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• W2511335722 abstract "Adequate medication adherence is key for optimal benefit of pharmacological treatments. A wealth of research has been conducted to understand and identify opportunities to intervene to improve medication adherence, but variations in adherence definitions within prior research have led to ambiguity in study findings. The lack of a standard taxonomy hinders the development of cumulative science in adherence research. This article reviews the newly established Ascertaining Barriers to Compliance (ABC) taxonomy for medication adherence with a particular focus on its relevance and applicability within the context of asthma and chronic obstructive pulmonary disease management. Building on traditional definitions and concepts within medication adherence, the ABC taxonomy considers the temporal sequence of steps a patient must undertake to be defined as “adherent to treatment”: (A) initiation, (B) implementation, and (C) persistence. We explain the clinical and research relevance of differentiating between these phases, point to differences in its applicability in observational and experimental research, review strengths and limitations of available measures, and highlight recent findings on specific determinants of these behaviors. Finally, we provide recommendations for research and practice with a view to supporting and sign posting opportunities to improve future respiratory medication adherence and associated research. Adequate medication adherence is key for optimal benefit of pharmacological treatments. A wealth of research has been conducted to understand and identify opportunities to intervene to improve medication adherence, but variations in adherence definitions within prior research have led to ambiguity in study findings. The lack of a standard taxonomy hinders the development of cumulative science in adherence research. This article reviews the newly established Ascertaining Barriers to Compliance (ABC) taxonomy for medication adherence with a particular focus on its relevance and applicability within the context of asthma and chronic obstructive pulmonary disease management. Building on traditional definitions and concepts within medication adherence, the ABC taxonomy considers the temporal sequence of steps a patient must undertake to be defined as “adherent to treatment”: (A) initiation, (B) implementation, and (C) persistence. We explain the clinical and research relevance of differentiating between these phases, point to differences in its applicability in observational and experimental research, review strengths and limitations of available measures, and highlight recent findings on specific determinants of these behaviors. Finally, we provide recommendations for research and practice with a view to supporting and sign posting opportunities to improve future respiratory medication adherence and associated research. Respiratory clinicians have access to a wide range of efficacious therapies. Randomized controlled trials (RCTs) have repeatedly demonstrated the efficacy of licensed asthma and chronic obstructive pulmonary disease (COPD) therapies in terms of their ability to minimize symptom burden, improve health-related quality of life, and maintain or slow disease progression.1Global Initiative for Asthma. GINA Report, Global Strategy for Asthma Management and Prevention; 2014. Available from: http://ginasthma.org/. Accessed December 28, 2015.Google Scholar, 2Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for Diagnosis, Management, and Prevention of COPD; 2016. Available from: http://goldcopd.org/. Accessed December 28, 2015.Google Scholar Yet reports of numerous asthma and COPD exacerbations and related pressures on emergency and respiratory services persist.3The Global Asthma Network The Global Asthma Report 2014. Global Asthma Network, Auckland, New Zealand2014Google Scholar, 4Guarascio A.J. Ray S.M. Finch C.K. Self T.H. The clinical and economic burden of chronic obstructive pulmonary disease in the USA.Clinicoecon Outcomes Res. 2013; 5: 235-245PubMed Google Scholar This apparent disconnect is primarily explained by the gap between efficacy results derived from well-controlled, short-term RCTs involving highly selected populations and effectiveness evaluations conducted in more every day, real-life settings, typically involving diverse patient populations, across a wide range of care settings and patient characteristics and evaluated over longer time intervals than are used in RCTs.5Blaschke T.F. Osterberg L. Vrijens B. Urquhart J. Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories.Annu Rev Pharmacol Toxicol. 2012; 52: 275-301Crossref PubMed Scopus (289) Google Scholar One of the important differentiating factors between efficacy RCTs and real-world effectiveness studies is medication adherence optimized in RCTs, but commonly suboptimal in everyday routine care. Through registration RCTs, regulatory authorities require an estimate of efficacy (or “method-effectiveness”) that assumes perfect adherence while, in practice, payers are often more interested in “use effectiveness” to inform cost-effectiveness analyses and guide market access and reimbursement decisions through pragmatic RCTs or noninterventional studies. All study designs reflect some aspect of the real world, but the ability to extrapolate the findings of registration RCTs to more routine clinical environments must be treated with caution.6Roche N. Reddel H.K. Agusti A. Bateman E.D. Krishnan J.A. Martin R.J. et al.Integrating real-life studies in the global therapeutic research framework.Lancet Respir Med. 2013; 1: e29-e30Abstract Full Text Full Text PDF PubMed Scopus (95) Google Scholar The real-world implications of differences between registration RCTs and routine care adherence behaviors depend on the characteristics of both the disease and the medications as drug actions are inherently dose and time dependent. As a result, variable under-dosing (which is the norm) diminishes the actions of medications in real life by various degrees compared with RCT settings.7Vrijens B. Urquhart J. Methods for measuring, enhancing, and accounting for medication adherence in clinical trials.Clin Pharmacol Ther. 2014; 95: 617-626Crossref PubMed Scopus (89) Google Scholar The importance of optimizing asthma medication in the context of routine (“real-world”) practice was recognized and stressed by the World Allergy Organization and Interasma in their joint manifesto on adherence to asthma treatment in respiratory allergy (also endorsed by Allergic Rhinitis and Its Impact on Asthma and the Global Allergy and Asthma European Network).8World health Organization. Manifesto on Adherence to Asthma Treatment in Respiratory Allergy. Available from: http://www.worldallergy.org/UserFiles/file/GWCManifestoAdherenceChicago_fullpage.pdf. Accessed December 28, 2015.Google Scholar The Ascertaining Barriers to Compliance (ABC) taxonomy began as an initiative of the European Union to standardize adherence-related terminology for clinical and research use.9Vrijens B. De Geest S. Huges D.A. Przemyslaw K. Demonceau J. Ruppar T. et al.A new taxonomy for describing and defining adherence to medications.Br J Clin Pharmacol. 2012; 73: 691-705Crossref PubMed Scopus (1076) Google Scholar The publication of the ABC taxonomy marked an important step forward in the standardization and future development of adherence research. To facilitate its use in respiratory research and practice, it is now important to consider its applicability and relevance to the real-life complexities of respiratory care. Although sharing many of the common barriers to optimal adherence reported in other chronic diseases,10Karve S. Cleves M.A. Helm M. Hudson T.J. West D.S. Martin B.C. Good and poor adherence: optimal cut-point for adherence measures using administrative claims data.Curr Med Res Opin. 2009; 25: 2303-2310Crossref PubMed Scopus (411) Google Scholar, 11Center for Health Policy Research Adherence to HIV Therapy: Building a Bridge to Success Forum for Collaborative HIV Research. George Washington University Medical Center, Washington, DC1999Google Scholar asthma and COPD stand apart because of the central role that inhaled therapy plays in their management, and the associated challenges that the effective inhaler technique presents to optimum therapy delivery and adherence.12Melani A.S. Bonavia M. Cilenti V. Cinti C. Lodi M. Martucci P. et al.Inhaler mishandling remains common in real life and is associated with reduced disease control.Respir Med. 2011; 105: 930-938Abstract Full Text Full Text PDF PubMed Scopus (716) Google Scholar Furthermore, the 2 conditions differ in their age of onset, pattern of symptoms, and disease course giving rise to potential differences in respective medication adherence behaviors. We consider the value of the ABC taxonomy in differentiating between adherence behaviors and clinical settings in these respiratory conditions, as a way to both understand behavior-specific determinants and establish a new standard for future respiratory adherence research. Finally, evidence gaps and unmet needs are outlined to act as a guide for future respiratory adherence researchers. On the basis of a systematic review of the medication adherence literature, Vrijens et al's9Vrijens B. De Geest S. Huges D.A. Przemyslaw K. Demonceau J. Ruppar T. et al.A new taxonomy for describing and defining adherence to medications.Br J Clin Pharmacol. 2012; 73: 691-705Crossref PubMed Scopus (1076) Google Scholar proposed ABC taxonomy conceptualizes adherence to medications in line with principles of behavioral and pharmacological science. This proposal was developed as a response to a 2003 World Health Organization call for action to address the disease burden associated with poor medication adherence.13World Health Organization. Adherence to Long-Term Therapies—Evidence for Action; 2003. Available from: http://apps.who.int/medicinedocs/pdf/s4883e/s4883e.pdf. Accessed October 21, 2015.Google Scholar It also furthered the thinking laid out by the International Society for Pharmacoeconomics and Outcomes Research in their 2008 consensus statement on adherence definitions.14Cramer J.A. Roy A. Burrell A. Fairchild C.J. Fuldeore M.J. Ollendorf D.A. et al.Medication compliance and persistence: terminology and definitions.Value Health. 2008; 11: 44-47Abstract Full Text PDF PubMed Scopus (1547) Google Scholar, 15Hutchins D.S. Zeber J.E. Roberts C.S. Williams A.F. Manias E. Peterson A.M. IPSOR Medication Adherence and Persistence Special Interest GroupInitial medication adherence-review and recommendations for good practices in outcomes research: an ISPOR medication adherence and persistence special interest group report.Value Health. 2015; 18: 690-699Abstract Full Text Full Text PDF Scopus (37) Google Scholar The ABC taxonomy defines the overarching concept of “medication adherence” as the process by which patients take their medication as prescribed and subdivides it into 3 essential elements: (A) initiation; (B) implementation, and (C) persistence (see Figure 1). This subdivision outlines the sequence of events that have to occur for a patient to experience the optimal benefit from his or her prescribed treatment regimen. Step “A” in the process, “initiation”—when the patient takes the first dose of a prescribed medication—is typically a binary event (patients either start taking their medication or not in a given time period). In contrast, step “B,” “implementation”—the extent to which a patient's actual dosing corresponds to the prescribed dosing regimen, from initiation until the last dose is taken—is a longitudinal description of patient behavior over time, that is, his or her dosing history. The final step “C,” defined within the taxonomy, “persistence,” is the time elapsed from initiation, until eventual treatment discontinuation (ie, time to event); after discontinuation, a period of nonpersistence may follow until the end of the prescribing period. A further adherence concept, although not specifically defined in the ABC taxonomy, is that of medication “reinitiation.” The temporal steps of initiation, implementation, and persistence defined by the taxonomy, in research terms, occur (or not) in a time period in which a specific medication is prescribed for regular intake to improve health outcomes, starting with a first prescription and ending after a drug exposure period deemed sufficient for achieving the expected effect. In RCTs, this sequence maps onto the process of study participation, from study inclusion to assessment of health outcomes. Thus, initiation is by definition a single event, and nonpersistence is readily operationalized as the time interval between the last medication intake to the end of the follow-up period (and consequently depends on the length of this period). In observational studies and clinical practice, the boundaries of this temporal sequence are less clear-cut and require additional specifications. For chronic conditions, patients can receive multiple prescriptions often over decades. Over this time interval, they may interrupt or change treatment (in consultation with the clinician or not) and they may alternate periods of substantial drug exposure with intervals without any drug exposure. Epidemiological research has employed the concepts of “treatment episodes” and “treatment gaps” to reflect such clinical realities, using time intervals for medication exposure representative of such behaviors derived from long-term patient records.16Gardarsdottir H. Souverein P.C. Egberts T.C. Heerdink E.R. Construction of drug treatment episodes from drug-dispensing histories is influenced by the gap length.J Clin Epidemiol. 2010; 63: 422-427Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar The 3 elements of the ABC taxonomy can be applied in long-term research and patient care in combination with these concepts. As such, a patient may have several treatment episodes, which may show different (re)initiation, implementation, and discontinuation values. Depending on the available data sources, the researcher or clinician may have the opportunity to assess more or less precisely these 3 elements. To explore the applicability of the ABC taxonomy in the context of asthma and COPD, it is important to consider the main characteristics of 2 conditions and their management. Asthma and COPD are both chronic obstructive lung conditions principally managed with inhaled therapies. There are 2 main categories of inhaled therapies prescribed in asthma and COPD: bronchodilators (short- or long-acting) to offer symptom relief, and anti-inflammatory therapy to target airway inflammation and minimize risk of future exacerbations (ie, acute periods of worsening).2Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for Diagnosis, Management, and Prevention of COPD; 2016. Available from: http://goldcopd.org/. Accessed December 28, 2015.Google Scholar, 3The Global Asthma Network The Global Asthma Report 2014. Global Asthma Network, Auckland, New Zealand2014Google Scholar Beyond these similarities in clinical presentation and therapeutic management, there are important differences between the 2 conditions that must be taken into consideration when evaluating adherence. COPD is characterized by fixed airflow obstruction, progressive, irreversible deterioration in lung function, older age of onset, and mediated primarily by neutrophilic inflammation.2Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for Diagnosis, Management, and Prevention of COPD; 2016. Available from: http://goldcopd.org/. Accessed December 28, 2015.Google Scholar Short- and long-acting bronchodilators, in the form of anti-muscarinics and β2-agonists, are the core pillar of COPD management. Inhaled corticosteroids are often prescribed, although only licensed for use in combination with bronchodilator therapy. Other treatment options exist, such as theophylline and phosphodiesterase-4 inhibitors. As a result of the fixed airflow obstruction and progressive lung function decline over time, COPD symptoms tend to be persistent and to occur in older patients (>50 years), resulting in a need for consideration of potential comorbidities and polypharmacy factors, cognitive implications, and tailoring of inhaler device (eg, potentially avoiding those requiring strong inspiratory flow). Costello et al discuss age-related determinants of respiratory medication adherence in more detail in their paper in this issue.17Costello R.W. Foster J.M. Grigg J. Eakin M.N. Canonica W. Yunus F. et al.Seven stages of man—the role of age and cognition on medication adherence.J Allergy Clin Immunol Pract. 2016; Google Scholar In contrast, asthma is a variable condition (often triggered by seasonal, viral, and/or environmental exposures) with reversible airflow obstruction.1Global Initiative for Asthma. GINA Report, Global Strategy for Asthma Management and Prevention; 2014. Available from: http://ginasthma.org/. Accessed December 28, 2015.Google Scholar It is primarily mediated by eosinophilic inflammation and can affect patients of any age (sometimes resolving over time), presenting different management challenges (eg, in terms of inhalation technique and successful delivery) depending on the particular age group under consideration. Inhaled corticosteroids are the mainstay of anti-inflammatory controller therapy and are prescribed in combination with short- and/or long-acting bronchodilators (β2-agonists) for symptom relief. Add-on therapies, such as oral steroids and/or monoclonal antibodies, are used in more severe cases. The Global Initiative for Asthma guidelines recommend a stepwise approach to management, with symptoms and risk optimized on the lowest dose of therapy appropriate, but stepped up, as required, to improve control. Use of add-on therapies (eg, theophylline and/or high-cost biologics) is recommended only in patients with severe asthma who have persistent symptoms and/or exacerbations despite optimized treatment with high-dose controller medications and treatment of modifiable risk factors. Thus, valid means of measuring and monitoring adherence are required to guide necessary therapy step-ups and, similarly, to avoid unnecessary treatment escalations. Yet owing to the sometimes variable nature of asthma, clinician-issued prescribing instructions can vary substantially between patients. For instance, daily controller medication use may be prescribed during a specific interval each year to treat seasonal asthma. In contrast, patients with persistent asthma may be prescribed daily controllers for long-term use, either with a fixed daily dosage or via a self-management plan, which typically specifies a fixed basis of daily controller use, rules for reliever use (eg, “as needed”), and thresholds for increased controller use. Prescribing instructions are an important element of meaningful adherence appraisal as its evaluation requires a comparison of actual medication use against a clinically appropriate intended reference regimen. Furthermore, waxing and waning symptoms can lead to practical research challenges of differentiating between periods of episodic implementation and nonpersistence and temporary nonpersistence (and reinitiation). Therefore, disease severity, prescription recommendations, and time intervals need to be carefully considered in asthma adherence research. Most treatment initiation research comes from observational studies using electronic medical records (EMRs) combined with pharmacy dispensing databases. Unlike RCTs, which typically administer the first dose on site, EMR-based studies draw on data captured within routine practice and can better reflect true initiation behaviors. However, evidence is scarce as treatment initiation is not often reported. Indeed, a systematic review of observational evidence on medication adherence determinants in asthma, which used the ABC taxonomy to identify which of the 3 stages were investigated in the studies included, found the vast majority focused on implementation; very few considered initiation or persistence.18Dima A.L. Hernandez G. Cunillera O. Ferrer M. de Bruin M. ASTRO-LAB group. Asthma inhaler adherence determinants in adults: systematic review of observational data.Eur Respir J. 2015; 45: 994-1018Crossref PubMed Scopus (90) Google Scholar Yet medication initiation should never be assumed. A community-based study of initiation rates of chronic disease medications in the United States found that 20% to 30% of patients failed to collect their first treatment prescription.19Fischer M.A. Stedman M.R. Lii J. Vogeli C. Shrank W.H. Brookhart M.A. et al.Primary medication non-adherence: analysis of 195,930 electronic prescriptions.J Gen Intern Med. 2010; 25: 284-290Crossref PubMed Scopus (409) Google Scholar Although asthma medications were among the higher dispensed e-prescriptions within the study, approximately one-quarter of patients prescribed new asthma therapy failed to collect their first prescription (see Figure 2). Pharmacy dispensing databases provide the best source for evaluating treatment initiation behaviors in observational studies, especially when linked to clinical EMRs (eg, primary and/or secondary care prescribing data; see Table I). EMR data indicate the physician's intention that a patient should take a specific drug and pharmacy dispensing data indicate the patient's collection of the prescribed therapy—one step closer to the act of initiation. A prescription event followed by a dispensation event for the same treatment is used in research to infer therapy initiation.Table ISome key features, strengths, and limitations of commonly used adherence measurement methods1. Initiation2. Implementation3. DiscontinuationRoutine EHR∗Electronic Health Records, e.g. prescription (prescribing and/or dispensing) data, and health insurance (or ‘claims’) data. Granularity/Precision†Granularity: the sampling rate at which it is possible to assess changes in the dynamic process of adherence (particularly relevant to objective measures); Precision: degree of reproducibility, that is, ability to measure the same value repeatedly (particularly relevant to patient reports).Granularity in days, if the prescription database is also availableImprecise—tends to average usage of a time interval of ≥3 monthsGranularity in weeks or months Validity‡Degree of potential systematic error in the measurement, that is, difference between the estimated and real value.Relatively high (if first use follows dispensation)Relatively high (if standard dosing regimen or if prescription details are available)Relatively high (if all sources of dispensation are known)Allows identification of changes in a same class of medications Ease of AccessFew linked datasets to compare prescribed and collected medication datesEasy to access if available in health systemEasy to access if available in health systemPatient reports Granularity/Precision†Granularity: the sampling rate at which it is possible to assess changes in the dynamic process of adherence (particularly relevant to objective measures); Precision: degree of reproducibility, that is, ability to measure the same value repeatedly (particularly relevant to patient reports).Granularity in days/weeks (depends on the time window of the tool used)Imprecise due to recall biasGranularity in days/weeks (depends on patient memory) Validity‡Degree of potential systematic error in the measurement, that is, difference between the estimated and real value.Subject to desirability biasSubject to desirability biasSubject to desirability bias Ease of UseEasy to implement. May require an additional contact with the patient after prescriptionEasy to implement at point of careAdds burden to the patientEasy to implement at point of careElectronic monitoring Granularity/Precision†Granularity: the sampling rate at which it is possible to assess changes in the dynamic process of adherence (particularly relevant to objective measures); Precision: degree of reproducibility, that is, ability to measure the same value repeatedly (particularly relevant to patient reports).Granularity in minutesGranularity in minutesGranularity in minutes Validity‡Degree of potential systematic error in the measurement, that is, difference between the estimated and real value.High (if first device use is followed by inhalation)High (especially if inhaler technique is also assessed)High (if medication is only used with the device) Ease of UseEasy to implement in clinical trialsIn medical practice, can be used as a good start program but requires activation and patient engagementEasy to implement in clinical trialsIn medical practice, can be used at specific time of care (when a problem is suspected, at treatment failure, or to support a behavioral intervention, etc.) for a defined period of timeEasy to implement in clinical trialsNot feasible for long-term treatments in large-scale populations—limited use due to complexity, costs, patient burden, limited availability, and fatigueEHR, Electronic health records.∗ Electronic Health Records, e.g. prescription (prescribing and/or dispensing) data, and health insurance (or ‘claims’) data.† Granularity: the sampling rate at which it is possible to assess changes in the dynamic process of adherence (particularly relevant to objective measures); Precision: degree of reproducibility, that is, ability to measure the same value repeatedly (particularly relevant to patient reports).‡ Degree of potential systematic error in the measurement, that is, difference between the estimated and real value. Open table in a new tab EHR, Electronic health records. Patient reports, that is, directly asking patients whether they started their prescribed treatment, provide a subjective means of assessing medication initiation. If answered truthfully, they are a direct method of assessing initiation and for capturing potential insights into the reasons and determinants of noninitiation. As with all patient reports, initiation reports will be limited by the reliability of patient responses and informed by the specificity and appropriateness of the questions asked; careful design of assessment timing and tools can optimize the accuracy of the reports. Electronic monitors provide an objective means by which the date of first treatment administration can be captured. Electronic monitors are the gold standard for precisely recording first treatment administration in clinical trials. In medical practice, after a prescription, the patient has to acquire the medication first and only then the electronic monitor can be activated, limiting its ability to fully capture treatment initiation in real life. In routine care, treatment initiation can be affected by a range of demographic, psychological, and practical factors, among them: denial or uncertainty of diagnosis20Barr R.G. Celli B.R. Martinez F.J. Ries A.L. Rennard S.I. Reilly Jr., J.J. et al.Physician and patient perceptions in COPD: the COPD Resource Network Needs Assessment Survey.Am J Med. 2005; 118: 1415Abstract Full Text Full Text PDF PubMed Scopus (132) Google Scholar; lack of trust in health care professionals; medication fears; health literacy; affordability and access to therapy, age, ethnicity and sex.21Restrepo R.D. Alvarez M.T. Wittnebel L.D. Sorenson H. Wettstein R. Vines D.L. et al.Medication adherence issues in patients treated for COPD.Int J Chron Obstruct Pulmon Dis. 2008; 3: 371-384Crossref PubMed Google Scholar, 22Cole S. Seale C. Griffiths C. ‘The blue one takes a battering’: why do young adults with asthma overuse bronchodilator inhalers? A qualitative study.BMJ Open. 2013; 3: e002247Google Scholar In one study designed to evaluate determinants of initiation of asthma controller medication, for example, a higher probability of noninitiation was recorded in younger patients, female patients, those of African American ethnicity (vs white), and in those who had with fewer short-acting β2-agonist refills in the preceding year.22Cole S. Seale C. Griffiths C. ‘The blue one takes a battering’: why do young adults with asthma overuse bronchodilator inhalers? A qualitative study.BMJ Open. 2013; 3: e002247Google Scholar In addition, in the context of both asthma and COPD, the inhaled mode of therapy delivery can present an additional obstacle, particularly in certain age and cultural groups owing to substantial stigma around the use of medication inhalers. Research is needed to determine the extent to which stigma may prevent initiation and (if collected and administered once) subsequent implementation and persistence.22Cole S. Seale C. Griffiths C. ‘The blue one takes a battering’: why do young adults with asthma overuse bronchodilator inhalers? A qualitative study.BMJ Open. 2013; 3: e002247Google Scholar, 23Price D. David-Wang A. Ho J.C.-M. Jeong J.W. Liam C.K. Lin J. et al.REALISE Asia Working GroupTime for a new language for asthma control: results from REALISE Asia.J Asthma Allergy. 2015; 8: 93-103PubMed Google Scholar The limited evidence available on treatment initiation suggests that a substantial proportion of patients with chronic disease fail to implement chronic disease therapies and highlights the need for a greater focus on treatment initiation research in asthma and COPD. Interest in implementation originally stems from RCTs, where accurate estimates of drug exposure are essential for the evaluation of drug efficacy and safety. However, the highly selective inclusion criteria applied to clinical trial populations, coupled with the close monitoring, short duration, and support of correct implementation, end up reducing variation and the representativenes" @default.
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• W2511335722 title "What We Mean When We Talk About Adherence in Respiratory Medicine" @default.
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