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Economic Impact of Harmonizing Medical Practices: Compliance With Clinical Practice Guidelines in the Follow-Up of Breast Cancer in a French Comprehensive Cancer Center

From the Groupe de Recherche Économie de la Santé et Réseaux de soins en CancérologieUnité Mixte de Recherche 5823 du Centre National de la Recherche Scientifique, Centre Régional Léon Bérard, Lyon, France.

Address reprint requests to Marie-Odile Carrère, MD, Groupe de Recherche Économie de la Santé et Réseaux de soins en Cancérologie, Centre Léon Bérard, 28 Rue Laennec, 69008 Lyon, France; email carrere{at}lyon.fnclcc.fr

	ABSTRACT

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PURPOSE: The introduction of clinical practice guidelines (CPGs) and the increasing desire to harmonize clinical practices draw attention to the economic impact of these trends. In 1994, CPGs were introduced in a French Comprehensive Cancer Center (Centre Régional Léon Bérard, Lyon). We evaluated the application of these CPGs in addition to the consequences of harmonizing clinical practices with respect to the distribution of resources by specifically analyzing the posttherapeutic follow-up of patients with localized breast cancer.

METHODS: A before-and-after analysis of the records of patients who received posttherapeutic follow-up for localized breast cancer as of either 1993 or 1995 was performed. Two hundred records were chosen at random, 100 from 1993 and 100 from 1995. Follow-up was continued for as long as possible and CPG compliance was studied for each year of the follow-up periods.

RESULTS: Follow-up that was not CPG-compliant required a significantly greater amount of resources. This difference was due to neither consultations nor mammographies, but was due to other examinations that were systematically performed without any warning signs to justify them. Depending on the follow-up year, noncompliant follow-up cost the Social Security from 2.2 to 3.6 times more than compliant follow-up. A noticeable change in medical practices was observed after the introduction of CPGs in 1994. This was confirmed by a sharp decrease in mean Social Security expenditure per patient of more than one third between 1993 and 1995, regardless of the follow-up year considered.

CONCLUSION: In the follow-up of patients with localized breast cancer, a large decrease in costs has been observed along with the evolution of medical practices toward CPG compliance. This finding is probably generalizable to other settings, but there is nothing that proves that it is applicable to other treatment strategies.

	INTRODUCTION

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THE OVERALL PREVALENCE of cancer, the disparity of current medical practices,^1-3 and the increasing costs of treatments are all arguments for the application of clinical practice guidelines (CPGs) in oncology. The aim of these guidelines is to make therapeutic decision making easier, increase the efficiency of medical care, and improve the distribution of the limited resources in the health care sector.^4,5 However, the introduction of CPGs has also drawn attention to the economic impact of such tools.

Few studies have analyzed the true economic consequences of harmonizing medical practices.^6-8 In 1994, after an internal audit to improve the quality of medical care, the Centre Régional Léon Bérard (CRLB), a Comprehensive Cancer Center in Lyon, France, elaborated and implemented CPGs.⁹ These guidelines were based on a review of the literature and a consensus of medical experts and specialists from the CRLB. These guidelines included initial investigations, therapeutic decisions, and posttherapeutic follow-up for each disease site. A before-and-after study, published in 1997,¹⁰ was performed to evaluate the application of these CPGs. The study reported significant modifications in medical practices between 1993 and 1995 in terms of CPG compliance in the treatment of localized breast cancer and colon cancer.

We then attempted to evaluate the consequences of harmonizing clinical practices with respect to the distribution of resources by specifically analyzing the posttherapeutic follow-up of patients with localized breast cancer. In fact, this is an area in which current medical practices tend to differ greatly¹¹ and where changes in clinical practices at the CRLB in relation to CPG compliance were most noticeable.¹⁰ A recent national^12,13 and international^14,15 consensus was reached in favor of minimal follow-up that is limited to regular clinical follow-up and yearly mammographies. This consensus was largely founded on the results of two randomized Italian studies.^16,17 The results from these studies did not show any benefit in terms of overall survival or quality of life from more intensive follow-up.

	METHODS

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Objectives
The general objective of the study was to evaluate the economic impact of changing medical practices, which are evolving toward CPG compliance, in the posttherapeutic follow-up of patients with localized breast cancer. Our analysis compared CPG-compliant follow-up with CPG-noncompliant follow-up based on the number of medical acts (consultations and examinations) performed. The analysis also examined changes in medical practices between 1993 and 1995. Finally, a cost evaluation of the results obtained was carried out from the Social Security’s point of view.

Database
The CRLB is a Comprehensive Cancer Center in the Rhône-Alpes region (5.4 million inhabitants, 3,500 km²) that treats approximately 500 patients with newly diagnosed localized breast cancer each year. A before-and-after analysis was carried out on the records of new patients treated in 1993 (before the introduction of CPGs) and in 1995 (after the introduction of CPGs). Data were collected until December 1997. No information concerning the follow-up of patients was taken into account in the analysis after this date.

Two hundred patient records were chosen at random for the analysis: 100 of the 412 new records in 1993, and 100 of the 701 new records in 1995. Follow-up after initial treatment was either performed exclusively at the CRLB, or partially at the CRLB and partially in other health care settings. Exclusion criteria included the following: (1) the absence of follow-up data, (2) incomplete follow-up data, (3) a follow-up period of less than 7 months, and (4) treatment as part of a clinical trial.

Data was collected from two sources: paper medical records and computerized medical records. This enabled us to access all available information. To ensure the quality of the data, medical records were read and analyzed by two different people, a medical oncologist and a health economist. Patient records were analyzed in relation to the medical acts (consultations and examinations) that were carried out from the start of the follow-up period and for the longest time frame possible. This, however, resulted in variable follow-up periods from one patient to another. For the economic analysis to be relevant, follow-up periods had to be homogeneous. Patient records were therefore analyzed according to each individual year of follow-up treatment. The starting date of the follow-up period corresponded to the end of adjuvant treatment, not to the initial treatment, so that only medical acts prescribed within the context of follow-up were taken into account. The end of the period corresponded to the date of relapse or death, or in the case of dropout patients, to the date of the last investigation recorded. If the follow-up period ended before the mandatory 7-month period in the year under consideration, the final study date was moved back to the end of the previous year (eg, follow-up data for 30 months was evaluated at 24 months).

The CRLB guidelines for the posttherapeutic follow-up of patients with localized breast cancer were in favor of minimal follow-up⁹ (three clinical consultations per year for the first 2 years followed by two consultations per year for the next 3 years; one mammography per year for 5 years; paraclinical investigations performed only in case of symptoms). Follow-up was determined to be CPG-compliant or CPG-noncompliant by analyzing the clinical relevance of each investigation performed. This enabled us to differentiate investigations that were prescribed systematically from those that were justified by the presence of warning signs. The analysis encompassed consultations, mammographies, tumor marker measurements (CA 15.3 and carcinoembryonic antigen), liver ultrasounds, chest x-rays, and bone scans. Other clinical investigations were excluded from the analysis because they were only occasionally prescribed.

Data Analysis
To compare the economic impact of CPG-compliant with -noncompliant follow-up, the number of medical acts in each category had to be compared. The mean numbers per patient were therefore calculated for all assessable patient records from 1993 and 1995, according to the type of medical acts, and for each follow-up year, for both CPG-compliant and -noncompliant follow-up.

An economic analysis was then carried out on changes in medical practices by examining the follow-up protocol with respect to the year in which the treatment started, either in 1993 or in 1995 (ie, before or after the introduction of CPGs). A previous study carried out on the overall follow-up period (ie, nonhomogenous time periods) had already shown significant changes in medical practices in terms of CPG compliance.¹⁰ However, because follow-up periods needed to be homogenous, the distribution between CPG-compliant and -noncompliant follow-up was analyzed separately for each follow-up year.

To measure the overall economic impact of changes in follow-up strategies in relation to CPG compliance, it would have been necessary to evaluate the costs associated with CPG-compliant and -noncompliant follow-up. Because of insufficient available data concerning the costs of the medical acts, only Social Security expenditure was evaluated. However, it was not possible to establish a relationship between this expenditure and costs.¹⁸ We should bear in mind that all of the medical acts included in the follow-up protocol took place on an outpatient basis and were covered 100% by Social Security. Total expenditure was obtained by multiplying the number of medical acts by 1997 Social Security reimbursement rates.

Mean expenditure was also evaluated for each follow-up year with respect to the year in which the treatment was started, either 1993 or 1995. Ninety-five percent confidence intervals (CI) for mean expenditure were calculated when the number of records enabled this.

Statistical Analysis
A comparison of the distribution of our observations according to different criteria was made by using Pearson’s ² test; Fisher’s exact test was used when the number of patients was too small. For these two bilateral tests, the significance level was fixed at P = .05. The same level was used for the Student’s t test in comparing mean values.

	RESULTS

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Of the 200 patient records chosen at random (100 from 1993 and 100 from 1995), 50 were excluded. Reasons for exclusion were absence of data (20 records), a follow-up period of less than 7 months (18 records), incomplete records (10 records), and participation in a clinical trial (two records). Therefore, only 150 patient records were evaluated, 74 from 1993 and 76 from 1995. In addition, the number of assessable records decreased as the duration of the follow-up period increased. For the first year of follow-up, 150 records were assessable, then 127 were assessable for the second year of follow-up, and finally 62 were assessable for the third year. The length of the follow-up period analyzed was never longer than 3 years, because there were too few assessable records in the fourth year.

No significant differences were observed between the mean number of clinical consultations and mammographies per year for CPG-compliant and -noncompliant follow-up (Table 1). However, all of the other investigations (tumor markers, chest x-rays, liver ultrasounds, and bone scans) were significantly more frequent on the average for CPG-noncompliant follow-up than for CPG-compliant follow-up. It should be remembered that follow-up was classified as CPG-compliant even if it included additional investigations, provided that they were prescribed as a result of warning signs. A more detailed analysis of the first-year follow-up period enabled us to identify those investigations that were the cause of noncompliance. The frequency with which each type of additional investigation was prescribed was then calculated for the noncompliant patient records: tumor marker measurement (84%), chest x-ray (63%), liver ultrasound (58%), and bone scan (12%).

	DISCUSSION

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The absence of benefits of maximal follow-up compared with minimal (CPG-compliant) follow-up, in terms of overall survival, placed our study into the cost-minimization category. This clinical conclusion was based on two prospective comparative studies,^16,17 although neither of these studies evaluated the utility of measuring tumor markers. This investigation is simple and inexpensive, but its potential efficacy in regard to overall survival remains unclear.¹⁹ A large randomized prospective study would need to be carried out to specifically evaluate the efficacy of measuring tumor markers in breast cancer follow-up, with quality-of-life and economic criteria being added to classical survival criteria.

The economic analysis was strictly limited to consultations and examinations included in the follow-up treatment protocol. Other costs could have been taken into account, such as ambulance transport for patients. In fact, studies conducted in France estimated that the cost of transportation represented approximately 30% of follow-up expenditure for the first year²⁰ and 15% of the overall management costs for breast cancer.²¹ Although these results underline the important costs that ambulances can incur, they probably cannot be generalized because they were obtained in a rural district, where the distances between the patients’ homes and the clinic were often quite long. Because of insufficient available data, it was only possible to calculate the expenditure borne by the Social Security rather than the costs of the various follow-up procedures. In a study performed at the Beth Israel Hospital in Boston, MA, Cohen et al¹⁸ found that the cost-to-charge ratio was quite stable for different treatment strategies. If this hypothesis were to be considered acceptable in our study setting, which would of course have to be confirmed, then the charges borne by the Social Security would be proportional with the corresponding costs.

As far as we know, only a few studies, most of them from the United States, examine the cost of posttherapeutic breast cancer follow-up treatment. However, we do know that comparing economic results from different contexts can pose problems.^22-24 This difficulty has been further highlighted by recent studies that examined the transferability of economic evaluation results from one context to another.²⁴

Two studies performed by Simon et al^11,25 in the United States estimated the cost of posttherapeutic follow-up management in menopausal patients with stage I and II breast cancer. The objective of the authors was similar to our own in that they attempted to describe and evaluate real management in monetary terms, but it differed in that no comparison was made in relation to recommended treatments.

The methodology of the first study was not based on patient records but rather on responses to questionnaires mailed out to doctors who were members of the American Society of Clinical Oncology.²⁵ The aim was to analyze the cost of follow-up treatment by calculating the frequency of examinations and consultations and then applying unit costs. The mean cost per patient for the first and third years of follow-up (figures were not given for the second year) were $366 and $269, respectively, in 1993 United States dollars. In our records from 1993, which was the closest year to the American study, the corresponding Social Security expenditures were F1,300 and FRF 872, respectively, in 1997 French francs. Using the inflation rate in France from 1993 to 1997 (8%) and 1993 purchasing power parity, these expenditures corresponded, respectively, to $183 and $123, expressed in 1993 United States dollars. The American estimates, therefore, exceeded our own by more than 50%. Two explanations were possible: either the number of medical acts included in the follow-up protocol were different or the unit prices applied for monetary evaluation were different. The American unit prices corresponded to the 1993 Medicare rates. Close comparison showed that, overall, these rates were similar to the rates that we applied. Therefore, the main explanation is that the numbers of medical acts differed. There are two reasons for this: (1) certain investigations were frequently performed in the follow-up protocol described in the American study, whereas we did not take them into account, because they were only occasionally prescribed (mainly blood tests, apart from markers, and in particular, liver function tests); and (2) the other medical acts were more intensive in the United States, the best example being the greater prescription of bone scans.

In a second study, the same authors adopted a methodology that was closer to our own and included 222 patient records.¹¹ The data included the number of examinations and consultations from 1989 to 1993. The unit costs applied were the same Medicare rates that were applied in the previous study. The mean costs per patient, in 1993 United States dollars, were $362 and $297 for the first and second years of follow-up, respectively. It is worth noting that these results are similar to those of their previous study, which estimated the mean cost for the first year at $366, despite the different sources of information. Our results for the first 2 years of follow-up for the patient records from 1993 were $183 and $169, respectively, in 1993 United States dollars. Overall, we reach the same conclusion as for the first study by Simon et al,²⁵ namely, that the higher American costs were principally due to more intensive follow-up.

Another American study was published by Schapira et al²⁶ in 1991, although their methodology was quite different. This study did not in fact observe real management, but instead defined theoretical management. The authors examined the cost of posttherapeutic follow-up of patients with stage I and II breast cancer by defining two theoretical management protocols that were referred to as minimal and intensive. They based their work on a literature review and concluded that the intensity of posttherapeutic follow-up in breast cancer patients did not significantly influence survival. They then simulated two theoretical situations, corresponding to the systematic application of either minimal or intensive follow-up, to all of the United States population affected by breast cancer. They then deduced the corresponding costs and the theoretical savings incurred by changing from one situation to the other. For example, the mean cost per patient for the first year was $250 for minimal follow-up and $1,417 for intensive follow-up, expressed in 1990 United States dollars. In our study, the closest comparative management groups would be the compliant and noncompliant follow-up groups, with an associated mean expenditure of F640 and F1,430, respectively, expressed in 1997 French francs. Using the French inflation rate from 1990 to 1997 and 1990 purchasing power parity, this expenditure corresponded to $83 and $185, expressed in 1990 United States dollars. The American follow-up strategies were therefore much more expensive. Part of the explanation lies in the fact that the unit costs used in the American study were much higher than the French Social Security rates. There is little point in comparing the number of examinations and consultations in the two studies, because the objectives were totally different; Schapira et al²⁶ tried to evaluate theoretical management, whereas we looked at real management and compared it to what was recommended by CPGs. For example, follow-up that was defined in our study as CPG-compliant was not the same as the minimal follow-up described by the American authors. The American study included only consultations and mammographies, whereas we included other complementary investigations, provided that they were justified by the presence of warning signs.

Finally, in a French study by Schraub et al,²¹ data from the cancer registry in the Doubs region of France were used to estimate the management costs of various types of cancer. In this study, a patient cohort, which included 24 breast cancer patients, was observed from 1988 to 1994. Here, the various stages of disease management were looked at separately: diagnosis, treatment, follow-up, and the terminal stage. All direct costs were taken into account, including the cost of ambulances. Monetary evaluation was performed, as in our study, by using Social Security reimbursement rates (in this case, the Agricultural Social Sickness Fund). The minimum observation period was fixed at 3 years, with all management stages combined. The mean cost of follow-up per patient (for the 19 cases with follow-up phases) was estimated at F24,000 (1992 French francs), which corresponds to $3,616 (1992 United States dollars) using 1992 purchasing power parity. This seems high when compared with our figures, but an accurate comparison is impossible. First, their estimation was based on a small number of records (n = 19). Second, the information provided was not very detailed: (1) the type of breast cancer was not specified (our study was limited to localized breast cancer), (2) the definition of costs was more extensive than ours, but details of the estimated costs were not supplied, and (3) the length of the follow-up period was not indicated.

Comparison of our study with other studies concerning the same subject does not help in answering the question of whether our results could be generalized, considering the difficulties that this comparison presents. There could be a wide variability in the follow-up of patients with breast cancer in France as well, but we do not have enough accurate information to affirm this. It is therefore probable that the details of our results are dependent on the site in which they were obtained. However, our observations do show that follow-up that is not CPG-compliant always produces overprescription and never underprescription. In view of this, changes in follow-up treatments in terms of CPG compliance can only have a positive influence on costs. It is probable that this conclusion could well be applicable to the follow-up of patients with nonmetastatic breast cancer in other settings. On the other hand, based on these results, there is no reason to suspect that compliance with CPGs in other therapeutic situations would also produce a reduction in costs.

In conclusion, the increasing quantity of CPGs and the current evolution of clinical practices toward these guidelines draw attention to the important question of the economic consequences of these trends, yet few studies have been carried out on this subject. Furthermore, as some studies apply theoretical management protocols and have not evaluated real costs, they are difficult to use for decision making.

Additional prospective research analyzing the economic impact of CPGs should be encouraged. Moreover, according to certain authors,²⁷ the economic dimension should actually be taken into account quite early on and integrated directly into the guideline development process.

	REFERENCES

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Submitted July 12, 1999; accepted December 15, 1999.

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