Primary Care COPD Patients Compared with Large Pharmaceutically-Sponsored COPD Studies: An UNLOCK Validation Study

Kruis, Annemarije; Ställberg, Björn; Jones, Rupert; Tsiligianni, Ioanna; Lisspers, Karin; Molen, Thys van der; Kocks, J.W.H.; Chavannes, Niels H.

doi:10.1371/journal.pone.0090145

Cited by 79 publications

(90 citation statements)

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“…For the latter models comparison with trial results may therefore be less valid because it is well known that patients included in clinical trials are a subgroup of the total COPD population. This was, for example, shown in a study of Kruis et al that found that patients participating in large clinical trials sponsored by pharmaceutical companies are on average younger, more likely to be male, have a lower FEV1% predicted and tend to have more exacerbations compared to patients in primary care [51]. In the current analysis this selection bias issue was most likely the explanation that no difference in mortality was found between smokers and ex-smokers in the UPLIFT trial.…”

Section: Discussionmentioning

confidence: 49%

Patient Heterogeneity in Health Economic Decision Models for Chronic Obstructive Pulmonary Disease: Are Current Models Suitable to Evaluate Personalized Medicine?

et al. 2016

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Patient heterogeneity in health economic decision models for chronic obstructive pulmonary disease (COPD): are current models suitable to evaluate personalized medicine? 3 AbstractObjectives: To assess how suitable current COPD cost-effectiveness models are to evaluate personalized treatment options for COPD by exploring the type of heterogeneity included in current models and by validating outcomes for subgroups of patients.Methods: A consortium of COPD modelling groups completed three tasks. First, they reported all patient characteristics included in the model and provided the level of detail in which the input parameters were specified. Second, groups simulated disease progression, mortality, quality-adjusted life-years (QALYs) and costs for hypothetical subgroups of patients that differed in terms of gender, age, smoking status and lung function (FEV1% predicted). Finally, model outcomes for exacerbations and mortality for subgroups of patients were validated against published subgroup results of two large COPD trials.Results: Nine COPD modelling groups participated. Most models included gender (seven), age (nine), smoking status (six) and FEV1% predicted (nine), mainly to specify disease progression and mortality.Trial results showed higher exacerbation rates for females (found in one model), higher mortality rates for males (two models), lower mortality for younger patients (four models), and higher exacerbation and mortality rates in patients with severe COPD (four models).Conclusions: The majority of currently available COPD cost-effectiveness models are able to evaluate the cost-effectiveness of personalized treatment based on gender, age, smoking and FEV1% predicted. Treatment in COPD is however, more likely to be personalized based on clinical parameters. Two models include several clinical patient characteristics and are therefore most suitable to evaluate personalized treatment, although some important clinical parameters are still missing.4

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Section: Discussionmentioning

confidence: 49%

Patient Heterogeneity in Health Economic Decision Models for Chronic Obstructive Pulmonary Disease: Are Current Models Suitable to Evaluate Personalized Medicine?

et al. 2016

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“…The International Primary Care Respiratory Group (IPCRG) set up the Uncovering and Noting Long-term Outcomes in COPD and asthma to enhance Knowledge (UNLOCK) cohort [31]. Kruis [32] evaluated the external validity of 6 large pharmaceutically-sponsored COPD studies (LPCS) and compared them to the characteristics of the patients in 7 database registers that constitute the UNLOCK cohort: between 53 and 84 % of the patients treated in primary care did not fulfil the inclusion criteria of the cohorts recruited in the hospital setting.…”

Section: Discussionmentioning

confidence: 99%

External validation of multidimensional prognostic indices (ADO, BODEx and DOSE) in a primary care international cohort (PROEPOC/COPD cohort)

et al. 2016

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BackgroundDue to the heterogeneous and systemic nature of the chronic obstructive pulmonary disease (COPD), the new guidelines are oriented toward individualized attention. Multidimensional scales could facilitate its proper clinical and prognostic assessment, but not all of them were validated in an international primary care cohort, different from the original ones used for model development. Therefore, our main aim is to assess the prognostic capacity of the ADO, BODEx and DOSE indices in primary care for predicting mortality in COPD patients and to validate the models obtained in subgroups of patients, classified by revised Global Initiative for Chronic Obstructive Lung Disease (2011) and updated Spanish Guideline (2014). Besides, we want to confirm that the prognostic capacity of all indices increases if the number of exacerbations is substituted by the interval between them and to assess the impact on health of the patient’s lifestyle, social network and adherence to treatment.MethodsDesign: External validation of scales, open and prospective cohort study in primary care.Setting: 36 health centres in 6 European high, medium and low income countries.Subjects: 477 patients diagnosed with COPD, captured in clinical visit by their General Practitioner/Nurse.Predictors: Detailed patient history, exacerbations, lung function test and questionnaires at baseline.Outcomes: Exacerbations, all-cause mortality and specific mortality, within 5 years of recruitment.Analysis: Multivariate logistic regression and Cox regression will be used. Possible non-linear effect of the indices will be studied by using Structured Additive Regression models with penalised splines. Subsequently, we will assess different aspects of the regression models: discrimination, calibration and diagnostic precision. Clinical variables modulated in primary care and the interval between exacerbations will be considered and incorporated into the analysis.DiscussionThe Research Agenda for General Practice/Family Medicine highlights that the evidence on predictive values of prognostic indices in primary care is scarce. A prospective cohort like that of PROEPOC/COPD provides good opportunities for research into COPD and make communication easier between family practitioners, nursing staff, pneumologists and other professionals, supporting a multi-disciplinary approach to the treatment of these patients.Trial registration ISRCTN52402811. Date: 15/01/2015. Prospectively registered.Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-016-0305-2) contains supplementary material, which is available to authorized users.

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“…The range of severity of COPD (using the GOLD criteria) in our patient sample was similar to that in other studies on COPD conducted in primary care. 322 Baseline data from seven primary care databases reveal that the proportion of COPD patients with mild, moderate, severe and very severe disease is 20.7%, 53.3%, 21% and 5.8%, respectively. The comparable proportions in the current study were 24.8%, 53.5%, 20.8% and 0.9%, respectively.…”

Section: Questionnaire Data: Quality Of Life and Depressionmentioning

confidence: 99%

CHOICE: Choosing Health Options In Chronic Care Emergencies

Guthrie

Afzal

Blakeley

et al. 2017

Programme Grants Appl Res

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BackgroundOver 70% of the health-care budget in England is spent on the care of people with long-term conditions (LTCs), and a major cost component is unscheduled health care. Psychological morbidity is high in people with LTCs and is associated with a range of adverse outcomes, including increased mortality, poorer physical health outcomes, increased health costs and service utilisation.ObjectivesThe aim of this programme of research was to examine the relationship between psychological morbidity and use of unscheduled care in people with LTCs, and to develop a psychosocial intervention that would have the potential to reduce unscheduled care use. We focused largely on emergency hospital admissions (EHAs) and attendances at emergency departments (EDs).DesignA three-phase mixed-methods study. Research methods included systematic reviews; a longitudinal prospective cohort study in primary care to identify people with LTCs at risk of EHA or ED admission; a replication study in primary care using routinely collected data; an exploratory and feasibility cluster randomised controlled trial in primary care; and qualitative studies to identify personal reasons for the use of unscheduled care and factors in routine consultations in primary care that may influence health-care use. People with lived experience of LTCs worked closely with the research team.SettingPrimary care. Manchester and London.ParticipantsPeople aged ≥ 18 years with at least one of four common LTCs: asthma, coronary heart disease, chronic obstructive pulmonary disease (COPD) and diabetes. Participants also included health-care staff.ResultsEvidence synthesis suggested that depression, but not anxiety, is a predictor of use of unscheduled care in patients with LTCs, and low-intensity complex interventions reduce unscheduled care use in people with asthma and COPD. The results of the prospective study were that depression, not having a partner and life stressors, in addition to prior use of unscheduled care, severity of illness and multimorbidity, were independent predictors of EHA and ED admission. Approximately half of the cost of health care for people with LTCs was accounted for by use of unscheduled care. The results of the replication study, carried out in London, broadly supported our findings for risk of ED attendances, but not EHAs. This was most likely due to low rates of detection of depression in general practitioner (GP) data sets. Qualitative work showed that patients were reluctant to use unscheduled care, deciding to do so when they perceived a serious and urgent need for care, and following previous experience that unscheduled care had successfully and unquestioningly met similar needs in the past. In general, emergency and primary care doctors did not regard unscheduled care as problematic. We found there are missed opportunities to identify and discuss psychosocial issues during routine consultations in primary care due to the ‘overmechanisation’ of routine health-care reviews. The feasibility trial examined two levels of an intervention for people with COPD: we tried to improve the way in which practices manage patients with COPD and developed a targeted psychosocial treatment for patients at risk of using unscheduled care. The former had low acceptability, whereas the latter had high acceptability. Exploratory health economic analyses suggested that the practice-level intervention would be unlikely to be cost-effective, limiting the value of detailed health economic modelling.LimitationsThe findings of this programme may not apply to all people with LTCs. It was conducted in an area of high social deprivation, which may limit the generalisability to more affluent areas. The response rate to the prospective longitudinal study was low. The feasibility trial focused solely on people with COPD.ConclusionsPrior use of unscheduled care is the most powerful predictor of unscheduled care use in people with LTCs. However, psychosocial factors, particularly depression, are important additional predictors of use of unscheduled care in patients with LTCs, independent of severity and multimorbidity. Patients and health-care practitioners are unaware that psychosocial factors influence health-care use, and such factors are rarely acknowledged or addressed in consultations or discussions about use of unscheduled care. A targeted patient intervention for people with LTCs and comorbid depression has shown high levels of acceptability when delivered in a primary care context. An intervention at the level of the GP practice showed little evidence of acceptability or cost-effectiveness.Future workThe potential benefits of case-finding for depression in patients with LTCs in primary care need to be evaluated, in addition to further evaluation of the targeted patient intervention.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

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Primary Care COPD Patients Compared with Large Pharmaceutically-Sponsored COPD Studies: An UNLOCK Validation Study

Cited by 79 publications

References 40 publications

Patient Heterogeneity in Health Economic Decision Models for Chronic Obstructive Pulmonary Disease: Are Current Models Suitable to Evaluate Personalized Medicine?

Patient Heterogeneity in Health Economic Decision Models for Chronic Obstructive Pulmonary Disease: Are Current Models Suitable to Evaluate Personalized Medicine?

External validation of multidimensional prognostic indices (ADO, BODEx and DOSE) in a primary care international cohort (PROEPOC/COPD cohort)

CHOICE: Choosing Health Options In Chronic Care Emergencies

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