Abstract
BackgroundGuideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care.ObjectiveWe aimed to evaluate the external validity of six LPCS (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) on which current guidelines are based, in relation to primary care COPD patients, in order to inform future clinical practice guidelines and trials.MethodsBaseline data of seven primary care databases (n = 3508) from Europe were compared to baseline data of the LPCS. In addition, we examined the proportion of primary care patients eligible to participate in the LPCS, based on inclusion criteria.ResultsOverall, patients included in the LPCS were younger (mean difference (MD)-2.4; p = 0.03), predominantly male (MD 12.4; p = 0.1) with worse lung function (FEV1% MD -16.4; p<0.01) and worse quality of life scores (SGRQ MD 15.8; p = 0.01). There were large differences in GOLD stage distribution compared to primary care patients. Mean exacerbation rates were higher in LPCS, with an overrepresentation of patients with ≥1 and ≥2 exacerbations, although results were not statistically significant. Our findings add to the literature, as we revealed hitherto unknown GOLD I exacerbation characteristics, showing 34% of mild patients had ≥1 exacerbations per year and 12% had ≥2 exacerbations per year. The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT).ConclusionPrimary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations. More research is needed to determine the effect of pharmacological treatment in mild to moderate patients. We encourage future guideline makers to involve primary care populations in their recommendations.
Highlights
Chronic obstructive pulmonary disease (COPD) is one of the most complex diseases seen by respiratory physicians and general practitioners (GPs)
Primary care chronic obstructive pulmonary disease (COPD) patients stand out from patients enrolled in large pharmaceutically-sponsored COPD studies (LPCS) in terms of gender, lung function, quality of life and exacerbations
The third dataset included 51 COPD diagnosed patients with a smoking history of . 10 years enrolled in a pilot for a randomized clinical trials (RCTs) (The MARCH study; NTR number 2643) assessing the effect of health status guided care compared to GOLD guideline guided care in the primary care setting
Summary
Chronic obstructive pulmonary disease (COPD) is one of the most complex diseases seen by respiratory physicians and general practitioners (GPs). In the last 30 years, more than 50 (inter)national guidelines on the management of COPD have been published worldwide [1]. Two surveys revealed that COPD management by GPs was well below guideline-recommended levels, with many GPs having very limited knowledge of COPD and its management [3,4]. About 25% of the GPs reported to be unfamiliar with GOLD and one-third with ATS/ERS guidelines [4]. Guideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care
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