Skip Navigation


Family Practice Advance Access originally published online on February 27, 2008
Family Practice 2008 25(2):86-91; doi:10.1093/fampra/cmn006
This Article
Right arrow Abstract Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
25/2/86    most recent
cmn006v1
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Google Scholar
Right arrow Articles by Lucas, A.
Right arrow Articles by van Schayck, C.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Lucas, A.
Right arrow Articles by van Schayck, C.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© The Author 2008. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org.

Overtreatment with inhaled corticosteroids and diagnostic problems in primary care patients, an exploratory study

AEM Lucasa, FWJM Smeenkb, IJ Smeelec and CP van Schaycka

a Department of General Practice, Research Institute Caphri, Maastricht University, Maastricht
b Department of Pulmonary Diseases and Tuberculosis, Catharina Hospital, Eindhoven
c COPD & Asthma Primary Care Group (CAHAG), Utrecht, The Netherlands

Correspondence to AEM Lucas, Department of General Practice (HAG), Research Institute Caphri, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands; Email: annelies.lucas{at}hag.unimaas.nl

Received 31 March 2007; Revised 7 December 2007; Accepted 18 January 2008.


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Conclusions
 Declaration
 References
 
Background. Underdiagnosis and undertreatment of patients with asthma or chronic obstructive pulmonary disease are widely discussed in the literature. Not much is known about the possible overdiagnosis and consequently the overtreatment with inhaled corticosteroids (ICS).

Aim. This study investigates how often ICS are prescribed without a proper indication and how big the diagnostic problem is caused by inappropriate prescription and use of ICS.

Methods. All patients referred to a primary care diagnostic centre during 6 months who used ICS without a clear indication were included. Their GPs were questioned about the reasons for prescribing ICS. If still no diagnosis could be assessed, GPs were advised to stop ICS and renew spirometry after a steroid-free period of at least 3 months. After 1 year, the use of ICS was evaluated and the diagnoses were reassessed.

Results. Of all referred patients (2271), 1171 used ICS, 505 (30%) without a clear indication. After 1 year, final results showed that 11% of all patients originally using ICS had no indication to use ICS and had successfully ceased using this mediation. For 15%, the reasons for using ICS remained unclear.

Conclusions. Overtreatment with ICS in primary care seems to be considerable, which falsely labels patients as asthmatic and which generates unnecessary costs and possible side effects. The awareness of GPs of the need for proper diagnostic testing before prescribing ICS needs to be improved. Overtreatment with ICS in primary care patients can be diminished by systematically supporting the GP in the diagnostic procedures and decision making.

Keywords. Asthma, COPD, overtreatment, primary care, use of ICS.


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Conclusions
 Declaration
 References
 
Underdiagnosis and undertreatment are considered to be major problems in the management of asthma and chronic obstructive pulmonary disease (COPD) in primary care and worries exist about the consequent undertreatment of obstructive pulmonary diseases.1 It is stressed that symptoms indicating asthma or COPD have to be interpreted more often as indicating these diseases.2 When, according to the international guidelines, a definite diagnosis is confirmed by spirometry3 and, consequently, proper medication is prescribed, undertreatment could be diminished. However, in daily practice, there are thresholds following this procedure4 and it is tempting for GPs to start medication already when a patient presents bronchial symptoms. Combined with the growing awareness of asthma/COPD in the general population, this practice could lead to too many prescriptions and to overtreatment with inhaled corticosteroids (ICS). When complaints disappear, a healthy person using ICS might be mistaken for a well-regulated asthma patient and be advised to continue treatment with ICS.

The recent development of diagnostic support services5–7 has triggered awareness of this problem.

These services offer GPs the possibility to refer all their patients with respiratory problems for diagnosis and advice. The services can be a solution for the problems GPs experience in performing good quality spirometry and good quality interpretations of the results.8

In a region (in The Netherlands) where such a diagnostic service is part of usual care, we examined the problem of overtreatment with ICS in primary care patients. We tried to answer the following questions:

(i) How often are ICS prescribed without a properly assessed indication?
(ii) What is the magnitude of the diagnostic problem caused by the inappropriate prescription and use of ICS?


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Conclusions
 Declaration
 References
 
Diagnostic support service
The study presented in this paper has been conducted at the asthma/COPD service of the primary care diagnostic centre in Eindhoven, The Netherlands.9 This diagnostic service supports 180 GPs (population: 300 000 people), most of them with no special interest in asthma or COPD. GPs can refer all their patients with respiratory complaints to this service for diagnostic spirometry. Written spirometry data are assessed in combination with written medical history data filled in by the patients at referral. The structured history form includes smoking habits (pack-years), physical condition (Medical Research Council dyspnoea score), respiratory complaints, exacerbations, prescribed medication and compliance. Assessments of the written data are performed by pulmonologists of the local hospitals. A diagnosis and—when indicated—advice is given about additional diagnostic examinations and about therapy and guidance. A report is then sent to the GP who is responsible for the patient's care. When a diagnosis asthma or COPD is assessed, patients are called for a yearly follow-up as recommended by the Dutch guidelines.10

Patients
During a 6-month period (April–September 2005), we examined the diagnoses of all patients referred to the asthma/COPD service. Included in the study were those patients who used ICS, had a normal or mildly obstructed lung function without reversibility and who did not have a definite diagnosis of asthma or exacerbations of COPD. The diagnosis asthma was considered definite when reversible bronchial obstruction was assessed, defined according to the Dutch guidelines as an increase in forced expiratory volume in the first second (of expiration) (FEV1) ≥9% of the predicted value after inhalation of 800 µg salbutamol.11 An exacerbation of COPD was defined as a period of worsened complaints that needed treatment with (oral) steroids and/or antibiotics.

Questionnaire and stop advice
For each patient in the study, the GP was asked to mark the reasons for prescribing ICS on a questionnaire that defined six reasons:

(i) Diagnosis assessed and ICS prescribed by a lung specialist or paediatrician in the past.
(ii) Bronchial reversibility previously shown by spirometry.
(iii) A previously positive response to a steroid reversibility test (when no reversibility is found in the first spirometry test, this test is repeated after using oral steroids for 2 weeks or ICS for 3 months. When in this second spirometry test the FEV1-post-bronchial dilatation (FEV1-PB) was ≥20% and >200 ml compared to FEV1-PB in the first spirometry test, this is considered an indication for the diagnosis asthma11).
(iv) Abnormal peak flow variability (a difference in the morning and evening peak flow of >20% of the mean peak flow measured on at least 2 of 14 consecutive days11).
(v) Asthma symptoms in childhood.
(vi) Other reason to be explained by the GP (e.g. bronchial symptoms, continued prescription because of start in the past, etc.).

Of these six reasons, the first four reasons were considered (a priori) as ‘valid reasons’ for the use of ICS7 and the fifth and sixth reasons were labelled as ‘unclear reasons’.

The GPs’ explanation for the use of ICS was taken into account by the assessing pulmonologist who then reconsidered his interpretation of the patient’s spirometry and medical history. When it was still not possible to diagnose asthma, GPs were advised to stop ICS and repeat the diagnostic procedure after a steroid-free period of at least 3 months. After 3 months, we examined the results of this advice by checking if the patient was referred for renewal of spirometry. In addition, these patients were asked in a telephone interview:

(i) Have you been given the advice to stop or step-down ICS?
(ii) Did you do so?
(iii) Has this caused complaints?
(iv) Did you start using (more) ICS again?

One year later, we evaluated the use of ICS and the number of still unclear diagnoses by examining the yearly follow-up assessments of all patients of whom the GP had not respond to the questionnaire in first instance or secondly had not followed the advice to stop ICS and renew spirometry.


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Conclusions
 Declaration
 References
 
Patients
Over a 6-month period, a total of 2271 patients were referred by their GPs for lung function tests. In all, 36% were diagnosed as asthma patients and 19% as COPD patients. Six per cent had both COPD and asthma. Twenty per cent had neither asthma nor COPD. In 19%, the diagnosis was unclear (Table 1).


View this table:
[in this window]
[in a new window]

  		TABLE 1 Characteristics of all patients (n = 2271) referred to an asthma/COPD service during 6 months: spirometry results, assessed diagnosis, use of ICS and validity of indication for ICS

 


View this table:
[in this window]
[in a new window]

  		TABLE 2 Reasons for prescribing ICS by GPs to patients showing a normal lung function or a medical history without severe complaints compared with the diagnostic assessments of pulmonologist who take these reasons into account

 
Reasons for prescribing ICS
Of all referred patients, 1177 (52%) used ICS (Fig. 1: first assessment). The reasons for this use were clear in 572 patients with the diagnostic assessment asthma or (severe) COPD (Table 1). In 505 patients, the use of ICS did not match the results of the spirometry test or the medical history. These patients were included in our study.


Figure 1
View larger version (57K):
[in this window]
[in a new window]
[Download PowerPoint slide]
  		FIGURE 1 Results of the assessments to clarify the reasons for using ICS and to define the magnitude of overtreatment in all patients referred for spirometry to a diagnostic support service in a period of 6 months

 
The size of overtreatment
GPs received a questionnaire for the included 505 patients about their reasons for prescribing ICS; 282 GPs responded (58%). As a second assessment, the answers of the GPs were evaluated (Fig. 1): the pulmonologists assessed a diagnosis for 174 additional patients (62%). Of those, 128 asthma patients and 5 COPD patients were advised to continue ICS. In 149 patients, doubts remained about the reason for the use (or the continuation of formerly indicated use) of ICS and the advice was given to stop.

In all, 71 (of 149) patients followed this advice and came to the asthma/COPD service for renewed spirometry testing after a steroid-free period of at least 3 months. Then a third assessment (Fig. 1) was done: five patients had developed asthma symptoms and had started ICS again. Six COPD patients could stop ICS without any problem, as could 60 persons with normal lung function.

One year after referral, patients of whom GPs did not respond to the questionnaire or did not follow the advice to renew the diagnostic procedure (283) were invited for follow-up spirometry (Fig. 1: fourth assessment). In all, 49 had stopped using ICS without problems, 43 of them had normal lung functions and 6 were mild COPD patients. Sixty asthma patients continued using ICS on indication, as did six COPD patients because of exacerbations. Eighty-nine patients still used ICS for unclear reasons and 79 did not show upon invitation or recall.

Through telephone interviews with the patients after their GPs completed the questionnaire, we found that, except for the patients who definitely stopped ICS, 43 of the 128 diagnosed as ICS-dependent asthma patients had reduced their dose of ICS without experiencing respiratory problems again.


   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Conclusions
 Declaration
 References
 
Use of ICS in primary care patients with respiratory problems
The first finding of this study is that about 50% of all patients referred to the asthma/COPD service for diagnostic assessment used ICS. For 43% of these patients, the assessing pulmonologist did not understand the reason for this use since all these patients had a normal or only mildly obstructed spirometry and none had complaints or a history suggesting asthma or exacerbations.

During the study, the referral of all primary care patients with respiratory problems had become a standard practice. However, there remained a number of eligible patients who were not referred yet. The patients referred were distributed over all primary care practices and there were no reasons to assume priority selection in referrals. Therefore, we believe that the research population represents the total population of primary care patients with respiratory problems fairly well.

Inappropriate use of ICS
Half of the GPs who responded to the questionnaire about the reason for the prescription of ICS could not provide valid arguments for this. When they followed the advice to have their patients stop the ICS and to repeat the diagnostic tests after a steroid-free period of 3 months, almost all these patients could stop using ICS without regaining respiratory complaints. This was the first indication that ICS were not appropriate for all the patients who used them.

One year after referral, we studied all patients who originally used ICS for unclear reasons, to also learn about the patients whose GP did not answer the questionnaire or who did not repeat spirometry because of cessation of ICS use. We found that 11% of the patients who originally used ICS had successfully stopped the medication and could be discharged from follow-up.

For 15% of the patients, the reason for the use of ICS at referral remained not clarified: 8% continued to use ICS for unclear reasons even after the GP had been questioned and advised to stop the prescription and 7% of the patients who originally used ICS for unclear reasons did not come for follow-up. Since, according to the protocol of the asthma/COPD service, these patients were called twice and because regular follow-up discipline is high, this could indicate that they were no longer considered to be patients and had stopped using medication.

The findings show that of all patients using ICS at the beginning of the study, at least 11%, probably 19% and maybe up to 26% of the patients could stop using these drugs because there was no proper indication.

Reasons for prescribing ICS
It is clear that there is no good reason to continue a prescription without a diagnosis or clear indication; yet many GPs will admit that these things ‘just happen’. Sending the questionnaire induced awareness in GPs. This was indeed necessary: patients that came for follow-up spirometry continued to use ICS without an obvious reason for many years. An yearly assessment reporting normal spirometry was not a sufficient reason for the GP to reconsider the use of ICS, even when a regular reminder was added to the report which read: ‘Is it really asthma? When there is any doubt, stop ICS and renew spirometry. In case asthma has been diagnosed, ICS can be continued’.

The GPs could mark—and comment upon—six reasons for prescribing ICS. The assessing pulmonologists did not discuss the diagnoses formerly given by a lung specialist or a paediatrician (25% of the patients). Also ‘shown reversibility’ (in 16%) was most often considered a valid reason for using ICS no matter whether spirometry was performed and/or interpreted by a respiratory specialist or by the GP. This might have biased the number of valid reasons since interpretation of spirometry is found to be difficult by GPs12 and supervision of interpretation is advisable.13

Abnormal peak flow variability, even though this is less reliable in daily primary care practice,14 was more often accepted as a diagnostic for asthma. A ‘positive response to a steroid reversibility test’, being a diagnostic recommendation in the Dutch guidelines, was considered a valid reason for the use of ICS. We realize that if we had been able to validate the interpretations of these tests, the number of patients with a doubtful indication for ICS could have been even higher. This emphasizes the importance of quality assurance in primary care diagnostic assessment of asthma and/or COPD, which is not the same as following the guidelines and which requires support and feedback.15

Diagnostic problems because of the use of ICS
The magnitude of the diagnostic problem could be reduced from 47% at the start to 17% at follow-up. This required active participation of the asthma/COPD service in the diagnostic process. This does not mean that responsibility for diagnosis is taken over from the GP. The final responsibility belongs to the GP, who should always judge whether the assessed diagnosis and advices given fit in the clinical profile of the patient.16 Our study shows that this is not a natural attitude. Some gentle force was needed to make GPs reconsider the use of ICS and to follow the diagnostic advice to stop the treatment. On the other hand, GPs did appreciate this type of support. After the study period, we continued to send questionnaires, when indicated, and the response continued to increase. It will be interesting to examine if this way of providing feedback adds to the diagnostic knowledge and self-confidence of the GP.

Shortcomings of this study
A relatively high percentage of the GPs did not respond to the questionnaire. We do not know if this means that the GPs were triggered sufficiently to reconsider the use of ICS and the diagnoses of their patients or that they ignored the questionnaire. We tried to discover this by studying the patients at the yearly follow-up, but also at that time we could not be sure whether no responds means good effect or no effect.

We could not prevent the possible bias introduced by asking the GPs to justify their own prescription behaviour. Nor could pulmonologists exclude the ‘benefit of the doubt’ when diagnosing asthma in patients using ICS who had a normal lung function and only minor complaints. For at least 30% of these patients, it was possible to decrease their dose of ICS without problems, which could indicate either achieved asthma control17 or—in some patients—misdiagnosed ‘asthma’.

These facts suggest a higher number of patients using ICS unnecessarily and an underestimation of the problem we examined.


   Conclusions
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
Declaration
 References
 
In primary care, ICS are frequently prescribed in patients having respiratory complaints but who have not had a proper diagnosis or indication for this kind of therapy. More than 10% of our patients on ICS used these drugs unnecessarily, leading to unnecessary costs. More important is the consequence that many healthy people risk by being labelled as asthmatic. This diagnosis is hard to turn back since the same ICS lead to misdiagnoses when spirometry shows a normal flow curve that fits to asthma in a stable condition.

Our study emphasizes the importance of adding medical history data to spirometry in the assessment of asthma and COPD. Diagnostic support, as given by an asthma/COPD service, can be further improved by an appropriate feedback system that should make GPs more aware of the importance of clear diagnosis before prescribing ICS.


   Declaration
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Declaration
References
 
Funding: ‘Partners in Care Solutions’, an initiative of the research institution Caphri, Pfizer Inc. and Boehringer Ingelheim Inc.

Ethical approval: Not applicable.

Conflicts of interest: None.


   Acknowledgments
 
We gratefully acknowledge the commitment of the participating pulmonologists from the Eindhoven Catharina Hospital, the GPs and the secretary and staff of the asthma/COPD service in administering the study.


   Notes
 
Lucas AEM, Smeenk FWJM, Smeele IJ and van Schayck CP. Overtreatment with inhaled corticosteroids and diagnostic problems in primary care patients, an exploratory study. Family Practice 2008; 25: 86–91.


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Declaration
 References
 
1 van Schayck CP, van der Heijden FMMA, van den Boom G, Tirimanna PRS, van Herwaarden CLA. Underdiagnosis of asthma: is the doctor or the patient to blame? The DIMCA project. Thorax (2000) 55:562–565.[Abstract/Free Full Text]

2 van Schayck CP, Chavannes NH. Detection of asthma and chronic obstructive pulmonary disease in primary care. Eur Respir J (2003) 21((suppl 39)):16S–22S.[Abstract/Free Full Text]

3 Østrem A, Stallberg B, Ostergaard MS, Singh RB. International Primary Care Respiratory Group (IPCRG) Guidelines: management of asthma. Prim Care Respir J (2006) 15:35–47.[CrossRef][Medline]

4 Bolton CE, Ionescu AA, Edwards PH, Faulkner TA, Edwards SM, Shale DJ. Attaining a correct diagnosis of COPD in general practice. Respir Med (2005) 99:493–500.[CrossRef][Web of Science][Medline]

5 Walker PP, Mitchell P, Diamantea F, Warburton CJ, Davies L. Effect of primary-care spirometry on the diagnosis and management of COPD. Eur Respir J (2006) 28:945–952.[Abstract/Free Full Text]

6 Vaughn RCR, MacIntyre D. An outreach spirometry service for greater Glasgow health board: does it help in diagnosis. Eur Respir J (2004) 24((suppl 48)):182s.[CrossRef]

7 Wolfenden HBL, Murphy K, Partridge MR. Use of an open access spirometry service by general practitioners. Prim Care Respir J (2006) 15:252–255.[CrossRef][Medline]

8 Frank TL, Hazel ML, Lineham MF, Frank PI. The diagnostic accuracies of chronic obstructive pulmonary disease (COPD) in general practice: the results of the MAGIC (Manchester Airways Group Identifying COPD) study. Prim Care Respir J (2006) 15:286–293.[CrossRef][Medline]

9 Lucas AEM, Smeenk FJWM, Smeele IJ, Brouwer T, van Schayck CP. Validity of diagnostic support of an asthma/COPD-service in primary care. Br J Gen Pract (2007) 57:892–896.[CrossRef][Medline]

10 Geijer RMM, Thiadens HA, Smeele IJM, et al. Standard of the Dutch College of General Practitioners on COPD: treatment (in Dutch). Huisarts en Wet (2001) 44(5):207–219.

11 Geijer RMM, Thiadens HA, Smeele IJM, et al. Standard of the Dutch College of General practitioners on asthma and COPD: diagnostics (in Dutch). Huisarts en Wet (2001) 44(3):107–117.

12 Kaminsky DA, Marcy TW, Bachand M, Irvin CG. Knowledge and use of office spirometry for the detection of chronic obstructive pulmonary disease by primary care physicians. Respir Care (2005) 50(12):1639–1648.[Medline]

13 White P, Wong W, Flemming T, Gray B. Primary care spirometry. Test quality and the use of specialists reporting. Br J Gen Pract (2007) 57:701–705.[Medline]

14 Thiadens HA, De Bock GH, Van Houwelingen JC, et al. Can peak expiratory flow measurements reliably identify the presence of airway obstruction and bronchodilator response as assessed by FEV1 in primary care patients presenting with a persistent cough? Thorax (1999) 54:1055–1060.[Abstract/Free Full Text]

15 Hassett RMK, Partridge MR. Enhancing the accuracy of respiratory diagnoses in primary care: a report on the establishment of a Community Respiratory Assessment Unit. Prim Care Respir J (2006) 15:354–361.[CrossRef][Medline]

16 Miller MR, Crapo R, Hankinson J, et al. General considerations for lung function testing. Eur Respir J (2005) 26:153–161.[Free Full Text]

17 Hawkins G, McMahon AD, Twaddle S, Wood SF, Ford I, Thomson NC. Stepping down inhaled corticosteroids in asthma: randomized controlled trial. Br Med J (2003) 326:1115.[Abstract/Free Full Text]


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?



This Article
Right arrow Abstract Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
25/2/86    most recent
cmn006v1
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Google Scholar
Right arrow Articles by Lucas, A.
Right arrow Articles by van Schayck, C.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Lucas, A.
Right arrow Articles by van Schayck, C.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?