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

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.

SUBMITTER: Kruis AL

PROVIDER: S-EPMC3943905 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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

Kruis Annemarije L AL Ställberg Björn B Jones Rupert C M RC Tsiligianni Ioanna G IG Lisspers Karin K van der Molen Thys T Kocks Jan Willem H JW Chavannes Niels H NH

PloS one 20140305 3

<h4>Background</h4>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.<h4>Objective</h4>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 ...[more]

PMID: 24598945

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Project description:Chronic obstructive pulmonary disease (COPD) often remains undiagnosed and untreated. To date, COPD screening/case finding has not been designed to identify clinically significant COPD, disease ready for therapies beyond smoking cessation. Herein, we describe the ongoing prospective, pragmatic cluster-randomized controlled trial to assess specificity and sensitivity of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) tool consisting of 5 questions and peak expiratory flow. The tool is designed to identify clinically significant COPD (forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ratio <.70 plus FEV1% predicted <60% or increased risk for exacerbation) and the trial will explore the impact of CAPTURE-based screening on COPD diagnosis and treatment rates in primary care patients. Of a total planned enrollment of 5000 English- or Spanish-speaking patients 45 to 80 years of age without a prior COPD diagnosis from 100 primary care practices, a total of 68 practices and 3064 patients have been enrolled in the study. Practices are centrally randomized to either usual care or clinician receipt of patient-level CAPTURE results. All clinicians receive basic COPD education with those in intervention practices also receiving CAPTURE interpretation education. In a single visit, patient participants complete a CAPTURE screening, pre- and post-bronchodilator spirometry and baseline demographic and health questionnaires to validate CAPTURE sensitivity, specificity, and predictive value of identifying undiagnosed, clinically significant COPD. One-year follow-up chart reviews and participant surveys assess the impact of sharing versus not sharing CAPTURE results with clinicians on clinical outcomes including level of respiratory symptoms and events and clinicians' initiation of recommendation-concordant COPD care. This is one of the first U.S. studies to validate and assess impact of a simple COPD screening tool in primary care.

Project description:Importance:Primary care is increasingly delivered at or near workplaces, yet utilization and cost of employer-sponsored primary care services remain unknown. Objective:To compare the health care utilization and cost of an employer-sponsored on-site, near-site, and virtual comprehensive primary care service delivery model with those of traditional community-based primary care. Design, Setting, and Participants:This population-based cohort study of 23 518 commercially insured employees and dependents of an engineering and manufacturing firm headquartered in southern California was performed from January 1, 2016, to July 1, 2019. A subset of the population with most (≥50%) primary care visits through employer-sponsored on-site, near-site, or virtual care clinics was matched to a subset not having most such visits through the employer-sponsored clinics using propensity score matching (n = 1983 each). In sensitivity analyses, employees were matched to dependents at neighboring firms that lacked access to the employer-sponsored primary care delivery model (additional n = 1680). Exposures:Integrated primary care, mental health, and physical therapy delivered through on-site, near-site, and virtual clinics. Main Outcomes and Measures:Utilization (inpatient, outpatient, emergency department, pharmaceutical, radiology, and laboratory visits per 1000 member-months) and spending (2019 costs per member per month in US dollars) by service type. Results:A total of 23 518 individuals (mean [SD] age, 27 [15] years; 14 604 [62.1%] male) were included in the full population sample and had been enrolled in the employer-sponsored health plan for a mean of 29 months (interquartile range, 14-48 months). Of eligible members, 5292 (22.5%) used the employer-sponsored services, with 2305 (9.8%) using them for most of their primary care. The mean (SD) cost of employer-sponsored service delivery was $87 ($32) per member month. Among the matched populations (mean [SD] age, 31 [11] years; 3349 [84.5%] male) of primary users vs control individuals, total spending was 45% lower per member per month (95% CI, 35%-55%; cost difference, -$167 per member per month; 95% CI, -$204 to -$130; P < .001) among users after adjustment. The lower spending was associated with lower spending on non-primary care services, such as emergency department (-33%; 95% CI, -44% to -22%) and hospital visits (-16%; 95% CI, -22% to -10%), despite higher spending on primary care (109%; 95% CI, 102%-116%) and mental health (20%; 95% CI, 13%-27%). Conclusions and Relevance:The findings suggest that individuals who used the models' services for most of their primary care had lower total spending despite higher primary care spending, which may be associated with self-selection of lower-risk persons to the employer-sponsored services and/or with the use of comprehensive primary care.

Dataset Information

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

Publications

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

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