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COMMENTARY

Sudden Acceleration of DiabetesQuality MeasuresLeonard Pogach, MD, MBA

David C. Aron, MD, MS

THE MODERN ERA IN DIABETES PERFORMANCE MEA-surement began in 1997, when the Diabetes Qual-ity Improvement Project (DQIP), the first nationaldisease-specific measure, set recommended thresh-

oldsfor intermediateoutcomes (glycated hemoglobin [HbA1c]levels, blood pressure, and low-density lipoprotein choles-

terol [LDL-C] levels). These thresholds, if not achieved,would clearlyresult in greater populationmorbidity andmor-tality. The DQIP explicitly stated that such threshold mea-sures were neither guidelines nor standards and that lowerintermediate outcome values should not be used for publicreporting owing to lack of evidence for efficacy and the ab-sence of validated risk-adjustment models that would al-low for fair comparisons. Also in the 1990s, major random-ized trials such as the Diabetes Control and ComplicationsTrial, Scandinavian Simvastatin Survival Study, United King-dom Prospective Diabetes Study, West of Scotland Coro-nary Prevention Study, and Hypertension Optimal Treat-ment Study established stronger evidence for treatment of

intermediate-outcome riskfactors. Thesepivotal studies pro-vided the impetus for studies conducted from 2000 on-ward to determine optimal values for these risk factors toreduce cardiovascular risk in patients with longer durationof disease.

The successor to the DQIP, the National Quality Im-provement Alliance (Alliance), made few major changes tothe measure set from 2001 through 2005 other than to de-crease threshold levels for HbA1c from 9.5% to 9.0% and forblood pressure from 140/90 mm Hg to 140/80 mm Hg andto add a threshold level for LDL-C of less than 100 mg/dL.1

The Alliance members, including liaisons from federal agen-ciesandmajor professional societies, were aware thatplanned

major trials would inform the choice of threshold values foroptimal measures by the end of the decade. However, be-ginning in 2004, the National Committee for Quality As-surance (NCQA) added optimal measures for HbA1c, bloodpressure, and cholesterol to the Diabetes Physician Recog-nition ProgramHbA1c values less than 7%, blood pres-sure less than 130/80 mm Hg, and LDL-C values less than100 mg/dLwhich were adopted by the Bridges to Excel-lence pay-for-performance program.2 In 2005 the Minne-

sota Community Measurement Program developed a com-posite measure, termed the Diabetes 5 (D5), that was basedon these optimal measures for HbA1c, blood pressure, andLDL-C; administration of aspirin; and nonsmoking status.3

Despite unanimous opposition from the Technical Ad-visory Panel of the Alliance, the NCQA approved the opti-mal measure set in May 2006.4 Even though inconsistentwith guidelines from nonspecialty societies, these mea-sureswerewidely viewed as evidence-based standards of carebecause they were based on the guidelines of specialty so-

cieties that lent their leadership to the industry-sponsoredpublic service campaign.1

Coincidentally, 1 week after approval of the optimal mea-sure set, scientific concerns were again raised at an Agencyfor Healthcare Research and Qualitysponsored confer-ence on diabetes performance measures attended by repre-sentatives from key federal agencies, professional soci-eties, the NCQA, and members of academic medicine.5 Inadditionto methodological concerns related to selection bias,lack of case-mix adjustment, patient preferences, and mea-surement variability, the possibility was raised of unin-tendedand unmeasuredconsequences such as harms,costs, and polypharmacy. Indeed, only 2 months later the

National Quality Forum did not endorse the optimal mea-sures.

Much has since changed. The glycemic treatment groupin the ACCORD (Action to Control Cardiovascular Risk inDiabetes) study was prematurely terminated because of in-creased deaths in the intensive treatment group,6 and theNCQA measure was then modified. Then, the hyperten-sion treatment approach in ACCORD failed to demon-strate benefit of tighter blood pressure control,7 resultingin modification of NCQAs optimal measure of 130/80mm Hg. Although the lipid treatment intervention was de-signed to evaluate the efficacy of fibrates, the subanalysisdid not demonstrate benefit of lower lipid levels; however,

this finding needs further evaluation.

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In the absence ofnewevidence from 1998 to 2008 and despite ongoing major trials

Author Affiliations: Veterans Affairs New Jersey Healthcare System, East Orange(Dr Pogach); University of Medicine andDentistry of NewJerseyNewJerseyMedi-cal School, Newark (Dr Pogach); Louis Stokes Cleveland Department of VeteransAffairs Medical Center, Cleveland, Ohio(Dr Aron); and CaseWesternReserveUni-versity, Cleveland (Dr Aron).Corresponding Author: David C. Aron, MD, MS, Education Office (14W), LouisStokes ClevelandDepartment of VeteransAffairs Medical Center, 10701 EastBlvd,Cleveland, OH 44106 (david.aron@va.gov).

2011 American Medical Association. All rights reserved. (Reprinted) JAMA, February 16, 2011Vol 305, No. 7 709

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to answer the critical questions about optimal thresholds,there was a sudden acceleration in implementation of op-timal measures. Why? Although we have previously com-mented on industry and professional society influence,1 thisalone cannot explain the failure of senior-level medical di-rectors, policy makers, medical researchers, and organiza-

tions that developed or used performance measurements tonote the obvious, ie, that new evidence had not come to thefore, but rather the perception of what constitutes qualityhad changed. Moreover, private sector leadership consis-tently ignored recommendations of private sector/federal coa-litions and conferences to reevaluate their decisions. Whywere the recommendations not only ignored, but accom-panied by proposals for even more stringent all or nonecomposite measures that incorporated each of the above op-timal measures as an assessment of physician perfor-mance? Examination of another industry may provide someanswers.

Until recently, Toyota held an unchallenged reputationfor the quality of its automotive products and for the means

by which that quality was achieved. The Toyota Cultureempowered workers to stop the assembly line by pulling anandon cord when they identified a problem, to prevent itspropagation down the line.Andon is derived from the Japa-nese word for lantern, and at Toyota it referred to a systemby which problems on an assembly line could be identifiedat a more central location using a dashboardof warning lights.These lightswere activated when theandoncordthat stoppedthe assembly line was pulled. Some have argued that asToyotagrew, the initial goal of its culture changed from mak-ing safe, high-quality cars without necessarily dominatingthe industry to a goal in which market domination as-sumed greater importance.9 Quality issues were not ob-

served to the same degree, early warnings were not heededor possibly not disclosed, and cars sold by the million laterrequired recall for examination and possibly repair for de-fects. One commentator suggested that although any workeris empowered to stop the assembly line because he spots aflaw . . . the company as a whole is loath to admit that thesystem broke down.9

The same thing has happened to the quality industry.Instead of trying to develop better measures using risk ad- justment, stratification, and linked or continuous mea-sures as recommended by many experts, readily auditableoptimal measures were introduced, with meeting the mea-sures as the goal. There was no effort to ascertain patient

preferencesor measureharms, andthe virtuous circle of mea-surement for improvement was replaced by a vicious circleof measurement for compliance. Leadership did not allowthe andon cord to be pulled. As a consequence, scarce healthcare dollars may have been spent without benefit, and pa-tients have been inconvenienced and perhaps harmed.

This case study indicates that the quality industrys pro-cess of developing performancemeasures is broken and thatsteps need to be taken to restore accountability. We have

previously suggested that independent centers be estab-lished under the Agency for Healthcare Research and Qual-ity to evaluate the strength of evidence and methodologyfor any proposed measures as well as transparency by mem-bers of agencies.1We reiterate those recommendations andsuggest additional safeguards based on the Medicare Clini-

cal Advisory Committees.

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Not only should the evidencebe made available, but meetings at which the evidence anddiscussion occur should be televised to the public. All in-dividuals who present and discuss evidence, and all votingmembers of any national organization proposing mea-sures, should publicly state any real or potential conflictsof interest and cast votes publicly. This process is the an-don cord that will minimize harm to patients, prevent poorlydesigned measures from bending the cost curve upward, andrestore professionalism. Only when those who promulgatemeasures are held personally responsible for their deci-sions should they hold physicians on the front line person-ally responsible for their implementation.

Conflict of Interest Disclosures: The authors have completed and submitted theICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Pogach reportedhaving previouslyserved on the operationscommitteeof the Diabetes Quality Im-provement Project and National Quality Improvement Alliance and as chairper-son of the Diabetes Subcommittee of the National Quality Forum and receivingtravel and accommodation expenses from the American College of Medical Qual-ity for a presentation. Dr Aron reported serving as the Endocrine Societys repre-sentative on the NCQA/AMA Physicians Consortium on Performance Measuresand receiving royalties from McGraw-Hill for a chapter in Greenspans Basic andClinical Endocrinology.Funding/Support: Drs Pogach and Aronreportedreceiving VeteransAffairs HealthServices Research funding to evaluate glycemic control in theVeteransHealth Ad-ministration.Role of theSponsor: TheDepartmentof Veterans Affairs hadno role in theprepa-ration, review, or approval of the manuscript.Disclaimer: The opinions expressed in this Commentary are solely those of theauthors and do not necessarily represent the views of the Department of Veter-ans Affairs or any other organization.

REFERENCES

1. Aron D, Pogach L. Transparency standardsfor diabetes performance measures.JAMA. 2009;301(2):210-212.2. Bridges to Excellence (BTE). Health Care IncentivesImprovement Institute Website. http://www.bridgestoexcellence.org/. 2010. Accessed January 20, 2011.3. Aligning forces in Minnesota: a community snapshot. Robert Wood JohnsonFoundation Web site. http://www.rwjf.org/files/research/af4qsnapshotminnesota.pdf. 2010. Accessed January 20, 2011.4. Pogach L, Engelgau M, Aron D. Measuring progress toward achieving hemo-globin A1c goals in diabetes care: pass/fail or partial credit. JAMA. 2007;297(5):520-523.5. Kerr EA; Agency for Healthcare Research and Quality and The National Insti-tute for Diabetes and Digestive and Kidney Diseases. Assessing quality of care fordiabetes. Agency for Healthcare Research and Quality Web site.http://www.ahrq.gov/qual/diabetescare/diabetescare.pdf.January 2008. Accessed January 20, 2011.6. Gerstein HC, Miller ME, Byington RP, et al; Action to Control CardiovascularRiskin Diabetes StudyGroup.Effects of intensiveglucose lowering in type 2 diabetes.N Engl J Med. 2008;358(24):2545-2559.

7. Cushman WC, Evans GW, Byington RP, et al; ACCORD Study Group. Effectsof intensiveblood-pressure control in type2 diabetes mellitus. N EnglJ Med. 2010;362(17):1575-1585.8. Ginsberg HN, Elam MB, Lovato LC, et al; ACCORD Study Group. Effects ofcombination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010;362(17):1563-1574.9. DeBord M. Toyotas blind spot. New York Times. http://www.nytimes.com/2010/02/06/opinion/06debord.html. February 5, 2010. Accessed January 25,2011.10. Medicare Evidence Development & Coverage AdvisoryCommittee (MEDCAC).Centers for Medicare & Medicaid Services Web site. https://www.cms.gov/FACA/02_MedCAC.asp. 2010. Accessed January 20, 2011.

COMMENTARY

710 JAMA, February 16, 2011Vol 305, No. 7 (Reprinted) 2011 American Medical Association. All rights reserved.

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