Juliet M. Foster

Adherence: The Goal to Control Asthma

Asthma management requires adequate adherence to many recommendations, including therapy, monitoring of asthma control, avoidance of environmental triggers, and attending follow-up appointments. Poor adherence is common in patients with asthma and is often associated with increased health care use, morbidity, and mortality. Many determinants of poor adherence have been identified and should be addressed, but there is no clear profile of the nonadherent patient. Interventions to improve adherence therefore demand tailoring to the individual by including patient-specific education, addressing patient fears and misconceptions, monitoring adherence, and developing a shared decision process.

Adherence Monitoring and E-Health: How Clinicians and Researchers Can Use Technology to Promote Inhaler Adherence for Asthma

In the past decade, rapid technological developments have advanced electronic monitoring devices (EMD) for asthma inhalers beyond simple recording of actuations to providing adherence promotion features and detailed information about patterns of medication use. This article describes currently available EMDs, discusses their utility and limitations in assessing adherence, and describes the potential for EMD-based adherence promotion interventions in clinical settings. To date, the main use of EMDs has been in clinical research. In selected populations, simple EMD-based adherence interventions, delivered either through clinician-to-patient feedback about medication use or by direct-to-patient reminders for missed doses, can significantly improve adherence. Further work is now needed to determine the impact of EMDs on clinical outcomes and their cost-effectiveness and feasibility for different clinical settings, including in disadvantaged populations. If this evidence can be provided, then the use of EMDs could expand into the management of asthma in populations with high health care costs, eg, severe asthma. In the future, medication monitoring could help distinguish poor treatment response from poor adherence, guide prescribing decisions, and prompt providers to discuss barriers to adherence; electronic health records may provide the gateway for integrating medication-use monitoring into digital chronic care management.

Identifying patient-specific beliefs and behaviours for conversations about adherence in asthma.

Background:  Asthma guidelines advise addressing adherence at every visit, but no simple tools exist to assist clinicians in identifying key adherence‐related beliefs or behaviours for individual patients.

The Reliability and Patient Acceptability of the SmartTrack Device: A New Electronic Monitor and Reminder Device for Metered Dose Inhalers

Objective: The SmartTrack (ST) is a new adherence monitoring device for pressurized metered-dose inhalers (pMDI), with remote upload and ringtone reminder capabilities. Our aim was to assess its reliability and patient acceptability. Methods: Baseline Quality Control (QC): Actuation log accuracy and device functionality tests were undertaken. Simulated Patient Use: Salmeterol/fluticasone inhalers with STs were actuated two times twice daily for 48 h. Accuracy of reminders, data logging, and uploads was tested. Patient Field Testing: Devices were quality tested before dispensing. Asthma patients each field-tested one ST for 7 days and recorded actuations in a diary. Uploaded data were compared to pMDI dose counter and patient diaries. Patient-reported ease of use for the ST was recorded. Results: Baseline QC: 9/10 devices had 100% accuracy; one had an electrical circuit failure. Simulated Patient Use: Accuracy was 99% (2/342 actuations duplicated). Patient Field Testing: One device failed pre-dispensing testing (electrical circuit failure). Eight devices were field-tested by asthma patients (mean age 45, 5 females). Mean actuation log accuracy was 97%. Reminders were 100% accurate. All devices successfully uploaded data. Average patient-rated difficulty of use was 6/100 (1 = extremely easy, 100 = extremely difficult). Conclusions: The ST has acceptable reliability and utility comparable to other electronic monitoring devices. Its remote data upload capability, reminder functions for missed doses, and graphical display of medication use for patient- and physician-feedback are useful additional features.

The use of questionnaires for measuring patient-reported side effects of drugs: its importance and methodological challenges.

Patient-reported outcomes such as Quality of Life often play an important part in the efficacy assessment of drug treatment. Although instruments that measure quality of life can detect the positive effects of treatments on health status, they may not measure the effect of negative treatment-related symptoms. Patients often fail to spontaneously report common or clinically mild drug-related symptoms, even though the same symptoms can result in the stopping or skipping of prescribed doses. Therefore, as with quality of life assessments, the perception of patients on possible side effects of treatments is best captured by the use of self-report questionnaires. There are substantial challenges with creating well-validated, relevant questionnaires that capture the full range of patient-reported symptoms and signs. A review of 13 existing instruments showed that many patient-rated side effect questionnaires had been developed, often to a high standard, using well-established psychometric methods. However, there were some inconsistencies in the methods used by the questionnaire developers, indicating the need for standardisation when creating new, or adapting previous, instruments. Even with their current deficits, it is important that patient-reported side effect questionnaires be used more in drug development, health outcomes research and resource allocation; all with the ultimate aim of improving quality of patient care.Patient‐reported outcomes such as Quality of Life often play an important part in the efficacy assessment of drug treatment. Although instruments that measure quality of life can detect the positive effects of treatments on health status, they may not measure the effect of negative treatment‐related symptoms. Patients often fail to spontaneously report common or clinically mild drug‐related symptoms, even though the same symptoms can result in the stopping or skipping of prescribed doses. Therefore, as with quality of life assessments, the perception of patients on possible side effects of treatments is best captured by the use of self‐report questionnaires. There are substantial challenges with creating well‐validated, relevant questionnaires that capture the full range of patient‐reported symptoms and signs. A review of 13 existing instruments showed that many patient‐rated side effect questionnaires had been developed, often to a high standard, using well‐established psychometric methods. However, there were some inconsistencies in the methods used by the questionnaire developers, indicating the need for standardisation when creating new, or adapting previous, instruments. Even with their current deficits, it is important that patient‐reported side effect questionnaires be used more in drug development, health outcomes research and resource allocation; all with the ultimate aim of improving quality of patient care. Copyright

Enhancing Respiratory Medication Adherence: The Role of Health Care Professionals and Cost-Effectiveness Considerations

Adherence to medication comprises a multiphased temporal process involving (1) initiation of prescribed therapy, (2) implementation as prescribed, and (3) subsequent persistence. Medication adherence remains suboptimal in most patients with long-term respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). Interventions have been shown to effectively improve treatment initiation, implementation, and persistence when delivered at the health care professional level or the system level, but demonstration of the cost-effectiveness of these interventions is necessary to ensure their widespread use. This review summarizes how health care professionals can intervene to improve medication adherence in patients with asthma and COPD, provides some examples of effective primary care interventions, and illustrates some of the challenges to optimal implementation arising from cost-effectiveness modeling. Improving adherence is shown to be an economically viable treatment option for patients with asthma and COPD, but there are differences in the health economics pertaining to each condition and setting that can affect whether an intervention is considered cost-effective. Targeting adherence interventions at patients with the greatest to gain, and tailoring them to individual patient needs, may help to optimize cost-effectiveness ratios and improve the probability of positive reimbursement decisions, systemwide implementation, and resultant health benefits.

Practice development plans to improve the primary care management of acute asthma: randomised controlled trial

BackgroundOur professional development plan aimed to improve the primary care management of acute asthma, which is known to be suboptimal.MethodsWe invited 59 general practices in Grampian, Scotland to participate. Consenting practices were randomised to early and delayed intervention groups. Practices undertook audits of their management of all acute attacks (excluding children under 5 years) occurring in the 3 months preceding baseline, 6-months and 12-months study time-points. The educational programme [including feedback of audit results, attendance at a multidisciplinary interactive workshop, and formulation of development plan by practice teams] was delivered to the early group at baseline and to the delayed group at 6 months. Primary outcome measure was recording of peak flow compared to best/predicted at 6 months. Analyses are presented both with, and without adjustment for clustering.Results23 consenting practices were randomised: 11 to early intervention. Baseline practice demography was similar. Six early intervention practices withdraw before completing the baseline audit. There was no significant improvement in our primary outcome measure (the proportion with peak flow compared to best/predicted) at either the 6 or 12 month time points after adjustment for baseline and practice effects. However, the between group difference in the adjusted combined assessment score, whilst non-significant at 6 months (Early: 2.48 (SE 0.43) vs. Delayed 2.26 (SE 0.33) p = 0.69) reached significance at 12 m (Early:3.60 (SE 0.35) vs. Delayed 2.30 (SE 0.28) p = 0.02).ConclusionWe demonstrated no significant benefit at the a priori 6-month assessment point, though improvement in the objective assessment of attacks was shown after 12 months. Our practice development programme, incorporating audit, feedback and a workshop, successfully engaged the healthcare team of participating practices, though future randomised trials of educational interventions need to recognise that effecting change in primary care practices takes time. Monitoring of the assessment of acute attacks proved to be a feasible and responsive indicator of quality care.

Patient-reporting of side effects may provide an important source of information in clinical practice.

Dear Editor, The results of the recent study by Lampela et al. [1] showing a great disparity between adverse effects reported by physicians and those reported by patients is, in our opinion, not surprising. However, the direction of the disparity found in this study is intriguing. The side effects reported by 404 randomly selected elderly patients (≥75 years of age; mean drug use: 6.5 drugs) were compared with those identified by a physician. Overall physician-reporting of side effects (patients with one or more side effect = 24%) was double that of patient-reporting (11.4%). This is indeed surprising because it is well-documented that physicians often under-report [2] – and may even fail to discuss [3] – side effects in clinical settings. With more careful reading of the article a number of explanations for this finding emerge. Firstly, the study physician who assessed patients was highly trained and motivated to actively search for side effects, as the authors clearly state. In contrast, the patients had received no training about potential side effects, making it unlikely that unexpected side effects, such as cardiovascular or urinary problems, would be spontaneously reported. All data in the paper were from the intervention group, but data from the control group were not reported. This is unfortunate because control data would have provided important information about the rates of side effect reporting in patients who did not receive the intervention and from the physicians treating them. Secondly, participating patients reported their side effects in the context of a randomised intervention study, but patients taking part in trials may under-report their symptoms [4]. Thirdly, the method of assessing a side effect can be crucial to the level of patient-reporting achieved. The ‘open-question method’ (for example: “have you had side effects?”), which is similar to that used in this study, may under-estimate patients’ experiences of side effects while the ‘rating-scale method’ (in which the patient is provided with a questionnaire listing potential side effects) can drastically increase the patient’s ability to report the side effects they experience [5]. In our view these interesting results from Lampela et al. should be regarded as a comparison of side effect reporting between expert-physician and naive-patient using the open-question method. Such results are unlikely to reflect what could be achieved with careful questioning of patients about side effects. Finally, the authors conclude, perhaps correctly, that elderly persons tend to neglect drug side effects. The inclusion of a comparison group of younger patients in this study would have been useful to support this supposition. In conclusion, this study raises an important issue about disparity between physician- and patient-reporting of side effects. However, the results of this research represent optimal physician-reporting of side effects, and it is important that readers are aware that in everyday clinical practice there are often sub-optimal conditions for physician-reporting. Furthermore, patient-reporting of side effects is considered to be a useful source of information on side effects in pharmacovigilance [6] and clinical practice [7]. Thus, the authors’ assertion that reliance on patient-reporting may lead to “many avoidable drug-related adverse effects (which) may be overlooked resulting in unnecessary distress to the patient” seems unfairly dismissive, considering that with the use of the appropriate methods (e.g. rating-scales), patient-reporting can be an important source of information about side effects in the context of real-life clinical practice.

The Seven Stages of Man: The Role of Developmental Stage on Medication Adherence in Respiratory Diseases

The circumstances and drivers of the decision to initiate, implement, or persist with a medication differ for individuals at each developmental stage. For school-age children with asthma, the social environment of their familys cultural beliefs and the influence of peer networks and school policies are strong determinants of medication adherence. The stage of adolescence can be a particularly challenging time because there is a reduction in parental supervision of asthma management as the young person strives to become more autonomous. To illustrate the importance of such factors, adherence interventions in children and young adults with asthma have used peer-based supports and social supports, particularly social media platforms. In older patients, it is internal rather than external factors and age-related decline that pose challenges to medication adherence. Seniors face the challenges of polypharmacy, reduced social support, increased isolation, and loss of cognitive function. Strategies to promote adherence must be tailored to the developmental stage and respective behavioral determinants of the target group. This review considers the different attitudes toward medication and the different adherence behaviors in young and elderly patients with chronic respiratory conditions, specifically asthma and chronic obstructive pulmonary disease. Opportunities to intervene to optimize adherence are suggested.

Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials

BackgroundPrimary-care based randomized controlled trials (RCTs) build an important evidence base for general practice but little evidence exists about barriers to recruitment which often hamper such trials.We investigated the issues that impeded and facilitated recruitment to a clinical trial in general practice.MethodsGPs participating in a cluster RCT that tested interventions for improving medication adherence and asthma control completed a survey comprising quantitative and free text questions about their recruitment experiences. We used backward regression to analyze quantitative data and coded free text responses into themes.Results40/55 of enrolled GPs recruited patients, but only one-third reached the planned recruitment target (5 patients/GP). In univariate analyses, poor patient recruitment by GPs was significantly associated with longer time to first patient enrolment, GP-perceived poor access to eligible patients and GP working in a practice training medical students. In regression analysis, only the first was significant (p = 0.001); the explained variance of the model was 48%. Themes from free text responses described recruitment barriers at the level of GP (e.g. GPs excluding patients for whom research appeared too challenging), practice (e.g. practice cultures disempowered GPs), patient (e.g. reluctance to change treatment for research) and study (e.g. protocol requirements complicating recruitment). Facilitators included GPs perceiving good support from the research team.ConclusionTargeted recruitment support early in the recruitment phase may enhance recruitment rates. Over time, interventions to enhance a general practice research culture are also likely to enhance skills to recruit patients, even for complex interventions. We recommend systematic evaluation of recruitment approaches and outcomes in future RCTs to optimize feasibility and success of these important trials.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12610000854033 (date registered 14/10/2010).