patients with mild copd often use inhaled corticosteroids without a need for them . a clinical audit including spirometry was useful for identifying overuse of inhaled corticosteroids .
asthma and chronic obstructive pulmonary disease ( copd ) are two separate diseases in terms of aetiology and pathophysiology , with different diagnostic and management strategies ( 1,2 ) . in clinical practice
stable asthmatics usually have normal spirometry findings and hyper - responsiveness testing with histamine or methacholine is rarely performed in general practice ( 4,5 ) .
the frequency and clinical impact of the overlap between asthma and copd have been emphasized ( 6 ) . in chronic asthma ,
long - term inflammation over time may lead to a remodelling of the lower respiratory tract quite similar to that seen in copd .
this can impair respiratory function as measured by spirometry , i.e. less reversibility after inhalation of a beta2-agonist ( 79 ) .
therefore , there may be considerable overlap between the two diagnoses , particularly in elderly patients ( 1,10,11 ) .
inhaled corticosteroids ( ics ) are generally not recommended for copd except for patients with severe copd and frequent exacerbations , and there are good reasons to withhold the treatment in mild or moderate stages of copd ( 1,12 ) .
however , ics have been marketed heavily , and in situations with diagnostic uncertainty , it may be tempting for a general practitioner ( gp ) to add ics to the medication list for patients with pulmonary obstruction . however , overtreatment with ics is problematic because of both unnecessary costs and possible side - effects including dysphonia , thrush , cough , osteoporosis , adrenal suppression and adverse ocular effects ( 13,14 ) .
ics therapy also increases the risk of pneumonia in patients with stable copd ( 15 ) . in norway in 2006 , separate reimbursement codes for asthma and copd were introduced and it became mandatory for drug cost reimbursement that the diagnoses should be confirmed by spirometry .
the principle became that costs for ics , alone or in combination with long - acting beta2-agonist ( laba ) , should only be reimbursed with a diagnosis of asthma .
patients with severe copd ( with forced expiratory volume in one second ( fev1 ) less than 50% predicted by spirometry ) could also be reimbursed , but only after a special and individual application .
physicians were , therefore , urged to reconsider their prescribing practice for patients with obstructive lung diseases to bring their prescription practice into accordance with the new regulations . as clinicians , it was a challenge to comply with the new reimbursement regulations because of difficulties in identifying copd patients who also suffered from asthma or who might benefit from using ics for other reasons ( 16 ) .
identification of copd patients and discontinuation of ics might not be a clinically straightforward decision .
therefore , a quality assurance project was undertaken , a clinical audit , in a gp group practice , focusing on middle - aged and elderly patients who were using ics ( ics / laba included ) , intending to comply with the new regulations .
the aim of this study was to investigate how the implementation of the new reimbursement terms affected gps use of diagnoses for patients using ics .
the study was undertaken in one group practice just outside oslo , norway , where approximately 8 100 patients were listed with six gps . from the shared electronic patient record ( epr )
database , all patients of 50 years and over were identified who had been prescribed ics ( including ics in combination with long - acting beta2-agonist ) during a one - year period before the regulation was put into practice ( 1 october 2006 ) . in october 2006 , all identified ics users were sent a letter informing them about the new reimbursement regulations and an invitation to a tailored consultation with their gp to assess their respiratory illness .
tailored consultations , undertaken in october to december 2006 , included the patients history , physical examination and spirometry with reversibility testing .
patients were instructed not to use any inhaled medications on the day of investigation prior to spirometry .
the spirometry was carried out by trained staff in accordance with the criteria of the american thoracic society and the european respiratory society ( 17 ) .
the spirometer used was a microloop ii with spirare software and the european coal and steel community reference for spirometry was used ( 18 ) .
reversibility was defined as increased forced expiratory volume in one second ( fev1 ) of  12% and 200 ml ( 2 ) .
the spirometry criterion for copd was based on the gold guidelines and was a ratio of fev1 to forced vital capacity ( fvc ) less than 0.7 after bronchodilation ( 1 ) .
based on predicted fev1% , patients were categorized to copd stage based on the gold guidelines ( 1 ) .
the decision about follow - up of findings was left to individual gps in collaboration with their patients . in april 2008 , one year and three months after the audit was completed ; a retrospective epr data search was performed regarding gps diagnoses and prescribing patterns for patients who had participated in the clinical audit .
all patients signed an informed consent giving the opportunity to analyse and publish the results at an aggregated level that did not compromise patients anonymity .
the study was presented to the regional committee for medical and health research ethics , south - east norway , who judged this to be a clinical audit project , and therefore , without the need for formal approval by the committee .
the study was undertaken in one group practice just outside oslo , norway , where approximately 8 100 patients were listed with six gps . from the shared electronic patient record ( epr )
database , all patients of 50 years and over were identified who had been prescribed ics ( including ics in combination with long - acting beta2-agonist ) during a one - year period before the regulation was put into practice ( 1 october 2006 ) . in october 2006 , all identified ics users were sent a letter informing them about the new reimbursement regulations and an invitation to a tailored consultation with their gp to assess their respiratory illness .
tailored consultations , undertaken in october to december 2006 , included the patients history , physical examination and spirometry with reversibility testing .
patients were instructed not to use any inhaled medications on the day of investigation prior to spirometry .
the spirometry was carried out by trained staff in accordance with the criteria of the american thoracic society and the european respiratory society ( 17 ) .
the spirometer used was a microloop ii with spirare software and the european coal and steel community reference for spirometry was used ( 18 ) .
reversibility was defined as increased forced expiratory volume in one second ( fev1 ) of  12% and 200 ml ( 2 ) .
the spirometry criterion for copd was based on the gold guidelines and was a ratio of fev1 to forced vital capacity ( fvc ) less than 0.7 after bronchodilation ( 1 ) .
based on predicted fev1% , patients were categorized to copd stage based on the gold guidelines ( 1 ) .
the decision about follow - up of findings was left to individual gps in collaboration with their patients . in april 2008 , one year and three months after the audit was completed ; a retrospective epr data search was performed regarding gps diagnoses and prescribing patterns for patients who had participated in the clinical audit .
all patients signed an informed consent giving the opportunity to analyse and publish the results at an aggregated level that did not compromise patients anonymity .
the study was presented to the regional committee for medical and health research ethics , south - east norway , who judged this to be a clinical audit project , and therefore , without the need for formal approval by the committee .
the search of the shared epr database revealed that 164 patients of 50 years and older ( mean age : 66 years , range : 5088 years ) had been prescribed ics the year before the 2006 regulation . of the 164 , 114 ( 69.5% )
of the 50 non - attendees , 14 no longer used ics ; three were too ill to participate ; two were deceased ; two had changed to a gp in another practice ; one was followed up by the pulmonary clinic at the hospital , and one letter was returned because of an unknown address . of the remaining 27 non - responders ( mean age : 73 ,
range : 5094 years ; females 44% ) , 13 had received only a single ics prescription .
the mean age of the 112 patients included in the analysis was 65 years ( range : 5088 years ) ; 57% were women ; 46% were daily smokers , 35% previous smokers and 19% never smokers .
post - bronchodilator spirometry revealed copd ( fev1/fvc < 0.7 ) in 55 patients ( table 1 ) .
reversibility  12% and 200 ml was found in 13 patients , of whom eight also met the spirometry criteria for copd ( table 1 ) .
fifteen of the copd patients met the criteria for gold stage 34 ( severe or very severe copd ) ; 30 were in stage 2 ( moderate copd ) , and 10 were in stage 1 ( mild copd ) .
spirometry findings in 112 patients treated with inhaled corticosteroids ( ics ) in primary care , and the continuation and discontinuation of ics after the spirometry results were known to the gp .
the clinical outcome of this exercise as recorded in retrospect was discontinuation of ics in 31 ( 27.7% ) of the 112 patients ( table 1 ) , of whom 20 ( 64.5% ) had mild to moderate copd , seven ( 22.6% ) had no history , symptoms or signs indicating obstructive lung disease and the remaining four ( 12.9% ) had episodic asthma without the need for long - term ics treatment .
one year and three months after this audit , we reviewed the electronic patient records ( eprs ) of these 31 patients and ics had been restarted in only one because of relapse of asthma .
the distribution of the gps diagnoses recorded in eprs changed significantly after the implementation of the new reimbursement terms ( table 2 ) .
the proportion of patients who were diagnosed with asthma more than doubled . among the 112 patients ,
25 were labelled as asthmatic before the 2006 regulation compared with 62 afterwards , of whom 25 in fact , had spirometry findings suggesting copd .
the proportion with a copd diagnosis increased only slightly ( table 2 ) while formerly used diagnoses such as chronic bronchitis , chronic cough , or pulmonary fibrosis had become considerably less common .
diagnosis given to 112 patients who had been using inhaled corticosteroids ( ics ) for pulmonary problems before and after the 2006 regulation stating that ics costs would be reimbursed for asthma but in general not for copd . 

diagnoses other than asthma and copd , i.e. chronic bronchitis , chronic cough , breathing problems , pulmonary fibrosis .
while underdiagnosis and undertreatment of asthma or copd in primary care have been highlighted in the literature ( 20,21 ) , over - diagnosis and overtreatment are rarely addressed ( 11 ) .
the results suggest that the incidence of overtreatment with ics may have been significant as it was possible to discontinue ics treatment in more than a quarter of the treated patients .
re - introduction of ics was only necessary in one patient during the following year .
this supports the notion that withdrawal of ics can be safe as underlined in a recent meta - analysis ( 22 ) . findings revealed that physicians tend to give a diagnosis that fits with the treatment given , rather than vice versa .
when an asthma diagnosis became a prerequisite for prescribing ics , the number of ics - using patients with this diagnosis increased considerably .
with spirometry , the diagnoses of asthma and/or copd in only about half of the ics users were confirmed .
this group may in part represent patients previously categorized as copd in gold stage 0 ( i.e. chronic airway symptoms with normal spirometry ) ( 23 ) .
this stage has been omitted from the copd classification because of lack of evidence that it predicted further copd development , a decision that may be questioned ( 1,20 ) .
a large fraction of those patients with normal spirometry were probably asthmatics in stable periods without current airway obstruction . according to the global initiative for asthma ( gina )
, a positive reversibility test is an important criterion for asthma , but detecting this often requires several tests over time ( 2 ) . in norwegian general practice , the diagnosis of asthma is commonly established based on patients symptoms and history without confirmation by spirometry ( 24 ) .
about one in seven of the copd patients had a positive reversibility test , which may partly represent long - lasting asthma with irreversible structural changes and permanent airway obstruction ( 6,2527 ) .
persistent asthma may also have been present in some patients with post - bronchodilator fev1/fvc < 0.7 and a negative reversibility test .
bronchodilator reversibility is also found in moderate to severe copd , and the distinction of chronic asthma with limited reversibility , therefore , remains notoriously difficult ( 28 ) . a dramatic shift in the gps use of diagnostic labels after the 2006 regulation was observed .
probably reflects that physicians tend to give a diagnosis that fits with a treatment rather than vice versa .
first , the 2006 regulation was controversial , and some gps did not agree with the health authorities in this case .
second , this regulation was not at all welcomed by the ics manufacturers , and the industry plays an important role in shaping physicians opinions about medication - related issues ( 29 ) .
use of costly ics that is easily available without personal cost only for patients with confirmed asthma may , therefore , have significant economic implications for patients who did not meet the new reimbursement terms .
fourth , gps diagnostic behaviour may be explained by concerns related to preserving the gp 
patient relationship , leading to unwillingness to admit previous inappropriate prescribing and an eagerness to please their patients . a fifth and maybe the most important explanation may be that gps often find it hard to distinguish asthma from copd , particularly in older patients .
prescribing ics may , therefore , represent a therapeutic strategy to play safe in a clinical situation characterized by diagnostic uncertainty .
misdiagnoses are known to occur for primary care patients with respiratory problems ( 30 ) .
after this audit , in january 2011 , the norwegian terms for ics cost reimbursement were changed again . from this time
, ics / laba may be prescribed without individual application for patients with moderate and severe copd if they have had several exacerbations and a predicted fev1 less than 60% ( before a reversibility test ) on spirometry .
this quality assurance project within one group practice has several limitations that must be taken into account when interpreting the results .
however , as one of the gps ( sr ) has a long - term interest in obstructive pulmonary diseases , it is believed the performance in this field is not inferior to the average norwegian general practice .
however , all staff who conducted the spirometry investigations had been trained for the task ( 32 ) .
therefore , it is regarded as unlikely that the spirometry done in the practice was below the average standard seen in primary care .
the spirometric gold criteria for defining and grading of copd in elderly people have been questioned because age - related changes in the fev1/fvc ratio are not taken into account ( 33 ) .
this may lead to increasing numbers of false - positives with advancing age ( 32 ) .
this is probably relevant here because of the average age of 66 years in participating patients .
only one patient who had ics treatment discontinued had to restart this medication within the following year .
restart of ics prescribed by doctors outside the group practice could in theory have taken place , but would probably be recorded in the epr .
worsening of symptoms because of discontinuation of ics was , therefore , a minor problem .
while underdiagnosis and undertreatment of asthma or copd in primary care have been highlighted in the literature ( 20,21 ) , over - diagnosis and overtreatment are rarely addressed ( 11 ) .
the results suggest that the incidence of overtreatment with ics may have been significant as it was possible to discontinue ics treatment in more than a quarter of the treated patients .
re - introduction of ics was only necessary in one patient during the following year .
this supports the notion that withdrawal of ics can be safe as underlined in a recent meta - analysis ( 22 ) . findings revealed that physicians tend to give a diagnosis that fits with the treatment given , rather than vice versa .
when an asthma diagnosis became a prerequisite for prescribing ics , the number of ics - using patients with this diagnosis increased considerably .
with spirometry , the diagnoses of asthma and/or copd in only about half of the ics users were confirmed .
this group may in part represent patients previously categorized as copd in gold stage 0 ( i.e. chronic airway symptoms with normal spirometry ) ( 23 ) .
this stage has been omitted from the copd classification because of lack of evidence that it predicted further copd development , a decision that may be questioned ( 1,20 ) .
a large fraction of those patients with normal spirometry were probably asthmatics in stable periods without current airway obstruction . according to the global initiative for asthma ( gina )
, a positive reversibility test is an important criterion for asthma , but detecting this often requires several tests over time ( 2 ) . in norwegian general practice , the diagnosis of asthma is commonly established based on patients symptoms and history without confirmation by spirometry ( 24 ) .
about one in seven of the copd patients had a positive reversibility test , which may partly represent long - lasting asthma with irreversible structural changes and permanent airway obstruction ( 6,2527 ) .
persistent asthma may also have been present in some patients with post - bronchodilator fev1/fvc < 0.7 and a negative reversibility test .
bronchodilator reversibility is also found in moderate to severe copd , and the distinction of chronic asthma with limited reversibility , therefore , remains notoriously difficult ( 28 ) .
a dramatic shift in the gps use of diagnostic labels after the 2006 regulation was observed .
probably reflects that physicians tend to give a diagnosis that fits with a treatment rather than vice versa .
first , the 2006 regulation was controversial , and some gps did not agree with the health authorities in this case .
second , this regulation was not at all welcomed by the ics manufacturers , and the industry plays an important role in shaping physicians opinions about medication - related issues ( 29 ) .
use of costly ics that is easily available without personal cost only for patients with confirmed asthma may , therefore , have significant economic implications for patients who did not meet the new reimbursement terms .
fourth , gps diagnostic behaviour may be explained by concerns related to preserving the gp  patient relationship , leading to unwillingness to admit previous inappropriate prescribing and an eagerness to please their patients .
a fifth and maybe the most important explanation may be that gps often find it hard to distinguish asthma from copd , particularly in older patients .
prescribing ics may , therefore , represent a therapeutic strategy to play safe in a clinical situation characterized by diagnostic uncertainty .
misdiagnoses are known to occur for primary care patients with respiratory problems ( 30 ) . after this audit , in january 2011 , the norwegian terms for ics cost reimbursement were changed again . from this time ,
ics / laba may be prescribed without individual application for patients with moderate and severe copd if they have had several exacerbations and a predicted fev1 less than 60% ( before a reversibility test ) on spirometry .
this quality assurance project within one group practice has several limitations that must be taken into account when interpreting the results .
however , as one of the gps ( sr ) has a long - term interest in obstructive pulmonary diseases , it is believed the performance in this field is not inferior to the average norwegian general practice .
however , all staff who conducted the spirometry investigations had been trained for the task ( 32 ) . therefore , it is regarded as unlikely that the spirometry done in the practice was below the average standard seen in primary care .
the spirometric gold criteria for defining and grading of copd in elderly people have been questioned because age - related changes in the fev1/fvc ratio are not taken into account ( 33 ) .
this may lead to increasing numbers of false - positives with advancing age ( 32 ) .
this is probably relevant here because of the average age of 66 years in participating patients .
only one patient who had ics treatment discontinued had to restart this medication within the following year .
restart of ics prescribed by doctors outside the group practice could in theory have taken place , but would probably be recorded in the epr .
worsening of symptoms because of discontinuation of ics was , therefore , a minor problem .
results suggest that the incidence of overtreatment with ics may be significant in middle - aged and elderly patients . although a diagnosis of copd and/or asthma could be confirmed in only half of the ics - using patients , reassessing the gps clinical diagnoses by a tailored consultation including spirometry was an effective measure to allow revised treatment in more than a quarter of the patients on ics therapy .
this audit also highlights how gps diagnoses are challenged by formal regulations and that this may result in a tendency to adjust the diagnosis to the treatment given , instead of vice versa .
lgd planned and directed this trial and is responsible for data analysis and preparation of the initial manuscript .
sr had the original idea for this project and performed the study together with lgd .
 background : inhaled glucocorticosteroids ( ics ) are first - line anti - inflammatory treatment in asthma , but not in chronic obstructive pulmonary disease ( copd ) . to restrict ics use in copd to cases of severe disease , 
 new terms for reimbursement of drug costs were introduced in norway in 2006 , requiring a diagnosis of copd to be verified by spirometry.objectives : to describe how gps diagnoses and treatment of patients who used ics before 2006 changed after a reassessment of the patients that included spirometry.methods : from the shared electronic patient record system in one group practice , patients  50 years prescribed ics ( including in combination with long - acting beta2-agonists ) during the previous year were identified and invited to a tailored consultation including spirometry to assure the quality of diagnosis and treatment . 
 gps diagnoses and ics prescribing patterns after this reassessment were recorded , retrospectively.results : of 164 patients identified , 112 were included . 
 post - bronchodilator spirometry showed airflow limitation indicating copd in 55 patients . of the 57 remaining patients , 
 five had a positive reversibility test . 
 the number of patients diagnosed with asthma increased ( from 25 to 62 ) after the reassessment . 
 a diagnosis of copd was also more frequently used , whereas fewer patients had other pulmonary diagnoses . 
 ics was discontinued in 31 patients ; 20 with mild to moderate copd and 11 with normal spirometry.conclusion : altered reimbursement terms for ics changed gps diagnostic practice in a way that made the diagnoses better fit with the treatment given , but over - diagnosis of asthma could not be excluded . 
 spirometry was useful for identifying ics overuse . 
KEY MESSAGE:
INTRODUCTION
METHODS
Selection of study subjects
Measurements and analysis
Ethics
RESULTS
DISCUSSION
Main findings
Diagnostic challenges
Labelling effects of reimbursement regulations
Strengths and limitations
Conclusion
AUTHORS CONTRIBUTIONS