Susan L. Janson

Individualized asthma self-management improves medication adherence and markers of asthma control.

BACKGROUND Adherence to inhaled anti-inflammatory therapy and self-management skills are essential parts of the asthma treatment plan to improve asthma control and prevent exacerbations. Whether self-management education improves long-term medication adherence is less clear. OBJECTIVE A 24-week prospective, randomized controlled trial was performed to study the effect of self-management education on long-term adherence to inhaled corticosteroid (ICS) therapy and markers of asthma control. METHODS After stabilization on ICS medication during a run-in phase, 95 adults with moderate-to-severe asthma were recruited from a large metropolitan community, and 84 were randomized to individualized self-management education, including self-monitoring of symptoms and peak flow or usual care with self-monitoring alone. The key components of the 30-minute intervention were asthma information, assessment, and correction of inhaler technique; an individualized action plan based on self-monitoring data; and environmental control strategies for relevant allergen and irritant exposures. The intervention was personalized based on pulmonary function, allergen skin test reactivity, and inhaler technique and reinforced at 2-week intervals. RESULTS Participants randomized to the self-management intervention maintained consistently higher ICS adherence levels and showed a 9-fold greater odds of more than 60% adherence to the prescribed dose compared with control subjects at the end of the intervention (P = .02) and maintained a 3-fold greater odds of higher than 60% adherence at the end of the study. Perceived control of asthma improved (P = .006), nighttime awakenings decreased (P = .03), and inhaled beta-agonist use decreased (P = .01) in intervention participants compared with control subjects. CONCLUSION Our results show that individualized asthma self-management education attenuates the usual decrease in medication adherence and improves clinical markers of asthma control.

Attrition and retention of ethnically diverse subjects in a multicenter randomized controlled research trial.

Recruitment and retention of subjects is critically important for the conduct of randomized clinical trials. When significant effort is given toward recruiting members of ethnic minorities in a sample, a similar rate of retention for all subgroups of subjects is essential. Little is known about why research subjects withdraw consent to participate in research and whether attrition is influenced by ethnicity or other factors. The purpose of this study was to determine the reasons for withdrawal from a large, multicenter randomized trial and whether these reasons differed among ethnic and gender subgroups. Additionally, we were interested in comparing withdrawn subjects to matched subjects who stayed in the trial to determine what factors encouraged full study completion. Using a cohort survey design, adult subjects (n = 35) who withdrew from a large, multicenter randomized trial and matched subjects who completed the study (n = 35) were interviewed by telephone after study completion. Subjects who withdrew consent tended to be female and members of ethnic minorities. The most frequent problems-reported significantly more often by subjects who withdrew consent compared to matched retained subjects-were interference with work, lack of time, complicated and cumbersome record-keeping requirements, difficult study medicine regimens, and difficulty rescheduling appointments due to lack of flexibility on the part of study personnel. Only 17% of withdrawn subjects were satisfied with the overall research experience compared to 52% of matched retained subjects. Matched subjects who completed all required visits in the randomized controlled trial reported three reasons that promoted completion: remuneration, commitment to finish, and belief that the study was important.

Clinical Differences Among Women with and Without Self-Reported Perimenstrual Asthma

BACKGROUND Studies suggesting that 30% to 40% of asthmatic women report significant perimenstrual (late luteal phase) exacerbations of asthma are primarily retrospective, rely on subjective findings and do not demonstrate a consistent association between asthma and the menstrual cycle. OBJECTIVE In this exploratory analysis, women with and without self-reported perimenstrual exacerbations of asthma (PMA) were examined prospectively to determine the association between asthma and the menstrual cycle and to characterize associated clinical factors. METHODS Thirty-two adult asthmatic women with regular menstrual periods recorded daily asthma symptoms, medication use, and peak expiratory flow rate (PEFR) over six consecutive menstrual cycles, and underwent spirometry and methacholine bronchoprovocation during the luteal and follicular phases of 2 cycles. RESULTS Nine of 32 subjects (28.2%) reported PMA. Daily means of rescue medication use and AM peak flow computed for each perimenstrual day demonstrated significant non-parallelism of group profiles; subjects with PMA had increasing inhaled short acting beta 2-agonist use and decreasing AM peak flow rates during the perimenstrual interval. Luteal-follicular phase differences in FEV1 or methacholine bronchoprovocation between the groups were not detected. Subjects with PMA were older (P=.007), had longer duration of asthma (P=.039), and increased baseline asthma severity (P=.076) compared with subjects without PMA. CONCLUSION The findings of this study suggest that women with self-reported perimenstrual asthma demonstrate perimenstrual differences in rescue bronchodilator use and AM peak flow and appear to constitute a distinct subset of women with asthma who are older, have longer duration of asthma, and increased severity of asthma compared with women without self-reported perimenstrual asthma. These factors identify women who require close monitoring of their asthma during their menstrual cycles.

Impact of the home indoor environment on adult asthma and rhinitis

Objective: We sought to study the combined effects of multiple home indoor environmental exposures in adult asthma and rhinitis. Methods: We studied 226 adults with asthma and rhinitis by structured interviews and home assessments. Environmental factors included dust allergen, endotoxin and glucan concentrations, and indoor air quality (IAQ) variables. Outcomes included forced expiratory volume in 1 second (FEV1) percent predicted, Severity of Asthma Score (SAS), Short-Form (SF)-12 Physical Component Scale (PCS), and asthma Quality of Life (QOL) score. Results: House dust-associated exposures together with limited IAQ variables were related to FEV1 % predicted (R2 = 0.24; P = 0.0001) and SAS (R2 = 0.18; P = 0.007). IAQ and limited dust variables were associated with SF-12 PCS (R2 = 0.15; P = 0.02), but not QOL (R2 = 0.13; P = 0.16). Conclusions: The home environment is strongly linked to lung function, health status, and disease severity in adult asthma and rhinitis.

Barriers to Patient-Clinician Collaboration in Asthma Management: The Patient Experience

Objective. To describe what adult patients with asthma report about their experiences with their own self-management behavior and working with their clinicians to control asthma. Methods. The study sample consisted of 104 patients with persistent asthma participating in a clinical trial on asthma monitoring. All subjects were seen by primary care clinicians of a large, academic medical center. This qualitative post hoc analysis examined the views of adults with asthma about their asthma-related health care. Patients attended monthly visits as part of their study participation, during which data were derived from semistructured interviews. All patients included in this analysis participated in the study for 1 year. At the end of study participation, patients were asked to complete an evaluation of their clinicians communication behavior. All study clinicians were also asked to complete a self-evaluation of their own communication behavior. Results. Five major themes of barriers to successful self-management were identified, including personal constraints, social constraints, communication failures, medication issues, and health care system barriers to collaboration with their clinicians. Patients most frequently reported lack of communication surrounding issues relating to day-to-day management of asthma (31%) and home management of asthma (24%). Clinicians generally rated themselves well for consistency in showing nonverbal attentiveness (89%) and maintaining interactive conversations (93%). However, only 30% of clinicians reported consistency in helping patients make decisions about asthma management and only 33% of clinicians reported consistency in tailoring medication schedules to the patients routines. Conclusion. These findings emphasize the difficulties of establishing and maintaining a therapeutic partnership between patients and clinicians. The results underscore the need for system-wide interventions that promote the success of a therapeutic patient-clinician relationship in order to achieve long-term success in chronic disease management.

Predictors of Asthma Medication Nonadherence

BACKGROUND The purpose of this study was to describe asthma medication adherence behavior and to identify predictors of inhaled corticosteroid (ICS) underuse and inhaled beta-agonist (IBA) overuse. METHODS Self-reported medication adherence, spirometry, various measures of status, and blood for immunoglobulin E measurement were collected on 158 subjects from a larger cohort of adults with asthma and rhinitis who were prescribed an ICS, an IBA, or both. RESULTS There was a positive association between ICS underuse and higher forced expiratory volume in one second percent (FEV1%) predicted (P = .01) and a negative association with lower income (P = 0.04). IBA overuse was positively associated with greater perceived severity of asthma (P = 0.004) and negatively with higher education level (P = 0.02). CONCLUSIONS Nonadherence to prescribed asthma therapy seems to be influenced by socioeconomic factors and by perceived and actual severity of disease. These factors are important to assess when trying to estimate the degree of medication adherence and its relationship to clinical presentation.

Impact of exogenous glucocorticoid use on salivary cortisol measurements among adults with asthma and rhinitis.

The diurnal rhythm of cortisol secretion in chronic disease can reflect the interactions between exogenous and endogenous factors. Exogenous glucocorticoid use may impact salivary cortisol measurements, but this has not been well-studied in ambulatory settings. In this report salivary cortisol levels were used to evaluate aspects of the diurnal rhythm of cortisol secretion within an ambulatory population of patients with asthma and allergic rhinitis. 183 persons with asthma with or without concomitant rhinitis and 34 persons with rhinitis alone were asked to collect at home, two saliva samples, 30 min after awakening and 12h later. The salivary cortisol levels were quantified by enzyme immunoassay. The recent use of glucocorticoids in the study group was determined by interview and direct examination of medications. We report that the median salivary cortisol levels 30 min post-awakening significantly differed by exogenous steroid status: no glucocorticoid use (n = 91), 10.1 nmol/l; nasal gluco-corticoid use alone (n = 25), 11.4 nmol/l; inhaled glucocorticoids (with or without concomitant nasal glucocorticoids; n = 76), 9.0 nmol/l; systemic glucocorticoids (n = 17), 4.0 nmol/l; (P = 0.02). 12-h post-awakening salivary cortisol values among the groups were similar (P = 0.85). The median 30-min post-awakening cortisol differed significantly by type and amount of inhaled steroid used: non-fluticasone users (n = 21), 11.5 nmol/l; lower dose fluticasone (<800 microg per day, n = 35); 9.2 nmol/l; and higher dose fluticasone (> or =800 microg, n=20), 5 nmol/l; (P=0.01). We conclude that in an ambulatory setting, exogenous glucocorticoid use can decrease the 30 min post-awakening but not the 12-h post-awakening salivary cortisol levels, an effect that should be taken into account in assessing the effects of other potential determinants on cortisol secretion.

Improving Chronic Care of Type 2 Diabetes Using Teams of Interprofessional Learners

Purpose To improve the care and outcomes of adult patients with type 2 diabetes by teaching interprofessional teams of learners the principles and practices of the Improving Chronic Illness Care Model. Method The study population consisted of 384 adult patients with type 2 diabetes. The study design was a nonrandomized, parallel-group, clinical trial conducted during 18 months in the University of California, San Francisco internal medicine clinics. Interprofessional team care provided by primary care internal medicine residents, nurse practitioner students, and pharmacy students was compared with usual care by internal medicine residents only. Processes of care, clinical status, and health utilization were measured in both patient groups. Learner outcomes also were assessed and compared. Results At study completion, intervention patients more frequently received assessments of glycosolated hemoglobin (79% versus 67%; P = .01), LDL-C (69% versus 55%; P = .009), blood pressure (86% versus 79%; P = .08), microalbuminuria (40% versus 30%; P = .05), smoking status assessment (43% versus 31%; P = .02), and foot exams (38% versus 20%; P = .0005). Intervention patients had more planned general medicine visits (7.9 ± 6.2 versus 6.2 ± 5.7; P = .006) than did control patients. Interprofessional learners rated themselves significantly higher on measures of accomplishment, preparation, and success for chronic care than did the usual care learners. Conclusions Interprofessional team care by learners was effective in improving quality of care for adult patients with diabetes treated in general medicine clinics. The chronic illness framework resulted in more appropriate health care utilization.

Effect of culturally tailored diabetes education in ethnic minorities with type 2 diabetes: a meta-analysis.

Background:Diabetes is a major cause of cardiovascular morbidity and mortality. Ethnic minorities experience a disproportionate burden of diabetes; however, few studies have critically analyzed the effectiveness of a culturally tailored diabetes intervention for these minorities. Objective:The aim of this study was to evaluate the effectiveness of a culturally tailored diabetes educational intervention (CTDEI) on glycemic control in ethnic minorities with type 2 diabetes. Method:We searched databases within PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Education Resources Information Center (ERIC), PsycINFO, and ProQuest for randomized controlled trials (RCTs). We performed a meta-analysis for the effect of diabetes educational intervention on glycemic control using glycosylated hemoglobin (HbA1c) value in ethnic minority groups with type 2 diabetes. We calculated the effect size (ES) with HbA1c change from baseline to follow-up between control and treatment groups. Results:The 12 studies yielded 1495 participants with a mean age of 63.6 years and a mean of 68% female participants. Most studies (84%) used either group education sessions or a combination of group sessions and individual patient counseling. The duration of interventions ranged from 1 session to 12 months. The pooled ES of glycemic control in RCTs with CTDEI was −0.29 (95% confidence interval, −0.46 to −0.13) at last follow-up, indicating that ethnic minorities benefit more from CTDEI when compared with the usual care. The effect of intervention was greatest and significant when HbA1c level was measured at 6 months (ES, −0.41; 95% confidence interval, −0.61 to −0.21). The ES also differed by each participant’s baseline HbA1c level, with lower baseline levels associated with higher ESs. Conclusions:Based on this meta-analysis, CTDEI is effective for improving glycemic control among ethnic minorities. The magnitude of effect varies based on the settings of intervention, baseline HbA1c level, and time of HbA1c measurement. More rigorous RCTs that examine tailored diabetes education, ethnically matched educators, and more diverse ethnic minority groups are needed to reduce health disparities in diabetes care.

Summary of NIH Medical-Surgical Emergency Research Roundtable Held on April 30 to May 1, 2009

STUDY OBJECTIVE In 2003, the Institute of Medicine Committee on the Future of Emergency Care in the United States Health System convened and identified a crisis in emergency care in the United States, including a need to enhance the research base for emergency care. As a result, the National Institutes of Health (NIH) formed an NIH Task Force on Research in Emergency Medicine to enhance NIH support for emergency care research. Members of the NIH Task Force and academic leaders in emergency care participated in 3 roundtable discussions to prioritize current opportunities for enhancing and conducting emergency care research. The objectives of these discussions were to identify key research questions essential to advancing the scientific underpinnings of emergency care and to discuss the barriers and best means to advance research by exploring the role of research networks and collaboration between the NIH and the emergency care community. METHODS The Medical-Surgical Research Roundtable was convened on April 30 to May 1, 2009. Before the roundtable, the emergency care domains to be discussed were selected and experts in each of the fields were invited to participate in the roundtable. Domain experts were asked to identify research priorities and challenges and separate them into mechanistic, translational, and clinical categories. After the conference, the lists were circulated among the participants and revised to reach a consensus. RESULTS Emergency care research is characterized by focus on the timing, sequence, and time sensitivity of disease processes and treatment effects. Rapidly identifying the phenotype and genotype of patients manifesting a specific disease process and the mechanistic reasons for heterogeneity in outcome are important challenges in emergency care research. Other research priorities include the need to elucidate the timing, sequence, and duration of causal molecular and cellular events involved in time-critical illnesses and injuries, and the development of treatments capable of halting or reversing them; the need for novel animal models; and the need to understand why there are regional differences in outcome for the same disease processes. Important barriers to emergency care research include a limited number of trained investigators and experienced mentors, limited research infrastructure and support, and regulatory hurdles. The science of emergency care may be advanced by facilitating the following: (1) training emergency care investigators with research training programs; (2) developing emergency care clinical research networks; (3) integrating emergency care research into Clinical and Translational Science Awards; (4) developing emergency care-specific initiatives within the existing structure of NIH institutes and centers; (5) involving emergency specialists in grant review and research advisory processes; (6) supporting learn-phase or small, clinical trials; and (7) performing research to address ethical and regulatory issues. CONCLUSION Enhancing the research base supporting the care of medical and surgical emergencies will require progress in specific mechanistic, translational, and clinical domains; effective collaboration of academic investigators across traditional clinical and scientific boundaries; federal support of research in high-priority areas; and overcoming limitations in available infrastructure, research training, and access to patient populations.