Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.

Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy.Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine.Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines.Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1) no RCTs are identified or RCTs are appraised as being of low- or very low-quality (replacement); 2) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded (complementary); or 3) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; "sequential").Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions.

Predicting Young Adult Tobacco, Drug and Alcohol Use Among Participants in the CAMP Trial.

The development of substance abuse in youth with asthma have seldom been examined with longitudinal research. The prospective and well-characterized CAMP cohort provides outcome data on youth with asthma over 13 years. This manuscript seeks to determine the contributions of asthma features and child behavioral/emotional functioning to subsequent tobacco, alcohol, and drug use in early adulthood. Childhood smoking exposures as well as parent report and youth report of substance use were prospectively assessed concurrently with assessments of asthma symptoms, study medication, and lung development. Logistic regression models evaluated predictors of adolescent and young adult tobacco, alcohol, and drug use. Use of tobacco products was reported by 33% of youth with mild/moderate asthma. Tobacco use was significantly associated with self-reported externalizing behaviors. Early life passive smoke exposure, especially in utero exposure, makes a significant contribution to tobacco use (OR1.58). Greater risk for tobacco use is conveyed by self-reported externalizing behaviors, which are consistently robust predictors of any future use of tobacco products, alcohol and drugs. These findings provide evidence for health care providers to use routine behavioral screening in youth with asthma.

Adults With Asthma Experience No Increase in Asthma-related Exacerbations When Digital Communication Technology Tools Are Employed to Offset Provider Workload: A Pragmatic Randomized Trial.

BACKGROUND: Challenges to health care efficiency are increasingly addressed with the help of digital communication technology tools (DCTs). OBJECTIVE: The objective of this study was to test whether DCT, compared with Usual Care, can reduce health care clinician burden without increasing asthma-related exacerbations among patients with asthma in a large integrated health care system. RESEARCH DESIGN: The (Breathewell) program was a pragmatic, randomized trial at (Kaiser Permanente Colorado), where asthma nurses screen patients for poor symptom control when beta2-agonist refill requests came within 60 days of previous fill or in the absence of a controller medication fill within 4 months (beta2-agonist overfill). A total of 14,978 adults with asthma were randomized to Usual Care or 1 of 2 DCT intervention groups (Text/Phone call or Email). SUBJECTS: Participants included adults 18 and older with an asthma diagnosis at the time of randomization and no history of chronic obstructive pulmonary disease. MEASURES: Primary outcome measures included asthma-related health care resource utilization (eg, asthma nurse contacts), medication use, and exacerbations. RESULTS: A total of 1933 patients had 4337 events which met beta2-agonist overfill criteria. Of the 2874 events in the intervention arm, 1188 (41%) were resolved by DCT contact and did not require additional clinician contact. Asthma medication use and exacerbations over 12 months did not differ among the 3 groups. CONCLUSIONS: DCT tools can successfully contact adult asthma patients to screen for symptoms and facilitate intervention. The absence of differences in medication fills and health care utilization indicates that the strategic replacement of nursing interventions by digital outreach did not reduce treatment adherence or compromise health care outcomes.

Digital technologies and adherence in respiratory diseases: the road ahead.

Outcomes for patients with chronic respiratory diseases remain poor despite the development of novel therapies. In part, this reflects the fact that adherence to therapy is low and clinicians lack accurate methods to assess this issue. Digital technologies hold promise to overcome these barriers to care. For example, algorithmic analysis of large amounts of information collected on health status and treatment use, along with other disease relevant information such as environmental data, can be used to help guide personalised interventions that may have a positive health impact, such as establishing habitual and correct inhaler use. Novel approaches to data analysis also offer the possibility of statistical algorithms that are better able to predict exacerbations, thereby creating opportunities for preventive interventions that may adapt therapy as disease activity changes. To realise these possibilities, digital approaches to disease management should be supported by strong evidence, have a solid infrastructure, be designed collaboratively as clinically effective and cost-effective systems, and reflect the needs of patients and healthcare providers. Regulatory standards for digital interventions and strategies to handle the large amounts of data generated are also needed. This review highlights the opportunities provided by digital technologies for managing patients with respiratory diseases.

Integrated behavioral health care for management of stress in allergic diseases.

OBJECTIVE: This article reviews current findings regarding the management of stress in allergic disease. DATA SOURCES: The authors use articles and books published between 1995 and 2017. Approximately 85% of sources used were published in the last 10 years, and 60% were published in the last 5 years. Most of the sources are peer-reviewed articles. STUDY SELECTIONS: Articles that focused on allergic diseases such as allergic rhinitis, food allergies, urticaria, and allergic asthma were included. Articles in which whether the underlying disorder was allergic in nature (for example, nonspecified asthma) were not included. Preference was given to articles published within the past five years. RESULTS: Patients with allergic diseases, particularly those with chronic or co-occurring allergic diseases, often experience stress and, in turn, this experience of stress can exacerbate disease presentation. High rates of treatment nonadherence in patients with allergic disease also can increase disease burden and stress. Research supports the benefit of behavioral health interventions for patients with allergic disease. Interventions with multidisciplinary teams, which include behavioral health, as well as interventions at the school, workplace, and community level, are recommended. CONCLUSION: Medical providers working with patients with allergic disease need to address patients' experience of stress and nonadherence to treatment recommendations. This could be done through routine screening and referrals to behavioral health or, ideally, through incorporation of a behavioral health provider within a multidisciplinary patient team.

Role of behavioral health in management of pediatric atopic dermatitis.

OBJECTIVE: To describe the behavioral components and complications in treating pediatric patients with atopic dermatitis (AD) and the critical role of behavioral health professionals in addressing disease impact and behavioral aspects of disease management for these patients and families. DATA SOURCES: Studies and review articles were selected from medical and psychology databases for relevance to pertinent topics. RESULTS: AD has significant negative effects in affected individuals and their families on quality of life, behavioral, emotional, and sleep disturbances, and family functioning. Effective treatment strategies for AD are available, but the challenges for children and parents in coping with disease-related concerns and in following through with the multiple aspects of treatment are considerable. A biopsychosocial model, which incorporates the interplay among biological, psychological, and social dimensions of medical care, can be implemented in various treatment settings to achieve an integrated medical and behavioral health care approach. By sharing a family orientation, using a stress and coping model, and taking into account children's developmental capabilities and concerns, medical and behavioral health care providers are equipped to bring an in-depth understanding and different evidence-based therapeutic tools to address emotional, behavioral, and interpersonal challenges imposed by moderate to severe AD in children and families. CONCLUSION: Behavioral health and medical providers working together to provide integrated care play a critical role in helping children and families cope with the burdens imposed by AD, successfully manage the disease, and achieve optimal quality of life for affected children and their families.

An Official American Thoracic Society Research Statement: Implementation Science in Pulmonary, Critical Care, and Sleep Medicine.

BACKGROUND: Many advances in health care fail to reach patients. Implementation science is the study of novel approaches to mitigate this evidence-to-practice gap. METHODS: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement on implementation science in pulmonary, critical care, and sleep medicine. The committee used an iterative consensus process to define implementation science and review the use of conceptual frameworks to guide implementation science for the pulmonary, critical care, and sleep community and to explore how professional medical societies such as the ATS can promote implementation science. RESULTS: The committee defined implementation science as the study of the mechanisms by which effective health care interventions are either adopted or not adopted in clinical and community settings. The committee also distinguished implementation science from the act of implementation. Ideally, implementation science should include early and continuous stakeholder involvement and the use of conceptual frameworks (i.e., models to systematize the conduct of studies and standardize the communication of findings). Multiple conceptual frameworks are available, and we suggest the selection of one or more frameworks on the basis of the specific research question and setting. Professional medical societies such as the ATS can have an important role in promoting implementation science. Recommendations for professional societies to consider include: unifying implementation science activities through a single organizational structure, linking front-line clinicians with implementation scientists, seeking collaborations to prioritize and conduct implementation science studies, supporting implementation science projects through funding opportunities, working with research funding bodies to set the research agenda in the field, collaborating with external bodies responsible for health care delivery, disseminating results of implementation science through scientific journals and conferences, and teaching the next generation about implementation science through courses and other media. CONCLUSIONS: Implementation science plays an increasingly important role in health care. Through support of implementation science, the ATS and other professional medical societies can work with other stakeholders to lead this effort.

Future Research Directions in Asthma. An NHLBI Working Group Report.

Asthma is a common chronic disease without cure. Our understanding of asthma onset, pathobiology, classification, and management has evolved substantially over the past decade; however, significant asthma-related morbidity and excess healthcare use and costs persist. To address this important clinical condition, the NHLBI convened a group of extramural investigators for an Asthma Research Strategic Planning workshop on September 18-19, 2014, to accelerate discoveries and their translation to patients. The workshop focused on (1) in utero and early-life origins of asthma, (2) the use of phenotypes and endotypes to classify disease, (3) defining disease modification, (4) disease management, and (5) implementation research. This report summarizes the workshop and produces recommendations to guide future research in asthma.

Motivating patient adherence to allergic rhinitis treatments.

Patient nonadherence significantly burdens the treatment of allergic rhinitis (AR). Fewer than half of prescribed doses of intranasal corticosteroid medication are taken. The challenges for immunotherapies are even greater. While sustained treatment for 3 to 5 years is required for full benefit, most patients receiving immunotherapy, either subcutaneous or sublingual, stop treatment within the first year. Although research into interventions to improve AR adherence is lacking, lessons learned from adherence interventions in other chronic health conditions can be applied to AR. Two well-established, overriding models of care-the chronic care model and patient-centered care-can improve adherence. The patient-centered care model includes important lessons for allergy providers in their daily practice, including understanding and targeting modifiable barriers to adherence. Additionally, recent studies have begun to leverage health information and communication technologies to reach out to patients and promote adherence, extending patient-centered interventions initiated by providers during office visits.

Nonadherence in chronic obstructive pulmonary disease patients: what do we know and what should we do next?

PURPOSE OF REVIEW: Although nonadherence research in patients with chronic obstructive pulmonary disease (COPD) lags well behind other diseases, new evidence helps inform understanding about the degree and underlying causes of patient nonadherence, interventions that can improve adherence, and areas of research needed to further progress in improving this problem in patients with COPD. RECENT FINDINGS: Fewer than half of treatments for COPD, including oxygen supplementation, physical rehabilitation, and medication, are taken as prescribed. Most patients abandon their treatment after an initial start. Nonadherence in turn contributes to rising rates of hospitalization, death, and healthcare costs. The reasons why patients choose not to use their COPD treatments are not fully understood, although depression is clearly a contributing factor. Although a substantial number of studies have tested adherence interventions, few have included COPD patients or addressed polypharmacy in patients with multiple comorbidities. SUMMARY: The paucity of research does not reflect the inadequacy of available treatments. Lessons learned from the research outside of COPD and a small number of COPD studies suggest that a collaborative care approach will likely provide the most potential for improving overall care, including management of depression and enhancement of adherence. Exploitation of mobile telephone technology to engage patients in a discussion of their self-care should not be ignored as a potential intervention for COPD patients.

Adherence to inhaled corticosteroids: an ancillary study of the Childhood Asthma Management Program clinical trial.

BACKGROUND: Information comparing subjective and objective measurements of adherence to study medications and the effects of adherence on treatment-related differences in asthma clinical trials are limited. OBJECTIVE: We sought to compare subjective and objective measurements of children's adherence to inhaled corticosteroids or placebo and to determine whether adherence to study medications modified treatment-related differences in outcomes. METHODS: In an ancillary study conducted in 3 of 8 Childhood Asthma Management Program Clinical Centers, adherence was assessed by using self-reported and objective data in 5- to 12-year-old children with mild or moderate asthma who were randomly assigned to 200 µg of inhaled budesonide twice per day (n = 84) or placebo (n = 56) for 4 years. The κ statistic was used to evaluate agreement between self-reported adherence (daily diary cards) and objectively measured adherence (number of doses left in study inhalers). Multivariable analyses were used to determine whether adherence to study treatment modified treatment-related differences in outcomes. RESULTS: Adherence of less than 80% was seen in 75% of 140 children when adherence was measured objectively but only in 6% of children when measured by means of self-report. There was poor agreement between objective and subjective measurements of adherence of at least 80% (κ = 0.00; 95% CI, -0.05 to 0.04); self-reported adherence over the 4-year period generally overestimated objectively measured adherence (93.6% vs 60.8%, P < .0001). There was little evidence to indicate that adherence modified treatment-related differences in outcomes. CONCLUSION: Researchers should use objective rather than self-reported adherence data to identify clinical trial participants with low levels of adherence to study treatment.

Teleallergy: Where Have We Been and Where Are We Going?

Telemedicine uptake in allergy/immunology was slow before the coronavirus disease 2019 pandemic, but has accelerated since. This review examines where telemedicine has been in allergy/immunology and where it is headed in the future. Focus is placed on patient, physician, and health care professional satisfaction with telemedicine, capacity to expand access to allergy/immunology care, cost considerations, the regulatory environment, and future applications of telemedicine including adherence monitoring, wearable biosensors, artificial intelligence, and machine learning addressed.

Adapting adaptive design methods to accelerate adoption of a digital asthma management intervention.

Investigators conducting translational research in real-world settings may experience changes that create challenges to the successful completion of the trial as well as post-trial adoption and implementation. Adaptive designs support translational research by systematically adapting content and methods to meet the needs of target populations, settings and contexts. This manuscript describes an adaptive implementation research model that provides strategies for changing content, delivery processes, and research methods to correct course when anticipated and unanticipated circumstances occur during a pragmatic trial. The Breathewell Program included two large pragmatic trials of the effectiveness of a digital communication technology intervention to improve symptom management and medication adherence in asthma care. The first trial targeted parents of children with asthma; the second targeted adults with asthma. Adaptations were made iteratively to adjust to dynamic conditions within the healthcare setting, informed by prospectively collected stakeholder input, and were categorized retrospectively by the authors as proactive or reactive. Study outcomes demonstrated improved treatment adherence and clinical efficiency. Kaiser Permanente Colorado, the setting for both studies, adopted the speech recognition intervention into routine care, however, both interventions required numerous adaptations, including changes to target population, intervention content, and internal workflows. Proactive and reactive adaptations assured that both trials were successfully completed. Adaptive research designs will continue to provide an important pathway to move healthcare delivery research into practice while conducting ongoing effectiveness evaluation.

Health care research often moves slowly and consequently important results may take a long time to reach the patients they are intended to help. Implementation studies conducted in routine clinical practice are intended to accelerate the process of delivering new discoveries into settings where they can be more quickly put to use. However, conducting research in real-world settings can be challenging if changes occur in those settings during the course of the study. Therefore, an adaptive implementation approach that allows researchers to make changes during the course of a study can facilitate study completion and improve likelihood of intervention adoption into routine care. This report demonstrates the use of an adaptive implementation model in two large studies of asthma in children and adults. In both studies, communication technology including computerized phone calls, texts, and email helped improve treatment consistency and efficiency.

Recognizing and Tackling Inhaler Technique Decay in Asthma and Chronic Obstructive Pulmonary Disesase (COPD) Clinical Practice.

A poor inhaler technique continues to represent a substantial barrier to effective asthma and chronic obstructive pulmonary disease management. It can result in perceived lack of treatment effectiveness even with apparent adherence to a prescribed regimen of inhaled maintenance therapies, potentially resulting in an unnecessary change or escalation of treatment. Many patients are not trained to inhaler mastery in real-world practice; furthermore, even where mastery is initially achieved, an ongoing assessment and education are seldom maintained. In this review, we present an overview of the evidence for deterioration of the inhaler technique over time after training, investigate the factors that contribute to this deterioration, and explore innovative approaches to addressing the problem. We also propose steps forward drawn from the literature and our clinical insights.

Effect of an Asthma Exacerbation on Medication Adherence.

BACKGROUND: Few studies have looked at the effect of an asthma exacerbation on asthma medication adherence. OBJECTIVE: To measure asthma medication adherence in the 12 months after an asthma exacerbation and the influence of care type (specialist vs primary care provider) as well as social economic status on adherence. METHODS: We measured portion of days covered (PDC) during the 12 months before and after an exacerbation in a cohort of patients with asthma who were aged 18 years and older. Subanalyses looked at PDC in those who had more than one exacerbation after the sentinel exacerbation, by type of care received (primary care, allergist or pulmonologist, or no care) during both periods and by socioeconomic status (SES), defined as the lower quartile of annual income for the group. RESULTS: In a cohort of 1,697 patients, PDC improved significantly (from 0.44 to 0.53; P < .001) after an asthma exacerbation. Improvement in PDC was even greater (from 0.45 to 0.57; P < .001) if they had more than one exacerbation after the sentinel exacerbation. Being seen by a specialist after the exacerbation but not before it, resulted in the greatest improvement in PDC (0.17 mean change). Patients not seen by a specialist either before the exacerbation or after had a mean change of just 0.07. Those with a lower SES had an overall lower PDC before the exacerbation (0.37 vs 0.43) but saw a similar improvement in the PDC compared with those in a higher SES (0.09 vs 0.10). CONCLUSIONS: An asthma exacerbation is associated with a significant and sustained effect on medication adherence.

Transition to Virtual Asthma Care During the COVID-19 Pandemic: An Observational Study.

BACKGROUND: The COVID-19 pandemic increased reliance on virtual care for patients with persistent asthma. OBJECTIVE: This retrospective cohort study assessed changes from in-person to virtual care during the pandemic. In patients with persistent asthma, compared with the same period before the pandemic. METHODS: Kaiser Permanente Colorado members aged 18 to 99 years with persistent asthma were evaluated during two periods (March to October 2019 and March to October 2020). Comparison of asthma exacerbations (hospitalizations, emergency department visits, and courses of oral prednisone) and asthma medication metrics were evaluated between the two periods and by type of care received during the pandemic (no care, virtual care only, in-person care only, or a mix of virtual and in-person care). Population characteristics by type of care received during the pandemic were also evaluated. RESULTS: Among 7,805 adults with persistent asthma, those who used more virtual care or sought no care during the pandemic were younger and had fewer comorbidities, mental health diagnoses, or financial barriers. Exacerbations decreased (0.264 to 0.214; P <.001) as did courses of prednisone (0.213 to 0.169). Asthma medication adherence (0.53 to 0.54; P <.001) and the asthma medication ratio, a quality-of-care metric (0.755 to 0.762; P = .019), increased slightly. Patients receiving a mix of in-person and virtual care had the highest rate of exacerbations (0.83) and a lower asthma medication ratio (0.74) despite having the highest adherence (.57). CONCLUSIONS: Despite an increase in virtual care, asthma exacerbations decreased except among individuals who received both in-person and virtual care, likely because they had more severe disease.