An informed approach to the development of primary care pediatric firearm safety messages.

BACKGROUND: Firearm ownership is prevalent in the US and many children spend time in areas where firearms are not stored safely. The AAP recommends firearm safety counseling at pediatric well-visits. METHODS: We developed and tested six contextual messages to promote safe firearm storage based on: absence of harm, collective appeal to understanding child behavior, pediatrician's authority, evidence-based, fear appeal, and general safety considerations. One hundred four parents who keep firearms at home were recruited from Amazon Mechanical Turk Prime and viewed video messages and reported behavioral intentions and emotional reactions following each message. RESULTS: All six contextual messages were perceived as important and believable and increased parents' intentions to follow safety advice provided, but also elicited negative emotions. The authority message elicited more negative emotions and resulted in lower intentions to follow safe storage advice. CONCLUSIONS: Including firearm messages with other child safety advice merits further evaluation. Authority messages should be avoided.

The Third Rail of Pediatric Communication: Discussing Firearm Risk and Safety in Well-Child Exams.

This research endeavors to understand how pediatricians and parents discuss - or do not discuss - firearm risks for children during well-child visits. Through individual semi-structured interviews with 16 pediatric providers and 20 parents, the research explores discursive barriers to open conversation, perspectives on anticipatory guidance, and new ideas for culturally competent messaging. The research focuses particularly on how parents' and providers' perspectives on firearm risk communication are tied to cultural norms and expectations. One salient theme that emerged is that the American Academy of Pediatrics recommendation that pediatricians ask parents about ownership status is deemed undesirable by pediatricians and parents because of the delicate intercultural setting. Born out of pediatric and parent experiences, and mindful of culturally salient barriers, this study offers alternative strategies for discussing firearm risk in well-child exams.

Barriers and facilitators to HPV vaccination in primary care practices: a mixed methods study using the Consolidated Framework for Implementation Research.

BACKGROUND: In the United States, the effective, safe huma papilloma virus (HPV) vaccine is underused and opportunities to prevent cancer continue to be missed. National guidelines recommend completing the 2-3 dose HPV vaccine series by age 13, well before exposure to the sexually transmitted virus. Accurate characterization of the facilitators and barriers to full implementation of HPV vaccine recommendations in the primary care setting could inform effective implementation strategies. METHODS: We used the Consolidated Framework for Implementation Research (CFIR) to systematically investigate and characterize factors that influence HPV vaccine use in 10 primary care practices (16 providers) using a concurrent mixed methods design. The CFIR was used to guide collection and analysis of qualitative data collected through in-person semi-structured interviews with the primary care providers. We analyzed HPV vaccine use with data abstracted from medical charts. Constructs that most strongly influenced vaccine use were identified by integrating the qualitative and quantitative data. RESULTS: Of the 72 CFIR constructs assessed, seven strongly distinguished and seven weakly distinguished between providers with higher versus lower HPV vaccine coverage. The majority of strongly distinguishing constructs were facilitators and were related to characteristics of the providers (knowledge and beliefs; self-efficacy; readiness for change), their perception of the intervention (relative advantage of vaccinating younger vs. older adolescents), and their process to deliver the vaccine (executing). Additional weakly distinguishing constructs that were facilitators were from outer setting (peer pressure; financial incentives), inner setting (networks and communications and readiness for implementation) and process (planning; engaging, and reflecting and evaluating). Two strongly distinguishing constructs were barriers to use, one from the intervention (adaptability of the age of initiation) and the other from outer setting (patient needs and resources). CONCLUSIONS: Using CFIR to systematically examine the use of this vaccine in independent primary care practices enabled us to identify facilitators and barriers at the provider, interpersonal and practice level that need to be addressed in future efforts to increase vaccine use in such settings. Our findings suggest that implementation strategies that target the provider and help them to address multi-level barriers to HPV vaccine use merit further investigation.

Characteristics of youth agreeing to electronic sexually transmitted infection risk assessment in the emergency department.

OBJECTIVES: Adolescents and young adults are at high risk for sexually transmitted infections (STIs). We previously reported an increase in STI testing of adolescents in our ED by obtaining a sexual history using an Audio-enhanced Computer-Assisted Self-Interview (ACASI). We now examine associations among demographics, sexual behaviour, chief complaint and willingness to be tested. METHODS: This was a prospective study conducted in a paediatric ED between April and December 2011. After triage, eligible patients between 15 and 21 years presenting with non-life-threatening conditions were asked to participate in the study. Consenting participants used an ACASI to provide their demographic data and answer questions about their sexual history and willingness to be tested. Our primary outcome was the association of demographics, chief complaint and ACASI recommendation with the participant's willingness to be tested. RESULTS: We approached 1337 patients, of whom 800 (59%) enrolled and completed the ACASI. Eleven who did not answer questions related to their sexual history were excluded from analysis. Of 789 participants, 461 (58.4%) were female and median age was 16.9 years (IQR 16.0-17.8); 509 (64.5%) endorsed a history of anal, oral and/or vaginal intercourse. Disclosing a sexual history and willingness to be tested did not differ significantly by gender. 131 (16.6%) had a chief complaint potentially referable to an STI; among the 658 participants with non-STI-related complaints, 412 (62.6%) were sexually active, many of whom disclosed risky behaviours, including multiple partners (46.4%) and inconsistent condom use (43.7%). The ACASI identified 419 patients as needing immediate STI testing; the majority (81%) did not have a chief complaint potentially related to STIs. 697 (88.3%) participants were willing to receive STI testing. Most (94.6%) of the patients with STI-related complaints were willing to be tested, and 92.1% of patients with a recommendation for immediate testing by the ACASI indicated a willingness to be tested. CONCLUSIONS: Adolescents were willing to disclose sexual activity via electronic questionnaires and were willing to receive STI testing, even when their chief complaint was not STI related. The ACASI facilitated identification of adolescent ED patients needing STI testing regardless of chief complaint.

What Are Parents Willing to Discuss with Their Pediatrician About Firearm Safety? A Parental Survey.

OBJECTIVE: To determine if parents are receptive to discussing firearm safety with their pediatrician. STUDY DESIGN: Parents completed a self-administered paper survey during a pediatric office visit. Responses of those who confirmed and denied household firearms were compared using Fisher exact test. RESULTS: Between March 23 and May 21, 2015, 1246 of 1363 eligible parents (91.4%) completed the survey (22.6% African American, 79.5% at least some college education); 36% of respondents reported household firearms (owners). An additional 14.3% reported that their child was often in homes that contained firearms. Of the 447 owners, 25.1% reported ≥1 firearm was stored loaded, and 17.9% carried a firearm when leaving the house. Seventy-five percent of parents thought the pediatrician should advise about safe storage of firearms (owners 71.1%, others 77.5%), 16.9% disagreed (owners 21.9%, others 13.4%), and 8.2% were uncertain. Sixty-six percent thought pediatricians should ask about the presence of household firearms (owners 58.4%, others 70.9%), 23.2% disagreed (owners 31.5%, others 17.8%), and 10.5% were uncertain. Differences in parental opinions between owners and other parents were statistically significant. Twenty-two percent of owners would ignore advice to not have household firearms for safety reasons, and 13.9% would be offended by such advice. Only 12.8% of all parents reported a discussion about firearms with the pediatrician. CONCLUSIONS: Avoiding direct questioning about firearm ownership and extending the discussion about why and how to ensure safe storage of firearms to all parents may be an effective strategy to decrease firearm-related injuries and fatalities in children.

A cluster-randomized trial shows telephone peer coaching for parents reduces children's asthma morbidity.

BACKGROUND: Childhood asthma morbidity remains significant, especially in low-income children. Most often, asthma management is provided by the child's primary care provider. OBJECTIVE: We sought to evaluate whether enhancing primary care management for persistent asthma with telephone-based peer coaching for parents reduced asthma impairment and risk in children 3 to 12 years old. METHODS: Over 12 months, peer trainers provided parents with asthma management training by telephone (median, 18 calls) and encouraged physician partnership. The intervention was evaluated in a cluster-randomized trial of 11 intervention and 11 usual care pediatric practices (462 and 486 families, respectively). Patient outcomes were assessed by means of telephone interviews at 12 and 24 months conducted by observers blinded to intervention assignment and compared by using mixed-effects models, controlling for baseline values and clustering within practices. In a planned subgroup analysis we examined the heterogeneity of the intervention effect by insurance type (Medicaid vs other). RESULTS: After 12 months, intervention participation resulted in 20.9 (95% CI, 9.1-32.7) more symptom-free days per child than in the control group, and there was no difference in emergency department (ED) visits. After 24 months, ED visits were reduced (difference in mean visits/child, -0.28; 95% CI, -0.5 to -0.02), indicating a delayed intervention effect. In the Medicaid subgroup, after 12 months, intervention participation resulted in 42% fewer ED visits (difference in mean visits/child, -0.50; 95% CI, -0.81 to -0.18) and 62% fewer hospitalizations (difference in mean hospitalizations/child, -0.16; 95% CI, -0.30 to -0.014). Reductions in health care use endured through 24 months. CONCLUSIONS: This pragmatic telephone-based peer-training intervention reduced asthma impairment. Asthma risk was reduced in children with Medicaid insurance.

Primary care visits for asthma monitoring over time and association with acute asthma visits for urban Medicaid-insured children.

OBJECTIVES: To examine the association between numbers of primary care provider (PCP) visits for asthma monitoring (AM) over time and acute asthma visits in the emergency department (ED) and at the PCP for Medicaid-insured children. METHODS: We prospectively enrolled 2-10 years old children during ED asthma visits. We audited hospital and PCP records for each subject for three consecutive years. We excluded subjects also receiving care from asthma subspecialists. PCP AM visits were those with documentation that suggested discussion of asthma management but no acute asthma symptoms or findings. PCP "Acute Asthma" visits were those with documentation of acute asthma symptoms or findings, regardless of treatment. ED asthma visits were those with documented asthma treatment. Generalized liner models were used to analyze the association between numbers of AM visits and acute asthma visits to the ED and PCP. RESULTS: One hundred three subjects were analyzed. Over the 3 years, the mean number of AM visits/child was 2.5 ± 2.3 (standard deviation), range 0-10. Only 50% of subjects had at least 1 PCP visit with an asthma controller medication documented. The mean number of ED asthma visits/child was 3.2 ± 2.8; range 1-18. The mean number of PCP Acute Asthma visits/child was 0.7 ± 1.6; range 0-11. Increasing AM visits was associated with more ED visits (estimate 0.088; 95% CI 0.001, 0.174), and more PCP Acute Asthma visits (estimate 0.297; 95% CI 0.166, 0.429). Increasing PCP visits for any diagnosis was not associated with ED visits (estimate 0.021; 95% CI -0.018, 0.06). CONCLUSIONS: Asthma monitoring visits and documented controller medication for these urban Medicaid-insured children occurred infrequently over 3 years, and having more asthma monitoring visits was not associated with fewer ED or PCP acute asthma visits.

Pediatric providers' attitudes toward retail clinics.

OBJECTIVE: To describe pediatric primary care providers' attitudes toward retail clinics and their experiences of retail clinics use by their patients. STUDY DESIGN: A 51-item, self-administered survey from 4 pediatric practice-based research networks from the midwestern US, which gauged providers' attitudes toward and perceptions of their patients' interactions with retail clinics, and changes to office practice to better compete. RESULTS: A total of 226 providers participated (50% response). Providers believed that retail clinics were a business threat (80%) and disrupted continuity of chronic disease management (54%). Few (20%) agreed that retail clinics provided care within recommended clinical guidelines. Most (91%) reported that they provided additional care after a retail clinic visit (median 1-2 times per week), and 37% felt this resulted from suboptimal care at retail clinics "most or all of the time." Few (15%) reported being notified by the retail clinic within 24 hours of a patient visit. Those reporting prompt communication were less likely to report suboptimal retail clinic care (OR 0.20, 95% CI 0.10-0.42) or disruption in continuity of care (OR 0.32, 95% CI 0.15-0.71). Thirty-six percent reported changes to office practice to compete with retail clinics (most commonly adjusting or extending office hours), and change was more likely if retail clinics were perceived as a threat (OR 3.70, 95% CI 1.56-8.76); 30% planned to make changes in the near future. CONCLUSIONS: Based on the perceived business threat, pediatric providers are making changes to their practice to compete with retail clinics. Improved communication between the clinic and providers may improve collaboration.

A telephone coaching intervention to improve asthma self-management behaviors.

Long recognizing that asthma, one of the most common chronic childhood diseases, is difficult to manage, the National Asthma Education Prevention Program developed clinical practice guidelines to assist health care providers, particularly those in the primary care setting. Yet, maintenance asthma care still fails to meet national standards. Therefore, in an attempt to improve and support asthma self-management behaviors for parents of children 5 to 12 years of age with persistent asthma, a novel nurse telephone coaching intervention was tested in a randomized, controlled trial. A detailed description of the intervention is provided along with parent satisfaction results, an overview of the training used to prepare the nurses, and a discussion of the challenges experienced and lessons learned.

Partner randomized controlled trial: study protocol and coaching intervention.

BACKGROUND: Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. METHODS AND DESIGN: This paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured. DISCUSSION: Twenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented.

Clinical and laboratory factors associated with negative oral food challenges.

Children with food-specific IgE (FSIgE) ≤2 kUa/L to milk, egg, or peanut (or ≤5kUa/L to peanut without history of previous reaction) are appropriate candidates for oral food challenge (OFC) to investigate resolution of food allergy, because these FSIgE cutoffs are associated with ∼50% likelihood of negative OFC. This study was designed to identify characteristics of children undergoing OFC, based on these FSIgE levels, who are most likely to show negative OFC. We collected demographics, severity of previous reaction, history of atopic diseases, total IgE and FSIgE values, and skin tests results on children who underwent OFCs to milk, egg, or peanut, based on the recommended FSIgE cutoffs. We identified independent factors associated with negative OFCs. Four hundred forty-four OFCs met our inclusion criteria. The proportions of negative OFCs performed based on FSIgE cutoffs alone were 58, 42, and 63% to milk, egg, and peanuts, respectively. Regression models identified independent factors associated with negative OFCs: lower FSIgE levels (all three foods), higher total IgE (milk), consumption of baked egg products (egg), and non-Caucasian race (eggs and peanuts). Combinations of these factors identified subgroups of children with proportions of negative OFCs of 83, 75, and 75% for milk, eggs, and peanuts, respectively. Combinations of clinical and laboratory elements, together with FSIgE values, might identify more children who are likely to have negative OFCs compared with current recommendations using FSIgE values alone. Once validated in a different population, these factors might be used for selection of patients who are most likely to show negative OFCs.

Amoxicillin for acute rhinosinusitis: a randomized controlled trial.

CONTEXT: Evidence to support antibiotic treatment for acute rhinosinusitis is limited, yet antibiotics are commonly used. OBJECTIVE: To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with clinically diagnosed acute rhinosinusitis. DESIGN, SETTING, AND PARTICIPANTS: A randomized, placebo-controlled trial of adults with uncomplicated, acute rhinosinusitis were recruited from 10 community practices in Missouri between November 1, 2006, and May 1, 2009. INTERVENTIONS: Ten-day course of either amoxicillin (1500 mg/d) or placebo administered in 3 doses per day. All patients received a 5- to 7-day supply of symptomatic treatments for pain, fever, cough, and nasal congestion to use as needed. MAIN OUTCOME MEASURES: The primary outcome was improvement in disease-specific quality of life after 3 to 4 days of treatment assessed with the Sinonasal Outcome Test-16 (minimally important difference of 0.5 units on a 0-3 scale). Secondary outcomes included the patient's retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, and satisfaction with and adverse effects of treatment. Outcomes were assessed by telephone interview at days 3, 7, 10, and 28. RESULTS: A total of 166 adults (36% male; 78% with white race) were randomized to amoxicillin (n = 85) or placebo (n = 81); 92% concurrently used 1 or more symptomatic treatments (94% for amoxicillin group vs 90% for control group; P = .34). The mean change in Sinonasal Outcome Test-16 scores was not significantly different between groups on day 3 (decrease of 0.59 in the amoxicillin group and 0.54 in the control group; mean difference between groups of 0.03 [95% CI, -0.12 to 0.19]) and on day 10 (mean difference between groups of 0.01 [95% CI, -0.13 to 0.15]), but differed at day 7 favoring amoxicillin (mean difference between groups of 0.19 [95% CI, 0.024 to 0.35]). There was no statistically significant difference in reported symptom improvement at day 3 (37% for amoxicillin group vs 34% for control group; P = .67) or at day 10 (78% vs 80%, respectively; P = .71), whereas at day 7 more participants treated with amoxicillin reported symptom improvement (74% vs 56%, respectively; P = .02). No between-group differences were found for any other secondary outcomes. No serious adverse events occurred. CONCLUSION: Among patients with acute rhinosinusitis, a 10-day course of amoxicillin compared with placebo did not reduce symptoms at day 3 of treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00377403.

A Novel Innovation and Entrepreneurship (I&E) Training Program for Biomedical Research Trainees.

PROBLEM: Contemporary science emphasizes efficient translation of scientific discoveries into tangible, innovative products and services to improve human health. Therefore, researchers need skills in innovation and entrepreneurship (I&E) to select which problems to address and bring to market the most promising solutions. Training in this skillset is not currently available to most biomedical research trainees. APPROACH: The Entrepreneurship for Biomedicine (E4B) training program was created to develop biomedical researchers' I&E skills. The program comprises 2 semester-length courses: E4B1 teaches core skills; E4B2 focuses on advanced skills for those interested in pursuing funding for a new venture. In addition to traditional entrepreneurship training, E4B teaches ethics and personal skills such as resilience, communication, and team-building. Each course is delivered online and requires about 4 hours weekly. Program elements include short videos for didactic content; a team-based capstone project; mentorship from experienced entrepreneurs; and a live, virtual pitch presentation. The program is housed at Washington University School of Medicine in St. Louis and is open to pre- and postdoctoral biomedical research trainees and faculty nationwide. OUTCOMES: In 2020, 77 trainees completed E4B1 and 13 went on to complete E4B2. Trainees in both courses were satisfied with learning content and mentorship and would recommend the program to a friend. Pre- and postanalyses demonstrated that trainees' confidence in their knowledge about and ability to perform I&E tasks taught throughout the program increased. Since completion, 4 graduates have received external funding for an innovation and 3 have started a company. NEXT STEPS: E4B is well accepted, and this preliminary evaluation suggests the program is effective. It could serve to support medical school curricula, business competitions, and technology transfer efforts, which are opportunities for future exploration. A more robust evaluation is planned and recruitment will be expanded to increase participation from women and underrepresented populations.

Opioids in Adolescents' Homes: Prevalence, Caregiver Attitudes, and Risk Reduction Opportunities.

OBJECTIVE: The most common source of misused opioids is pain relievers prescribed for family and friends. This study was conducted to assess knowledge, attitudes, and behaviors of adolescents' caregivers regarding prescribed opioids in the home. METHODS: The self-administered survey was completed by caregivers in the waiting rooms of 12 pediatric practices in the Midwest. Eligibility required living in a home where youth age ≥10 years were frequently present. Out of 793 eligible caregivers, 700 (88.3%) completed the survey, 76.8% of whom were the parent. RESULTS: Among the 700 caregiver respondents, 34.6% reported opioids in the home (13.6% active prescriptions, 12.7% leftover medications, 8.3% both). Of those with an active prescription, 66.0% intended to keep any leftover medications for future needs (for the patient, 60.1%; for someone else, 5.9%). Of those with leftover medications, 60.5% retained them for the same reason (for the patient, 51.0%; for someone else, 9.5%). Others kept medications unintentionally, either because they never got around to disposing of them (30.6%), they did not know how to dispose of them properly (15.7%), or it never occurred to them to dispose of the medications (7.5%). Many caregivers were unaware that adolescents commonly misuse opioids (30.0%) and use them to attempt suicide (52.3%), and that opioid use can lead to heroin addiction (38.6%). According to the surveys, 7.1% would give leftover opioid medications to an adolescent to manage pain and 5.9% might do so. CONCLUSIONS: Opioids are prevalent in homes in our community, and many parents are unaware of the risks they pose. Study findings can inform strategies to educate parents about opioid risk and encourage and facilitate timely, safe disposal of unused medications.

Designing for Accelerated Translation (DART) of Emerging Innovations in Health.

Accelerating innovation translation is a priority for improving healthcare and health. Although dissemination and implementation (D&I) research has made significant advances over the past decade, it has attended primarily to the implementation of long-standing, well-established practices and policies. We present a conceptual architecture for speeding translation of promising innovations as candidates for iterative testing in practice. Our framework to Design for Accelerated Translation (DART) aims to clarify whether, when, and how to act on evolving evidence to improve healthcare. We view translation of evidence to practice as a dynamic process and argue that much evidence can be acted upon even when uncertainty is moderately high, recognizing that this evidence is evolving and subject to frequent reevaluation. The DART framework proposes that additional factors-demand, risk, and cost, in addition to the evolving evidence base-should influence the pace of translation over time. Attention to these underemphasized factors may lead to more dynamic decision-making about whether or not to adopt an emerging innovation or de-implement a suboptimal intervention. Finally, the DART framework outlines key actions that will speed movement from evidence to practice, including forming meaningful stakeholder partnerships, designing innovations for D&I, and engaging in a learning health system.

Low Back Pain--Related Disability in Parkinson Disease: Impact on Functional Mobility, Physical Activity, and Quality of Life.

BACKGROUND: People with Parkinson disease (PD) frequently experience low back pain (LBP), yet the impact of LBP on functional mobility, physical activity, and quality of life (QOL) has not been described in PD. OBJECTIVE: The objectives of this study were to describe body positions and functional activities associated with LBP and to determine the relationships between LBP-related disability and PD motor sign severity, physical activity level, and QOL. DESIGN: The study was a cross-sectional study. METHODS: Thirty participants with idiopathic PD (mean age = 64.6 years [SD = 10.3]; 15 women) completed the Revised Oswestry Disability Questionnaire (RODQ), a measure of LBP-related disability. PD motor symptom severity was measured using the Movement Disorder Society-Unified Parkinson Disease Rating Scale Part III (MDS-UPRDS III). The Physical Activity Scale for the Elderly (PASE) was used to measure self-reported physical activity. The Parkinson Disease Questionnaire-39 (PDQ-39) was used to measure QOL. Descriptive statistics were used to characterize LBP intensity and LBP-related disability. Spearman correlations were used to determine relationships between the RODQ and the MDS-UPDRS III, PASE, and PDQ-39. RESULTS: LBP was reported to be of at least moderate intensity by 63.3% of participants. LBP most frequently impaired standing, sleeping, lifting, and walking. The RODQ was significantly related to the MDS-UPDRS III (r = 0.38), PASE (r = -0.37), PDQ-39 summary index (r = 0.55), PDQ-39 mobility subdomain (r = 0.54), and PDQ-39 bodily pain subdomain (r = 0.44). LIMITATIONS: Limitations included a small sample of people with mild to moderate PD severity, the fact that RODQ is a less frequently used measure of LBP-related disability, and the lack of a non-PD control group. CONCLUSIONS: LBP affected walking, sleeping, standing, and lifting in this small sample of people with mild to moderate PD. Greater LBP-related disability was associated with greater motor sign severity, lower physical activity level, and lower QOL in people with PD.

Theory-based development of an implementation intervention to increase HPV vaccination in pediatric primary care practices.

BACKGROUND: The national guideline for use of the vaccine targeting oncogenic strains of the human papillomavirus (HPV) is an evidence-based practice that is poorly implemented in primary care. Recommendations include completion of the vaccine series before the 13th birthday for girls and boys, giving the first dose at the 11- to 12-year-old check-up visit, concurrent with other recommended vaccines. Interventions to increase implementation of this guideline have had little impact, and opportunities to prevent cancer continue to be missed. METHODS: We used a theory-informed approach to develop a pragmatic intervention for use in primary care settings to increase implementation of the HPV vaccine guideline recommendation. Using a concurrent mixed methods design in 10 primary care practices, we applied the Consolidated Framework for Implementation Research (CFIR) to systematically investigate and characterize factors strongly influencing vaccine use. We then used the Behavior Change Wheel (BCW) and the Theoretical Domains Framework (TDF) to analyze provider behavior and identify behaviors to target for change and behavioral change strategies to include in the intervention. RESULTS: We identified facilitators and barriers to guideline use across the five CFIR domains: most distinguishing factors related to provider characteristics, their perception of the intervention, and their process to deliver the vaccine. Targeted behaviors were for the provider to recommend the HPV vaccine the same way and at the same time as the other adolescent vaccines, to answer parents' questions with confidence, and to implement a vaccine delivery system. To this end, the intervention targeted improving provider's capability (knowledge, communication skills) and motivation (action planning, belief about consequences, social influences) regarding implementing guideline recommendations, and increasing their opportunity to do so (vaccine delivery system). Behavior change strategies included providing information and communication skill training with graded tasks and modeling, feedback of coverage rates, goal setting, and social support. These strategies were combined in an implementation intervention to be delivered using practice facilitation, educational outreach visits, and cyclical small tests of change. CONCLUSIONS: Using CFIR, the BCW and the TDF facilitated the development of a pragmatic, multi-component implementation intervention to increase use of the HPV vaccine in the primary care setting.

Physical therapy and deep brain stimulation in Parkinson's Disease: protocol for a pilot randomized controlled trial.

BACKGROUND: Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson's Disease (PD). Walking speed, known to be reduced in PD, typically improves after surgery; however, other important aspects of gait may not improve. Furthermore, balance may worsen and falls may increase after STN-DBS. Thus, interventions to improve balance and gait could reduce morbidity and improve quality of life following STN-DBS. Physical therapy (PT) effectively improves balance and gait in people with PD, but studies on the effects of PT have not been extended to those treated with STN-DBS. As such, the efficacy, safety, and feasibility of PT in this population remain to be determined. The purpose of this pilot study is to address these unmet needs. We hypothesize that PT designed to target balance and gait impairment will be effective, safe, and feasible in this population. METHODS/DESIGN: Participants with PD treated with STN-DBS will be randomly assigned to either a PT or control group. Participants assigned to PT will complete an 8-week, twice-weekly PT program consisting of exercises designed to improve balance and gait. Control group participants will receive the current standard of care following STN-DBS, which does not include prescription of PT. The primary aim is to assess preliminary efficacy of PT on balance (Balance Evaluation Systems Test). A secondary aim is to assess efficacy of PT on gait (GAITRite instrumented walkway). Participants will be assessed OFF medication/OFF stimulation and ON medication/ON stimulation at baseline and at 8 and 12 weeks after baseline. Adverse events will be measured over the duration of the study, and adherence to PT will be measured to determine feasibility. DISCUSSION: To our knowledge, this will be the first study to explore the preliminary efficacy, safety, and feasibility of PT for individuals with PD with STN-DBS. If the study suggests potential efficacy, then this would justify larger trials to test effectiveness and safety of PT for those with PD with STN-DBS. TRIAL REGISTRATION: NCT03181282 (clinicaltrials.gov). Registered on 7 June 2017.