Methods used to quit vaping among adolescents and associations with perceived risk, addiction, and socio-economic status.

Despite widespread evidence suggesting that e-cigarettes are harmful to youth, the prevalence of adolescent vaping continues to rise. The first aim of this cross-sectional study was to determine which methods adolescents have previously used to quit vaping and their interest in using various methods to quit vaping in the future. The second aim was to investigate the associations between vaping-related characteristics and (1) motivation to quit vaping and (2) previous use of pharmacological methods to quit vaping or previous use of unassisted quitting. Participants were 185 current or former vapers, aged 14-19 (M age = 16.9 years, SD = 1.1; 52% female), recruited online from different U.S. regions. Data were collected through online questionnaires. Most participants reported at least one prior attempt to quit vaping (81.3%). Unassisted quitting was the most prevalent method to quit vaping (78.4%), followed by "advice from a friend" (51.9%). Participants were interested in using a variety of methods for quitting vaping in the future, including medication (28.8%), and mobile apps (34.6%). Greater perceived harm of vaping was significantly associated with motivation to quit vaping, while greater perceived risk of addiction and higher SES were significantly associated with lifetimeuse of nicotine replacement to quit vaping. Adolescents may be open to trying methods to quit that are different from what they have used previously. These findings could help direct resources toward the development of vaping cessation programs that are acceptable to adolescents.

Inequities and oral health: A behavioural sciences perspective.

OBJECTIVES: The importance of tackling ongoing dental health inequities, observed both within and across countries, cannot be overstated. Alarmingly, health inequities in some areas are widening, resulting in an urgent need to act. The objective of this commentary is to explore oral health inequities through the lens of behavioral science and discuss adapting evidence based interventions for populations experiencing health inequities. METHOD/RESULTS: The first section of this paper aims to describe the role of health disparities and inequities within oral health, with a specific focus on behaviours. The determinants, from upstream to downstream, and the interplay between these levels of intervention are discussed. This is followed by an overview of oral health promotion interventions, again with a focus on behaviours, which could potentially improve oral health while also taking into account oral health inequities. It is essential to translate evidence-based interventions (EBIs) to populations that have the greatest burden of disease. The second section of this paper discusses the rationale for cultural adaption of EBIs, criteria to justify EBIs and considers different cultural adaptation strategies necessary for the development and testing of effective, engaging, equitable and culturally relevant interventions. CONCLUSIONS: We conclude with future directions for the development of theory-based multi-level interventions, guided by extent evidence-based interventions, and transdisciplinary approaches to science and key stakeholders such as patients, providers and payers.

Behavioural and social oral health intervention research: Looking to the future.

Behavioural and social oral health intervention has made great strides in intervention development and testing. Future research should focus on applying successful methods and interventions of disciplines outside oral health to oral health research and practice as well as focus on raising the visibility of oral health research by applying our established methods and interventions to outside domains. Behavioural and social oral health is strategically positioned to be a leader across several research domains, perhaps most prominently in digital health, disparities and developing and testing theories and frameworks, given the progress that has already been made, and significant investment in these areas from funders like the National Institute for Craniofacial Research.

Integrating Social Determinants of Health With Tobacco Treatment for Individuals With Opioid Use Disorder: Feasibility and Acceptability Study of Delivery Through Text Messaging.

BACKGROUND: Individuals with opioid use disorder (OUD) have a high prevalence of smoking and frequently experience unmet social determinants of health (SDOH), which may be barriers to smoking cessation. Hospitalization is an opportunity to encourage smoking cessation. Unfortunately, many clinicians do not provide tobacco treatment to support the maintenance of cessation achieved during hospitalization. Interventions are required to support these high-risk individuals after hospital discharge. OBJECTIVE: This study aimed to test the feasibility and acceptability of a 28-day SMS text messaging program tailored to individuals with OUD, which provides smoking cessation support and addresses unmet SDOH needs. METHODS: From July to December 2019, we enrolled 25 individuals who were hospitalized with tobacco dependence and OUD at our large safety net hospital. The SMS text messaging program was initiated during hospitalization and continued for 28 days. Participants were enrolled in either the ready to quit within 30 days or the not ready to quit within 30 days program based on their readiness to quit. Automated SMS text messages were sent twice daily for 4 weeks. The topics included health and cost benefits of quitting, both general and opioid specific (16 messages); managing mood and stress (8 messages); motivation, coping strategies, and encouragement (18 messages); addressing medication misconceptions (5 messages); links to resources to address substance use (2 messages providing links to the Massachusetts Substance Use Helpline and Boston Medical Center resources), tobacco dependence (1 message providing a link to the Massachusetts Quitline), and unmet SDOH needs (6 messages assessing SDOH needs with links to resources if unmet SDOH needs were identified). Questionnaires and interviews were conducted at baseline and at 2 and 4 weeks after enrollment. RESULTS: The participants were 56% (14/25) female, 36% (9/25) African American, 92% (23/25) unemployed, and 96% (24/25) Medicaid insured. Approximately 84% (21/25) activated the program, and none of the participants unsubscribed. Approximately 57% (12/21) completed either the 2- or 4-week questionnaires. Program satisfaction was high (overall mean 6.7, SD 0.8, range 1-7). Many perceived that the SMS text messaging program provided social support, companionship, and motivation to stop smoking. Messages about the health benefits of quitting were well received, whereas messages on how quitting cigarettes may prevent relapse from other substances had mixed views, highlighting the importance of tailoring interventions to patient preferences. CONCLUSIONS: SMS text messaging to promote smoking cessation and address SDOH needs may be an effective tool for improving quit rates and health outcomes in individuals with tobacco dependence and OUD. Our study adds to the growing body of evidence that SMS text messaging approaches are feasible and acceptable for providing tobacco treatment to all individuals who smoke, even among low-income populations who have OUD and are not ready to quit.

Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial.

BACKGROUND: Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients' clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists. METHODS AND ANALYSIS: A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions. ETHICS AND DISSEMINATION: North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN28555470.

COVID-19 Impact on Community-Based Participatory Randomized Controlled Trials-Lessons From the Oral Health Disparities in Children Consortium.

The COVID-19 pandemic has had a major impact on nearly every sector of science and industry worldwide, including a significant disruption to clinical trials and dentistry. From the beginning of the pandemic, dental care was considered high risk for viral transmission due to frequent aerosol-generating procedures. This resulted in special challenges for dental providers, oral health care workers, patients, and oral health researchers. By describing the effect that the COVID-19 pandemic had on four community-based randomized clinical trials in the Oral Health Disparities in Children (OHDC) Consortium, we highlight major challenges so researchers can anticipate impacts from any future disruptions.

Design, deployment, and usability of a mobile system for cardiovascular health monitoring within the electronic Framingham Heart Study.

Background: The electronic Framingham Heart Study (eFHS) is an ongoing nested study, which includes FHS study participants, examining associations between health data from mobile devices with cardiovascular risk factors and disease. Objective: To describe application (app) design, report user characteristics, and describe usability and survey response rates. Methods: Eligible FHS participants were consented and offered a smartwatch (Apple Watch), a digital blood pressure (BP) cuff, and the eFHS smartphone app for administering surveys remotely. We assessed usability of the new app using 2 domains (functionality, aesthetics) of the Mobile App Rating Scale (MARS) and assessed survey completion rates at baseline and 3 months. Results: A total of 196 participants were recruited using the enhanced eFHS app. Of these, 97 (49.5%) completed the MARS instrument. Average age of participants was 53 ± 9 years, 51.5% were women, and 93.8% were white. Eighty-six percent of participants completed at least 1 measure on the baseline survey, and 50% completed the 3-month assessment. Overall subjective score of the app was 4.2 ± 0.7 on a scale from 1 to 5 stars. Of those who shared their health data with others, 46% shared their BP and 7.7% shared their physical activity with a health care provider. Conclusion: Participants rated the new, enhanced eFHS app positively overall. Mobile app survey completion rates were high, consistent with positive in-app ratings from participants. These mobile data collection modalities offer clinicians new opportunities to engage in conversations about health behaviors.

An Interactive Parent-Targeted Text Messaging Intervention to Improve Oral Health in Children Attending Urban Pediatric Clinics: Feasibility Randomized Controlled Trial.

BACKGROUND: Effective preventive treatments for dental decay exist, but caries experience among preschoolers has not changed, with marked disparities in untreated decay. Despite near-universal use of SMS text messaging, there are no studies using text messages to improve the oral health of vulnerable children. OBJECTIVE: This randomized controlled feasibility trial aimed to test the effects of oral health text messages (OHT) versus a control (child wellness text messages or CWT). OHT was hypothesized to outperform CWT on improving pediatric oral health behaviors and parent attitudes. METHODS: Parents with a child aged <7 years were recruited at urban clinics during pediatric appointments (79% [41/52] below poverty line; 66% [36/55] black) and randomized to OHT (text messages on brushing, dental visits, bottle and sippy cups, healthy eating and sugary beverages, and fluoride) or CWT (text messages on reading, safety, physical activity and development, secondhand smoke, and stress) groups. Automated text messages based on Social Cognitive Theory were sent twice each day for 8-weeks. Groups were equivalent on the basis of the number of text messages sent, personalization, interactivity, and opportunity to earn electronic badges and unlock animated characters. Assessments were conducted at baseline and 8 weeks later. Data were analyzed with linear mixed-effects models. RESULTS: A total of 55 participants were randomized (28 OHT and 27 CWT). Only one participant dropped out during the text message program and 47 (24 OHT and 23 CWT) completed follow up surveys. Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range). Of the OHT group participants, 84% (21/25) would recommend the program to others. Overall program likeability scores were high (OHT mean 5.90; CWT mean 6.0; 1-7 scale range). Participants reported high perceived impact of the OHT program on brushing their child's teeth, motivation to address their child's oral health, and knowledge of their child's oral health needs (mean 4.7, 4.6, and 4.6, respectively; 1-5 scale range). At follow up, compared with CWT, OHT group participants were more likely to brush their children's teeth twice per day (odds ratio [OR] 1.37, 95% CI 0.28-6.50) and demonstrated improved attitudes regarding the use of fluoride (OR 3.82, 95% CI 0.9-16.8) and toward getting regular dental checkups for their child (OR 4.68, 95% CI 0.24-91.4). There were modest, but not significant, changes in motivation (F1,53=0.60; P=.45) and self-efficacy (F1,53=0.24; P=.63) to engage in oral health behaviors, favoring OHT (d=0.28 and d=0.16 for motivation and self-efficacy, respectively). CONCLUSIONS: The OHT program demonstrated feasibility was well utilized and appealing to the target population and showed promise for efficacy.

Twelve-Month Outcomes of a Group-Randomized Community Health Advocate-Led Smoking Cessation Intervention in Public Housing.

Background: Lower rates of smoking cessation are a major reason for the higher prevalence of smoking among socioeconomically disadvantaged adults. Because barriers to quitting are both more numerous and severe, socioeconomically disadvantaged smokers may benefit from more intensive intervention. We sought to determine whether a smoking cessation intervention delivered by public housing residents trained as Tobacco Treatment Advocates (TTAs) could increase utilization of cessation resources and increase abstinence. Methods: We conducted a group-randomized trial among Boston public housing residents who were interested in quitting smoking. Participants at control sites received standard cessation materials and a one-time visit from a TTA who provided basic counseling and information about cessation resources. Participants at intervention sites were eligible for multiple visits by a TTA who employed motivational interviewing, cessation counseling, and navigation to encourage smokers to utilize cessation treatment (Smokers' Quitline and clinic-based programs). Utilization and 7-day and 30-day point prevalence abstinence were assessed at 12 months. Self-reported abstinence was biochemically verified. Results: Intervention participants (n = 121) were more likely than control participants (n = 129) to both utilize treatment programs (adjusted odds ratio [aOR]: 2.15; 95% confidence interval [CI]: 0.93-4.91) and 7-day and 30-day point prevalence abstinence (aOR: 2.60 (1.72-3.94); 2.98 (1.56-5.68), respectively). Mediation analysis indicated that the higher level of utilization did not explain the intervention effect. Conclusions: An intervention delivered by peer health advocates was able to increase utilization of treatment programs and smoking abstinence among public housing residents. Future studies of similar types of interventions should identify the key mechanisms responsible for success. Implications: In order to narrow the large and growing socioeconomic disparity in smoking rates, more effective cessation interventions are needed for low-income smokers. Individual culturally-relevant coaching provided in smokers' residences may help overcome the heightened barriers to cessation experienced by this group of smokers. In this study among smokers residing in public housing, an intervention delivered by peer health advocates trained in motivational interviewing, basic smoking cessation skills, and client navigation significantly increased abstinence at 12 months. Future research should address whether these findings are replicable in other settings both within and outside of public housing.

Retention strategies for health disparities preventive trials: findings from the Early Childhood Caries Collaborating Centers.

OBJECTIVES: To identify successful strategies for retention of participants in multiyear, community-based randomized controlled trials (RCTs) aiming to reduce early childhood caries in health disparities populations from diverse racial/ethnic backgrounds and across diverse geographic settings. METHODS: Four RCTs conducted by the Early Childhood Caries Collaborating Centers (EC4), an initiative of the National Institute of Dental and Craniofacial Research, systematically collected information on the success of various strategies implemented to promote participant retention in each RCT. The observational findings from this case series of four RCTs were tabulated and the strategies rated by study staff. RESULTS: Participant retention at 12 months of follow-up ranged from 52.8 percent to 91.7 percent, and at 24 months ranged from 53.6 percent to 85.9, across the four RCTs. For the three RCTs that had a 36-month follow-up, retention ranged from 53.6 percent to 85.1 percent. Effectiveness of different participant retention strategies varied widely across the RCTs. CONCLUSIONS: Findings from this case series study may help to guide the design of future RCTs to maximize retention of study participants and yield needed data on effective interventions to reduce oral health disparities.

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.

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.

Special issue on eHealth and mHealth: Challenges and future directions for assessment, treatment, and dissemination.

This special issue is intended to promote a discussion of eHealth and mHealth and its connection with health psychology. "eHealth" generally refers to the use of information technology, including the Internet, digital gaming, virtual reality, and robotics, in the promotion, prevention, treatment, and maintenance of health. "mHealth" refers to mobile and wireless applications, including text messaging, apps, wearable devices, remote sensing, and the use of social media such as Facebook and Twitter, in the delivery of health related services. This special issue includes 11 articles that begin to address the need for more rigorous methodology, valid assessment, innovative interventions, and increased access to evidence-based programs and interventions.

Progress in Early Childhood Caries and Opportunities in Research, Policy, and Clinical Management.

The 2014 Early Childhood Caries Conference encompassed evidence-based reviews on the state of the science regarding early childhood carries (ECC) epidemiology, etiology, prevention, and disease management. The purpose of this paper was to discuss the work presented at the conference and identify opportunities in research, policy, and clinical management that may improve early childhood caries outcomes and lower costs of care. While great progress has been made since the 1997 ECC Conference, there remains a paucity of high-quality evidence from randomized controlled trials on what are the most effective means to prevent and manage ECC. Analyses of studies indicate that some approaches, such as chlorhexidine, iodine, and remineralizing agents, have not shown consistent findings in preventing ECC. However, evidence exists to yield recommendations in some areas. There are useful risk assessment indicators to identify preschool children at risk for caries. Fluoridated toothpaste and fluoride varnish currently are the most effective chemotherapeutic strategies to prevent ECC. Motivational interviewing, a form of patient-centered counseling, is effective for motivating oral health behaviors and shows promise for reducing caries. Additionally, evidence is emerging that shows the value of chronic disease management approaches and integrating ECC oral health care within medical care settings. Recommendations for future directions in ECC research and policy were also key outcomes of the conference.

Income predictors of smoking cessation among Hispanics.

Higher socioeconomic status smokers are more successful at smoking cessation. Few studies have investigated the prospective association between multiple measures of socioeconomic status and Hispanic smoking cessation. We assessed four measures to examine which predicted smoking cessation. Hispanics without debt had 18.5 times higher odds of 30-day cessation (odds ratio = 18.47, 95% confidence interval = 3.26-104.66, p < .01) and 11-fold increased odds of 7-day point prevalence abstinence (odds ratio = 11.32, 95% confidence interval = 2.45-52.24, p < .01) at 3-month follow-up. Yearly income, education, work status, money to see a doctor, and money for medications were not predictive of smoking cessation. Debt level may better measure socioeconomic inequities by capturing objective and subjective social status associated with Hispanic smoking cessation.

Integrating asthma education and smoking cessation for parents: financial return on investment.

BACKGROUND: Caregivers who smoke and have children with asthma are an important group for intervention. Home-based interventions successfully reduce asthma morbidity, yet are costly. This study evaluated the financial return on investment (ROI) of the Parents of Asthmatics Quit Smoking (PAQS) program, a combined asthma education and smoking cessation intervention. METHODS: Participants included caregivers (n = 224) that smoked, had a child with asthma, and were enrolled in a Medicaid managed care plan. Participants received nurse-delivered asthma education and smoking counseling in three home visits. Program implementation costs were estimated, and healthcare expenses were obtained from insurance claims data 12 months pre- and 12 months post intervention. ROI was calculated for all participants, children <6 years, children 6-18 years, and children with moderate/severe persistent asthma. RESULTS: Total program implementation cost was $34,481. After intervention, there was increased mean annual refills of beta-agonist (0.51 pre, 1.64 post; P < 0.001), and controller medications (0.65 pre, 2.44 post; P < 0.001). Reductions were found in mean annual emergency department visits (0.33 pre, 0.14 post; P < 0.001), hospitalizations (0.23 pre, 0.08 post; P < 0.001), and outpatient visits (2.33 pre, 1.45 post, P < 0.001). The program had negative ROI (-21.8%) for the entire sample. The ROI was positive (+106.9) for children <6 years, negative (-150.3) for children 6-18, and negligible for moderate/severe persistent asthma (+6.9%). CONCLUSION: PAQS was associated with increased medication use and decreased healthcare utilization. While the overall ROI for PAQS was negative, PAQS had a positive ROI for caregivers of young children with asthma.

A cultural adaptation of motivational interviewing to address heavy drinking among Hispanics.

Although the need for cultural adaptations is often noted in addiction research, there are few templates to guide the process. The rationale for a social contextual framework to culturally adapt motivational interviewing for an immigrant heavy drinking Latino population in the U.S. Northeast is presented. The aim of the pilot study was to obtain data on acceptability of this approach. Participant responses to the adaptation were examined qualitatively and quantitatively in a preliminary study. Participants recruited from the community met criteria for risky drinking (men, ≥5 drinks/occasion or ≥14 drinks/week; women, ≥4 drinks/occasion or ≥7 drinks/week). Participants (n = 25) who completed baseline assessments and a culturally adapted brief motivational interview (CAMI) were asked to complete a qualitative exit interview to give feedback on their interview experience. Participants reported being highly engaged with treatment (M = 3.58 on a scale of 1-4, SD = .50), and felt very satisfied with treatment (M = 3.58 on a scale of 1-4, SD = .93). Nearly all (95%) reported that understanding their culture was important to understanding their drinking behavior. Results support the acceptability and relevance of this adaptation from participants' perspectives.

The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials.

OBJECTIVES: To discuss methods of preservation of treatment fidelity in health behavior change trials conducted in public health contexts. METHODS: The treatment fidelity framework provided by the National Institutes of Health's Behavioral Change Consortium includes five domains of treatment fidelity (Study Design, Training, Delivery, Receipt, and Enactment). A measure of treatment fidelity was previously developed and validated using these categories. RESULTS: Strategies for assessment, monitoring, and enhancing treatment fidelity within each of the five treatment fidelity domains are discussed. The previously created measure of treatment fidelity is updated to include additional items on selecting providers, additional confounders, theory testing, and multicultural considerations. CONCLUSIONS: Implementation of a treatment fidelity plan may require extra staff time and costs. However, the economic and scientific costs of lack of attention to treatment fidelity are far greater than the costs of treatment fidelity implementation. Maintaining high levels of treatment fidelity with flexible adaptation according to setting, provider, and patient is the goal for public health trials.

The Assessment, Monitoring, and Enhancement of Treatment Fidelity In Public Health Clinical Trials.

OBJECTIVES: To discuss methods of preservation of treatment fidelity in health behavior change trials conducted in public health contexts. METHODS: The treatment fidelity framework provided by the NIH's Behavioral Change Consortium (BCC) (1) includes five domains of treatment fidelity (Study Design, Training, Delivery, Receipt, and Enactment). A measure of treatment fidelity was previously developed and validated using these categories. RESULTS: Strategies for assessment, monitoring, and enhancing treatment fidelity within each of the five treatment fidelity domains are discussed. The previously created measure of treatment fidelity is updated to include additional items on selecting providers, additional confounders, theory testing, and multicultural considerations. CONCLUSIONS: Implementation of a treatment fidelity plan may require extra staff time and costs. However, the economic and scientific costs of lack of attention to treatment fidelity are far greater than the costs of treatment fidelity implementation. Maintaining high levels of treatment fidelity with flexible adaptation according to setting, provider, and patient is the goal for public health trials.

Perceptions of barriers and facilitators: self-management decisions by older adolescents and adults with CF.

BACKGROUND: Adherence to CF treatments is poor, which can lead to negative health outcomes. The objective of our study was to qualitatively investigate the barriers and facilitators of self-management among older adolescents and adults with CF. METHODS: Individual semi-structured interviews were conducted, audio-taped, transcribed verbatim and coded to identify common themes. RESULTS: Twenty-five patients were interviewed. Four broad themes were identified: Barriers to Self-Management (e.g., treatment burden (identified by 64% of patients), accidental or purposeful forgetting (60%), no perceived benefit (56%)), Facilitators of Self-Management (e.g., CF clinic visits (76%), social support (68%), perceived benefit (68%)), Substitution of Alternative Approaches to Conventional Management (36%) and Planned Non-adherence (32%). CONCLUSIONS: Older adolescents and adults with CF identified many barriers and facilitators of adherence that may be amenable to self-management counseling strategies, particularly the use of health feedback.