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Eur J Cardiothorac Surg 2003;24:571-577
© 2003 Elsevier Science NL
Institute of Health Economics and Clinical Epidemiology, University of Cologne, Gleueler Straße 176-178, 50935 Cologne, Germany
Received 20 February 2003; received in revised form 23 April 2003; accepted 17 July 2003.
* Corresponding author. Tel.: +49-221-46867-20; fax: +49-221-46867-10
e-mail: afschin.gandjour{at}medizin.uni-koeln.de
| Abstract |
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Key Words: Percutaneous transluminal coronary angioplasty Coronary artery bypass Carotid endarterectomy
| 1. Introduction |
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The high rate of revascularization procedures in Germany can hardly be explained by Germany's demographic composition. Among the 29 OECD countries, Germany ranks 9th in terms of the percentage of inhabitants aged 65 years and above [2]. The question appears whether a high rate of unnecessary procedures provides an explanation. One way to test this hypothesis is to apply the RAND/UCLA appropriateness criteria to the procedures done in Germany. This would give an indication if there is substantial overuse, i.e. a high rate of inappropriate use. RAND criteria were developed by first reviewing the scientific literature and then developing a consensus by convening an expert panel, which rated the appropriateness, and sometimes the necessity, of a comprehensive list of indications for selected procedures [3,4]. The validity of the RAND/UCLA criteria for the appropriateness of coronary artery bypass grafts (CABGs) and PTCAs has been demonstrated by studies showing that among patients meeting the criteria for the necessity of revascularization, those receiving a revascularization procedure had a lower mortality rate than those treated medically [5,6]. The validity of the RAND/UCLA criteria for measuring the appropriateness of CEA has also been confirmed. A comparison of ratings to the results of subsequent randomized clinical trials found that the trials confirmed the ratings for 44 indications (covering almost 30% of operations performed in 1981 and including 14 appropriate, six uncertain, and 24 inappropriate indications) and refuted the ratings for none [7]. The reproducibility of the RAND/UCLA appropriateness criteria for CEAs is excellent, but not perfect, as Shekelle et al. [8] pointed out.
Studies using the RAND/UCLA appropriateness criteria for investigating the overuse of coronary revasculariztions and CEAs have been conducted in Canada [9], Italy [10], The Netherlands [11], Spain [12], the United Kingdom [13], and the United States [9,1418]. In Germany, two studies have been conducted [19,20]. However, the validity of both studies is limited by a small sample size (only one hospital enrolled) and by the inclusion of only one procedure (PTCA). The results are also dated, as they consider data from the early 1980s and 1990s.
Recently, a European panel including experts from the Netherlands, Spain, Sweden, Switzerland, and the United Kingdom revised appropriateness criteria for PTCAs and CABGs using the RAND appropriateness method [3]. To the best of our knowledge no study has yet used these criteria.
The goal of this retrospective study was to evaluate the appropriateness of PTCA, CABG, and CEA in German hospitals using the latest RAND appropriateness criteria by Fitch et al. [3] for PTCAs and CABGs and by Matchar et al. [4] for CEAs. Our hypothesis was that the rate of inappropriate invasive revascularization procedures in 2000/2001 would prove to be higher in Germany than in most other OECD countries given the high rates of use.
| 2. Methods |
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At each participating institution a physician or senior medical student entered data from the patient chart into a questionnaire. The questionnaires were developed based on the RAND appropriateness criteria [3,4] (see Appendix A for the development process of the criteria).
Ninety-five percent confidence intervals were calculated depending upon the single trial probability of an event p. If p was small and the number of trials n was large, and nxp
10, the Poisson distribution was used to approximate the binomial. The Poisson distribution essentially describes processes for which the single trial probability of an event is very small but in which the number of trials is so large that there is nevertheless a reasonable rate of events. The limits of the 95% confidence interval of nxp were obtained from a standard table.
If nxp>10, the normal distribution was used to approximate the binomial. The standard error of an event p was then calculated as
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| 3. Results |
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| 4. Discussion |
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In addition, the study showed that pre-interventional stress tests were performed in less than 50% of PTCAs and CABGs. While the RAND appropriateness criteria do not rate the appropriateness of pre-interventional stress tests, they require information on pre-interventional stress tests to rate the appropriateness of PTCAs and CABGs in most scenarios. Although scenarios may exist where alternative sources of information are acceptable (e.g. from an immediate angiography), the high rate of absent pre-interventional stress tests suggests considerable underuse.
Our result for the inappropriate performance of CABGs is on par with the results of studies from other countries (Canada, Italy, Netherlands, and United States) using the RAND appropriateness criteria and yielding rates between 2% and 16% with a median of 4% [9,10,11,13,14,17,18].
However, our study's result for the inappropriate performance of PTCAs is lower than the rate of inappropriateness in studies from other countries (Italy, Netherlands, Spain, and United States). These studies list rates of inappropriateness ranging from 4% to 29% with a median of 14% [1012,16,18]. On the other hand, our result is in line with the results of two previous German studies, which also yielded relatively low inappropriate rates (1% and 10%, respectively) [19,20].
Our study shows a much lower rate of overuse of CEAs than the only prior study in which the RAND appropriateness criteria were applied to the performance of CEAs. The study was conducted in the USA in 1981 and yielded an inappropriateness rate of 32% [15].
What are possible reasons for the low inappropriateness rates for the performance of cardiovascular interventions in German hospitals? First, the low result may be a reflection of improved decision-making in Germany (and other OECD countries) over time. Second, national quality registers exist for all three interventions and comprise between 25% [21]2 and 61% [22]3 of all interventions. The registers collect data on patient characteristics and clinical outcomes. Participation is voluntary. Third, with regard to CEAs, the higher rate of severe ipsilateral stenosis in our sample (87%) compared to that of the US study by Winslow et al. [15] (62%) could be critical for explaining the difference in rates of inappropriateness. Even asymptomatic patients with severe ipsilateral stenosis benefit from a CEA if perioperative morbidity and mortality is low [23]. Furthermore, the rate of patients with minimal ipsilateral stenosis was much lower in our study compared to the rate in the US study by Winslow et al. [16] (2% vs. 19%). In the latter study a large share of these patients (62%) had an inappropriate procedure done.
It is unlikely that financial incentives have a role in explaining the low rate of inappropriateness for the performance of cardiovascular interventions in Germany. The costs of the three interventions we considered are reimbursed through fixed payments independent of their appropriateness. Furthermore, the annual number of procedures to be reimbursed is negotiated each year between hospitals and the statutory health insurance (approx. 90% of the population is insured through statutory insurance). The number of procedures to be reimbursed is calculated based on the numbers in previous years. While this reimbursement process prevents major increases in the number of procedures, it does not question the appropriateness of the existing number of interventions.
The likely high rate of underuse of stress tests may be explained by any of the usual barriers to practice related to physician knowledge and attitude as well as external barriers such as lack of resources [24].
This study has several strengths that increase the validity and reduce the bias of its results. First, participating hospitals were randomly chosen across the whole country. All previous studies evaluating the appropriateness of cardiovascular interventions using the RAND appropriateness criteria focused on certain geographic regions or hospitals. Second, the number of institutions participating in this study (121) was higher than in all previous studies evaluating the appropriateness of cardiovascular interventions using the RAND appropriateness criteria. Third, we did not use any exclusion criteria limiting the external validity of results.
There are, however, reasons why the results of this study should be interpreted with caution. First, despite the high number of participating institutions, the overall number of patients enrolled in the study was low compared to other studies in other countries. However, the upper limits of the 95% CIs of the inappropriateness rates were sufficiently low to examine our hypothesis that the rate of inappropriate procedures would prove to be higher in Germany than in most other OECD countries. Furthermore, if we assume that appropriateness ratings correlate within each hospital, the effective sample size of studies enrolling a high number of patients, but a low number of hospitals is much smaller than the actual sample size. Even if we assume a low correlation of appropriateness ratings, e.g. 5%, the effective sample size of a study enrolling 50 patients per hospital is only 29% of the actual sample size (while our effective sample size is still 91% of the actual).[25] In fact, assuming a 5% correlation of appropriateness ratings, our study ranked 5th in terms of effective sample size among the 14 studies investigating the appropriateness of PTCA, CABBG, and/or TEA.
A second limitation of this study was that we cannot exclude a bias in provider and patient selection. We did not, for example, recruit outpatient offices as PTCA sites. However, outpatient offices conduct only 15% of all percutaneous coronary interventions in Germany [21]. Furthermore, despite the fact that hospitals were recruited nationwide and that the participation rate was approximately 50%, study hospitals may not have been typical of all hospitals; for example, those hospitals that chose to participate may be particularly interested in quality assurance. In addition, the median annual PTCA and CEA volume of participating hospitals was higher than the median of a sample including two-thirds of all German hospitals (PTCA: 450 vs. 394; CEA: 50 vs. 23). On the other hand, several studies did not find a relationship between procedural volume and appropriateness [12,16,17].
The probability of a bias in patient selection is alleviated by the fact that the characteristics of patients enrolled in this study compare well with those of patients included in the national registers: for example, 95% of the 12.402 CEAs included in the national register had a severe ipsilateral stenosis which is close to the 93% considered in our study as assessable. For CEAs, the probability of a bias is further mitigated by the fact that assuming an elevated surgical risk did not influence the inappropriateness rate. For PTCAs, the rate of three-vessel disease was lower in our sample (13%) compared to the PTCA register (27%)4, which may cause a bias towards a lower inappropriateness rate. On the other hand, the impact of the potential bias on the conclusions of the study is rather small given the small difference in the rate of three-vessel disease (14%). Another reasons why patient selection was rather unlikely is the large number of questionnaire items, which made it difficult for study participants to anticipate appropriateness ratings. Finally, concealment of inappropriate procedures seems unlikely given that severe ethical misconduct must be assumed: procedures were performed despite knowledge of their inappropriateness.
A third limitation of this study is that we did not exclude PTCA and CABG patients with intra-coronary stents in place as suggested by the European panel. Exclusion of these patients would have been unlikely to change our conclusions, however, because according to the German PTCA register4 only 18% of PTCA patients had had an intra-coronary stents in place. Exclusion of these patients also limits the external validity of results.
Fourth, there were some missing data, but for most questionnaire items they accounted for less than 10%. One surprising exception was gender, which is easy to collect from the patient chart but was not provided for 18% of PTCA patients. Possibly, this item was simply in a blind spot of the questionnaire and therefore missed.
Fifth, the RAND/UCLA criteria, which form the basis of this study's evaluation show the following limitations. Although the criteria are developed in a process that involves an evaluation of the literature, the link between appropriateness ratings and evidence is not specified to the extent that is now expected of recommendations included in clinical practice guidelines. The ratings, for example, are not weighted by the level of evidence. The fact that previous studies suggest higher degrees of underuse than overuse [5,6] may point to a further limitation of the RAND/UCLA criteria. This result may reflect daily practice, but it may also mean that the appropriateness criteria are more sensitive to underuse than overuse. In addition, the European panel's suggestion to exclude patients with previous coronary surgery is inconsistent with the fact that all appropriateness ratings consider a scale which quantifies operative risk and explicitly takes re-operations into account. With regard to the assessment of the appropriateness of CEAs, the degree of carotid stenosis plays a critical role. However, the method used to determine the degree of stenosis is under debate. Moreover, one may argue that the RAND/UCLA criteria for measuring the appropriateness of CEA are outdated because they were established in the early 1990s. However, the validity both of appropriate and inappropriate indications was confirmed by the results of subsequent randomized clinical trials [7].
A final reason why it is necessary to interpret the results of this study with caution is that it is difficult to determine the peri-operative risk of CEA patients because this requires combining both the hospital's baseline risk and the individual's risk. In our study we asked hospitals to give an overall assessment of the patient's level of risk. We cannot exclude an estimation bias favoring lower estimates. On the other hand, our sensitivity analysis showed that there was no decrease in the percentage of inappropriate procedures if we assumed lower estimates.
In conclusion, this study shows a low rate of inappropriateness for invasive cardiovascular procedures in Germany, but a relatively high rate of uncertain procedures implying some additional overuse. The results of this study should, however, be interpreted with caution. The study can not explain the high per capita rate of invasive cardiovascular interventions in Germany. Thus, the lower rate of invasive cardiovascular interventions in most OECD countries may be explained by a higher rate of underuse.
Concerning the conduct of future studies on invasive cardiovascular procedures in an international setting we recommend a stronger focus on problems of underuse. Furthermore, additional studies are needed to clarify the clinical benefit of interventions that are currently labeled as uncertain. Based on current research, introducing measures to reduce the inappropriateness of invasive cardiovascular procedures such as second opinion programs does not seem to be economically attractive in Germany.
| Acknowledgments |
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| Footnotes |
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2 Arbeitsgemeinschaft leitender kardiologischer Krankenhausärzte. Qualitätssicherung. http://www.alkk.org/ (accessed 31 March 2002). ![]()
3 Ärztekammer Nordrhein. Bundesarbeitsgemeinschaft Qualitätssicherung Herz. http://www.aekno.de/htmljava/c/herzchirurgie.htm (accessed 31 March 2002). ![]()
4 Arbeitsgemeinschaft leitender kardiologischer Krankenhausärzte. Qualitätssicherung. http://www.alkk.org/ (accessed 31 March 2002). ![]()
| Appendix A |
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| Appendix B |
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CABG: Herzchirurgische Klinik, Zentralklinikum Augsburg, Augsburg; Kerckhoff Klinik GmbH, Bad Nauheim; Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen; Klinikum für Herz-, Gefäß- und Thoraxchirurgie und Kardiologie, Coswig; Klinik für Herz-, Thorax und Gefäßchirurgie, St. Johannes-Hospital Dortmund, Dortmund; Herz- und Kreislaufzentrum Dresden e.V., Technischen Universität, Dresden; Klinik für Thorax- und kardiovaskuläre Chirurgie, Heinrich-Heine-Universität Düsseldorf, Düsseldorf; Universität Erlangen-Nürnberg, Erlangen; Klinik für Thorax- und kardiovaskuläre Chirurgie, Universitätsklinikum Essen, Essen; Herzzentrum Frankfurt, Frankfurt; Abteilung für Herz- und Gefäßchirurgie, Universitätsklinikum Freiburg, Freiburg; Klinik für Thorax-, Herz- und Gefäßchirurgie, Klinikum Fulda, Fulda; Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie, Martin-Luther-Universität Halle-Wittenberg, Halle/Saale; Abteilung für Thorax-, Herz- und Gefäßchirurgie, Chirurgische Klinik und Poliklinik, Universitätskliniken des Saarlandes, Homburg/Saar; Klinik und Poliklinik fuer Chirurgie, Klinikum der Friedrich-Schiller-Universität Jena, Jena; Klinik für Herz- und Gefäßchirurgie, Christian-Albrechts-Universität zu Kiel, Kiel; Abteilung für Herz- und Gefäßchirurgie, Bundeswehrzentralkrankenhaus Koblenz, Koblenz; Klinik und Poliklinik für Herz- und Thoraxchirurgie, Universität zu Köln, Köln; Klinik für Herz- und Thoraxchirurgie, Klinikum Krefeld, Krefeld; Klinik für Herz-, Thorax- und Gefäßchirurgie, Herzzentrum Lahr, Lahr/Baden; Herzzentrum Leipzig GmbH, Universität Leipzig, Leipzig; Klinik für Herzchirurgie, Universitätsklinikums Lübeck, Lübeck; Klinik für Herzchirurgie, Philipps-Universität Marburg, Marburg; Deutsches Herzzentrum München, Klinik für Herz- und Gefäßchirurgie, Technischen Universität München, München; Klinik für Herzchirurgie, Klinikum Passau, Passau; Herz- und Kreislaufzentrum Rotenburg a. d. Fulda, Rotenburg a. d. Fulda; Sana Herzchirurgische Klinik Stuttgart GmbH, Stuttgart; Abteilung für Thorax-, Herz.- und Gefäßchirurgie, Eberhard-Karls-Universität Tübingen, Tübingen; Abteilung für Herz- und Thoraxchirurgie, Herzzentrum Völklingen, Völklingen.
CEA: Chirurgische Klinik, Kreiskrankenhaus Bad Salzungen GmbH, Bad Liebenstein; Herzzentrum Bad Krotzingen, Bad Krotzingen; Gefäßchirurgische Klinik, Knappschafts-Krankenhaus, Bottrop; Abteilung für Allgemein- und Gefäßchirurgie, Zentralkrankenhaus Bremen-Nord, Bremen; Klinikum der Heinrich-Heine-Universität Düsseldorf, Düsseldorf; Katholisches Klinikum St. Johannes Hospital, Duisburg; Gefäßchirurgische Klinik, Städtische Kliniken Esslingen, Esslingen; Klinik für Gefäß- und Thoraxchirurgie, Krankenhaus Nordwest, Frankfurt/Main; Abteilung für Herz- und Gefäßchirurgie, Klinikum der Albert-Ludwigs-Universität Freiburg, Freiburg; St. Josef Krankenhaus, Haan; Allgemeines Krankenhaus Harburg, Hamburg; Chirurgische Klinik der Ruprecht-Karls-Universität Heidelberg, Heidelberg; Abteilung für Thorax-, Herz- und Gefäßchirurgie, Universitätskliniken des Saarlandes, Homburg/Saar; Klinik für Thorax- und Gefäßchirurgie, Friedrich-Schiller-Universität Jena, Jena; Gefäßchirurgische Abteilung, Städtisches Klinikum Karlsruhe, Karlsruhe; Abteilung für Allgemein-, Gefäß- und Unfallchirurgie, Evangelisches Diakonissenkrankenhaus, Karlsruhe; Krankenhaus des Kurhessischen Diakonissenhauses, Kassel; Klinik für Herz- und Gefäßchirurgie, Christian-Albrechts-Universität zu Kiel, Kiel; Abteilung für Herz- und Gefäßchirurgie, Bundeswehrzentralkrankenhaus Koblenz, Koblenz; Klinik und Poliklinik für Visceral- und Gefäßchirurgie, Universität zu Köln, Köln; Krankenhaus Porz am Rhein, Köln; Klinik für Herz-, Thorax- und Gefäßchirurgie, Herzzentrum Lahr, Lahr/Baden; Klinik für Abdominal-, Transplantations- und Gefäßchirurgie, Universität Leipzig, Leipzig; Gefäßchirurgische Klinik, Kreiskrankenhaus Leonberg, Leonberg; Klinikum Ludwigsburg, Ludwigsburg; Klinik für Herz-, Thorax- und Gefäßchirurgie, Klinikum der Johannes Gutenberg Universität Mainz, Mainz; Deutsches Herzzentrum München, Technische Universität München, München; St. Franziskus Hospital Münster, Münster; Gefäßchirurgische Klinik Hallerwiese, Nürnberg; Klinikum der Universität Regensburg, Regensburg; Klinik für Gefäß- und Thoraxchirurgie, Mathias-Spital, Rheine; Abteilung für Thorax- und Gefäßchirurgie, Klinikum Schwerin, Schwerin; Klinik für Gefäßchirurgie, Asklepios-Kliniken Schildautal, Seesen/Harz; Klinikum Niederlausitz GmbH, Senftenberg; Hegau-Klinikum Singen, Singen am Hohentwiel; Katharinenhospital Stuttgart, Stuttgart; Abteilung für Thorax-, Herz- und Gefäßchirurgie, Eberhard-Karls-Universität Tübingen, Tübingen; Klinikum der Universität Ulm, Ulm; Abteilung für Gefäßchirurgie, St. Josefs Hospital, Wiesbaden; Städtisches Krankenhaus Wismar, Wismar.
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