QJM Advance Access originally published online on January 7, 2008
QJM 2008 101(2):145-153; doi:10.1093/qjmed/hcm155
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The impact of the 2004 NICE guideline and 2003 General Medical Services contract on COPD in primary care in the UK
From the Division of Epidemiology and Public Health, Clinical Sciences Building, Nottingham City Hospital, NG5 1PB
Address correspondence to Richard Hubbard, Respiratory Medicine, Clinical Sciences Building, Nottingham City Hospital, NG5 1PB, UK. email: richard.hubbard{at}nottingham.ac.uk
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Summary |
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Background: The introduction of the NICE guideline on COPD and the inclusion of COPD in the new Quality and Outcomes Framework (QOF) were designed to improve the care of people with COPD in primary care in the UK.
Aim: We have investigated whether these initiatives have had an impact on the prevalence of COPD, the recording of spirometry data and the use of combined inhaled corticosteroid/long-acting beta-agonist inhalers.
Design: We analysed data from The Health Improvement Network for the year before and after the introduction of the NICE guideline.
Methods: Data were analysed using logistic regression.
Results: The prevalence of COPD in 2003 was 1.27%, and this increased by 14–1.45% in 2005. The risk of COPD was strongly related to age, male gender, socioeconomic disadvantage and living in the North of England, Scotland and Wales. People with COPD had an increased mortality (adjusted rate ratio for 2003 is 2.38, 95% confidence interval 2.30–2.47). The presence of recorded spirometry data in people with COPD increased from 18% in 2003 to 62% in 2005, and FEV1 was consistently a strong predictor of survival. The use of combination inhalers in people with moderate to severe COPD also increased markedly during the study.
Conclusions: Following the introduction of the NICE guideline for COPD and the new QOF, there has been an increase in the prevalence of COPD in general practice and a large increase in spirometry data and prescriptions for combination inhalers. This represents significant progress for people with COPD.
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Introduction |
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COPD is an important public health problem but up until recently there have been virtually no large-scale attempts in the UK to improve the care of people with COPD.1–3 In an attempt to rectify this problem two important initiatives have been introduced. First in February 2004, the National Institute for Health and Clinical Excellence (NICE) published its guideline for the management of COPD.4 This guideline recommended that a diagnosis of COPD should always be considered in people over the age of 35 with respiratory symptoms and risk factors for COPD, that a diagnosis of COPD should be confirmed with spirometry and that a combination of long-acting bronchodilators and inhaled corticosteroids should be used in people with a forced expiratory volume in 1 s (FEV1) of <50% and two or more exacerbations in the last twelve months. Secondly, the new General Medical Services (GMS) contract included an optional Quality and Outcomes Framework (QOF) section in which General Practices would receive additional payments if they were able to demonstrate high levels of clinical care for people with specific diseases (http://www.dh.gov.uk/en/index.htm). Within the COPD section of the QOF payments were given to practices which were able to produce a specific register of people with COPD, and which had recorded spirometry data, provided smoking cessation advice, checked inhaler technique and given influenza immunizations to these patients.
In this study, our aim was to determine whether the introduction of the NICE guideline and the QOF contract have altered the prevalence, natural history and medical care of COPD in the UK. To do this we have analysed data from a computerized general practice research database for the years before February 2003 and February 2005.
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Methods |
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For this study we used The Health Improvement Network (THIN), a computerized general practice database which contains medical data entered by general practitioners and general practice staff as part of routine primary care.5 Since we specifically wanted to assess the impact of the NICE guideline and the QOF, we chose to analyse data available on and before 25 February 2003 and 25 February 2005 (The NICE Guideline was published on 25 February 2004, the QOF was first implemented in April 20044). To do this we restricted the total THIN dataset to the 279 (93%) practices that were contributing data on both dates.
We first identified all people who were alive and contributing data to THIN on 25 February 2003 and from this population identified all people who had a diagnosis of COPD at any point in their medical records before this date. To define whether or not COPD was present we used the diagnostic code list for COPD proposed for use in the QOF. We then calculated age for each person on 25 February 2003 and in keeping with the NICE guideline we restricted our diagnoses of COPD to people over the age of 35 years. We also extracted data on gender, region of residence in UK, smoking habit, socioeconomic status, forced expiratory volume in 1 s (FEV1), height and prescriptions for combined inhalers (defined as an inhaled corticosteroid and a long-acting beta-agonist in the same inhaler). For smoking habit, we defined people simply as ever having been a smoker if any code was present in their notes to suggest that they had smoked at any point in time. Our marker of socioeconomic status was the Townsend score recorded at the 2001 census recoded into quintiles and was linked via postcode to output areas that cover approximately 150 houses. Where data were available on FEV1 and height, we calculated the percent predicted value of FEV1 for each person using the equations defined by Hankinson et al.6 and grouped these into severity categories to reflect those in the NICE guidelines as follows—normal >80%, mild 80–50%, moderate 30–49%, severe <30%. There were considerably fewer data available on force vital capacity than FEV1 and for this reason we did not calculate ratio measures of airflow obstruction. We extracted all prescriptions for combination inhalers for the twelve months prior to 25 February 2003 and identified all deaths in people with and without COPD during the follow-up time after 25 February 2003.
We first estimated the prevalence of COPD in the UK and stratified our results by age group, gender, Townsend score and region of the UK. We used logistic regression to compare the prevalence of COPD between different population strata and constructed a simple multivariate model including all of the variables listed above to look for evidence of confounding. Using a similar modelling strategy, we looked for factors associated with the availability of FEV1 data within people with COPD. We then compared the mortality rates between people with and without COPD using Cox regression, adjusting for the effects of age, sex and Townsend score. To determine the extent to which FEV1 and the use of combination inhalers predicted mortality in people with COPD, we then repeated our survival analyses restricting our dataset to people with COPD. Finally we used a logistic regression model to determine whether the use of combination inhalers varied by age, gender, socioeconomic status or geographic region in a population of people with a diagnosis of COPD and an FEV1 of <50% predicted.
We then repeated our analysis for the 2005 dataset. All analyses were conducted using Stata (version 7, Stata corporation, Texas). Hypothesis tests, where used, were done using likelihood ratio tests. The study protocol was reviewed and approved by the Nottingham Ethics Committee.
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Results |
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The total number of people alive and contributing data to THIN on 25 February 2003 was 2 020 424 and of these 25 565 (1.27%) had a diagnosis of COPD at any point prior to this. When we restricted our denominator population to people over the age of 35 years to be consistent with the age restrictions for COPD, the prevalence of COPD was 2.2%. Among the people with a diagnosis of COPD the median age on 1 February 2003 was 72 years (interquartile range 63–79 years), 13 476 (52.7%) were male and 21 061 (82%) were recorded as having been a smoker at some point in time. The risk of having COPD was strongly related to social deprivation, with people living in the most deprived areas having more than three times the risk of having COPD as people living in the least deprived areas. There was evidence of a marked heterogeneity in the prevalence of COPD in different regions in the UK with the highest levels of disease being in the North of England, Scotland and Wales. Some of this heterogeneity was explained by our confounding variables, particularly socioeconomic status, but even after allowing for these variables people living in the North West were twice as likely to have a diagnosis of COPD as those living in the South East (Table 1). In the 2005 dataset, there were a total of 2 063 130 people of whom 29 870 (1.45%) had a diagnosis of COPD. This represents a 14.4% (95% confidence interval 12.5–16.3%) increase in the crude prevalence of COPD between the 2003 and 2005 datasets. In people over the age of 35 years the prevalence of COPD was 2.5%. The distribution of people with COPD by age, gender and socioeconomic status was similar to that in the 2003 dataset although the heterogeneity by region was marginally less (Table 2).
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In the 2003 dataset, we were able to calculate a percent predicted FEV1 value for 4607 (18%) of the people with COPD and the median value was 56% (interquartile range 42–71%). There was no evidence of a socioeconomic gradient in relation to recording of spirometry values and no strong effects of age or gender (Table 3). The highest level of recorded spirometry was present in the East Midlands and the lowest in the East. By 2005 there had been a dramatic increase in the recording of spirometry values with 18 494 (62%) of people with a diagnosis of COPD having a recorded FEV1 value. The median percent predicted FEV1 was similar to that seen in 2003 at 56% (interquartile range 42–70%). Again no evidence of a socioeconomic gradient with regard to spirometry data was present. There was some evidence that women and people under the age of 50 or over the age of 80 years were less likely to have FEV1 values recorded. The amount of spirometry data had increased markedly in all regions of the UK, with the largest relative increases in the East and South East and the smallest in the East Midlands (Table 3). The increase in the presence of spirometry data was similar for all levels of disease severity as assessed by FEV1 (Table 4).
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The median duration of follow-up for the 2003 dataset was 2.3 years and during this time there were 3863 deaths in the COPD cohort (equivalent to a crude mortality rate of 74.1 per 1000 person-years, 95% confidence interval 71.8–76.5) and 31 286 deaths in the population of people over the age of 35 years without COPD (equivalent to a crude mortality rate of 12.5 per 1000 person-years, 95% confidence interval 12.4–12.6). After allowing for the effects of age, gender and socioeconomic status people with COPD had more than double the mortality rate of the remaining general population (hazard ratio 2.38, 95% confidence interval 2.30–2.47). The severity of COPD on the basis of spirometry was a strong predictor of mortality (Table 4) with people with COPD with an FEV1 of <30% predicted having a mortality rate of 2.46 times that of people with COPD and an FEV1 of between 50% and 80% predicted. The median follow-up for the 2005 dataset was much shorter at 0.34 years and during this time there were 575 deaths in the COPD cohort giving a slightly lower crude mortality rate than that seen in 2003 (crude mortality rate 60.7 per 1000 person-years—95% confidence interval 56.0–65.9). There were 4569 deaths during the same time period in the population of people over the age of 35 years without COPD (crude mortality rate 12.2 per 1000 person-years—95% confidence interval 11.9–12.6), and after allowing for the effects of age, gender and socioeconomic status people with COPD had roughly double the mortality rate of the remaining general population (hazard ratio 1.97, 95% confidence interval 1.80–2.15). Again severity of FEV1 impairment was a strong predictor of mortality (Table 4).
In 2003, among the 1820 people with COPD with a recorded FEV1 of <50% predicted 461 (25%) had received a prescription for a combined inhaler in the preceding 12 months. The results of our multivariate analysis demonstrated that the use of combination inhalers was not related to age or socioeconomic status but was related to gender and region. There was a marked variation in the use of combination inhalers in different regions with the highest use in Yorkshire and Humber and Wales and the lowest use in the North East and the East Midlands. The presence of prescriptions for a combination inhaler was not associated with mortality in people with COPD and a percent predicted FEV1 of <50% (hazard ratio adjusted for age, sex, percent predicted FEV1 group and Townsend score 0.90, 95% confidence interval 0.66–1.24). By 2005, 3200 (44%) of the 7268 people with COPD and an FEV1 of <50% had received a prescription for a combination inhaler in the previous 12 months. There was no association between prescriptions for combination inhalers and either socioeconomic status or gender. There was a progressive decrease in the chance of having a combination inhaler prescribed with increasing age (P for trend 0.0001) and again marked variation in prescribing rates by region. In 2005, the North East and East Midlands were still the lowest users of combination inhalers and Wales was still one of the highest. In 2005, the presence of prescriptions for a combination inhaler was associated with an increase in mortality in people with COPD and a percent predicted FEV1 of <50% (hazard ratio adjusted for age, sex, percent predicted FEV1 group and Townsend score 1.55, 95% confidence interval 1.12–2.15).
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Discussion |
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In this large general population-based study, we have quantified the current extent of the public health burden of COPD in the UK and the changes which have followed the introduction of the NICE guideline and the QOF. Not surprisingly our findings show that COPD is common and strongly related to older age, male gender, socioeconomic disadvantage and geographical region. For example in 2003, in men over the age of 60 years in the bottom 40% of the socioeconomic scale, 8.8% had a diagnosis of COPD, whilst in 2005 the equivalent figure was 9.7%. In the North East and North West, these figures rose to 10.0% and 13.3% respectively in 2003 and 10.2% and 14.4% in 2005. Our results show that there has been an increase in the prevalence of recorded diagnoses of COPD in the UK between 2003 and 2005 and a dramatic increase in the recording of spirometry data and prescriptions for combination inhalers. We found a large increase in the mortality of people with COPD compared to the general population, and among people with COPD mortality was strongly related to percent predicted FEV1 (Table 5).
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Our study has a number of strengths and weakness that need consideration. Important strengths of our study are the large population size, which at more than 2 million for each year represents
3.4% of the UK general population, and the fact that our findings relate to recent events on either side of the introduction of the NICE guidelines and the new GMS contract. Two potential weaknesses of our study are the validity of the diagnoses of COPD and whether the GP surgeries contributing to THIN are representative of all GP surgeries in the UK. We were not able to specifically test the validity of our general practitioner recorded diagnoses of COPD against diagnoses after review by a chest physician. However, demographics and smoking habit of our population appear appropriate for people with COPD and the overall prevalence of COPD from our data is very similar to the value of 1.46% reported for national data collected from the new GMS contract (http://www.dhsspsni.gov.uk/qof-bulletin.pdf). The general practices that contribute data to THIN are self-selected on the basis of the software they use and their willingness to provide data and so the practices included in this study are not a true random sample of practices in the UK.5 It seems likely that the practices which contribute to THIN have a particular interest in recording data, but unlikely that any systematic bias is present such that practices will over or under-report diagnoses of COPD. It seems likely to us therefore that the regional variations in the prevalence of COPD we observed reflect true underlying variations in disease prevalence rather than differences in diagnostic recording between regions.
Information on the prevalence of COPD is available from a number of other sources including routinely collected data and studies specifically designed to find all cases of COPD in a population. Examples of routinely collected data include death certification and other general practice database studies. For example, information from death certificates reported in the recent Burden of Lung Disease document suggest that 4.7% of people have a diagnosis of COPD recorded on their death certificate, and a figure similar to our prevalence estimate in people over the age of 60 years.1 A previous study using another general practice database (UK General Practice Research Database) reported a prevalence of COPD in female adults in 1997 of 1.4% and of male adults in the same year of 1.8%.7 At the time in which this study was conducted information on geographical region, socioeconomic status and spirometry were not available in general practice databases and so the impact of these exposures was not examined. An analysis of the spirometry data from the Health Survey for England found that in people over the age of 35 years 13% had evidence of airflow obstruction consistent with a diagnosis of COPD, although the researchers were unable to exclude other diagnosis such as asthma from this patient group.8 An analysis of the European Community Respiratory Health Survey was able to analyse spirometry data and exclude people with self-reported asthma. This dataset was limited to people between the age of 20 and 44 years however, but did suggest that the prevalence of COPD in this age group for GOLD stages greater than 0 was 3.6%.9 In an analysis of the Third National Health and Nutritional Examination Survey, Mannino et al. 10 found that in people over the age of 17 years 8.5% had obstructive lung disease, but that in two-thirds of the cases no diagnosis was present. A recent meta-analysis of 62 papers of COPD prevalence from around the world concluded that 9% of adults over the age of 40 years have obstructive lung disease.3 Taken together these studies suggest that the prevalence of COPD is probably much higher than that reported in our study, and other analyses of routinely collected data, and that in reality there are a large number of people with COPD in the general population who are currently undiagnosed. Our findings also suggest that changes in policy, such as the introduction of the new GMS contract and the NICE guidelines, has led to an increase in the recorded prevalence of COPD over a short time frame and that this happens at all levels of disease severity and does not just reflect an increased recognition of milder disease. Interestingly, the same has not been seen in other chronic illnesses and there is some evidence that the introduction of the QOF has led to a spurious fall in the prevalence of coronary heart disease.11
There are a number of studies which have shown that level of lung function is an important predictor of survival in the general population.12–14 There are fewer data available on the impact of lung function on survival in general population cohorts of people with COPD. In a follow-up study using NHANES 111, Mannino et al. 12 was able to demonstrate that in people with COPD and an FEV1 of <50% the mortality was 3.5 times that seen in the general population. This study differs from our own because we used people with mild COPD as the baseline group rather than people without COPD but the dose–response effects across different levels of severity of COPD are similar.
Our findings of a strong social class gradient and North/South divide in the prevalence of COPD were not unexpected, but we found no evidence to suggest that access to spirometry and/or combination inhalers was related to these factors.1 One of the most notable features of our study is the dramatic increase in the recording of spirometry data and use of combination inhalers over a two-year period. The use of spirometry in people with COPD, and combination inhalers in those with severe disease, was recommended in the NICE guideline. Within the terms of the new GMS contract, general practices receive remuneration for the recording of spirometry data but not for the appropriate prescribing of combination inhalers. It seems likely to us, therefore, that both the NICE guideline and the QOF have contributed to improving care for people with COPD.
The efficacy of combination inhalers in people with COPD has recently been quantified in the large TORCH trial.15 The trial found that in comparison to placebo a combination inhaler was associated with a 17.5% reduction in all cause mortality (the primary outcome) and a 25% reduction in annual exacerbation rate. The findings for mortality were only on the borderline of statistical significance (P = 0.052) but the P value for the exacerbation analysis was <0.001. Similar improvements in exacerbation rates have been reported in other trials of combination inhalers and also inhaled corticosteroids alone.16–18 Taken together these results suggest that these drugs have efficacy in people with COPD and that moves to improve their use in people with severe disease will lead to improved health for people with COPD. The one proviso to this statement is that inhaled corticosteroids do have systemic side effects including pneumonia, bruising and suppression of the HPA axis and there is some evidence that they are associated with an increased risk of fracture.19 In our study, the use of combination inhalers in people with severe disease was not associated with mortality in 2003 and associated with increased mortality in 2005. The likely explanation for these results is a selection bias such that general practitioners prescribe these drugs for people with more severe and progressive disease.
In conclusion our study provides contemporary information on the prevalence of COPD in the UK and the excess mortality associated with this diagnosis. In addition we have quantified the current geographical and socioeconomic inequalities with regard to COPD prevalence. Finally our results suggest that the introduction of the NICE guideline and the QOF have increased the recording of spirometry data and prescribing of combination inhalers to people with moderate to severe COPD and thereby had a beneficial impact on the care of people with COPD in primary care in the UK.
Conflict of interest: None declared.
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References |
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1. The British Thoracic Society. The Burden of Lung Disease: A Statistical Report from the British Thoracic Society (2006) 2nd. London: The British Thoracic Society.
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19. Tattersfield AE, Harrison TW, Hubbard RB, Mortimer K. Safety of inhaled corticosteroids. Proc Am Thorac Soc (2004) 1:171–5.
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