Factors Associated With Non-vaccination for Influenza Among Patients With CKD: Findings From the Chronic Renal Insufficiency Cohort (CRIC) Study.

RATIONALE & OBJECTIVE: Vaccination for influenza is strongly recommended for people with chronic kidney disease (CKD) due to their immunocompromised state. Identifying risk factors for not receiving an influenza vaccine (non-vaccination) could inform strategies for improving vaccine uptake in this high-risk population. STUDY DESIGN: Longitudinal observational study. SETTING & PARTICIPANTS: 3,692 Chronic Renal Insufficiency Cohort Study (CRIC) participants. EXPOSURE: Demographic factors, social determinants of health, clinical conditions, and health behaviors. OUTCOME: Influenza non-vaccination, which was assessed based on a receipt of influenza vaccine ascertained during annual clinic visits in a subset of participants who were under nephrology care. ANALYTICAL APPROACH: Mixed-effects Poisson models to estimate adjusted prevalence ratios (APRs). RESULTS: Between 2009 and 2020, the pooled mean vaccine uptake was 72% (mean age, 66 years; 44% female; 44% Black race). In multivariable models, factors significantly associated with influenza non-vaccination were younger age (APR, 2.16 [95% CI, 1.85-2.52] for<50 vs≥75 years), Black race (APR, 1.58 [95% CI, 1.43-1.75] vs White race), lower education (APR, 1.20 [95% CI, 1.04-1.39 for less than high school vs college graduate]), lower annual household income (APR, 1.26 [95% CI, 1.06-1.49] for <$20,000 vs >$100,000), formerly married status (APR, 1.22 [95% CI, 1.09-1.35] vs currently married), and nonemployed status (APR, 1.13 [95% CI, 1.02-1.24] vs employed). In contrast, participants with diabetes (APR, 0.80 [95% CI, 0.73-0.87] vs no diabetes), chronic obstructive pulmonary disease (COPD) (APR, 0.80 [95% CI, 0.70-0.92] vs no COPD), end-stage kidney disease (APR, 0.64 [0.56 to 0.76] vs estimated glomerular filtration rate≥60mL/min/1.73m2), frailty (APR, 0.86 [95% CI, 0.74-0.99] vs no frailty), and ideal physical activity (APR, 0.90 [95% CI, 0.82-0.99] vs. physically inactive) were less likely to have non-vaccination status. LIMITATIONS: Possible residual confounding. CONCLUSIONS: Among adults with CKD receiving nephrology care, younger adults, Black individuals, and those with adverse social determinants of health were more likely to have the influenza non-vaccination status. Strategies are needed to address these disparities and reduce barriers to vaccination. PLAIN-LANGUAGE SUMMARY: Identifying risk factors for not receiving an influenza vaccine ("non-vaccination") in people living with kidney disease, who are at risk of influenza and its complications, could inform strategies for improving vaccine uptake. In this study, we examined whether demographic factors, social determinants of health, and clinical conditions were linked to the status of not receiving an influenza vaccine among people living with kidney disease and receiving nephrology care. We found that younger adults, Black individuals, and those with adverse social determinants of health were more likely to not receive the influenza vaccine. These findings suggest the need for strategies to address these disparities and reduce barriers to vaccination in people living with kidney disease.

Hydroxyurea to prevent brain injury in children with sickle cell disease (HU Prevent)-A randomized, placebo-controlled phase II feasibility/pilot study.

Central nervous system (CNS) injury is common in sickle cell disease (SCD) and occurs early in life. Hydroxyurea is safe and efficacious for treatment of SCD, but high-quality evidence from randomized trials to estimate its neuroprotective effect is scant. HU Prevent was a randomized (1:1), double-blind, phase II feasibility/pilot trial of dose-escalated hydroxyurea vs. placebo for the primary prevention of CNS injury in children with HbSS or HbS-ß0-thalassemia subtypes of SCD age 12-48 months with normal neurological examination, MRI of the brain, and cerebral blood flow velocity. We hypothesized that hydroxyurea would reduce by 50% the incidence of CNS injury. Two outcomes were compared: primary-a composite of silent cerebral infarction, elevated cerebral blood flow velocity, transient ischemic attack, or stroke; secondary-a weighted score estimating the risk of suffering the consequences of stroke (the Stroke Consequences Risk Score-SCRS), based on the same outcome events. Six participants were randomized to each group. One participant in the hydroxyurea group had a primary outcome vs. four in the placebo group (incidence rate ratio [90% CI] 0.216 [0.009, 1.66], p = .2914) (~80% reduction in the hydroxyurea group). The mean SCRS score was 0.078 (SD 0.174) in the hydroxyurea group, 0.312 (SD 0.174) in the placebo group, p = .072, below the p-value of .10 often used to justify subsequent phase III investigations. Serious adverse events related to study procedures occurred in 3/41 MRIs performed, all related to sedation. These results suggest that hydroxyurea may have profound neuroprotective effect in children with SCD and support a definitive phase III study to encourage the early use of hydroxyurea in all infants with SCD.

User Engagement With mHealth Interventions to Promote Treatment Adherence and Self-Management in People With Chronic Health Conditions: Systematic Review.

BACKGROUND: There are numerous mobile health (mHealth) interventions for treatment adherence and self-management; yet, little is known about user engagement or interaction with these technologies. OBJECTIVE: This systematic review aimed to answer the following questions: (1) How is user engagement defined and measured in studies of mHealth interventions to promote adherence to prescribed medical or health regimens or self-management among people living with a health condition? (2) To what degree are patients engaging with these mHealth interventions? (3) What is the association between user engagement with mHealth interventions and adherence or self-management outcomes? (4) How often is user engagement a research end point? METHODS: Scientific database (Ovid MEDLINE, Embase, Web of Science, PsycINFO, and CINAHL) search results (2016-2021) were screened for inclusion and exclusion criteria. Data were extracted in a standardized electronic form. No risk-of-bias assessment was conducted because this review aimed to characterize user engagement measurement rather than certainty in primary study results. The results were synthesized descriptively and thematically. RESULTS: A total of 292 studies were included for data extraction. The median number of participants per study was 77 (IQR 34-164). Most of the mHealth interventions were evaluated in nonrandomized studies (157/292, 53.8%), involved people with diabetes (51/292, 17.5%), targeted medication adherence (98/292, 33.6%), and comprised apps (220/292, 75.3%). The principal findings were as follows: (1) >60 unique terms were used to define user engagement; "use" (102/292, 34.9%) and "engagement" (94/292, 32.2%) were the most common; (2) a total of 11 distinct user engagement measurement approaches were identified; the use of objective user log-in data from an app or web portal (160/292, 54.8%) was the most common; (3) although engagement was inconsistently evaluated, most of the studies (99/195, 50.8%) reported >1 level of engagement due to the use of multiple measurement methods or analyses, decreased engagement across time (76/99, 77%), and results and conclusions suggesting that higher engagement was associated with positive adherence or self-management (60/103, 58.3%); and (4) user engagement was a research end point in only 19.2% (56/292) of the studies. CONCLUSIONS: The results revealed major limitations in the literature reviewed, including significant variability in how user engagement is defined, a tendency to rely on user log-in data over other measurements, and critical gaps in how user engagement is evaluated (infrequently evaluated over time or in relation to adherence or self-management outcomes and rarely considered a research end point). Recommendations are outlined in response to our findings with the goal of improving research rigor in this area. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42022289693; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022289693.

Medication adherence in youths with CKD: habits for success.

BACKGROUND: Poor adherence habits are key contributors to nonadherence but there are few clinically feasible methods for evaluating adherence habits, particularly for youths with chronic kidney disease (CKD). This study investigated how participants' qualitative responses to three interview questions about adherence habits mapped to primary principles of habit formation and objectively measured medication adherence in youths with CKD. METHODS: Participants (ages 11-21 years) were recruited from a pediatric nephrology clinic as part of a larger study. Participants' daily objective antihypertensive medication adherence was measured with an electronic pill bottle over a 4-week baseline period. Qualitative interviews about adherence habits and routines were conducted with a subset of participants (N = 18). RESULTS: Clear qualitative differences emerged in how participants with high-medium adherence (80-100%) discussed adherence habits compared to participants with low adherence (0-79%). Participants with high-medium adherence discussed situational cues for taking medicine, including locations that cue adherence, step-by-step events leading up to taking medicine, and people who cue adherence. Participants with high-medium adherence regularly described taking medicine as "automatic," "second nature," and a "habit." Participants with low adherence rarely discussed these habit features nor did they explicitly acknowledge currently missing doses. Participants with low adherence tended to discuss challenges with organization and routines for taking medicine. CONCLUSIONS: Evaluating patient responses to questions about adherence habits may uncover challenges with adherence habit formation, provide direction for habit-strengthening intervention focused on developing automatic cues for taking medication, and support adherence successes for youths with CKD. CLINICAL TRIAL REGISTRATION NUMBER: NCT03651596. A higher resolution version of the Graphical abstract is available as Supplementary information.

Family management of asthma in Head Start preschool children.

BACKGROUND: Urban minority preschool children are disproportionately affected by asthma with increased asthma morbidity and mortality. It is important to understand how families manage asthma in preschool children to improve asthma control. OBJECTIVE: To evaluate family asthma management and asthma outcomes among a low-income urban minority population of Head Start preschool children. METHODS: The family asthma management system scale (FAMSS) evaluates how families manage a child's asthma. A total of 388 caregivers completed the FAMSS at baseline. Asthma outcomes were evaluated at baseline and prospectively at 6 months, including asthma control (based on the Test for Respiratory and Asthma Control in Kids), courses of oral corticosteroids (OCSs) required, and caregiver health-related quality of life (Pediatric Asthma Caregiver's Quality of Life Questionnaire [PACQLQ]). Multiple regression models evaluated the relationship between the FAMSS total score, FAMSS subscales, and asthma outcomes. RESULTS: Higher FAMSS total scores were associated with fewer courses of OCSs required (b = -0.23, P < .01) and higher PACQLQ scores (b = 0.07, P < .05). At baseline, higher integration subscale scores (b = -0.19, P < .05) were associated with fewer courses of OCSs required, and higher family response scores were associates with higher PACQLQ scores (b = 0.06, P < .05). Nevertheless, higher collaboration scores were associated with lower PACQLQ at baseline (b = -0.06, P < .05) and 6 months (b = -0.07, P < .05). CONCLUSION: Among this population of low-income minority preschool children, understanding how a family manages their child's asthma may help identify gaps for education to possibly improve caregiver asthma-related quality of life and reduce courses of OCSs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01519453 (https://clinicaltrials.gov/ct2/show/NCT01519453); protocol available from meakin1@jhmi.edu.

Effect of the School-Based Asthma Care for Teens (SB-ACT) program on asthma morbidity: a 3-arm randomized controlled trial.

Urban adolescents with asthma often have inadequate preventive care. We tested the effectiveness of the School-Based Asthma Care for Teens (SB-ACT) program on asthma morbidity and preventive medication adherence.Methods:Subjects/Setting- 12-16yr olds with persistent asthma in Rochester, NY schools. Design- 3-group randomized trial (2014-2019). SB-ACT Intervention- Two core components: 1) Directly observed therapy (DOT) of preventive asthma medications, provided in school for at least 6-8 weeks for the teen to learn proper technique and experience the benefits of daily preventive therapy; 2) 4-6 weeks later, 3 sessions of motivational interviewing (MI) to discuss potential benefits from DOT and enhance motivation to take medication independently. We included 2 comparison groups: 1) DOT-only for 6-8wks, and 2) asthma education (AE) attention control. Masked follow-up assessments were conducted at 3, 5, and 7mos. Outcomes- Mean number of symptom-free days (SFDs)/2 weeks and medication adherence. Analyses- Modified intention-to-treat repeated measures analysis.Results: We enrolled 430 teens (56% Black, 32% Hispanic, 85% Medicaid). There were no group differences at baseline. We found no difference in SFDs at any follow-up timepoint. More teens in the SB-ACT and DOT-only groups reported having a preventive asthma medication at each follow-up (p<.001), and almost daily adherence at 3 and 5-months (p<.001, p=.003) compared to AE. By 7 months there were no significant differences between groups in adherence (p=.49).Conclusion: SB-ACT improved preventive medication availability and short-term adherence but did not impact asthma symptoms. Further work is needed to create developmentally appropriate and effective interventions for this group.

Agreement between attended home and ambulatory blood pressure measurements in adolescents with chronic kidney disease.

BACKGROUND: This study aimed to compare attended home blood pressure (BP) measurements (HBPM) with ambulatory BP monitor (ABPM) readings and examine if level of agreement between measurement modalities differs overall and by subgroup. METHODS: This was a secondary analysis of data from a 2-year, multicenter observational study of children 11-19 years (mean 15, SD = 2.7) with chronic kidney disease. Participants had 3 standardized resting oscillometric home BPs taken by staff followed by 24-h ABPM within 2 weeks of home BP. BP indices (measured BP/95%ile BP) were calculated for mean triplicate attended HBPM and mean ABPM measurements. Paired HBPM and ABPM measurements taken during any of 5 study visits were compared using linear regression with robust standard errors. Generalized estimating equation-based logistic regression determined sensitivity, specificity, negative, and positive predictive values with ABPM as the gold standard. Analyses were conducted for the group overall and by subgroup. RESULTS: A total of 103 participants contributed 251 paired measurements. Indexed systolic BP did not differ between HBPM and daytime APBM (mean difference - 0.002; 95% CI: - 0.006, 0.003); the difference in indexed diastolic BP was minimal (mean difference - 0.033; 95% CI: - 0.040, - 0.025). Overall agreement between HBPM and 24-h ABPM in identifying abnormal BP was high (81.8%). HBPM had higher sensitivity (87.5%) than specificity (77.4%) and greater negative (89.8%) than positive (73.3%) predictive value, and findings were consistent in subgroups. CONCLUSIONS: Attended HBPM may be reasonable for monitoring BP when ABPM is unavailable. The greater accessibility and feasibility of attended HBPM may potentially help improve BP control among at-risk youth. A higher resolution version of the Graphical abstract is available as Supplementary information.

Enhancing Recruitment and Retention of Minority Populations for Clinical Research in Pulmonary, Critical Care, and Sleep Medicine: An Official American Thoracic Society Research Statement.

Background: Well-designed clinical research needs to obtain information that is applicable to the general population. However, most current studies fail to include substantial cohorts of racial/ethnic minority populations. Such underrepresentation may lead to delayed diagnosis or misdiagnosis of disease, wide application of approved interventions without appropriate knowledge of their usefulness in certain populations, and development of recommendations that are not broadly applicable.Goals: To develop best practices for recruitment and retention of racial/ethnic minorities for clinical research in pulmonary, critical care, and sleep medicine.Methods: The American Thoracic Society convened a workshop in May of 2019. This included an international interprofessional group from academia, industry, the NIH, and the U.S. Food and Drug Administration, with expertise ranging from clinical and biomedical research to community-based participatory research methods and patient advocacy. Workshop participants addressed historical and current mistrust of scientific research, systemic bias, and social and structural barriers to minority participation in clinical research. A literature search of PubMed and Google Scholar was performed to support conclusions. The search was not a systematic review of the literature.Results: Barriers at the individual, interpersonal, institutional, and federal/policy levels were identified as limiting to minority participation in clinical research. Through the use of a multilevel framework, workshop participants proposed evidence-based solutions to the identified barriers.Conclusions: To date, minority participation in clinical research is not representative of the U.S. and global populations. This American Thoracic Society research statement identifies potential evidence-based solutions by applying a multilevel framework that is anchored in community engagement methods and patient advocacy.

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.

The Patient Reported Outcomes as a Clinical Tool (PROACT) Pilot Study: What Can be Gained by Sharing Computerized Patient-Reported Mental Health and Substance Use Symptoms with Providers in HIV Care?

Substance use and mental health (SU/MH) disorders are insufficiently recognized in HIV care. We examined whether conveying SU/MH screening results to patients and providers increased SU/MH discussions and action plans. Intervention participants completed a computerized patient-reported questionnaire before their HIV visit; screened positive on ≥ 1 measure: depression, anxiety, PTSD symptoms, at-risk alcohol use, or drug use; and reviewed screening results to decide which to prioritize with their provider. Screening results and clinical recommendations were conveyed to providers via medical record. A historic control included patients with positive screens but no conveyance to patient or provider. The patient-provider encounter was audio-recorded, transcribed, and coded. For the overall sample (n = 70; 38 control, 32 intervention), mean age (SD) was 51.8 (10.3), 61.4% were male, and 82.9% were Black. Overall, 93.8% raised SU/MH in the intervention compared to 50.0% in the control (p < 0.001). Action plans were made for 40.0% of intervention and 10.5% of control encounters (p = 0.049). Conveying screening results with clinical recommendations increased SU/MH action plans, warranting further research on this intervention to address SU/MH needs.

Evaluating the implementation of a multicomponent asthma education program for Head Start staff.

OBJECTIVE: Asthma disproportionately affects minority groups, low income populations, and young children under 5. Head Start (HS) programs predominantly serve this high-risk population, yet staff are not trained on asthma management. The objective of this study was to assess a 5-year, multicomponent HS staff asthma education program in Baltimore City HS programs. METHODS: All HS programs were offered annual staff asthma education by a medical research team that included didactic lectures and hands-on training. Attendees received continuing education credits. HS staff were anonymously surveyed on asthma knowledge and skills and asthma medication management practices in Year 1 (preimplementation) and Year 5. RESULTS: There was an estimated response rate of 94% for Year 1 and 82% for Year 5. Compared to staff in Year 1, Year 5 staff were significantly more likely to report they had very good knowledge and skills related to asthma [odds ratio (OR) 1.63; p < 0.05] and were engaged in asthma care activities (OR 2.02; p < 0.05). Self-reported presence of asthma action plans for all children with asthma was 82% at Year 1 and increased to 89% in Year 5 (p = 0.064). CONCLUSIONS: Year 5 HS staff reported higher self-assessed knowledge and skills, self-reports of asthma medication management practices, and self-reports of asthma activities compared to Year 1 staff. HS serves high-risk children with asthma, and a multicomponent program can adequately prepare staff to manage asthma in the child care setting. Our results indicate the feasibility of providing efficacious health skill education into child care provider training to reduce asthma knowledge gaps.

Does a multimethod approach improve identification of medication nonadherence in adolescents with chronic kidney disease?

BACKGROUND: Medical provider assessment of nonadherence is known to be inaccurate. Researchers have suggested using a multimethod assessment approach; however, no study has demonstrated how to integrate different measures to improve accuracy. This study aimed to determine if using additional measures improves the accurate identification of nonadherence beyond provider assessment alone. METHODS: Eighty-seven adolescents and young adults (AYAs), age 11-19 years, with chronic kidney disease (CKD) [stage 1-5/end-stage renal disease (ESRD)] and prescribed antihypertensive medication, their caregivers, and 17 medical providers participated in the multisite study. Five adherence measures were obtained: provider report, AYA report, caregiver report, electronic medication monitoring (MEMS), and pharmacy refill data [medication possession ratio (MPR)]. Concordance was calculated using kappa statistic. Sensitivity, specificity, positive predictive power, and negative predictive power were calculated using MEMS as the criterion for measuring adherence. RESULTS: There was poor to fair concordance (kappas = 0.12-0.54), with 35-61% of AYAs classified as nonadherent depending on the measure. While both providers and MEMS classified 35% of the AYAs as nonadherent, sensitivity (0.57) and specificity (0.77) demonstrated poor agreement between the two measures on identifying which AYAs were nonadherent. Combining provider report of nonadherence and MPR < 75% resulted in the highest sensitivity for identifying nonadherence (0.90) and negative predictive power (0.88). CONCLUSIONS: Nonadherence is prevalent in AYAs with CKD. Providers inaccurately identify nonadherence, leading to missed opportunities to intervene. Our study demonstrates the benefit to utilizing a multimethod approach to identify nonadherence in patients with chronic disease, an essential first step to reduce nonadherence.

Patient Health Beliefs and Characteristics Predict Longitudinal Antihypertensive Medication Adherence in Adolescents With CKD.

Objective: To investigate longitudinal associations of health beliefs, which included self-efficacy, outcome expectancies, and perceived barriers, and demographic risk factors (i.e., age, gender, race, and family income) with antihypertensive medication adherence in adolescents with chronic kidney disease (CKD) over 24 months. Method: The sample included 114 adolescents (M age = 15.03 years, SD = 2.44) diagnosed with CKD. Adolescents reported their self-efficacy for taking medications, medication outcome expectancies, and barriers to adherence at baseline and 12 and 24 months after baseline. Antihypertensive medication adherence was assessed via electronic monitoring for 2 weeks at baseline and 6, 12, 18, and 24 months after baseline. Results: Adherence increased and then decreased over the 2-year study period (inverted U-shape). Self-efficacy, outcome expectancies, and barriers did not change over time. Older adolescent age, female gender, African American race, <$50,000 annual family income, and public health insurance were associated with lower adherence. However, family income was the primary demographic risk factor that predicted adherence over time (≥$50,000 annual family income was longitudinally associated with higher adherence). Higher self-efficacy and more positive and less negative outcome expectancies across time were also associated with higher antihypertensive medication adherence across time. Conclusions: Clinical interventions should be developed to target medication self-efficacy and outcome expectancies to improve long-term antihypertensive medication adherence in adolescents with CKD. Family income may be considered when conceptualizing contextual factors that likely contribute to adolescents' consistent challenges with medication adherence over time.

Identifying Factors that Facilitate Treatment Adherence in Cystic Fibrosis: Qualitative Analyses of Interviews with Parents and Adolescents.

Cystic fibrosis (CF) is a progressive, genetic disease affecting multiple organ systems. Treatments are complex and take 2-4 h per day. Adherence is 50% or less for pulmonary medications, airway clearance, and enzymes. Prior research has identified demographic and psychological variables associated with better adherence; however, no study has extensively identified facilitators of treatment adherence (e.g., adaptive behaviors and cognitions) in a sample of parents and adolescents. Forty-three participants were recruited from four CF centers as part of a larger measurement study. Participants included 29 parents (72% mothers; 72% Caucasian) and 14 adolescents (ages 11-20, 64% female, 71% Caucasian). Participants completed semi-structured interviews to elicit barriers to adherence. However, facilitators of adherence naturally emerged, therefore indicating need for further exploration. Interviews were audiotaped, transcribed and content-analyzed in NVivo to identify those behaviors and beliefs that facilitated adherence, using a phenomenological analysis. Frequencies of these themes were tabulated. Nine themes emerged, with individual codes subsumed under each. Themes included social support, community support, organizational strategies, "intrinsic characteristics," combining treatments with pleasurable activity, flexibility, easier or faster treatment, prioritizing treatments, and negative effects of non-adherence. Results demonstrated the importance of identifying strategies that positively affect adherence. Interventions that are strength-focused, build on prior success, and utilize positive models generated by those who have successfully integrated CF treatments into their lives are more likely to be efficacious.

A qualitative study examining the benefits and challenges of incorporating patient-reported outcome substance use and mental health questionnaires into clinical practice to improve outcomes on the HIV care continuum.

BACKGROUND: Inadequate identification and treatment of substance use (SU) and mental health (MH) disorders hinders retention in HIV care. The objective of this study was to elicit stakeholder input on integration of SU/MH screening using computer-assisted patient-reported outcomes (PROs) into clinical practice. METHODS: We conducted semi-structured interviews with HIV-positive patients who self-reported SU/MH symptoms on a computer-assisted PROs (n = 19) and HIV primary care providers (n = 11) recruited from an urban academic HIV clinic. Interviews were audio-recorded and transcribed. We iteratively developed codes and organized key themes using editing style analysis. RESULTS: Two themes emerged: (1) Honest Disclosure: Some providers felt PROs might improve SU/MH disclosure; more were concerned that patients would not respond honestly if their provider saw the results. Patients were also divided, stating PROs could help overcome stigma but that it could be harder to disclose SU/MH to a computer versus a live person. (2) Added Value in the Clinical Encounter: Most providers felt PROs would fill a practice gap. Patients had concerns regarding confidentiality but indicated PROs would help providers take better care of them. CONCLUSIONS: Both patients and providers indicated that PROs are potentially useful clinical tools to improve detection of SU/MH. However, patients and providers expressed conflicting viewpoints about disclosure of SU/MH using computerized PROs. Future studies implementing PROs screening interventions must assess concerns over confidentiality and honest disclosure of SU/MH to understand the effectiveness of PROs as a clinical tool. More research is also needed on patient-centered integration of the results of PROs in HIV care.

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.

Cost Analysis of Motivational Interviewing and Preschool Education for Secondhand Smoke Exposures.

INTRODUCTION: This study determines if expenditures associated with implementing a combined motivational interviewing (MI) and Head Start-level education program (MI+Education), as compared to education alone, yield cost savings to society. METHODS: Post hoc cost analyses were applied to a randomized controlled-trial of MI among predominantly African American, low-income caregivers of 330 Baltimore City Head Start students who reside with a smoker. The primary outcome was the cost savings of MI+Education from averted direct secondhand smoke exposure (SHSe)-related acute healthcare events and inferred indirect costs (work days lost, transportation and reduction in cigarettes smoked). The net direction of savings was defined by the sum of averted direct and indirect costs of the MI+Education intervention at 3, 6 and 12 months, benchmarked against the Education alone cohort at the equivalent time periods. RESULTS: The costs saved by the MI+Education intervention, relative to Education alone, resulted in savings at solely the 12-month follow-up time point. Significant savings were appreciated from averted emergency department (ED) visits at 12 months ($4410; 95% simulation interval [SI]: $2241, $6626) for the MI+Education group. The total savings at 12 months ($2274; 95% SI: -3916, $8442) could not overcome additional program costs of implementing MI to Head Start-level education ($13 695; 95% SI: $11 250, $16 034). CONCLUSIONS: This study is the first to examine the cost of either intervention on SHSe-attributed pediatric healthcare costs from a population level relevant for federal and community decision makers. Intervention costs could not be offset by short-term savings but a trend towards positive savings was appreciated 1 year after implementation. IMPLICATIONS: Behavioral interventions are effective in reducing SHSe in children. However, many of these interventions are not implemented in community settings due to lack of resources and money. Behavioral strategies may be a cost-saving addition to the national initiatives to create smoke-free home environments. The long-term benefits of MI, as evidenced from cost savings from averted ED visits, appeared to show MI+Education to be a robust long-term strategy. The decrease of acute healthcare services at 12 months may be informative for policy decision makers seeking to allocate limited resources to reduce the usage of costly ED services and hospital readmissions.

Associations Between Caregiver Health Literacy and Preschool Children's Secondhand Smoke Exposure.

OBJECTIVE: Examine the associations between caregiver health literacy (HL) and smoking-related outcome expectancies, implementation of home/car smoking bans (H/CSBs), and child secondhand smoke exposure (SHSe). METHODS: Caregivers of Head Start children residing with a smoker(s) completed measures assessing HL, outcome expectancies, and H/CSB implementation. Biomarkers of child SHSe included home air nicotine monitors and child salivary cotinine. RESULTS: Caregivers with lower HL had higher levels of home air nicotine and child salivary cotinine in the full sample and among smokers. After controlling for child age and number of smokers in the home, lower HL was associated with higher endorsement of negative smoking expectancies in the full sample and in smokers. HL was not associated with H/CSB implementation across groups. CONCLUSIONS: Caregiver HL is associated with child SHSe and is important in shaping smoking-related beliefs. HL is not directly related to adoption of SHSe-reduction behaviors such as H/CSBs.

Barriers and motivators to reducing secondhand smoke exposure in African American families of head start children: a qualitative study.

OBJECTIVE: To identify barriers and motivators for reducing secondhand smoke exposure (SHSe) for families of African-American, low-income, urban children. METHOD: Audiotaped intervention sessions of 52 African-American caregivers of Head Start children who reported being a smoker and/or had at least one smoker in the home were randomly sampled from a larger trial examining the effectiveness of a motivational-interviewing intervention in reducing child's SHSe. Counseling sessions were qualitatively coded to identify barriers and motivators to implementing a home smoking ban or quitting smoking. RESULTS: African-American families identified several themes that were either or both barriers and motivators for SHSe reduction, including: asking others not to smoke, other family living in the home, neighborhood safety, absence of childcare, cost/availability of cessation tools, physician support and prevention of health problems. DISCUSSION: Urban, low-income African-American families face numerous barriers to reducing SHSe. Families were able to identify many motivators for reducing SHSe, suggesting an awareness of the importance for SHSe reduction but uncertainty in their confidence to change behaviors. Counseling should include tailoring to be most effective in supporting health behavior change. Greater emphasis on motivators is needed, such as low-cost/free cessation tools, engagement from physicians and greater involvement of extended family members.

Family Beliefs and Behaviors About Smoking and Young Children's Secondhand Smoke Exposure.

INTRODUCTION: Home smoking bans (HSBs) reduce children's secondhand smoke exposure (SHSe), a contributor to health disparities. General psychosocial characteristics and SHSe beliefs and behaviors within the family may relate to HSB existence. This study's aim was to identify general psychosocial characteristics and SHSe beliefs associated with HSB presence and lower SHSe among children living with a smoker. METHODS: Caregivers (n = 269) of Head Start preschool students (age 1-6 years) living with a smoker reported on HSBs, caregiver depressive symptoms and stress, family routines, SHSe beliefs, and household smoking characteristics. SHSe biomarkers included air nicotine in 2 areas of the home and child salivary cotinine. RESULTS: One-quarter of families reported complete HSBs, and HSBs were more common among nonsmoking (37%) versus smoking caregivers (21%; p < .01). Perceived importance of HSBs differed between nonsmoking (9.7±1.0) versus smoking caregivers (9.1±2.0; p < .01). Smoking caregivers, more smokers in the home, and lower self-efficacy and intent to implement an HSB were consistently associated with lower likelihood of HSB existence and children's higher SHSe. Caregiver SHSe beliefs were more consistently associated with HSBs and SHSe than were general psychosocial factors. CONCLUSIONS: Despite greater HSB likelihood and higher perceived importance of HSBs among nonsmoking versus smoking primary caregivers, SHSe reduction self-efficacy and intent are protective for Head Start students at high-risk for exposure. Pediatric healthcare providers and early education professionals may be able to support SHSe reduction efforts (e.g., smoking cessation, HSB implementation) and reduce children's SHSe with counseling strategies to address caregivers' HSB self-efficacy, intent, and related behaviors.