Primary Care COPD Patients Compared with Large Pharmaceutically-Sponsored COPD Studies : An UNLOCK Validation Study
Citations
88 citations
Cites background from "Primary Care COPD Patients Compared..."
..., the COPD population without selection of any kind, which is unprecedented and impossible to derive from clinical trial populations [21]....
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82 citations
Cites methods from "Primary Care COPD Patients Compared..."
...Chronic bronchitis, musculoskeletal symptoms, osteoporosis, and depression were associated with worse HRQL....
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...We conclude that the chronic bronchitis phenotype and musculoskeletal symptoms in COPD patients indicate a higher risk of low HRQL....
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...The outcomes of CAT and SGRQ show a fairly good correlation in patients with COPD.7 Many COPD patients suffer from more than one condition,8 and comorbidities are known to influence mortality, morbidity, and hospitalizations as well as HRQL.9–11 The associations of cardiovascular disease, depression, and underweight with poor HRQL are well documented,12–15 although our understanding of these associations remains limited....
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...Depression is common in COPD.8 The finding that depression influenced EQ-5D index in our study is consistent with and confirms previous studies, in which depression in COPD was associated with worse HRQL as assessed using EQ-5D,31 SGRQ,32 and Clinical COPD Questionnaire (CCQ).14 Heart disease influences HRQL when estimated by both the generic instrument SF-12 and the disease-specific instrument SGRQ in COPD.12,15 In our study, both generic and disease-specific HRQL instruments were used, but we were not able to identify an association of cardiovascular disease and lower HRQL. Underweight is associated with worse SGRQ score in COPD,13 but no associations with HRQL were found in the present study....
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...It cannot be excluded that the use of a broad definition of cardiovascular disease may have masked an association between cardiovascular disease and HRQL....
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82 citations
Cites background from "Primary Care COPD Patients Compared..."
...There is a need for future trials to include more female participants and to prespecify subanalyses on the basis of sex to study whether biological differences affect the way women respond to medications and therapeutic strategies.(82) In addition, studies should consider the use of sex as a variable in its own right....
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...Analyses suggest that clinical trial populations differ from real-world patients, particularly in sex distribution.(82) There is a need for future trials to include more female participants and to prespecify subanalyses on the basis of sex to study whether biological differences affect the way women respond to medications and therapeutic strategies....
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77 citations
66 citations
References
632 citations
"Primary Care COPD Patients Compared..." refers methods in this paper
...In the UPLIFT [30] and POET-COPD [14] studies, an exacerbation was defined as an increase in or the onset of more than one respiratory symptom (cough, sputum, sputum purulence, wheezing, or dyspnea) lasting 3 days or more and requiring treatment with an antibiotic or a systemic corticosteroid....
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...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....
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...These studies were published in the year 2000 or later: the ISOLDE [9,24,25], TRISTAN [10], TORCH [11,26–29], UPLIFT [12,30], ECLIPSE [13,31,32] and POET-COPD [14] studies....
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...Furthermore, step-by-step we applied the inclusion criteria of the trials [9,10,14,29,30,32] to the UNLOCK population and calculated the proportion of patients eligible for inclusion....
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462 citations
"Primary Care COPD Patients Compared..." refers result in this paper
...Selection for large COPD studies The proportion of patients from primary care that would be eligible to be included in the LPCS ranged from 17% (TRISTAN trial) to 42% (ECLIPSE and UPLIFT study) (Table 7)....
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...Exacerbation data Individual datasets: UNLOCK studies reporting exacerbation data were compared with baseline data of the ISOLDE, TRISTAN, TORCH, UPLIFT and ECLIPSE studies (Table 3)....
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...Subgroup analysis of UPLIFT showed promising results of tiotropium in GOLD II patients on FEV1 decline [12], but inclusion was limited to patients with FEV1,70%, leading to incomplete representation of GOLD II....
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...The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT)....
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...In the UPLIFT [30] and POET-COPD [14] studies, an exacerbation was defined as an increase in or the onset of more than one respiratory symptom (cough, sputum, sputum purulence, wheezing, or dyspnea) lasting 3 days or more and requiring treatment with an antibiotic or a systemic corticosteroid....
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420 citations
Additional excerpts
...Exacerbation data Individual datasets: UNLOCK studies reporting exacerbation data were compared with baseline data of the ISOLDE, TRISTAN, TORCH, UPLIFT and ECLIPSE studies (Table 3)....
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...Characteristic UNLOCK 1 NL UNLOCK 2 UK UNLOCK 3 NL UNLOCK 7 NL ISOLDE 2000 TRISTAN 2003 TORCH 2007 UPLIFT 2008 ECLIPSE 2010 Patients (N) 86 375 1665 902 370 * 361 * 6112 5992 2138 Mean exacerbation rate p/year 1.05 (1.3) 1.32 (1.6) 0.72 (1.1) 0.54 (1.19) 1.90 (2.63)* 1.30 * 1.0 (1.3) 0.85 (0.02)* 0.9 (1.2) $1 in preceding year, % (n/N) 55 (47/85) 59 (222/374) 43 (713/1661) 27 (174/636) 63* - 57 68* 47 $2 in preceding year, % (n,N) 29 (25/85) 33 (124/374) 19 (312/1661) 11 (72/636) - - 32 - 29 Data are baseline data and mean values (SD), unless stated otherwise....
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...Definition of exacerbations: The definition of exacerbation used in the UNLOCK, ISOLDE [9], TRISTAN [10], TORCH [29] and ECLIPSE [32] studies was based on worsening of symptoms and the decision by a patient’s clinician (or by study personnel) to prescribe antibiotics or systemic corticosteroids, alone or in combination....
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...These studies were published in the year 2000 or later: the ISOLDE [9,24,25], TRISTAN [10], TORCH [11,26–29], UPLIFT [12,30], ECLIPSE [13,31,32] and POET-COPD [14] studies....
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...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....
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339 citations
Additional excerpts
...Subsequent post-hoc analysis of the TORCH trial concluded that a combination of salmeterol and fluticasone propionate reduced exacerbations and FEV1 decline in patients with a FEV1 of 50–60% predicted [28]....
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321 citations
"Primary Care COPD Patients Compared..." refers background in this paper
...However, reliable judgments about the external validity of RCTs are essential if treatments are to be used correctly in as many patients as possible in routine clinical practice [7]....
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