannix R. Firearm legislation and firearm-related fatalities in the United States. JAMA Intern Med. 2013;173(9):732-740. 2. Kronmal RA. Spurious correlation and the fallacy of the ratio standard revisited. J R Stat Soc Ser A Stat Soc. 1993;156(3):379-392. 3. Osgood DW. Poisson-based regression analysis of aggregate crime rates. J Quant Criminol. 2000;16(1):21-43.

In Reply Jena and colleagues address the concern of an apparent rise in nonfatal gunshot injuries in the United States from 2002 to 2011, as reported in the Web-Based Injury Statistics Query and Reporting System (WISQARS) database. The methodology for collecting firearm fatality data differs from that for nonfatal injury data; the differences effect the interpretation of the data. By law, every state must provide information about deaths within its borders; thus, the accuracy of the firearm fatality data are considered excellent. However, rates of nonfatal firearm injuries are estimates based on data collected from a stratified probability sample of 66 US hospitals that participate in the National Electronic Injury Surveillance System–All Injury Program (NEISS-AIP). Although rates of nonfatal firearm injuries appear to have increased from 2002 to 2011, the uncertainty in the estimates precludes definitive conclusions. Improvements in the delivery of trauma care may have contributed to a JAMA Internal Medicine November 25, 2013 Volume 173, Number 21

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2011

Letters

stable injury fatality rate over the decade; however, this is an open question requiring further study. Westphal addresses the use of fatality rates in the Poisson regression models to determine the relationship between firearm legislation and firearm-related fatalities. The regression models we used in our study accurately evaluated this relationship 1 ; however, we repeated the analysis using Poisson models with counts of deaths rather than rates, adjusted for population. Using this methodology in our previous multivariable model, we found a similar effect of legislation (incident rate ratio for suicide, 0.41 in the fourth compared with the first quartile; 95% CI, 0.21-0.82). This effect persisted after correction for gun prevalence (incident rate ratio, 0.48; 95% CI, 0.23-0.98).

Eric W. Fleegler, MD, MPH Michael Monuteaux, PhD Rebekah Mannix, MD, MPH Author Affiliations: Division of Emergency Medicine, Boston Children’s Hospital, Harvard Medical School, Boston, Massachusetts (Fleegler, Monuteaux, Mannix).

4. The study was conducted in 2 hospitals. Generalizability of results is unknown. 5. The authors suggest that appropriateness should be assessed and compared across other health services.1 A recent study in 12 Spanish public and private hospitals across 6 regions shows that at least 11.9% of the lumbar MRI in routine practice are inappropriate; this proportion increases to 17.2% in private care and to 27.8% among patients without pain referred down to the leg.4 Differences in results may derive from limitations described in points 1 to 3 and from differences in methods, which in the Spanish study were designed to ensure that all lumbar MRIs classified as “inappropriate” were actually so, at the expense of underestimating its percentage.4 6. To reduce the inappropriate use of lumbar MRI, we advocate for implementing electronic clinical decision support tools and empowering radiologists to decline inappropriate lumbar MRI referrals.4,5 Francisco M. Kovacs, MD, PhD Estanislao Arana, MD, PhD Ana Royuela, PhD

Previous Presentation: Our study on firearm legislation and firearm-related fatalities in the United States1 was presented at the Pediatric Academic Societies; May 6, 2013; Washington, DC.

Author Affiliations: Spanish Back Pain Research Network (REIDE), Fundación Kovacs, Palma de Mallorca, Spain (Kovacs, Arana, Royuela); Research Department, Fundación Kovacs, Palma de Mallorca, Spain (Kovacs); Servicio de Radiología. Fundación Instituto Valenciano de Oncología, Valencia, Spain (Arana); Fundación Instituto de Investigación en Servicios de Salud, Valencia, Spain (Arana); Centros de Investigación Biomédica en Red Epidemiología y Salud Pública (CIBERESP), Madrid, Spain (Royuela); Unidad de Bioestadística Clínica, Hospital Ramón y Cajal, Madrid, Spain (Royuela).

1. Fleegler EW, Lee LK, Monuteaux MC, Hemenway D, Mannix R. Firearm legislation and firearm-related fatalities in the United States. JAMA Intern Med. 2013;173(9):732-740.

Corresponding Author: Estanislao Arana, MD, PhD, Servicio de Radiología, Fundación Instituto Valenciano de Oncología, Beltrán Báguena 19, Valencia 46009, Spain.

Corresponding Author: Eric W. Fleegler, MD, MPH, Division of Emergency Medicine, Boston Children’s Hospital, 300 Longwood Ave, Boston, MA 02115 ([email protected]). Conflict of Interest Disclosures: None reported.

Conflict of Interest Disclosures: None reported. 1. Emery DJ, Shojania KG, Forster AJ, Mojaverian N, Feasby TE. Overuse of magnetic resonance imaging. JAMA Intern Med. 2013;173(9):823-825.

2012

Inappropriate Use of Lumbar Magnetic Resonance Imaging: Limitations and Potential Solutions

2. Davis PC, Wippold FJ II, Brunberg JA, et al. ACR Appropriateness Criteria on low back pain. J Am Coll Radiol. 2009;6(6):401-407.

To the Editor A recent compelling study reports that 28.5% of prescriptions of lumbar magnetic resonance imaging (MRI) are inappropriate.1 We would like to point out the following: 1. Criteria for defining appropriateness were developed ad hoc following the RAND–University of California, Los Angeles, method,1 instead of using existing and widely accepted evidence-based criteria.2 The validity and reproducibility of the former are suboptimal; consensus does not necessarily mean agreement.3 2. Cases were “matched to a clinical scenario for which the appropriateness rating had been determined.”1(p823) Therefore, appropriateness was not determined by the patients’ actual signs or symptoms. Moreover, in 63.7% of the lumbar MRI requests, the information provided was insufficient to determine appropriateness, so classification was based on information from “other sources.”1 As acknowledged by the authors, this may affect validity of results.1 3. The study does not reveal whether clinicians knew that the appropriateness of their prescriptions was going to be assessed,1 which could influence results.

3. Tan C, Treasure T, Browne J, Utley M, Davies CW, Hemingway H. Seeking consensus by formal methods: a health warning. J R Soc Med. 2007;100(1):10-14. 4. Kovacs FM, Arana E, Royuela A, et al. Appropriateness of lumbar spine magnetic resonance imaging in Spain. Eur J Radiol. 2013;82(6):1008-1014. 5. Blackmore CC, Mecklenburg RS, Kaplan GS. Effectiveness of clinical decision support in controlling inappropriate imaging. J Am Coll Radiol. 2011;8(1):19-25.

In Reply We thank the authors for their interest in our study1 and will respond to their criticisms. The RAND-University of California, Los Angeles, appropriateness method2 was criticized for not following “widely-accepted evidence-based criteria.” Rather than accepting published guidelines with their reliance on other sources, we used the RAND method, which combines all the available evidence with expert opinion. In many cases, there is inadequate published evidence to classify a medical procedure or test as appropriate or inappropriate, which is certainly the case for lumbar magnetic resonance imaging (MRI), making the use of published guidelines questionable. The use of an expert multispecialty panel has been shown to be a substantial strength of the

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Firearm legislation and gun-related fatalities.

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