Colonoscopy Outreach for Rural Communities (CORC): A study protocol of a pragmatic randomized controlled trial of a patient navigation program to improve colonoscopy completion for colorectal cancer screening.

BACKGROUND: Colonoscopy is one of the primary methods of screening for colorectal cancer (CRC), a leading cause of cancer mortality in the United States. However, up to half of patients referred to colonoscopy fail to complete the procedure, and rates of adherence are lower in rural areas. OBJECTIVES: Colonoscopy Outreach for Rural Communities (CORC) is a randomized controlled trial to test the effectiveness of a centralized patient navigation program provided remotely by a community-based organization to six geographically distant primary care organizations serving rural patients, to improve colonoscopy completion for CRC. METHODS: CORC is a type 1 hybrid implementation-effectiveness trial. Participants aged 45-76 from six primary care organizations serving rural populations in the northwestern United States are randomized 1:1 to patient navigation or standard of care control. The patient navigation is delivered remotely by a trained lay-person from a community-based organization. The primary effectiveness outcome is completion of colonoscopy within one year of referral to colonoscopy. Secondary outcomes are colonoscopy completion within 6 and 9 months, time to completion, adequacy of patient bowel preparation, and achievement of cecal intubation. Analyses will be stratified by primary care organization. DISCUSSION: Trial results will add to our understanding about the effectiveness of patient navigation programs to improve colonoscopy for CRC in rural communities. The protocol includes pragmatic adaptations to meet the needs of rural communities and findings may inform approaches for future studies and programs. TRIAL REGISTRATION: National Clinical Trial Identifier: NCT05453630. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT05453630. Registered July 6, 2022.

Bag-Valve-Mask Ventilation and Survival From Out-of-Hospital Cardiac Arrest: A Multicenter Study.

BACKGROUND: Few studies have measured ventilation during early cardiopulmonary resuscitation (CPR) before advanced airway placement. Resuscitation guidelines recommend pauses after every 30 chest compressions to deliver ventilations. The effectiveness of bag-valve-mask ventilation delivered during the pause in chest compressions is unknown. We sought to determine: (1) the incidence of lung inflation with bag-valve-mask ventilation during 30:2 CPR; and (2) the association of ventilation with outcomes after out-of-hospital cardiac arrest. METHODS: We studied patients with out-of-hospital cardiac arrest from 6 sites of the Resuscitation Outcomes Consortium CCC study (Trial of Continuous Compressions versus Standard CPR in Patients with Out-of-Hospital Cardiac Arrest). We analyzed patients assigned to the 30:2 CPR arm with ≥2 minutes of thoracic bioimpedance signal recorded with a cardiac defibrillator/monitor. Detectable ventilation waveforms were defined as having a bioimpedance amplitude ≥0.5 Ω (corresponding to ≥250 mL VT) and a duration ≥1 s. We defined a chest compression pause as a 3- to 15-s break in chest compressions. We compared the incidence of ventilation and outcomes in 2 groups: patients with ventilation waveforms in <50% of pauses (group 1) versus those with waveforms in ≥50% of pauses (group 2). RESULTS: Among 1976 patients, the mean age was 65 years; 66% were male. From the start of chest compressions until advanced airway placement, mean±SD duration of 30:2 CPR was 9.8±4.9 minutes. During this period, we identified 26 861 pauses in chest compressions; 60% of patients had ventilation waveforms in <50% of pauses (group 1, n=1177), and 40% had waveforms in ≥50% of pauses (group 2, n=799). Group 1 had a median of 12 pauses and 2 ventilations per patient versus group 2, which had 12 pauses and 12 ventilations per patient. Group 2 had higher rates of prehospital return of spontaneous circulation (40.7% versus 25.2%; P<0.0001), survival to hospital discharge (13.5% versus 4.1%; P<0.0001), and survival with favorable neurological outcome (10.6% versus 2.4%; P<0.0001). These associations persisted after adjustment for confounders. CONCLUSIONS: In this study, lung inflation occurred infrequently with bag-valve-mask ventilation during 30:2 CPR. Lung inflation in ≥50% of pauses was associated with improved return of spontaneous circulation, survival, and survival with favorable neurological outcome.

Localized microbially induced inflammation influences distant healthy tissues in the human oral cavity.

Variation in human immune response to the same bacterial or viral pathogen is well established in the literature. Variation in immune response to microbial challenge has also been observed within the human oral cavity. Our recent study focused on characterizing observed variations in microbially induced gingival inflammation-resulting in three distinct clinical Inflammatory Responder Types (IRTs): High-IRT, Low-IRT, and Slow-IRT. Here, we applied a high-resolution temporal multiomic analysis during microbially induced inflammation in order to characterize the effects of localized oral inflammation on distant healthy tissues in young healthy adults. Our results highlight a nonlocalized subclinical effect with alterations in proinflammatory host mediators and an ecological shift toward dysbiosis within the subgingival microbiome in an IRT-dependent manner-despite maintained oral hygiene. Our results provide mechanistic insight into how healthy tissues within humans are influenced by distant localized inflammation and may ultimately become susceptible to disease.

Methamphetamine use and illicit opioid use during buprenorphine treatment.

Introduction: Although methamphetamine use is rising in the United States, its impacts on patient outcomes among persons undergoing treatment for opioid use disorder (OUD) remain unclear. This study aims to assess the association between baseline methamphetamine/amphetamine (MA/A) use and subsequent illicit opioid use among patients with OUD initiating buprenorphine in an office-based setting. Methods: We conducted a secondary analysis of a pilot randomized controlled trial of a behavioral mobile health intervention for buprenorphine adherence conducted over a 12-week study period at two clinic sites. The study defined baseline MA/A use by a positive urine drug test (UDT) and/or self-report of use within the past 30-days. Separate Poisson regression models with robust standard errors evaluated associations between MA/A and: i) illicit opioid use measured by weekly UDT (primary) and ii) self-reported past 30-day use at end of study (secondary). Other secondary outcomes included buprenorphine positive UDTs throughout the study and retention in OUD treatment at both weeks 12 and 24 post-randomization. Results: At baseline, 28 (36%) of the 78 participants had MA/A use and use was associated with a statistically significant increase in risk of testing positive for illicit opioids on UDT during the study follow-up period (adjusted relative risk (aRR)=1.54; 95% CI=1.09-2.17; p=0.015), as well as an increased risk for reported past 30-day illicit opioid use at week 12 (aRR=3.86; 95% CI=1.47-10.18; P=0.006). The study found no significant associations between MA/A use and buprenorphine positive UDT or retention in OUD treatment. Conclusions: In this sample of patients initiating buprenorphine, methamphetamine/amphetamine use at baseline was associated with illicit opioid use over a 12-week period. These findings demonstrate how co-use of methamphetamine can impede attainment of ideal OUD treatment outcomes.

Use of Video Directly Observed Therapy and Characteristics Associated With Use Among Patients Treated With Buprenorphine in an Office-based Setting.

OBJECTIVES: Video directly observed therapy (video DOT) is a tool for confirming buprenorphine adherence that could complement the use of urine toxicology; research is needed to characterize the patients who are receptive and able to use this technology. We aimed to describe video DOT utilization and assess participant characteristics associated with use. METHODS: We performed a secondary analysis of data from a pilot randomized controlled trial of adults who recently initiated sublingual buprenorphine in office-based programs, restricting to intervention arm participants, which consisted of 12 weeks of video DOT via a mobile health technology platform. Participants were instructed to record at least 1 daily video of buprenorphine self-administration. Poisson regression models with robust standard errors were used to measure associations between participant characteristics and frequency of submitted videos. RESULTS: The sample included 39 participants. Of 3276 possible videos, 1002 (31%) were submitted. Age ≥40 years (relative risk [RR], 2.54 [95% confidence interval {CI}, 1.31-4.91]) and once-daily buprenorphine dosing (RR, 3.10 [95% CI, 1.76-5.48]) were positively associated with video submissions. Non-White race (RR, 0.43 [95% CI, 0.19-0.97]), less than high school education (RR, 0.27 [95% CI, 0.10-0.74]), history of previous buprenorphine treatment (RR, 0.50 [95% CI, 0.25-0.97]), and ≥3 previous treatment attempts (RR, 0.16 [95% CI, 0.07-0.37]) were negatively associated. CONCLUSIONS: Video DOT utilization resulted in about a third of expected videos, although there were differences in use according to age, race, buprenorphine treatment factors, and educational status. Such differences underscore that mobile-health interventions such as video DOT may not be equally used by all patients.Trial Registration : ClinicalTrails.gov , NCT03779997 , registered on December 19, 2018.

Buprenorphine adherence and illicit opioid use among patients in treatment for opioid use disorder.

Background: Buprenorphine is a partial mu opioid agonist medication that has been shown to decrease non-prescribed opioid use, cravings, and opioid related morbidity and mortality. There is an assumption that full adherence is needed to achieve ideal treatment outcomes, and that non-adherence is associated with ongoing opioid use. However, literature documenting the strength of that assertion is lacking.Objectives: Evaluate the association between daily buprenorphine adherence and illicit opioid use.Methods: Secondary analysis of a 12-week randomized controlled trial of adults with opioid use disorder who recently initiated buprenorphine. Weekly study visits included self-report of daily buprenorphine adherence over the past 7 days (Timeline Follow Back method) and urine drug tests (UDT). A log-linear regression model accounting for clustering by participant was used to assess the association between buprenorphine adherence and illicit opioid use. Buprenorphine adherence was measured as a continuous variable (0-7 days).Results: Among 78 participants (56 men, 20 women, 2 nonbinary) with 737 visits, full 7-day adherence was reported at 70% of visits. The predominant form of non-adherence was missed doses (92% of cases). Each additional day of adherence was associated with an 8% higher rate of negative UDT for illicit opioids (RR = 1.08; 95% CI:1.03-1.13, p = .0002).Conclusion: In this sample of participants starting buprenorphine, missed doses were not uncommon. Fewer missed days was significantly associated with a lower risk of illicit opioid use. These findings suggest that efforts to minimize the number of missed days of buprenorphine are beneficial for treatment outcomes.

Observations by Caregivers Using the Infant with Clefts Observation Outcomes Instrument (iCOO): A Comparison of Three Versus Seven-day Daily Diaries.

OBJECTIVE: Our goal was to compare data collected from 3- and 7-day Infant with Clefts Observation Outcomes (iCOO) diaries. DESIGN: Secondary data analysis of an observational longitudinal cohort study. Caregivers completed the daily iCOO for 7 days before cleft lip surgery (T0) and for 7 days after cleft lip repair (T1). We compared 3- and 7-day diaries collected at T0 and 3- and 7-day diaries collected at T1. SETTING: United States. PARTICIPANTS: Primary caregivers of infants with cleft lip with and without cleft palate (N = 131) planning lip repair and enrolled in original iCOO study. MAIN OUTCOMES MEASURE(S): Mean differences and Pearson correlation coefficients. RESULTS: Correlation coefficients were high for global impressions (>0.90) and scaled scores (0.80-0.98). Mean differences were small across iCOO domains at T0. T1 comparisons reflected the same pattern. CONCLUSIONS: Three-day diary data is comparable to 7-day diaries for measuring caregiver observations using iCOO across T0 and T1.

Bias in the superimposition of lateral cephalograms in adult patients with anterior open bite.

INTRODUCTION: Anterior open bite malocclusion can be treated nonsurgically using fixed appliances, clear aligners, or temporary anchorage devices (TADs). Proponents of clear aligners and TADs often attribute bite closure to molar intrusion and counterclockwise rotation of the mandibular plane. These changes may be supported by superimpositions. However, the process of creating a superimposition is subjective and may be influenced by practitioner bias. METHODS: The initial and final lateral cephalograms from 30 adult anterior patients with open bite were used in this study. Ten patients were treated with fixed appliances, 10 with clear aligners, and 10 with TADs. We asked 6 orthodontic graduate students and 6 orthodontic practitioners to complete superimpositions using these radiographs in 3 separate sessions. In the first session, the raters were told that all patients only received treatment with fixed appliances. In the second session, the raters were told that all patients were treated with clear aligners only, and in the third session, they were told all patients were treated with fixed appliances and TADs. Superimpositions were performed using Dolphin software, and each superimposition was saved as a Portable Document Format image. Change in the mandibular plane was the primary outcome and was assessed categorically (closed, no change, opened). Cephalometric values were measured and used to investigate the dental and skeletal changes associated with treatment. RESULTS: Although the raters demonstrated a slight tendency toward the mandibular plane closing or staying the same when told the treatment was clear aligners or TADs, these differences were not statistically significant. A high degree of intrarater and interrater variability in the mandibular plane change was present in all 3 superimposition sessions. The measurements from the lateral cephs showed significant changes for overbite and incisor vertical and angular movements. Almost no change was observed in anterior facial height, mandibular plane angle, or vertical movement of the first molars. CONCLUSIONS: This study did not observe a significant amount of superimposition bias. However, there was considerable intrarater and interrater reliability. This suggests that the same initial and final cephs may be interpreted very differently on the basis of the subjective superimposition of the raters.

Exploration of Caregiver Interrater Agreement and Test-Retest Reliability on the Infant Cleft Observer Outcomes (iCOO).

Caregiver and observer-reported measures are frequently used as outcomes for research on infants and young children who are unable to report on their own health. Our team developed the Infant with Clefts Observation Outcomes Instrument (iCOO) for infants with cleft lip with or without cleft palate. This exploratory study compared test-retest and interrater reliabilities to inform whether differences in caregiver perspective might affect the iCOO.This study is a secondary analysis comparing caregiver interrater agreement to test-retest reliability. Twenty-five pairs of caregivers completed the iCOO before surgery, 1 week later for test-retest reliability, 2 days after surgery, and 2 months after surgery. Reliability was assessed using intraclass correlations (ICCs) and t-tests were used to compare ratings between caregivers.Infants had cleft lip (28%) or cleft lip and palate (72%). Primary caregivers were predominantly mothers (92%) and secondary caregivers were predominantly fathers (80%). Test-retest reliability met psychometric standards for most items on the iCOO (81%-86% of items). Caregiver agreement on the iCOO items was lower than test-retest reliability (33%-46% of items met psychometric standards). Caregivers did not systematically differ in whether they rated infants as healthier or less healthy than the other caregiver (5%-16% of items had statistically significant differences).Caregivers used the measure consistently, but had different experiences and perceptions of their infant's health and functioning. Future studies are needed to explore mechanisms for the differences in test-retest and interrater reliability. Whenever possible, the same caregiver should provide ratings of the infant, including on the iCOO.

Local Anesthetic Efficacy in Marijuana Users and Nonusers: A Pilot Study.

OBJECTIVE: Despite the common clinical impression that patients with a history of drug use are challenging to anesthetize with local anesthesia, literature on this clinical phenomenon is sparse. The objective of this pilot study was to assess if differences in local anesthetic efficacy for dental treatment exist between marijuana users and nonusers. METHODS: Subjects were healthy adult males and females who qualified as either chronic marijuana users or nonusers. All subjects had an asymptomatic, vital maxillary lateral incisor that responded to an electric pulp test (EPT). A standard maxillary infiltration injection technique was employed using 1.7 mL 2% lidocaine with 1:100,000 epinephrine over the test tooth, and the tooth was tested with an EPT at 3-minute intervals. RESULTS: A total of 88% of nonusers (15/17) and 61% of users (11/18) were successfully anesthetized, defined as anesthesia onset within 10 minutes and lasting at least 15 minutes. The difference in the proportion of anesthetized subjects was not statistically significant (P = .073). For subjects with successful anesthesia, there was no significant difference between nonusers and users in the onset or duration of anesthesia. CONCLUSION: No significant differences in local anesthetic efficacy with respect to local anesthetic success, onset, or duration of action were found between chronic marijuana users and nonusers. However, larger studies are likely needed to provide more definitive evidence.

Caregiver Observations of Infant Well-Being Before and After Cleft Lip Surgery.

OBJECTIVE: To evaluate the sensitivity to change of daily ratings of the comfort (COMF) and behavioral/emotional health (BEH) domains of the Infants with Clefts Observation Outcomes Instrument (iCOO) at 3 time points, and to assess the association of post-surgical interventions on iCOO ratings. DESIGN: The COMF and BEH domains were completed by caregivers before (T0), immediately after (T1), and 2-months after (T2) cleft lip (CL) surgery. Analyses included descriptive statistics, correlations, t-tests, and generalized estimating equations. PARTICIPANTS: Caregivers (N = 140) of infants with CL with/without cleft palate. MAIN OUTCOME MEASURES: The COMF and BEH domain scores of the iCOO: Scale (SCALE), a summary of observable signs; and Global Impression (IMPR), a single item measuring caregivers' overall impression. RESULTS: Daily COMF and BEH SCALE and IMPR scores changed significantly during T1 (P's < 0.001) but not T0 or T2. Day 1 and 7 T0 scores were significantly higher than Day 1 and 7 T1 scores (P's <0.001 to <0.012) but similar at T2 (P's > 0.05). After CL surgery, the combined use of immobilizers and nasal stents and the use of multiple feeding methods with treatment for gastroesophageal reflux were associated with lower daily scores in COMF and BEH SCALE and IMPR (P's: 0.040 to <0.001). CONCLUSIONS: COMF and BEH iCOO scores were sensitive to daily changes in infant well-being following CL surgery. Future studies should further investigate impact of post-surgical treatments on infant well-being.

Clinical-community linkages as a strategy for increasing evidence-based program reach: Results of the PT-REFER randomized controlled trial with older adults and YMCA associations.

BACKGROUND: Most older adults do not meet recommended guidelines for physical activity. Referrals from physical therapists (PTs) to community- and evidence-based physical-activity programs like Enhance®Fitness have potential to address this gap. We tested an intervention intended to increase referrals of older adults to Enhance®Fitness programs offered at YMCAs. MATERIALS AND METHODS: We developed a capacity-building intervention that included a structured toolkit and technical-assistance calls. From April 2016 to September 2018, using stratified randomization, we conducted a trial with 20 YMCA Associations randomized into intervention and control arms. The primary outcome was the number of new Enhance®Fitness enrollees during the trial period. Using both quantitative and qualitative methods, we also conducted process and intermediate-outcome evaluations to assess intervention implementation and Association outreach activities, barriers, and facilitators. RESULTS: The intervention was implemented as intended, but PT outreach was similar for both intervention and control YMCA Associations. The intervention arm had similar enrollment (1695 new enrollees) to the control arm (1326 new enrollees; 95% confidence interval, -47%-199%, P = 0.61). Interviews revealed that barriers, including lack of staff and time for outreach, limited capacity for Enhance®Fitness program growth, and competing priorities, outweighed facilitators, including existing partnerships, presence of an outreach team, senior leadership support, and infrastructure for referrals. CONCLUSIONS: YMCA Associations in the intervention arm were unable to increase their outreach to PTs and enrollment in Enhance®Fitness. Our evaluation findings indicate that community organizations that prioritize program growth, have support at all organizational levels, and allocate staff and time for outreach and partnership development may be more successful in creating sustainable linkages with clinical partners and increasing evidence-based-program reach.

Closing the gap: Triangulation of surgeons' respectful behaviors perceived by medical students, residents, and patients.

BACKGROUND: Professionalism in academia requires surgical faculty to establish a safe clinical learning environment based on respectful behaviors that span the training and patient interface. National data reporting trainee mistreatment suggest that there are significant gaps between resident and medical student perceptions of attending behavior. It is unknown whether patient perceptions mirror those of surgical trainees. HYPOTHESIS: Based on triangulated ratings, patients, surgical residents, and medical students have similar perceptions of a surgeons' respectful behaviors. METHODS: Respect scores from end-of-rotation evaluations by surgical residents and rotating medical students were compared for 50 academic surgeons over the period of 2014 to 2018. Clinician and Group Consumer Assessment surveys were collected from patients of 36 of these surgeons and mined for respect and listening behavior ratings. Data were triangulated and analyzed for correlation and variability across the trainee and patient experiences. RESULTS: Resident respect ratings of faculty were consistently higher than those from medical students. Despite a wider variability, medical students still rated their surgical faculty as being respectful to themselves and others most often, almost always, and always 95% of the time. Patient scores were generally lower than trainee scores for an individual surgeon, particularly regarding listening skills. Triangulation of trainee data with patient data identified surgeons demonstrating strong respectful behaviors across the clinical environment as well as those with gaps in behavior toward trainees and patients. CONCLUSION: Triangulation of feedback from trainees and patients provides a unique opportunity to target interventions in professionalism across the clinical learning environment.

Anterior openbite malocclusion in adults.

OBJECTIVES: To investigate stability and satisfaction in adult anterior open bite (AOB) patients at least 9 months post-treatment, as well as patient and practitioner factors that may be associated with stability and satisfaction. MATERIALS AND METHODS: Practitioners and their adult AOB patients were recruited through the National Dental Practice-Based Research Network. Data on patient and practitioner characteristics, treatment recommendations and factors were previously collected. Treatment stability was determined by assessing post-treatment intraoral photographs. Patient satisfaction was determined from post-treatment questionnaires. Treatment was categorized into aligners, fixed appliances, temporary anchorage devices, and orthognathic surgery. Extractions were also investigated. Retention type was categorized into vacuum-formed, Hawley-style, or bonded retainers, and regimens were classified as full-time or part-time wear. RESULTS: Retention data collected from 112 patients had a mean post-treatment time of 1.21 years. There were no statistically significant differences in stability between treatment groups. Depending on whether a qualitative index or a millimetric measure was employed, stability ranged from 65% to 89%. Extractions and less initial lower incisor proclination were associated with higher stability in patients treated with fixed appliances only. High satisfaction was reported by patients at retention. There were no clear differences in stability or satisfaction among retention types or regimens. CONCLUSIONS: The stability of adult AOB orthodontic treatment was high, regardless of treatment or retainer modality. Satisfaction in adult AOB patients was high, regardless of retention type or regimen.

Infant with Clefts Observation Outcomes Instrument (iCOO): A New Outcome for Infants and Young Children with Orofacial Clefts.

OBJECTIVE: We evaluated the measurement properties for item and domain scores of the Infant with Clefts Observation Outcomes Instrument (iCOO). DESIGN: Cross-sectional (before lip surgery) and longitudinal study (preoperative baseline and 2 days and 2 months after lip surgery). SETTING: Three academic craniofacial centers and national online advertisements. PARTICIPANTS: Primary caregivers with an infant with cleft lip with or without cleft palate (CL ± P) scheduled to undergo primary lip repair. There were 133 primary caregivers at baseline, 115 at 2 days postsurgery, and 112 at 2 months postsurgery. MAIN OUTCOME MEASURE(S): Caregiver observation items (n = 61) and global impression of health and function items (n = 8) across eight health domains. RESULTS: Mean age at surgery was 6.0 months (range 2.7-11.8 months). Five of eight iCOO domains have scale scores, with Cronbach's alphas ranging from 0.67 to 0.87. Except for the Facial Skin and Mouth domain, iCOO scales had acceptable intraclass correlation coefficients (ICCs) ranging from 0.76 to 0.84. The internal consistency of the Global Impression items across all domains was 0.90 and had acceptable ICCs (range 0.76-0.91). Sixteen out of 20 (nonscale) items had acceptable ICCs (range 0.66-0.96). As anticipated, iCOO scores 2 days postoperatively were generally lower than baseline and scores 2 months postsurgery were consistent with baseline or higher. The iCOO took approximately 10 min to complete. CONCLUSIONS: The iCOO meets measurement standards and may be used for assessing the impact of cleft-related treatments in clinical research and care. More research is needed on its use in various treatment contexts.

Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial.

BACKGROUND: We conducted a pilot study to assess feasibility of using video directly-observed therapy (DOT) for patients initiating buprenorphine to evaluate whether it is associated with better opioid use disorder (OUD) outcomes when compared to treatment-as-usual (TAU). METHODS: Pilot randomized controlled trial of adult patients with OUD initiating buprenorphine treatment (n = 78) at two sites (Seattle, WA and Boston, MA) from January 2019 to May 2020. Intervention was video DOT using a HIPAA-compliant smartphone application to record taking daily buprenorphine. Study smartphones, text reminders to upload a video, and calendar summaries of video DOT adherence were provided. Main outcomes were 1) percentage of 12 weekly urine drug tests (UDT) negative for illicit opioids and 2) engagement in treatment at week 12 (i.e., having an active prescription for buprenorphine within the last 7 days). RESULTS: Of 78 enrolled, 20 (26 %) were female; 29 (37 %) non-white; and 31 (40 %) homeless. The mean (standard deviation) percentage of doses confirmed by video was 31 % (34 %). In intention-to-treat analysis, the average percentage of weekly opioid negative UDT was 50 % (95 % CI: 40-63 %) in the intervention arm versus 64 % (95 % CI: 55-74 %) among controls; RR = 0.78 (95 % CI: 0.60-1.02, p = 0.07). Engagement at week 12 was 69 % (95 % CI: 56-86 %) v. 82 % (95 % CI: 71-95 %) in the intervention vs. TAU arms, respectively; RR = 0.84 (95 % CI: 0.65-1.10, p = 0.20). CONCLUSIONS: The video DOT intervention did not result in improvements in illicit opioid use and treatment engagement compared to TAU. The study was limited by low rates of intervention use. TRIAL REGISTRATION: ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.

Human variation in gingival inflammation.

Oral commensal bacteria actively participate with gingival tissue to maintain healthy neutrophil surveillance and normal tissue and bone turnover processes. Disruption of this homeostatic host-bacteria relationship occurs during experimental gingivitis studies where it has been clearly established that increases in the bacterial burden increase gingival inflammation. Here, we show that experimental gingivitis resulted in three unique clinical inflammatory phenotypes (high, low, and slow) and reveal that interleukin-1ß, a reported major gingivitis-associated inflammatory mediator, was not associated with clinical gingival inflammation in the slow response group. In addition, significantly higher levels of Streptococcus spp. were also unique to this group. The low clinical response group was characterized by low concentrations of host mediators, despite similar bacterial accumulation and compositional characteristics as the high clinical response group. Neutrophil and bone activation modulators were down-regulated in all response groups, revealing novel tissue and bone protective responses during gingival inflammation. These alterations in chemokine and microbial composition responses during experimental gingivitis reveal a previously uncharacterized variation in the human host response to a disruption in gingival homeostasis. Understanding this human variation in gingival inflammation may facilitate the identification of periodontitis-susceptible individuals. Overall, this study underscores the variability in host responses in the human population arising from variations in host immune profiles (low responders) and microbial community maturation (slow responders) that may impact clinical outcomes in terms of destructive inflammation.

Prediction of school-age IQ, academic achievement, and motor skills in children with positional plagiocephaly.

INTRODUCTION: Children with positional plagiocephaly and/or brachycephaly (PPB) are at risk of early developmental delay, but little is known about early life factors associated with school-age neurodevelopment. This study examined associations of demographic characteristics, prenatal risk factors and early neurodevelopment assessment with school-age IQ, academic performance, and motor development in children with PPB. METHODS: The study sample consisted of 235 school-age children with PPB followed since infancy. Outcome measures included IQ using the Differential Ability Scales-Second Edition, academic achievement as measured by the Wechsler Individualized Achievement Tests-Third Edition), and motor function using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition. Linear regression was used to examine the incremental improvement of model fit of demographics, prenatal and early life characteristics, severity of PPB, and neurodevelopment at ages 7, 18, and 36 months as measured by the Bayley-3 on school-age scores. RESULTS: Mean age at school-age assessment was 9.0 years. Adjusted r2 for demographic, prenatal, and early life risk factors ranged from 0.10 to 0.22. Addition of PPB severity and Bayley-3 measures at ages 7 and 18 months did not meaningfully change model fit. Adjusted r2 after inclusion of Bayley-3 at 36 months ranged from 0.35 to 0.41. CONCLUSION: This study suggests that PPB severity and very early life neurodevelopment have little association with school-age neurodevelopment above and beyond demographic and early life risk factors. However, preschool-age neurodevelopmental assessment may still be useful in identifying children with PPB at risk for delay and who may benefit from early intervention.

Association of Intra-arrest Transport vs Continued On-Scene Resuscitation With Survival to Hospital Discharge Among Patients With Out-of-Hospital Cardiac Arrest.

Importance: There is wide variability among emergency medical systems (EMS) with respect to transport to hospital during out-of-hospital cardiac arrest (OHCA) resuscitative efforts. The benefit of intra-arrest transport during resuscitation compared with continued on-scene resuscitation is unclear. Objective: To determine whether intra-arrest transport compared with continued on-scene resuscitation is associated with survival to hospital discharge among patients experiencing OHCA. Design, Setting, and Participants: Cohort study of prospectively collected consecutive nontraumatic adult EMS-treated OHCA data from the Resuscitation Outcomes Consortium (ROC) Cardiac Epidemiologic Registry (enrollment, April 2011-June 2015 from 10 North American sites; follow-up until the date of hospital discharge or death [regardless of when either event occurred]). Patients treated with intra-arrest transport (exposed) were matched with patients in refractory arrest (at risk of intra-arrest transport) at that same time (unexposed), using a time-dependent propensity score. Subgroups categorized by initial cardiac rhythm and EMS-witnessed cardiac arrests were analyzed. Exposures: Intra-arrest transport (transport initiated prior to return of spontaneous circulation), compared with continued on-scene resuscitation. Main Outcomes and Measures: The primary outcome was survival to hospital discharge, and the secondary outcome was survival with favorable neurological outcome (modified Rankin scale <3) at hospital discharge. Results: The full cohort included 43 969 patients with a median age of 67 years (interquartile range, 55-80), 37% were women, 86% of cardiac arrests occurred in a private location, 49% were bystander- or EMS-witnessed, 22% had initial shockable rhythms, 97% were treated by out-of-hospital advanced life support, and 26% underwent intra-arrest transport. Survival to hospital discharge was 3.8% for patients who underwent intra-arrest transport and 12.6% for those who received on-scene resuscitation. In the propensity-matched cohort, which included 27 705 patients, survival to hospital discharge occurred in 4.0% of patients who underwent intra-arrest transport vs 8.5% who received on-scene resuscitation (risk difference, 4.6% [95% CI, 4.0%- 5.1%]). Favorable neurological outcome occurred in 2.9% of patients who underwent intra-arrest transport vs 7.1% who received on-scene resuscitation (risk difference, 4.2% [95% CI, 3.5%-4.9%]). Subgroups of initial shockable and nonshockable rhythms as well as EMS-witnessed and unwitnessed cardiac arrests all had a significant association between intra-arrest transport and lower probability of survival to hospital discharge. Conclusions and Relevance: Among patients experiencing out-of-hospital cardiac arrest, intra-arrest transport to hospital compared with continued on-scene resuscitation was associated with lower probability of survival to hospital discharge. Study findings are limited by potential confounding due to observational design.

Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial.

BACKGROUND: Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT delivered via a smartphone app on office-based buprenorphine treatment outcomes, namely illicit opioid use and retention. METHODS: Participants will be recruited from office-based opioid addiction treatment programs in outpatient clinics at two urban medical centers and randomized to either video DOT (intervention) delivered via a HIPAA-compliant, asynchronous, mobile health (mHealth) technology platform, or treatment-as-usual (control). Eligibility criteria are: 18 years or older, prescribed sublingual buprenorphine for a cumulative total of 28 days or less from the office-based opioid treatment program, and able to read and understand English. Patients will be considered ineligible if they are unable or unwilling to use the intervention, provide consent, or complete weekly study visits. All participants will complete 13 in-person weekly visits and be followed via electronic health record data capture at 12- and 24-weeks post-randomization. Data gathered include the following: demographics; current and previous treatment for OUD; self-reported diversion of prescribed buprenorphine; status of their mental and physical health; and self-reported lifetime and past 30-day illicit substance use. Participants provide urine samples at each weekly visit to test for illicit drugs and buprenorphine. The primary outcome is percentage of weekly urines that are negative for opioids over the 12-weeks. The secondary outcome is engagement in treatment at week 12. DISCUSSION: Video DOT delivered through mHealth technology platform offers possibility of improving patients' buprenorphine adherence by providing additional structure and accountability. The TAAB study will provide important preliminary estimates of the impact of this mHealth technology for patients initiating buprenorphine, as well as the feasibility of study procedures, thus paving the way for further research to assess feasibility and generate preliminary data for design of a future Phase III trial. Trial Registration ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.