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Comparative Study
. 2014 Mar 5;9(3):e90145.
doi: 10.1371/journal.pone.0090145. eCollection 2014.

Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study

Annemarije L Kruis  1 , Björn Ställberg  2 , Rupert C M Jones  3 , Ioanna G Tsiligianni  4 , Karin Lisspers  2 , Thys van der Molen  5 , Jan Willem H Kocks  5 , Niels H Chavannes  1
Affiliations
Comparative Study

Primary care COPD patients compared with large pharmaceutically-sponsored COPD studies: an UNLOCK validation study

Annemarije L Kruis et al. PLoS One. .

Erratum in

  • PLoS One. 2014;9(5):e98725

Abstract

Background: 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.

Objective: We 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.

Methods: Baseline 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.

Results: Overall, 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).

Conclusion: Primary 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.

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Conflict of interest statement

Competing Interests: I have read the journal's policy and have the following conflicts: AK: no conflict of interest. BS: he took part in Advisory Board meetings supported by AstraZeneca, Boehringer Ingelheim and Novartis and received payment for educational lectures, supported by AstraZeneca, Boehringer Ingelheim, Merck Sharp and Dohme, Glaxo Smith Kline, Pfizer, Meda and Nycomed. He received payment for educational presentations supported by AstraZeneca, Nycomed, MSD and Meda. RJ: in the last 3 years he has been paid to speak at scientific and educational meetings or take part in advisory boards related to COPD for Almirall, Astra Zeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Pfizer and TEVA. He has undertaken research supported by Novartis and GSK. He was a consultant on the Global emPOWER educational programme and is a consultant for (i) COPDexchange educational website supported by Pfizer and Boehringer Ingelheim, (ii) for Health Intelligence and the (iii) iCOPD template produced by Almirall and the PCRS-UK. IT: no conflict of interest. KL: took part in board membership for the Swedish Respiratory Advisory Board, supported by Novartis and Meda. She acts as advisor for AstraZeneca. She received payment for lectures supported by AstraZeneca, MSD, Boehringer Ingelheim, Novartis and Pfizer. She received payment for development of educational presentations supported by AstraZeneca, MSD, Nycomed and Meda. TvdM: He received fees for lecturing, consultations, and his department received grants from Allmiral, Glaxo Smith Kline, MSD, Astrazeneka and Boehringer Ingelheim JwhK: received grants from stichting Zorgdraad, and fees for lectures from GlaxoSmithKline. He received travel grants from GlaxoSmithKline, Chiesi, Boehringer Ingelheim. He acts as advisor for GlaxoSmithKline, Boehringer Ingelheim, Novartis. NC: PICASSO, an initiative by Boehringer Ingelheim and Caphri Research Institute, provided funding for the Bocholtz Study. NC was part of the advisory board and individual consultancy for Boehringer Ingelheim. Novartis, Chiesi, Pfizer and AstraZeneca. He received payment for lectures supported by Boehringer Ingelheim and Novartis. The International Primary Care Respiratory Group (IPCRG) provided funding for this research project, through an unrestricted grant by Novartis AG, Basel, Switzerland, which is overseen by an independent Steering Group. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

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