Mark Small

Importance of inhaler-device satisfaction in asthma treatment: Real-world observations of physician-observed compliance and clinical/patient-reported outcomes

IntroductionIt is hypothesized that health and patient-reported outcomes in asthma are positively influenced by the level of patient satisfaction with their inhaler device. This paper uses data from a real-world observational study to investigate the extent of the relationship between inhaler satisfaction and patient compliance, and the influence this has on health and patient-reported outcomes.MethodsData were drawn from the Adelphi Respiratory Disease Specific Programme® (Adelphi, Macclesfield, UK), a cross-sectional study of consulting patients in five European countries undertaken between June and September 2009. A range of clinical and patient-reported outcomes were observed allowing analysis of these and their relationship with patient-reported inhaler satisfaction and patient compliance.ResultsThe analysis demonstrates that for the majority of patients the higher the level of satisfaction that the patient reports for their device the more likely the patient is observed to be compliant and to experience better outcomes including quality of life (as measured by EuroQol 5 Dimensions [EQ-5D] utility score, P<0.001), fewer exacerbations (P<0.001), fewer hospital visits (P=0.011), fewer healthcare visits (P=0.001), fewer primary care physician visits (P=0.001), and fewer sleep disturbances (P<0.001).ConclusionThe level of patient satisfaction with their inhaler device is observed to have a positive influence on the treatment goals for asthma through its association with improved compliance.

Impact of night-time symptoms in COPD: a real-world study in five European countries

Background Sleep quality is often poor in patients with chronic obstructive pulmonary disease (COPD). A cross-sectional European survey investigated the prevalence of night-time symptoms in COPD to evaluate the level of disconnect between physician and patient perceptions of the presence of night-time symptoms, and to compare the characteristics of patients with and without night-time symptoms. Methods A total of 251 primary care physicians and 251 respiratory specialists completed record forms on 2,807 patients with COPD. The forms captured information on patient demographics, lung function, COPD severity, and symptoms. Patients completed questionnaires on the time of day when their COPD symptoms bothered them, and the impact of COPD on their ability to get up in the morning and on sleep. Data were compared between groups (those with and without night-time symptoms) using t-tests or Wilcoxon signed rank tests. The kappa statistic was used to assess the level of disconnect between physician and patient perceptions of the impact of night-time symptoms. Results Most patients (78%) reported night-time disturbance. Patients with night-time symptoms experienced more daytime breathlessness (mean modified Medical Research Council dyspnea scale score 2.4 versus 1.1) and exacerbations in the previous 12 months (mean 1.7 versus 0.4), and received more maintenance therapy (mean of 2.8 versus 2.3 products) than those without. Concordance between the frequency of physician-reported (67.9% of patients) and patient-reported (68.5% of patients) night-time symptoms was good. Physicians significantly underestimated the impact of COPD on the patient’s ability to get up in the morning and on sleep (fair–moderate agreement). Physician-reported night-time symptoms were present for 41.2% of patients who could be categorized by Global initiative for chronic Obstructive Lung Disease (GOLD) group (n=937), increasing from 20.9% of those in the low-risk group to 77.4% of those in the high-riskgroup. Conclusion Patients with COPD experience night-time symptoms regardless of GOLD group, that impact on their ability to get up in the morning and on their sleep quality.

Understanding the GOLD 2011 Strategy as applied to a real-world COPD population

STUDY OBJECTIVES The aim of this analysis was to understand the implications of the GOLD 2011 multidimensional system for the assessment and management of COPD, using data from a real-world observational study. METHODS Data were drawn from the Adelphi Respiratory Disease Specific Programme, a cross-sectional survey of consulting patients in five European countries and in the U.S. undertaken between June and September 2011. Patients were classified using both the GOLD 2010 and revised GOLD 2011 criteria, and profiled with regards to demographics, disease characteristics and treatment patterns. RESULTS Information on 3813 COPD patients was collected. Disease characteristics showed a general tendency to worsen in parallel with worsening of symptoms. When comparing dual versus single risk criteria, the inclusion of exacerbation history resulted in an increase in the number of patients in high risk groups. The highest proportions of patients receiving inhaled corticosteroids (ICS) were in group D. However, a considerable proportion of patients in low risk groups were receiving ICS/long-acting β2 agonists. CONCLUSIONS Our analysis confirmed the relationship between higher symptomatic burden, increased airflow limitation and exacerbation, and further illustrated the importance of including exacerbation history in the assessment of COPD to identify patients at high risk. As based on data from current clinical practice, this study also highlighted the frequent and potentially inappropriate use of ICS and bronchodilators in patients at low risk of experiencing exacerbations.

Real World COPD: Association of Morning Symptoms with Clinical and Patient Reported Outcomes

Abstract This research examined the prevalence of morning symptoms and their relationship with health status, exacerbations and daily activity in patients with chronic obstructive pulmonary disease (COPD). Data on 1489 patients were analysed from a European and USA sample. Results were tested for significance (p < 0.05) using Mann-Whitney and regression modelling accounting for age, gender, body mass index, comorbidities, symptom severity, smoking status and medication adherence. Morning symptoms were experienced by 39.8% of patients. Controlling for potential confounders, morning symptoms were significantly associated with higher COPD assessment test scores (p < 0.001) and exacerbation frequency (p < 0.001), more frequent worsening of symptoms without consulting a Health Care Professional (p = 0.008), and increased impact on normal daily activities (p = 0.007); and in the working population, a significantly greater impact on getting up and ready for the day (p < 0.001) and significantly more days off work per year (p < 0.001). Our research concluded that in patients with COPD, morning symptoms are associated with poorer health status, impaired daily activities and increased risk of exacerbation in affected patients compared with those patients without morning symptoms. Improved control of patients’ morning symptoms may lead to substantial reduction in COPD impact and frequency of exacerbations, and enable patients to increase daily activities, particularly early morning activities. This could, in turn, enable working patients with COPD to be more productive in the workplace.

The patient-physician partnership in asthma: Real-world observations associated with clinical and patient-reported outcomes

IntroductionIt is hypothesized that a good partnership between asthma patients and their physicians has a direct and positive influence on the patients’ clinical and patient-reported outcomes. Conversely, poor partnership has a detrimental effect on clinical and patient-reported outcomes. This paper uses data from a real-world observational study to define partnership through matched physician and patient data and correlate the quality of partnership with observed clinical and patient-reported outcomes.MethodsData were drawn from Adelphi’s Respiratory Disease Specific Programme, a cross-sectional study of consulting patients in five European countries undertaken between June and September 2009. A range of clinical and patient-reported outcomes were observed allowing analysis of the partnership between 2251 asthma patients and their physicians.ResultsAnalysis demonstrates that the better the partnership between patient and physician, the more likely the patient is to have their asthma condition controlled (P<0.001), to experience fewer exacerbations (P<0.001), to have better quality of life (P<0.001), to have fewer sleep disturbances (P<0.001), and to have fewer patient-reported symptoms (P<0.001). Partnership is also associated with lower impact on lifestyle (P<0.01) and reduced days lost at work/school (P<0.05), and with patient satisfaction with their inhaler device (P<0.05).ConclusionThe patient-physician partnership is a contributory factor in the improvement of asthma treatment, and patient education may lead to improvement in a patient’s ability to contribute to this. Device satisfaction is one of the markers of good partnership.

Establishing the relationship of inhaler satisfaction, treatment adherence, and patient outcomes: a prospective, real-world, cross-sectional survey of US adult asthma patients and physicians

BackgroundInhaled asthma medications are the mainstay of treatment for chronic asthma. However, nonadherence rates for long-term inhaler therapy among adults are estimated to exceed 50 %. Nonadherence is associated with unfavorable clinical outcomes and diminished quality of life. Research suggests that adherence is associated with patients’ satisfaction with their treatment regimen and other factors, such as concomitant allergic rhinitis and tobacco use.MethodsThis prospective, cross-sectional survey of physicians and their patients evaluated the relationship between patient satisfaction with attributes of inhaler devices, treatment adherence, and clinical outcomes. Primary care and specialist physicians completed a physician-reported patient record form for patients with a confirmed asthma diagnosis. Patients for whom a physician-reported form was completed were invited to complete a patient-reported form. Both surveys collected information about demographics, symptoms, exacerbation history, treatment, smoking status, comorbidities, type of inhaler device, and treatment adherence. Patients also indicated the degree to which they were satisfied with attributes of their currently prescribed inhaler device(s). Partial least squares path modeling quantified relationships between latent variables and clinical outcomes.ResultsA total of 243 patients were included in our analysis and 41 % had poorly controlled asthma. More favorable clinical outcomes were significantly associated with greater patient satisfaction with drug delivery (P = 0.002), higher medication adherence (P = 0.049), no history of tobacco use (P < 0.001), and absence of comorbid allergic rhinitis (P = 0.005). Attributes associated with device satisfaction included patient perceptions of consistency in the amount of drug delivery to the lungs, ease of use, and feedback about the number of remaining doses.ConclusionsHigher patient satisfaction with their asthma drug delivery inhaler device is a significant predictor of more favorable clinical outcomes while allergic rhinitis and smoking history were negatively associated with optimal control of asthma. These findings provide clinicians with opportunities to improve patients’ clinical outcomes by tailoring choice of inhaler device therapy and providing education about the correct way to use the device to ensure optimal outcomes. Patients will likely benefit from medical therapy to manage comorbid allergic rhinitis and smoking cessation interventions. Patients unable to stop smoking may require alternative medical therapies to improve their clinical outcomes.

P185 Quantification and Treatment Patterns of Real-World Patients Classified by the GOLD 2011 Strategy

Objectives The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 Strategy classifies COPD patients into 4 categories (A: low risk, less symptoms; B: low risk, more symptoms; C: high risk, less symptoms; D: high risk, more symptoms) based on risk (FEV1 ≥ or <50% predicted and/or exacerbation history < or ≥2 per year) and symptoms (COPD Assessment test [CAT] score < or ≥10 or modified Medical Research Council [mMRC] dyspnoea scale < or ≥2). We examined the proportion of patients in each category when evaluated by CAT or mMRC, and corresponding pharmacological treatment (CAT classification). Methods GOLD 2011 criteria were applied to a real-world international COPD population sampled from the Adelphi Respiratory Disease Specific. Programme undertaken between June 2011 and September 2011. Physicians and patients completed matched questionnaires. Results 2392 patients completed a questionnaire, of which 1508 with all 4 GOLD classification parameters were analyzed. The proportion of patients in categories A, B, C and D, respectively, when evaluated by CAT was 10, 49, 1 and 40%, and when evaluated by mMRC was 39, 20, 13 and 28%. By CAT evaluation in categories A, B, C, and D, patients were using a long-acting β2-agonist (LABA) alone (8, 6, 0 and 1%), long-acting muscarinic antagonist (LAMA) alone (37, 25, 8 and 5%), inhaled corticosteroid plus LABA (ICS/LABA) alone (22, 18, 8 and 8%), and ICS/LABA plus LAMA only (11, 20, 46, 43%). Conclusion CAT assessment increased the number of patients in the more symptomatic categories (B and D), compared with mMRC. Contrary to the GOLD 2011 recommendations, by CAT assessment, a high proportion of low-risk patients (A and B) were using ICS/LABA.

Incremental burden of disease in patients diagnosed with pulmonary arterial hypertension receiving monotherapy and combination vasodilator therapy.

IntroductionPulmonary arterial hypertension (PAH) is a rare, severely debilitating disease with high mortality. There are limited data available on treatment patterns and burden of disease from conditions of actual care.MethodsThis analysis assesses the burden of disease for patients with PAH treated with monotherapy and combination therapies excluding and including intravenous (IV) prostacyclin analogues (PGI2). Data were drawn from the Adelphi PAH Disease Specific Programme, a cross sectional survey of consulting patients undertaken in the US, Germany, Italy and the UK in 2010. Outcomes included demographics, clinical characteristics, health-care resource utilization, and quality of life measured by the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR).ResultsData were analyzed from 446 patients receiving ≥1 of 3 PAH-specific treatment classes. Physicians comprised mainly pulmonologists and cardiologists. The symptoms, functioning and quality of life scales of the CAMPHOR instrument were completed by 218, 229, and 214 patients, respectively. Although 46.2% of patients were classified as World Health Organization (WHO) functional class III or IV, only 24.4% of the population received combination therapy. Combination therapy including IV PGI2 was used in 4.7% of all patients. Patients on monotherapy had the lowest pulmonary vascular resistance values, the highest recorded 6-min walk distance and the lowest recorded levels of dyspnea. Patients on combination therapy including IV PGI2 scored worse on all three variables and had more hospitalizations than patients on less aggressive combination therapy. With increasing therapeutic regimens, the CAMPHOR scores were higher, indicating worse states of health.ConclusionsCombination treatment and particularly the use of prostacyclins remain underused in an unselected population of PAH patients surveyed under conditions of actual care. The disease burden is substantial and increases with greater severity of disease and more aggressive treatments. This necessitates improvement in optimizing current therapy, as well as novel and innovative combination options.

Prevalence and burden of dyspnoea among COPD patients in Japan

Dyspnoea is the most common symptom of chronic obstructive pulmonary disease (COPD) significantly affecting activity, impairing patients’ well‐being and contributing to the economic burden of COPD. The objective of this study was to estimate the prevalence of dyspnoea and its impact on COPD management costs in Japan.

A cross-sectional survey of night-time symptoms and impact of sleep disturbance on symptoms and health status in patients with COPD

Background Sleep disturbance has been termed the forgotten dimension of chronic obstructive pulmonary disease (COPD), but it is clinically important as most patients are affected. This study examined the incremental burden of illness associated with sleep disturbance in COPD, with reference to health status and disease impact, and the degree of concordance between physicians and patients in reporting night-time COPD symptoms. Methods Real-world data from >2,500 patients with COPD consulting for routine care were derived from respiratory Disease-Specific Programs conducted in Europe, the USA, and China. Night-time COPD symptom burden was assessed from patient and physician perspectives. Patients completed the Jenkins Sleep Evaluation Questionnaire (JSEQ), COPD assessment test (CAT), and EuroQol five-dimension questionnaire (EQ-5D). A regression approach was used to analyze the relationship between sleep disturbance (JSEQ score) and health status (EQ-5D score), adjusting for confounding variables. Results Frequency of night-time symptoms was high and was higher when reported by patients than physicians (69.7% and 65.7%, respectively). According to the JSEQ, 73.3% of patients had trouble falling asleep, 75.3% experienced night-time awakenings, 70.6% had trouble staying asleep, and 67.7% woke after a usual amount of sleep feeling worn out. Over half (52.7%) of patients received maintenance treatment where night-time symptom relief was stated by the physician as a treatment aim. A one unit increase in JSEQ score was associated with increased CAT score (0.7 units in Europe and the USA; 0.2 units in China). Sleep disturbance was significantly associated with worse health status (odds ratio [OR]: 1.27, 95% confidence interval [CI]: 1.18, 1.36, P<0.001 for Europe; OR: 1.23, 95% CI: 1.12, 1.38, P<0.001 for the USA; and OR: 1.19, 95% CI: 1.10, 1.28, P<0.001 for China). Conclusions Night-time symptoms and sleep disturbance are common among patients with COPD, and sleep disturbance has a detrimental impact on COPD symptoms and health status.