Leape Et Al 2003

8/10/2019 Leape Et Al 2003

1/12

www.medscape.com

Background: Physician adherence to guidelines is often poor, but the reasons have not been completely studied. Weinvestigated whether physician adherence to guidelines for percutaneous transluminal coronary angioplasty (PTCA) andcoronary artery bypass grafting (CABG) varied by source, development methods, or the extent of their evidence-base.

Methods and Results: We assessed adherence to guidelines developed by the American College ofCardiology/American Heart Association (ACC/AHA) for PTCA (1988 and 1993) and for CABG (1990) and guidelinesdeveloped by RAND for PTCA and CABG in 1990. We randomly sampled patients on Medicare who were undergoingcoronary angiography in 5 states in 1991 and 1992, extracting clinical and laboratory data from medical records andusing computer programs to classify the appropriateness of each procedure. A total of 543 PTCA and 676 CABGprocedures were studied.

By use of the 1988 ACC/AHA guidelines, 30% of PTCAs were rated class III (inappropriate), whereas 24% were class IIIby use of the 1993 guidelines. Only 1.5% of CABG procedures were class III with ACC/AHA guidelines. By use of RANDguidelines, 12% of PTCA and 9% of CABG procedures were classified as inappropriate.

Conclusions: Adherence to guidelines is higher when the recommendations are supported by evidence fromrandomized clinical trials (CABG). The credibility of the source and familiarity with the guidelines do not ensurecompliance. When evidence is lacking, as with PTCA at the time of this study, guideline recommendations may lagbehind appropriate changes in clinical practice. More frequent revisions coupled with on-line access have the potential tomake guidelines more useful.

Practice guidelines have been widely advocated as a means of both improving quality and reducing costs. From the

quality standpoint, guidelines can be an aid in managing complexity and ensuring consistent treatment. The use ofguidelines should also reduce the extent of inappropriate care and related costs.

Despite the theoretical appeal of practice guidelines, voluntary physician adherence to guidelines is frequently poor. [1,2]

Poor adherence has been attributed to a number of factors, including lack of perceived need, aversion to "cookbookmedicine," lack of awareness or familiarity with the guidelines, [2] lack of confidence in the developer, and suspicion thattheir only purpose is cost control. A common theme is that physicians are less likely to trust guidelines imposed byexternal authorities. Guidelines are more likely to be followed when they are easy to implement, specific, not toocomplex, useful, and when they come from a highly respected source. [1,3-7] Specialists in research settings have thehighest adherence rates. [5]

In these circumstances, one might expect that physicians would view guidelines developed by their own specialtysocieties more favorably and would be more likely to follow them. Guideline adherence should also be higher whenrecommendations are supported by scientific evidence. [1,4]

To assess whether specialty society guidelines are more likely to be followed, we examined 2 procedures (percutaneoustransluminal coronary angioplasty [PTCA] and coronary artery bypass grafting [CABG]) for which guidelines have beendeveloped by 2 independent bodies, the American College of Cardiology/American Heart Association (ACC/AHA) andRAND. We assessed the extent to which patients who underwent these procedures in 1991 or 1992 received them forindications classified as not indicated (class III) by then-current 1988 ACC/AHA guidelines or as inappropriate by RANDappropriateness ratings developed in 1990. For PTCA, we also evaluated the extent to which guidelines may lag behindevolving practice by comparing the extent of class III use in 1991 through 1992 according to the ACC/AHA guidelinespublished in 1993.

In 1980, the ACC and the AHA established a Task Force on Assessment of Diagnostic and Therapeutic CardiovascularProcedures to "define the role of... procedures in the diagnosis and management of cardiovascular disease." Theydeveloped a formal process for creating guidelines for the management of cardiac disease. The members of the task

Adherence to Practice Guidelines: The Role of Specialty SocietyGuidelinesLucian L. Leape, MD, Joel S. Weissman, PhD, Eric C. Schneider, MD, MSc, Robert N. Piana, MD, FACC, Constantine

Gatsonis, PhD, Arnold M. Epstein, MD, MAAm Heart J. 2003;145(1)

http://www.medscape.com/viewarticle/448529_print

12 10/12/2014 11:07 a.m.

8/10/2019 Leape Et Al 2003

2/12

force were recognized leaders in cardiology, national experts who were widely respected both as clinicians and asinvestigators.

The first ACC/AHA guidelines for PTCA were developed in 1988. Indications were grouped into 5 categories or chapters:IA, single vessel coronary artery disease (SVD) with mild (class 1) or no angina; IB, SVD with severe (classes 2-4) orunstable angina; IIA, multivessel coronary artery disease (MVD) with mild or no angina; IIB, MVD with severe or unstableangina; and III, acute myocardial infarction (AMI). [8]

Indications were assigned by consensus into 1 of 3 classes: class I, conditions for which there is general agreement thatcoronary angioplasty is justified; class II, conditions for which there is divergence of opinion regarding its justification interms of value and appropriateness; and class III, conditions with general agreement that angioplasty is not indicatedand may be harmful.

An example of a class I indication for PTCA is a patient with single-vessel coronary artery disease and no symptomswho has a significant lesion (50% stenosis) in a major epicardial artery that subtends a large area of viable myocardiumand who shows evidence of severe myocardial ischemia while on medical therapy during laboratory testing. The patientmust have 1 type A lesions and be in the low-risk group for morbidity (

8/10/2019 Leape Et Al 2003

3/12

appropriateness, [16] the sampling intentionally over-represented patients who were African-American, female, and whoresided in zip codes with a low household income. We corrected for this by weighting the final results to reflect the actualpopulations. From this group of 3960 patients undergoing angiography, we selected all 1692 patients who underwentCABG surgery or PTCA within 90 days of angiography.

Of the 1692 patients eligible for inclusion in the study, medical records or angiography reports were not available forevaluation of 87 patients (including 21 reports from 14 hospitals that did not participate and 66 records that could not belocated by participating hospitals). An additional 13 patients were excluded because the angiography was performed out

of state or was not performed for the evaluation of coronary artery disease. Thus, the records of 1592 patients (94%)were available for study.

Data were not sufficient to rate the adherence to guidelines in 138 patients (9%), because information in theangiographic report was insufficient for determining the extent of disease (n = 22), medical records were incomplete (n =59), or the results of the exercise stress test were missing and necessary to rate the procedure (n = 57). Adequateinformation was thus available for assessing adherence in 1454 patients who underwent 706 PTCA procedures and 763CABG procedures.

Of the 706 patients who underwent PTCA, 163 (23%) underwent the procedure for conditions that were not addressedby the ACC/AHA guidelines: 108 patients had previously undergone CABG, 15 patients had congestive heart failure,

and 39 patients underwent revascularization after their initial hospitalization for myocardial infarction. These patientswere excluded, leaving a final sample of 543 patients who underwent PTCA available for analysis.

Of the 763 patients who underwent CABG, 87 (11%) did so for conditions that were not included in the ACC/AHAguidelines: 59 had undergone an earlier CABG and 28 had congestive heart failure. The final sample of patients whounderwent CABG available for analysis was 676.

We collected clinical data on each patient from 4 sources: (1) Medicare part A data, (2) Medicare part B data, (3)hospital medical records, and (4) outpatient offices. Physicians trained by the investigators reviewed a copy of the indexcoronary angiography report and entered the coronary anatomy findings into a study database. Nurse abstractors at thecollaborating state peer review organizations were trained to use a computerized data collection instrument to obtainpertinent clinical and laboratory data from medical records. These included all the elements used by both the RAND andthe ACC/AHA guidelines. When the results of a stress test were needed to rate the procedure, we requested a reportfrom the hospital, physician's office, or medical group identified by the Health Care Financing Administrations's Medicarepart B claims data. When an actual report was not available, we accepted the admission history account of the exerciseor pharmacologic stress test results only when the note gave sufficient information.

For 3% of procedures, we assessed the inter-rater reliability of chart abstraction by comparing results from data obtainedby abstractors at the professional review organizations with results obtained from the same records by the study'scentral nurse-abstractor. There was substantial agreement between the 2 raters for CABG (

= 0.73) and PTCA (

= 0.88).

We applied a computer-based algorithm to the data collected from medical records to classify each patient's procedureinto 1 of the 3 categories: class I, II, or III. We then calculated the percentage of patients whose procedures wereclassified in each category overall and for each chapter in the guidelines. For PTCA, we performed the analysis usingboth 1988 and 1993 guidelines and compared the results.

We used the X 2 analysis to provide descriptive statistics comparing the results with 1988 guidelines and 1993guidelines and with RAND guidelines. All statistical analyses were performed by use of the svytab subroutine from theStata statistical software, which is appropriate for the analysis of data derived from weighted samples. In these analyses,each observation was weighted by the inverse of the probability of being included in the sample (Stata, Release 6, 1999,Stata Corporation, College Station, Tex). Tables show percentages based on weighted analysis.

The clinical characteristics, indications, and extent of coronary artery disease are shown in . Although 83% of patients


12 10/12/2014 11:07 a.m.

8/10/2019 Leape Et Al 2003

4/12

received PTCA for 1- or 2-vessel disease, 3 patients had left main disease, and 5 patients did not have significant(>50%) occlusive disease.

Table I. Characteristics of the patient sample

PTCA CABG

No. % No. %

Demographic71-75 y 228 42 273 40

Female 263 48 301 45

Noted history of

Hypertension 387 71 482 71

Peripheral vascular disease 41 7 67 10

Prior CVA, TIA, RIND, CEA 68 13 88 13

Congestive heart failure 87 16 135 20

ESRD on dialysis 9 2 9 1

Diabetes mellitus 172 32 244 36

Pulmonary condition 69 13 117 17

Smoker 113 21 138 20

Prior CABG 0 0 0 0

Prior PTCA 63 12 35 5

Myocardial infarction

21 days before angiography 102 19 195 29

Extent of CAD

Left main disease 3 1 168 25

3-vessel disease 80 15 321 47



No significant disease 5 1 2 0

Parsonnet score at time of angiography

0-7 291 43

8-14 265 39

>14 120 18

Duke Risk Score at time of angiography

Low 172 35

Medium 154 31High 168 34

Insufficient data 49


12 10/12/2014 11:07 a.m.

8/10/2019 Leape Et Al 2003

5/12

Total 543 100 676 100

Of the 543 patients who underwent angioplasty, 19% received the procedure for indications that were rated by the 1988guidelines as class I (justified), 51% as class II (uncertain), and 30% (166) as class III (not indicated) ( ). Ratings variedconsiderably according to indication. Among patients with asymptomatic or class I angina and single-vessel disease(chapter IA), 53% of procedures were rated class III. Three fourths of these were patients with negative results on stresstests. In contrast, only 9% of procedures in patients with multivessel disease and class II to IV angina (chapter IIB) wererated class III. More than one third (35%) of procedures done for AMI were rated class III.

Table II. Appropriateness of PTCA according to 1988 ACC/AHA guidelines

ACC/AHA chapter No. Weighted %

Appropriateness classification*

Class I% Class II% Class III%

Chapter IA (single CAD, class I angina) 72 16.1 0.0 46.9 53.1

Chapter IB (single CAD, class II-V angina) 104 20.5 33.5 46.0 20.5

Chapter IIA (multi CAD, class I angina) 71 15.0 0.0 57.8 42.2

Chapter IIB (multi CAD, class II-V angina) 115 21.0 24.8 66.7 8.5

Chapter III (acute myocardial infarction) 181 27.4 23.4 42.0 34.6

Total 543 100 18.5 51.2 30.3

Of the 166 procedures rated class III, 24% were so classified because of contraindications related to the characteristicsof the vessel being treated. These included stenosis of

8/10/2019 Leape Et Al 2003

6/12

ACC/AHA 1993

ACC/AHA 1988

Total (%)Class I (%) Class II (%) Class III (%)

Class I 101 (18.6) 7 (1.3) 0 (0) 108 (19.9)

Class II 20 (3.7) 247 (45.4) 2 (0.4) 269 (49.5)

Class III 0 (0.0) 49 (9.0) 117 (21.6) 166 (30.6)

Total 121 (22.3) 303 (55.7) 119 (22.0) 543 (100)When the study cases were rated with the 1990 RAND guidelines, 33% of the cases were classified as appropriate, 55%as uncertain, and 12% as inappropriate ( ).

Table V. Comparison of ACC/AHA and RAND ratings of appropriateness for PTCA

ACC/AHA 1988

RAND

TotalAppropriate (%) Uncertain (%) Inappropriate (%)

Class I 68 (12.7) 37 (6.9) 2 (0.4) 107 (19.9)

Class II 82 (15.3) 166 (30.9) 19 (3.5) 267 (49.7)

Class III 26 (4.8) 93 (17.3) 44 (8.2) 163 (30.4)

Total 176 (32.8) 296 (55.1) 65 (12.1) 537 (100)

The clinical characteristics, indications, and extent of coronary artery disease for 676 patients who received CABG areshown in . Although most patients (72%) underwent CABG for left main or 3-vessel disease, 4% of patients underwentbypass grafting for single-vessel disease, and 2 patients did not have significant occlusive disease.

Table I. Characteristics of the patient sample

PTCA CABG

No. % No. %

Demographic

71-75 y 228 42 273 40

Female 263 48 301 45

Noted history of

Hypertension 387 71 482 71

Peripheral vascular disease 41 7 67 10

Prior CVA, TIA, RIND, CEA 68 13 88 13

Congestive heart failure 87 16 135 20

ESRD on dialysis 9 2 9 1

Diabetes mellitus 172 32 244 36

Pulmonary condition 69 13 117 17

Smoker 113 21 138 20

Prior CABG 0 0 0 0

Prior PTCA 63 12 35 5

Myocardial infarction

8/10/2019 Leape Et Al 2003

7/12

>21 days before angiography 102 19 195 29

Extent of CAD

Left main disease 3 1 168 25



1-vessel disease 241 44 26 4No significant disease 5 1 2 0

Parsonnet score at time of angiography

0-7 291 43

8-14 265 39

>14 120 18

Duke Risk Score at time of angiography

Low 172 35

Medium 154 31

High 168 34

Insufficient data 49

Total 543 100 676 100

The pattern of ratings for CABG was very different from that for PTCA. Of the 676 patients who underwent CABG, 84%received the procedure for indications rated as class I, 15% for class II indications, and 1.5% for class III indications. Ofall indications, procedures in patients in the asymptomatic category had the highest likelihood of being classified as classIII (15%); procedures in patients undergoing CABG after AMI were most likely (7/8) to be classified as class II ( ).

Table VI. Appropriateness of CABG according to 1990 ACC/AHA guidelines

ACC/AHA chapter No. Weighted %

Appropriateness classification

Class I% Class II% Class III%

Chapter 1 (asymptomatic patients) 36 7.5 48.8 36.4 14.8

Chapter 2 (stable angina class I,II) 136 24.3 75.3 23.1 1.6

Chapter 3 (stable angina III, IV) 80 11.5 85.6 14.3 0.1

Chapter 4 (unstable angina) 211 29.5 85.5 14.5 0.0

Chapter 5 (acute MI) 8 0.6 21.7 78.3 0.0Chapter 6 (post MI) 205 26.6 99.6 0.3 0.1

Total 676 100 83.7 14.8 1.5

Application of the RAND CABG guidelines to these same patients resulted in 76% of the cases being classified asappropriate, 15% as uncertain, and 9% as inappropriate (data not shown).

Doctors chose not to follow the ACC/AHA guidelines for a substantial fraction of patients who underwent PTCA in 1991and 1992. Thirty percent received procedures for class III indications according to the then-current (1988) guidelines.When measured against the 1993 guidelines, the class III percentage declined to 24%. Adherence to guidelines forCABG was much higher; only 1.5% of procedures were for class III indications. Adherence to contemporary RANDguidelines for these 2 procedures was higher for PTCA (12% rated inappropriate), but lower for CABG (9%inappropriate).

These findings provide additional evidence in support of several conclusions from earlier studies about practiceguidelines that are relevant today: (1) neither a highly credible source nor physician familiarity with the guidelines


12 10/12/2014 11:07 a.m.

8/10/2019 Leape Et Al 2003

8/12

ensures compliance; (2) doctors are more likely to follow guidelines that are evidence-based; (3) the guidelinerecommendations themselves vary substantially according to the process used for their derivation; and (4) advances inpractice may precede changes in guidelines.

The ACC/AHA guidelines come from a highly credible source; cardiologists recognize them as products of their ownspecialty society, developed by respected leaders in the field. They are widely disseminated among the target populationbecause they are published in the 2 premier peer-reviewed national journals read by cardiologists. Although this doesnot ensure they will be either read or understood, it is unlikely that there are many cardiologists who are not aware of the

existence of the guidelines. Our findings are consistent with those of other studies in showing that merely distributingguidelines does not lead to compliance, regardless of the source (ie, dissemination is not the same as diffusion[widespread use]).

Several authors have noted that guidelines are more likely to be followed when they are evidence-based. [1,4] Ourfindings support this conclusion. Physician adherence was much higher with CABG guidelines than with PTCAguidelines. The CABG recommendations of the time were largely made on the basis of evidence derived from a largenumber of randomized clinical trials in 30 years, whereas the guidelines for PTCA were made almost entirely on thebasis of expert opinion. PTCA was an evolving technique at the time. No randomized trials of the effectiveness of PTCAhad been published when the ACC guidelines were developed in 1988.

Although the difference in the evidence base for CABG and PTCA is striking, cardiologists may be more likely to departfrom established guidelines for PTCA than for CABG for other reasons, including economic incentives, their PTCAdecision being less likely to be reviewed by another physician, and the higher mortality risk of CABG.

Adherence varied markedly according to which guidelines were evaluated. For PTCA, class III use was 30% withACC/AHA guidelines, compared with 15% by use of RAND guidelines. For CABG, nonadherence rates were 9% by useof RAND guidelines, compared with 2% when ACC/AHA guidelines were used. In both methods, the panelists wererecognized leaders in their fields. However, panel composition and the methods used to obtain judgments ofappropriateness were quite different.

In the ACC/AHA process, the PTCA expert panel was composed entirely of cardiologists, whereas the CABG panel wasdominated by cardiac surgeons. In the RAND process, both procedures were rated by the same panel, which included 2primary care physicians, 4 cardiologists, and 3 cardiac surgeons. The methods also differed. The ACC/AHA used aconsensus process without formal voting. RAND used a modified Delphi process, in which the second round is aface-to-face meeting for discussion and rerating. The rating process is confidential and quantitative, using a 9-pointscale. The final ratings are the median scores of the 9 panelists' confidential ratings for each indication. [14]

The panels also used somewhat different criteria for determining appropriateness of PTCA. Although some of thesevariations seem minor, they could have a substantial impact on the rating for an individual patient. These differences areillustrated by 2 patients with moderately severe angina. One patient's procedure was rated class I by use of ACC/AHAguidelines, but uncertain (equal to ACC/AHA class II) by use of RAND guidelines because the patient's symptoms werewell controlled with medications. ACC/AHA guidelines don't include medication response as a factor. The second patienthad negative results on an exercise stress test and symptoms remained during maximal medical therapy. This patient

was rated as appropriate for PTCA by use of RAND guidelines, but the procedure was rated class III by use of ACC/AHAguidelines because 1 of the 2 diseased vessels supplied a small area of myocardium, a factor not included in RANDguidelines.

The RAND guidelines for PTCA also do not consider lesion type. However, presence of a C lesion was acontraindication in both the 1988 and 1993 ACC/AHA guidelines, despite the fact that some cardiologists were alreadysuccessfully dilating C lesions. This had little effect on our results because few patients (n = 15) in our cohort had Clesions.

These variations attributable to panel composition and methods are inherent in any process for developing guidelines,particularly when there is a paucity of evidence from controlled studies. [17] This is why they are guidelines (ie,

recommendations), not standards.

The percentage of class III use fell by 20% when the same patients were evaluated with 1993 guidelines. This decreasewas almost entirely accounted for by changes in the ratings of procedures in patients with AMI who had no symptoms,among whom the class III rate fell from 35% to 10%. Practicing cardiologists appeared to be responding to new


12 10/12/2014 11:07 a.m.

8/10/2019 Leape Et Al 2003

9/12

information presented at meetings and in the literature showing that PTCA should not be reserved for thrombolyticfailures. In 1993, the expert panel eliminated the requirement for an earlier trial of thrombolytic therapy. Practice ledguidelines.

During the interval studied, there were few major efforts to induce adherence to guidelines. Physicians were free tofollow them as they deemed appropriate. With growing interest in evidence-based medicine and the ascendancy ofmanaged care, pressure to follow guidelines has since increased. Recently, the ACC and AHA have launched majorefforts to improve clinical performance through the use of guidelines: the "Get With the Guidelines" program for the

secondary prevention of coronary artery disease [18] and the "Guidelines Applied in Practice" (GAP) program designed tobring the guidelines to the point of care to enhance their implementation in actual clinical practice. [19]

As physicians increasingly demand up-to-date evidence and turn to the Internet for information to guide their decision-making, it will become even more important to keep guidelines current by processing data from new studies. TheACC/AHA has recognized the need for keeping guidelines for these continually changing technologies current and isworking toward frequent updating and making the changes instantly accessible on the Internet. Useful guidelines willalways be "a work in progress."

One way that work can progress is by continual infusion of new information, such as the self-reported data now beingamassed by the ACC National Cardiovascular Data Registry (NCDR). [20] Analyses of these data (numbering 169,098

cases in the first 2 years of operation) can inform the guideline process much more rapidly and in ways impossible toachieve with controlled studies. In addition, feedback of results in risk-adjusted form are a means of providingpractitioners with valuable information about their own performance. This approach has been shown to reducecomplication rates and mortality in 2 well-established models: the New York State reporting systems for cardiac surgeryand cardiology [21,22] and the Veterans Affairs National Surgical Quality Improvement Project. [23]

On the surface, our studying patients who were treated in 1991 and 1992 might be considered a limitation. However, itwas only by reviewing cases from those years that this study was possible, because we were able to observe the effectsof 2 natural experiments: a change in the ACC/AHA guidelines with time and simultaneous availability of guidelinesdeveloped by another method. These conditions have not been present before or since. More important, the purpose ofthis study was not to assess the appropriateness of practice then or now, but to gain insight into the factors that leaddoctors to follow guidelines. Clearly, the substantial changes in percutaneous coronary intervention (PCI) that havetaken place since then mitigate against applying our findings to the state of practice today.

In this regard, the recently reported findings from analysis of the data from the first 18 months of the ACC-NCDRoperation (January 1998-June 1999) are of interest. By use of the 1993 ACC/AHA guidelines, 84% of 17,603 PCI casesreported were judged to have been performed for appropriate indications. [24] Although the data collected by the registryare self-reported and in less detail than those used for our study, the findings suggest that nonindicated use hasdecreased, even when measured against the outdated guidelines of 1993.

There are, however, limitations to our study. First, the study was confined to patients aged 65 to 75 years. Thesepatients may not be representative of all patients undergoing these procedures. Since the ACC/AHA guidelines weredeveloped, the fraction of patients receiving these procedures in the "old-old" category (aged >80 years) has increased

substantially.

Second, information in hospital records and doctors' offices are sometimes incomplete. In 3% of patients, Medicareclaims data indicated that an exercise stress test had been performed, but we were unable to obtain the results. Thesepatients were not included in our analysis. However, whatever the test results, inclusion of these patients would not havealtered the study findings substantially.

Patients with incomplete data on lesion type (A, B, or C) and myocardial viability were not excluded. In these cases, weassumed that cardiologists followed accepted practice, and, thus, that the lesions that were dilated were type A and themyocardium was viable. To the extent that these assumptions are incorrect, our results are biased in favor of labelingthese patients' procedures as appropriate. (Neither of these factors are included in the NCDR.)

Medical records may also lack information that physicians might have that would justify procedures that were classifiedas class III by means of our methods. Our study design did not permit interviewing the responsible physicians. However,in an earlier multi-institutional study of CABG, subsequent review of cases by the operating surgeons uncoveredadditional data that changed the ratings in only 6% of patients. [13] For all these reasons, 100% adherence to guidelines


12 10/12/2014 11:07 a.m.

8/10/2019 Leape Et Al 2003

10/12

would neither be expected nor desired.

Third, a substantial potential "upward" bias was introduced by the assumption that all patients were at low risk. This isclearly not so, but we concluded that the definitions of elevated risk were unrealistic and could not be applied. However,some fraction of patients in the study whose indications were classified as class I or class II were at high risk, whichwould have placed them in the class III category. Thus, the extent of nonadherence we report here on the basis of theACC/AHA guidelines represents a lower bound.

Our findings suggest that adherence to guidelines depends more on whether the recommendations are made on thebasis of evidence from clinical trials than on either the nature or the source of the guidelines. This is particularly truewhen adherence to guidelines is voluntary and not formally monitored. In the absence of data, reasonable physicianscan come to opposite conclusions about the appropriateness of performing a procedure for any specific indication. Theywere more likely to deviate from recommendations for PTCA in situations in which its value was debatable, such as inpatients with mild symptoms and negative results on exercise stress tests, or in which it might be more risky, as inpatients with AMI. For some of these indications, later studies proved their judgment to be correct.

Thus, to remain useful and credible, guidelines should be revised frequently when practice is advancing rapidly, as PCIwas and still is. Annual revisions may be needed. With Internet-based guidelines, date-stamped changes can be easilydisseminated to users whenever indicated.

In addition, the panel approved the use of the Cooperative Cardiovascular Project PTCA Tool(Peterson E, personalcommunication; 1996) to define mortality risk. This tool calculates the probability of mortality on the basis of age,creatinine level, ejection fraction, presence of diabetes mellitus, presence of acute myocardial infarction, presence ofmitral insufficiency, number of diseased vessels, and presence of cardiogenic shock. In the guidelines, patients in thehigh-risk category were categorized as class III. To test its usefulness in advance, we applied the CooperativeCardiovascular Project Tool to our data. Using the cutoff points found in the ACC/AHA guidelines, we found that 34% ofpatients who had undergone PTCA fell into the high-risk category, 31% fell into the medium-risk category, and 35% fellinto the low-risk category.

In consultation with one of the developers of the guidelines, we agreed that having such a large percentage of patientsranked as high risk (and, therefore, class III) was neither reasonable nor the intent of the guidelines. Accordingly, weassigned every patient to the low-risk category, in effect excluding mortality risk from the evaluation. This biases ourresults in favor of finding cases to be appropriate.

References

Grol R, Dalhuijsen J, Thomas S, et al. Attributes of clinical guidelines that influence use of guidelines in generalpractice: observational study. Br Med J 1998;317:858-61.

1.

Cabana MD, Rand CS, Powe NR, et al. Why don't physicians follow clinical practice guidelines? a framework forimprovement [review]. JAMA 1999;282:1458-65.

2.

Ellrodt A, Conner L, Riedinger M, et al. Measuring and improving physician compliance with clinical practiceguidelines: a controlled interventional trial. Ann Intern Med 1995;122:277-82.

3.

Tudiver F, Herbert C, Goel V. Why don't family physicians follow clinical practice guidelines for cancer screening?Family Physician Study Group, Sociobehavioral Cancer Research Network, National Cancer Institute of Canada[editorial]. CMAJ 1998;159:797-8.

4.

Grilli R, Lomas J. Evaluating the message: the relationship between compliance rate and the subject of a practiceguideline. Med Care 1994;32:212-3.

5.

Fix KN, Oberman A. Barriers to following National Cholesterol Educational Program guidelines. an appraisal ofpoor physician compliance [editorial; comment]. Arch Intern Med 1992;152:2385-7.

6.

Cook D, Giacomini M. The trials and tribulations of clinical practice guidelines. JAMA 1999;281:1950-1.7.

Ryan T, Faxon D, Gunnar R, et al. Guidelines for percutaneous transluminal coronary angioplasty: a report of theAmerican College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and

8.


e 12 10/12/2014 11:07 a.m.

8/10/2019 Leape Et Al 2003

11/12

Acknowledgments

We thank the members of the expert panel who provided advice on using the ACC/AHA guidelines to review medicalrecords: James Ferguson, MD, Alice Jacobs, MD, Robert Jones, MD, Thomas Ryan, MD, and Michael Stadius, MD.

Funding information

Supported by grant #5 RO HS07098-02S1 from the Agency for Health Care Policy and Research.

Reprint Address

Lucian L. Leape, MD, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115. E-mail:[email protected] .

Theraperutic Cardiovascular Procedures. J Am Coll Cardiol 1988;12:529-45.

Ryan T, Bauman W, Kennedy J, et al. Guidelines for percutaneous transluminal coronary angioplasty. JACC1993;22:2033-54.

9.

Kirklin J, Akins C, Blackstone E, et al. Guidelines and indications for coronary artery bypass graft surgery. J AmColl Cardiol 1991;17:543-89.

10.

Leape LL, Hilborne LH, Park RE, et al. The appropriateness of use of coronary artery bypass graft surgery inNew York state. JAMA 1993;269:753-60.11.

Hilborne LH, Leape LL, Bernstein SJ, et al. The appropriateness of use of percutaneous transluminal coronaryangioplasty in New York state. JAMA 1993;269:761-5.

12.

Leape LL, Hilborne LH, Schwartz JS, et al. The appropriateness of coronary artery bypass graft surgery inacademic medical centers. Ann Int Med 1996;125:8-18.

13.

Park RE, Fink A, Brook RH, et al. Physician ratings of appropriate indications for six medical and surgicalprocedures. Am J Public Health 1986;76:766-72.

14.

Kosecoff J, Fink A, Brook RH, et al. The appropriateness of using a medical procedure: is information in themedical record valid? Med Care 1987;25:196-201.

15.

Schneider EC, Leape LL, Weissman JS, et al. Racial differences in cardiac revascularization rates: does"overuse" explain higher rates among whites? Ann Int Med 2001;135:328-37.

16.

Shekelle PG, Kahan JP, Bernstein SJ, et al. The reproducibility of a method to identify the overuse and underuseof medical procedures. N Engl J Med 1998;338:1888-95.

17.

AHA. Get with the guidelines. Available at: http://216.185.112.5/presenter.jhtml?identifier = 1165. 2000.18.

ACC. Guidelines applied in practice (GAP). Available at: http://www.acc.org/gap/gap_structure.htm. 2000.19.

Anderson HV, McKay CR, Shaw Re, et al. Variations in risk-adjusted mortality with PCI: the ACC-NCDR registry[abstract]. Circulation 2000;102(Suppl):II-841.

20.

Hannan E, Siu A, Kumar D, et al. The decline in coronary artery bypass graft surgery mortality in NY. JAMA1995;273:209-13.

21.

Hannan E, Kilburn H, Racz M, et al. Improving the outcomes of coronary artery bypass surgery in New York state.JAMA 1994;271:761-6.

22.

Khuri SF, Daley J, Henderson W, et al. The Department of Veterans Affairs' NSQIP: the first national, validated,

outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the qualityof surgical care. National VA Surgical Quality Improvement Program. Ann Surg 1998;228:491-507.

23.

Anderson HV, Shaw RE, McKay CR, et al. Indications for coronary intervention by ACC criteria: the ACC-NCDRregistry [abstract]. Circulation 2000;102(Suppl):II-841.

24.


e 12 10/12/2014 11:07 a.m.

Leape Et Al 2003

Documents

Transcript of Leape Et Al 2003