Adherence intervention research: What have we learned and what do we do next?

doi:10.1016/S0091-6749(03)01718-4

Journal of Allergy and Clinical Immunology

Volume 112, Issue 3, September 2003, Pages 489-494

https://doi.org/10.1016/S0091-6749(03)01718-4 Get rights and content

Abstract

Although there is general agreement from studies demonstrating that adherence to inhaled corticosteroid therapy is often inadequate to establish consistent control, relatively little concurrence exists in reports of interventions to correct the problem. Half of the studies reviewed found that the experimental intervention did not change adherence, and behavior change reported by patients was often not accompanied by changes in treatment success. Studies used a variety of methods that differed in quality with findings that were often contradictory. Key limitations in many studies included reliance on inadequate adherence measures, inclusion of convenience samples of well-motivated patients, and assessments of intervention outcomes artificially boosted by attrition of least adherent participants. Research is encouraged into innovative interventions that are brief, easily implemented, and can be tailored to individual patients and diverse clinical settings. Of particular importance is inclusion of hard-to-reach patients, including urban and rural poor and the use of valid measures of adherence at intervals sufficient to establish enduring benefit.

Section snippets

Intervention studies have addressed adherence

Numerous research efforts have been directed at improving adherence to asthma treatments. An adherence intervention is one in which a change in behavior is sought to increase adherence with medical or health provider advice.⁷ A literature search for relevant intervention studies was executed using the MEDLINE, CINAHL, PsychInfo, ACP, Central, Coch, Dare, and Ipab databases from 1992 to the present. A total of 205 potential published reports was identified. The source literature population of

Published intervention studies do not seem to provide benefit sufficient to justify the resources they require

Many interventions involved a significant amount of professional time, yet few were very effective. In consideration of the positive selection bias operating in most studies as described in the following, the absence of behavior change resulting in better asthma control in these studies is striking. Reviewing adherence interventions described in 34 citations with patients representing a variety of chronic conditions, including diabetes, rheumatoid arthritis, epilepsy, hypertension, chronic

Self-reports usually exaggerate adherence

Most studies used self-report to measure adherence, largely ignoring sizable literature establishing that patients greatly overreport adherence.6, 26, 27, 28 Seven of the 12 studies using self-reported measurement found improved adherence after the intervention. Absence of improvement was found in 2 of the remaining 4 studies in which adherence was assessed by returned canister weight¹³ or electronic peak flow meter.¹² In 2 studies, electronically recorded peak flow meter use actually decreased

Studies may exclude patients with poor adherence

Studies include only patients who are willing to volunteer. Those patients who are inconsistent users of health care (ie, those who are most in need of an adherence intervention) do not typically enter research studies. Adolescents with diabetes who agree to participate in studies have higher rates of adherence than those who do not.³¹ Thus, from the onset, most of the educational intervention studies are biased by inclusion of relatively motivated and cooperative patients.²⁸ Few studies in

Guidelines for future adherence intervention research

Although many efforts have been directed at creating interventions to enhance treatment adherence and improve disease outcomes, no cost-effective, easily implemented, and disseminated program able to target difficult-to-reach patients has been established. The need for methodologically sound studies of innovative approaches to adherence promotion is evident. As with all clinical trials, such studies should include randomized assignment to treatment, equal treatment across groups aside from the

Create new strategies for improving adherence

Creating new strategies for improving adherence must start with efforts to identify root causes of undertreatment, particularly in minority populations. Recent surveys have established that medication adherence is particularly problematic among low-income and minority patients with asthma.27, 36, 37 African-American patients might not trust their health care provider or the medications they prescribe. Qualitative research such as focus groups allows the investigator into the personal world of

Adopt strong research methods

This review has established that adherence-intervention research must move away from studies that include only convenience samples of motivated patients and target those whose adherence is often most discrepant with guidelines and for whom the consequences of nonadherence might be most damaging. Studies that target hard-to-reach patient populations, such as the urban and rural poor, might ultimately bring the greatest benefit by improving attempts to reverse trends of increased morbidity and

References (46)

R Beasley
The burden of asthma with specific reference to the United States
J Allergy Clin Immunol
(2002)
RC Strunk et al.
Reducing disparities in asthma care: priorities for research National Heart, Lung, and Blood Institute workshop report
J Allergy Clin Immunol
(2002)
H Milgrom et al.
Noncompliance and treatment failure in children with asthma
J Allergy Clin Immunol
(1996)
H Kotses et al.
A self-management program for adult asthma. Part I: Development and evaluation
J Allergy Clin Immunol
(1995)
SM van Es
An intervention programme using the ASE-model aimed at enhancing adherence in adolescents with asthma
Patient Educ Couns
(2001)
ML Levy et al.
A randomized controlled evaluation of specialist nurse education following accident and emergency department attendance for acute asthma
Respir Med
(2000)
A López-Vina et al.
Influence of peak expiratory flow monitoring on an asthma self-management education programme
Respir Med
(2000)
S Wilson et al.
A controlled trial of an environmental tobacco smoke reduction intervention in low-income children with asthma
Chest
(2001)
B Bender et al.
Measurement of children's asthma medication adherence by self report, mother report, canister weight, and Doser CT
Ann Allergy Asthma Immunol
(2000)
JL Probstfield et al.
Successful program for recovery of dropouts to a clinical trial
Am J Med
(1986)

IH Zuckerman et al.

Adherence to asthma treatment guidelines among children in the Maryland Medicaid program

Curr Therap Res

(2000)

SM Julius et al.

Accuracy of three electronic monitors for metered-dose inhalers

Chest

(2002)

DM Mannino et al.

Surveillance for asthma United States, 1980-1999

MMWR

(2002)

TL Creer et al.

CS Rand et al.

Metered-dose inhaler adherence in a clinical trial

Am Rev Respir Dis

(1992)

RB Haynes et al.

Interventions for helping patients to follow prescriptions for medications

The Cochrane Database of Systematic Reviews

(2002)

SA Diamond et al.

The impact of a nationally coordinated pharmacy-based asthma education intervention

Can Respir J

(2001)

M Weinberger et al.

Effectiveness of pharmacist care for patients with reactive airways disease: A randomized controlled trial

JAMA

(2002)

S Guendelman et al.

Improving asthma outcomes and self-management behaviors of inner-city children

Arch Pediatr Adolesc Med

(2002)

WC Bailey et al.

Asthma self-management: Do patient education programs always have an impact?

Arch Intern Med

(1999)

PV Burkhart et al.

Children's adherence to recommended asthma self-management

Pediatr Nurs

(2002)

J Coté et al.

Influence on asthma morbidity of asthma education programs based on self-management plans following treatment optimization

Am J Respir Crit Care Med

(1997)

Cited by (134)

The time to PREPARE is over; the time to improve diversity in asthma studies is now
2022, Journal of Allergy and Clinical Immunology
A systematic review of interventions to enhance adherence and persistence with ADHD pharmacotherapy
2022, Journal of Psychiatric Research
Citation Excerpt :
Two RCTs had large drop-out rates (So et al., 2008; Weisman et al., 2018) - study drop-outs are often less adherent than those who remain. Hence, exclusion of these patients increases positive selection bias as the overall adherence of the intervention group is artificially enhanced (Bender et al., 2003). In our review, there is a general lack of consistency in the measurement of adherence and persistence to pharmacotherapy, as well as in the definitions used – this challenge has been documented by other researchers (Gajria et al., 2014; Aoki et al., 2021) and makes it difficult to compare the effectiveness of individual interventions.
Although high rates of poor adherence/persistence have been documented in ADHD, there is limited research targeting the problem. This systematic review evaluated interventions to address poor adherence/persistence to ADHD pharmacotherapy, with the aim of guiding the development of future interventions. An extensive search was conducted from January 1980 until January 2021. Thirteen studies were identified involving interventions based on psychoeducation, behavioural therapy, combined psychoeducation/behavioural therapy, technology-based interventions, written informed consent and a nursing support line. All 13 studies (including five RCTs) reported improvement in adherence/persistence and five studies (including four RCTs) also reported improvement in ADHD symptomatology. Almost all studies involved interventions utilising some form of education. Three RCTs of psychoeducation alone were included, with two of the three studies reporting adherence benefits at three and 12 months respectively. The third RCT was terminated early due to poor recruitment. A behavioural intervention RCT reported improved adherence six months post intervention (but not at 12 months), although a substantial drop-out rate was observed. A final included RCT used a Smartphone Application and reported a short term increase in adherence. The authors of the studies in this review make salient attempts at improving adherence and provide insight for future intervention development. We believe future interventions should involve combinations of strategies, have a theoretical framework and target the most common reasons for non-adherence. Interventions should also be integratable into routine care and include patient input to maximise sustainability.
Severe adult asthma and treatment adherence: Results of the FASE-CPHG study
2021, Revue des Maladies Respiratoires
L’objectif de cette étude est d’évaluer l’observance aux traitements et ses déterminants dans une population d’asthmatiques sévères.
Le collège des pneumologues des hôpitaux généraux a réalisé une vaste étude observationnelle, prospective, transversale et multicentrique sur 1502 patients adultes asthmatiques sévères.
Le nombre moyen de traitements de fond était de 2,5 ± 1,1. L’observance évaluée par auto-questionnaire chez 1289 patients était de 64,8 %, concordant avec l’impression du pneumologue traitant (p < 0,0001). Le contrôle de l’asthme selon GINA était meilleur chez les patients observants (p < 0,01). En analyse univariée, les patients exacerbateurs fréquents (p = 0,02), avec polypose naso-sinusienne (p = 0,01), traités par anticholinergique (p < 0,01), biothérapie anti-IgE (p < 0,0001) ou corticothérapie orale (p < 0,01) étaient plus observants. Les moins observants étaient plus jeunes (p < 0,0001), fumeurs actifs (p < 0,001), avaient une plus courte ancienneté de la maladie (p < 0,0001) et un moindre nombre de traitements de fond (2,2 ± 1 vs 2,6 ± 1, p < 0,0001). En analyse multivariée, seuls ressortaient l’âge, la durée de la maladie et la présence d’un anti-IgE.
Dans cette large étude, 64,8 % des patients asthmatiques sévères étaient observants et semblaient être associés à un meilleur contrôle selon les critères définis dans notre étude. L’observance est meilleure chez les patients plus âgés, de longue durée d’évolution de l’asthme ou recevant une biothérapie par anti-IgE.
Data on severe asthma in France are scarce. The aim of this study was to evaluate adherence to asthma treatments and its determinants in a population of severe asthmatics.
From May 2016 to June 2017, the French Collège des Pneumologues des Hôpitaux Généraux organized a large-scale prospective, cross-sectional, multicenter study on this topic; 1502 patients with severe asthma were included.
The average number of substantive treatments was 2.5 ± 1.1. Assessed by self-questionnaire in 1289 patients, overall adherence was 64.8%, in good agreement with the findings of the pneumologist in charge (p < 0.0001). Control of asthma according to the GINA criteria was more successful in compliant patients (p < 0.01). In univariate analysis, the most compliant participants were frequent exacerbator patients (p = 0.02), those with nasal polyposis (p = 0.01) and those receiving an anticholinergic agent (p < 0.01), anti-IgE biotherapy (p < 0.0001) or oral corticosteroids (p < 0.01). The least compliant participants were younger (p < 0.0001), active smokers (p < 0.001), with shorter average disease duration (24.2 ± 15.7 vs 29.1 ± 18.7 years, p < 0.0001) and a lower number of substantive asthma treatments (2.2 ± 1 vs 2.6 ± 1, p < 0.0001). In multivariate analysis, age, length of disease and anti-IgE treatment were the only factors affecting therapeutic compliance.
In this large-scale study of severe asthmatic patients, 64.8% were compliant according to the MMAS-4© self-administered questionnaire and appeared to be better monitored according to the criteria defined in our study. Overall, adherence was more satisfactory among older patients and those whose disease had been evolving over a long period of time or were receiving anti-IgE biotherapy.
Design, methods, and baseline characteristics of a pilot, randomized, controlled trial of the effects of an electronic monitoring device on medication adherence in children with asthma
2021, Contemporary Clinical Trials Communications
Current methods of assessing adherence are inaccurate. Electronic monitoring devices (EMDs) may more accurately assess adherence, but are not currently used in practice. The design, methods, and participant baseline characteristics are described for a pilot trial of the effects of an EMD on asthma medication adherence in a pediatric population.
This was a pilot, randomized, controlled trial of children with persistent asthma managed with daily inhaled corticosteroids (ICS). Seventy-five children were randomized 2:1 to receive either two EMDs (one for ICS and one for rescue) linked via Bluetooth to a mobile application (app) or standard of care (controls). EMDs recorded dates and times of inhaler actuations and the app sent daily medication reminders to participants. Controls were provided standard care. Medication adherence was measured using pharmacy refill records and self-report, whereas EMD data were used to measure adherence in the intervention group. Secondary outcomes included asthma control, pulmonary function, and quality of life.
One hundred sixty children were screened for eligibility, with 123 individuals excluded. Seventy-five children were enrolled, with 25 allocated to the control group and 50 to the intervention. The mean age of participants is 12 years old (±2.9), with equal proportions of male and female children; 45% are Latinx and 19% African-American; 77% report Medicaid or CHIP coverage. Half of participants have moderate persistent asthma and 48% had marginally controlled asthma at time of enrollment. There were no significant inter-group differences in baseline sociodemographic characteristics.
This pilot successfully reached target populations and met recruitment and enrollment goals. It is addressing an important knowledge gap by evaluating the effects of an EMD with a mobile app on adherence rates, findings which could prove useful in determining whether routine use of EMDs in clinical practice help children achieve better asthma control and outcomes.
NCT03734861.
A Systematic Review of Patient- and Family-Level Inhaled Corticosteroid Adherence Interventions in Black/African Americans
2019, Journal of Allergy and Clinical Immunology: In Practice
Citation Excerpt :
Future asthma medication adherence interventions in adult black/African Americans can also be informed by effective adherence interventions in predominately non–black/African-American populations and studies conducted in adult race/ethnic minorities with various medical conditions. Previous systematic reviews of general medication adherence interventions, evaluated in predominately non–black/African-American populations, report that behavior change theory, multiple intervention components, or interventions with education, self-management, or shared decision-making components are most often found in effective general medication adherence interventions.14,15,17,18,47 To our knowledge, there are no reviews on adherence interventions with a stratified analysis by race/ethnicity or reviews that have explored intervention components associated with differential adherence outcomes by race/ethnicity.
Inhaled corticosteroid (ICS) adherence rates are suboptimal among adult black/African Americans. Comprehensive studies characterizing the effectiveness and the methodological approaches to the development of interventions to improve ICS adherence in adult black/African Americans have not been performed.
Conduct a systematic review of patient/family-level interventions to improve ICS adherence in adult black/African Americans.
We searched MEDLINE, EMBASE, Web of Science, and CINAHL from inception to August 2017 for English-language US studies enrolling at least 30% black/African Americans comparing patient/family-level ICS adherence interventions with any comparator. Two investigators independently selected, extracted data from, and rated risk of bias. We collected information on intervention characteristics and outcomes, and assessed whether studies were informed by behavior theory, stakeholder engagement, or both.
Among 1661 abstracts identified, we reviewed 230 full-text articles and identified 4 randomized controlled trials (RCTs) and 1 quasi-experimental (pre-post design) study meeting criteria. Study participants (N range, 17-333) varied in mean age (22-47 years), proportion black/African Americans studied (71%-93%), and sex (69%-82% females). RCTs evaluated problem-solving classes, self-efficacy training, technology-based motivational interviewing program, and the use of patient advocates. The RCT testing self-efficacy training was the only intervention informed by both behavior theory and stakeholder engagement. All 4 RCTs compared interventions with active control and rated as medium risk of bias. No RCTs found a statistically significant improvement in adherence.
Few studies assessing asthma adherence interventions focused on adult black/African-American populations. No RCTs demonstrated improved ICS adherence in participants. Future studies that are informed by behavior change theory and stakeholder engagement are needed.
High prevalence of severe asthma in a large random population study
2018, Journal of Allergy and Clinical Immunology
Citation Excerpt :
It is complicated to objectively estimate the level of adherence to treatment in epidemiology, partly because of the lack of standardized methods to measure adherence but also because each method has limitations.55,56 However, previous data from our cohort19 and other studies18,57-59 suggest that subjects with more severe disease report greater use of medications, although a subgroup reports that they are not taking any medication on a regular basis. Overall, however, we should assume that the increased level of severity is not likely to depend simply on undertreatment.
The prevalence of asthma severity is not well described at a population level.
We sought to determine the prevalence of phenotypic signs of asthma severity among asthmatic patients in a general population and to describe risk factors for asthma severity.
We performed an epidemiologic study conducted between 2008 and 2012 (West Sweden Asthma Study). A postal questionnaire was sent to a random population (n = 30,000) in west Sweden, with 18,087 responses. A total of 2,006 subjects were carefully phenotyped. Only subjects with “active asthma” (symptoms or medication in the last year, n = 744) were analyzed in this study to determine the degree of severity of the disease within an asthma cohort. Phenotypes of severity were calculated based on (1) multiple symptoms during the day despite ongoing use of asthma medications, (2) FEV₁ of less than 70% of predicted value, (3) daily or almost daily use of rescue medications, (4) nighttime symptoms once a week or more, and (5) oral corticosteroid use/emergency department visits. Asthmatic patients were grouped as having nonsevere disease, 1 sign of severity, or 2 or more signs of severity.
A total of 36.2% of asthmatic patients expressed at least 1 sign of asthma severity, and 13.2% had 2 or more signs. The group with 2 or more signs was older in age and had higher body mass index, a higher rate of tobacco smoking, and lower lung function. Bronchial hyperreactivity, airway inflammation, and sensitization were significantly different among the 3 groups. At a population level, the prevalence of asthma severity was 3.1% for 1 sign and 1.3% for at least 2 signs.
More than 1 in 3 asthmatic patients show at least 1 sign of asthma severity. The phenotypes of asthma severity are highly diverse, which is important to consider when implementing personalized medicine in asthmatic patients.

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Reviews and Feature ArticlesAdherence intervention research: What have we learned and what do we do next?

Abstract

Section snippets

Intervention studies have addressed adherence

Published intervention studies do not seem to provide benefit sufficient to justify the resources they require

Self-reports usually exaggerate adherence

Studies may exclude patients with poor adherence

Guidelines for future adherence intervention research

Create new strategies for improving adherence

Adopt strong research methods

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

Patient Educ Couns

Respir Med

Respir Med

Chest

Ann Allergy Asthma Immunol

Am J Med

Curr Therap Res

Chest

Surveillance for asthma United States, 1980-1999

MMWR

Metered-dose inhaler adherence in a clinical trial

Am Rev Respir Dis

Interventions for helping patients to follow prescriptions for medications

The Cochrane Database of Systematic Reviews

The impact of a nationally coordinated pharmacy-based asthma education intervention

Can Respir J

Effectiveness of pharmacist care for patients with reactive airways disease: A randomized controlled trial

JAMA

Improving asthma outcomes and self-management behaviors of inner-city children

Arch Pediatr Adolesc Med

Asthma self-management: Do patient education programs always have an impact?

Arch Intern Med

Children's adherence to recommended asthma self-management

Pediatr Nurs

Influence on asthma morbidity of asthma education programs based on self-management plans following treatment optimization

Am J Respir Crit Care Med

Reviews and Feature Articles
Adherence intervention research: What have we learned and what do we do next?