Objective Assessment of Adherence to Inhalers by COPD Patients.

RATIONALE: Objective adherence to inhaled therapy by patients with COPD has not been reported. OBJECTIVES: The aim of this study was to objectively quantify adherence to preventer DiskusTM inhaler therapy by patients with COPD with an electronic audio recording device (INCATM). METHODS: This was a prospective observational study. On discharge from hospital patients were given a salmeterol/fluticasone inhaler with an INCATM device attached. Analysis of this audio quantified the frequency and proficiency of inhaler use. MEASUREMENTS AND MAIN RESULTS: COPD patients (n=265) were recruited. The mean age 71 years, mean Forced Expiratory Volume in 1-second 1.3 Litres, and 80% had evidence of mild/moderate cognitive impairment. By combining time of use, interval between doses and critical technique errors, thus incorporating both intentional and unintentional non-adherence, a measure \u22Actual Adherence\u22 was calculated. Mean Actual Adherence was 22.9% of that expected if the doses were taken correctly and on time. Seven percent had an Actual Adherence\u3e80%. Hierarchical clustering found three equally sized well-separated clusters corresponding to distinct patterns: Cluster 1 (34%) had low inhaler use and high error rates, Cluster 2 (31%) had high inhaler use and high error rates, and Cluster 3 (30%) had overall good adherence. Lung function and co-morbidities were predictive of poor technique, while age and cognition with poor lung function distinguished those with poor adherence and frequent errors in technique. CONCLUSION: These data may inform clinicians both in understanding why a prescribed inhaler is not effective and to devise strategies to promote adherence in COPD

A protocol for a randomised clinical trial of the effect of providing feedback on inhaler technique and adherence from an electronic device in patients with poorly controlled severe asthma

ntroduction In clinical practice, it is difficult to distinguish between patients with refractory asthma from those with poorly controlled asthma, where symptoms persist due to poor adherence, inadequate inhaler technique or comorbid diseases. We designed an audio recording device which, when attached to an inhaler, objectively identifies the time and technique of inhaler use, thereby assessing both aspects of adherence. This study will test the hypothesis that feedback on these two aspects of adherence when passed on to patients improves adherence and helps clinicians distinguish refractory from difficult-to-control asthma. Methods This is a single, blind, prospective, randomised, clinical trial performed at 5 research centres. Patients with partially controlled or uncontrolled severe asthma who have also had at least one severe asthma exacerbation in the prior year are eligible to participate. The effect of two types of nurse-delivered education interventions to promote adherence and inhaler technique will be assessed. The active group will receive feedback on their inhaler technique and adherence from the new device over a 3-month period. The control group will also receive training in inhaler technique and strategies to promote adherence, but no feedback from the device. The primary outcome is the difference in actual adherence, a measure that incorporates time and technique of inhaler use between groups at the end of the third month. Secondary outcomes include the number of patients who remain refractory despite good adherence, and differences in the components of adherence after the intervention. Data will be analysed on an intention-to-treat and a per-protocol basis. The sample size is 220 subjects (110 in each group), and loss to follow-up is estimated at 10% which will allow results to show a 10% difference (0.8 power) in adherence between group means with a type I error probability of 0.05. Trial registration number NCT01529697; Pre-results

The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA®, in a community pharmacy setting: study protocol for a randomised controlled trial.

BACKGROUND: Poor adherence to inhaled medication may lead to inadequate symptom control in patients with respiratory disease. In practice it can be difficult to identify poor adherence. We designed an acoustic recording device, the INCA® (INhaler Compliance Assessment) device, which, when attached to an inhaler, identifies and records the time and technique of inhaler use, thereby providing objective longitudinal data on an individual\u27s adherence to inhaled medication. This study will test the hypothesis that providing objective, personalised, visual feedback on adherence to patients in combination with a tailored educational intervention in a community pharmacy setting, improves adherence more effectively than education alone. METHODS/DESIGN: The study is a prospective, cluster randomised, parallel-group, multi-site study conducted over 6 months. The study is designed to compare current best practice in care (i.e. routine inhaler technique training) with the use of the INCA® device for respiratory patients in a community pharmacy setting. Pharmacies are the unit of randomisation and on enrolment to the study they will be allocated by the lead researcher to one of the three study groups (intervention, comparator or control groups) using a computer-generated list of random numbers. Given the nature of the intervention neither pharmacists nor participants can be blinded. The intervention group will receive feedback from the acoustic recording device on inhaler technique and adherence three times over a 6-month period along with inhaler technique training at each of these times. The comparator group will also receive training in inhaler use three times over the 6-month study period but no feedback on their habitual performance. The control group will receive usual care (i.e. the safe supply of medicines and advice on their use). The primary outcome is the rate of participant adherence to their inhaled medication, defined as the proportion of correctly taken doses of medication at the correct time relative to the prescribed interval. Secondary outcomes include exacerbation rates and quality of life measures. Differences in the timing and technique of inhaler use as altered by the interventions will also be assessed. Data will be analysed on an intention-to-treat and a per-protocol basis. Sample size has been calculated with reference to comparisons to be made between the intervention and comparator clusters and indicates 75 participants per cluster. With an estimated 10 % loss to follow-up we will be able to show a 20 % difference between the population means of the intervention and comparator groups with a power of 0.8. The Type I error probability associated with the test of the null hypothesis is 0.05. DISCUSSION: This clinical trial will establish whether providing personalised feedback to individuals on their inhaler use improves adherence. It may also be possible to enhance the role of pharmacists in clinical care by identifying patients in whom alteration of either therapy or inhaler device is appropriate. REGISTRATION: ClinicalTrials.gov NCT02203266

A Method to Calculate Adherence to Inhaled Therapy That Reflects the Changes in Clinical Features of Asthma.

Rationale Currently studies on adherence to inhaled medications report Average Adherence over time. This measure does not account for variations in the interval between doses nor for errors in inhaler use. Objectives We investigated whether adherence calculated as a single Area Under the concentration-time Curve (AUC) measure, incorporating the interval between doses and inhaler technique, was more reflective of patient outcomes than current methods of assessing adherence. Methods We attached a digital audio device (INCATM) to a dry powder inhaler. This recorded when the inhaler was used and analysis of the audio data indicated if the inhaler had been used correctly. These aspects of inhaler use were combined to calculate adherence over time, as an AUC measure. Over a 3 month period a cohort of asthma patients were studied. Adherence to a twice-daily inhaler preventer therapy using this device and clinical measures were assessed. Measurements and Results Recordings from 239 patients with severe asthma were analysed. Average Adherence, based on the dose counter was 84.4%, whereas the ratio of expected to observed accumulated AUC, Actual Adherence, was 61.8% (

In patients with severe uncontrolled asthma, does knowledge of adherence and inhaler technique using electronic monitoring improve clinical decision making? A protocol for a randomised controlled trial

Introduction: Many patients with asthma remain poorly controlled despite the use of inhaled corticosteroids and long-acting beta agonists. Poor control may arise from inadequate adherence, incorrect inhaler technique or because the condition is refractory. Without having an objective assessment of adherence, clinicians may inadvertently add extra medication instead of addressing adherence. This study aims to assess if incorporating objectively recorded adherence from the Inhaler Compliance Assessment (INCA) device and lung function into clinical decision making provides more cost-effective prescribing and improves outcomes. Methods and analysis: This prospective, randomised, multicentre study will compare the impact of using information on adherence to influence asthma treatment. Patients with severe uncontrolled asthma will be included. Data on adherence, inhaler technique and electronically recorded peak expiratory flow rate will be used to promote adherence and guide a clinical decision protocol to guide management in the active group. The control group will receive standard inhaler and adherence education. Medications will be adjusted using a protocol based on Global Initiativefor Asthma (GINA) recommendations. The primary outcome is the between-group difference in the proportion of patients who have refractory disease and are prescribed appropriate medications at the end of 32 weeks. A co-primary outcome is the difference between groups in the rate of adherence to salmeterol/fluticasone inhaler over the last 12 weeks. Secondary outcomes include changes in symptoms, lung function, type-2 cytokine biomarkers and clinical outcomes between both groups. Cost-effectiveness and cost-utility analyses of the INCA device intervention will be performed. The economic impact of a national implementation of the INCA-SUN programme will be evaluated. Ethics and dissemination:The results of the study will be published as a manuscript in peer-reviewed journals. The study has been approved by the ethics committees in the five participating hospitals. Trial registration NCT02307669; Pre-results

Improving medication adherence in asthma

In little over a generation, the ingenuity of scientists and clinician researchers has developed inhaled medications and pathway-specific biological agents that control the inflammation and physiology of asthma. Unfortunately, whether it is because of cost or difficulty understanding why or how to use inhaled medications, patients often do not take these medications. The consequences of poor treatment adherence, loss of control and exacerbations, are the same as if the condition remained untreated. Furthermore, poor adherence is difficult to detect without direct measurement. Together this means that poor treatment adherence is easily overlooked and, instead of addressing the cause of poor adherence, additional medicines may be prescribed. In other words, poor treatment adherence is a risk for the patient and adds cost to healthcare systems. In this article, we discuss the rationale for and the delivery of successful interventions to improve medication adherence in asthma. We contextualize these interventions by describing the causes of poor treatment adherence and how adherence is assessed. Finally, future perspectives on the design of new interventions are described

Colonisation of Irish patients with chronic obstructive pulmonary disease by Streptococcus pneumoniae and analysis of the pneumococcal vaccine coverage: a non-interventional, observational, prospective cohort study.

OBJECTIVES: To characterise the pattern of colonisation and serotypes of Streptococcus pneumoniae among patients with chronic obstructive pulmonary disease (COPD) who currently receive the 23-valent pneumococcal polysaccharide vaccine (PPV-23) according to vaccination status, use of antibiotics and steroids. To investigate the prevalence of PPV-23 and 13-valent pneumococcal conjugate vaccine (PCV-13) serotypes within the study cohort. DESIGN: A non-interventional, observational, prospective cohort study with a 12 -month follow-up period inclusive of quarterly study visits. SETTING: Beaumont Hospital and The Royal College of Surgeons in Ireland Clinical Research Centre, Dublin, Ireland. PARTICIPANTS: Patients with an established diagnosis of COPD attending a tertiary medical centre. PRIMARY OUTCOME MEASURE: Colonisation rate of S. pneumoniae in patients with COPD and characterisation of serotypes of S. pneumoniae with correlation to currently available pneumococcal vaccines. Sputum and oropharyngeal swab samples were collected for the isolation of S. pneumoniae. SECONDARY OUTCOME MEASURE: Seasonality of colonisation of S. pneumoniae and its relationship with the incidence of exacerbations of COPD. RESULTS: S. pneumoniae was detected in 16 of 417 samples, a colonisation incident rate of 3.8% and in 11 of 133 (8%) patients at least once during the study. The majority of S. pneumoniae isolates were identified in spring and were non-vaccine serotypes for either the PPV-23 or PCV-13 (63%). The colonisation incident rate of S. pneumoniae fluctuated over the four seasons with a peak of 6.6% in spring and the lowest rate of 2.2% occurring during winter. Antibiotic use was highest during periods of low colonisation. CONCLUSIONS: There is seasonal variation in S. pneumoniae colonisation among patients with COPD which may reflect antibiotic use in autumn and winter. The predominance of non-vaccine types suggests that PCV-13 may have limited impact among patients with COPD in Ireland who currently receive PPV-23. TRIAL REGISTRATION NUMBER: NCT02535546; post-results

Relationship of inhaler adherence behaviour to clinical outcomes in copd:an observational study

COPD remains a leading cause of healthcare use despite the availability of effective inhaled therapies. We examined adherence to maintenance therapy by assessing the key components of good inhaler use: habit of use and inhaler technique. The relationship between adherence patterns, specific patient characteristics and clinical outcomes at one year was examined. We recruited 226 hospitalised patients with a diagnosis of COPD to this prospective observational study. Inhaler adherence was remotely monitored for 90 days after hospital discharge using an INCATM audio recording device. Cluster analysis grouped patients by their adherence behaviour based on the mean rate of attempted use and critical technique errors. The clinical and psychosocial characteristics of each cluster were examined. The rate of all–cause mortality and healthcare use at 12 months was recorded. Survival analysis was used to evaluate the time to first event across adherence groups. Adherence data was available for 195 patients. We identified four patterns of Adherence behaviour: (1) Regular habit of use and good technique (28%); (2) Regular habit of use and poor technique (21%); (3) Poor habit of use and good technique (33%); (4) Poor habit of use and poor technique (19%). The overall event rate was lowest in Cluster 1, 5.46/person/year. Cluster 2 had the lowest annual rate of hospital presentation, but accounted for the majority of community prescriptions for antibiotics and steroids, mean 4.6/person/ Poster sessions A228 Thorax 2017;72(Suppl 3):A1–278 on 20 June 2018 by guest. Protected by copyright. http://thorax.bmj.com/ Thorax: first published as 10.1136/thoraxjnl-2017-210983.410 on 15 November 2017. Downloaded from year. In an adjusted Cox regression model, Cluster 3 had an increased risk of any adverse outcome compared to Cluster 1, Hazard Ratio 1.8 (1.1–2.9), p=0.02. This group were notable for high anxiety scores and mild cognitive impairment. There was a stepwise increase in mortality across groups, from 11% in Cluster 1% to 33% in Cluster 4, p<0.001. Cluster 4 was older, female, with higher co-morbidity and cognitive impairment. We have identified four clusters of adherence behaviour. There is an association between adherence patterns and clinical outcomes. Each cluster also exhibits distinct clinical and psychosocial traits which may act as drivers of their behaviour. Personalised interventions targeting these specific adherence behaviour patterns may prove a cost-effective strategy to curtail COPD-related healthcare costs