Peer Texting to Promote Quitline Use and Smoking Cessation Among Rural Participants in Vietnam: Randomized Clinical Trial.

Objectives: We tested an adapted version of an effective U.S.-based peer-texting intervention to promote Quitline use and smoking cessation among rural participants in Vietnam. Methods: We conducted a two-arm randomized trial with participants recruited at four rural community centers. The intervention included peer messages sent for six months that promoted Quitline use and smoking cessation. Additionally, biweekly two-way text messages assessed participants' interest in Quitline referral and current smoking status. Comparison participants received only the bi-weekly text message assessment of their current smoking status. At six months, we assessed Quitline use and smoking cessation. Smoking cessation was assessed using the 7-day point prevalence question and verified with a carbon monoxide breath monitor (<=6 ppm). Results: Among 750 participants, the intervention had higher Quitline verified use (18%, 95% CI 0.14, 0.22) than comparison (1%, 95% CI .2, 2, p < 0.0001). Carbon-monoxide-verified smoking cessation did not differ between the two groups. However, intervention (28.3%, 95% CI) and comparison (28.1%, 95% CI) participants had substantial rates of carbon monoxide cessation at 6 months (both 28%). Conclusion: Our study highlighted the promise of texting interventions to extend tobacco control efforts in Vietnam.

Examining racial/ethnic inequities in treatment participation among perinatal individuals with depression.

OBJECTIVE: A cluster randomized controlled trial (RCT) of two interventions for addressing perinatal depression treatment in obstetric settings was conducted. This secondary analysis compared treatment referral and participation among Minoritized perinatal individuals compared to their non-Hispanic white counterparts. METHODS: Among perinatal individuals with depression symptoms, we examined rates of treatment 1) referral (i.e., offered medications or referred to mental health clinician), 2) initiation (i.e., attended ≥1 mental health visit or reported prescribed antidepressant medication), and 3) sustainment (i.e., attended >1 mental health visit per study month or prescribed antidepressant medication at time of study interviews). We compared non-Hispanic white (NHW) (n = 149) vs. Minoritized perinatal individuals (Black, Asian, Hispanic/Latina, Pacific Islander, Native American, Multiracial, and white Hispanic/Latina n = 157). We calculated adjusted odds ratios (aOR) for each outcome. RESULTS: Minoritized perinatal individuals across both interventions had significantly lower odds of treatment referral (aOR = 0.48;95% CI = 0.27-0.88) than their NHW counterparts. There were no statistically significant differences in the odds of treatment initiation (aOR = 0.64 95% CI:0.36-1.2) or sustainment (aOR = 0.54;95% CI = 0.28-1.1) by race/ethnicity. CONCLUSIONS: Perinatal mental healthcare inequities are associated with disparities in treatment referrals. Interventions focusing on referral disparities across race and ethnicity are needed.

Effectiveness of two systems-level interventions to address perinatal depression in obstetric settings (PRISM): an active-controlled cluster-randomised trial.

BACKGROUND: Perinatal depression is a common and undertreated condition, with potential deleterious effects on maternal, obstetric, infant, and child outcomes. We aimed to compare the effectiveness of two systems-level interventions in the obstetric setting-the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and the PRogram In Support of Moms (PRISM)-in improving depression symptoms and participation in mental health treatment among women with perinatal depression. METHODS: In this cluster-randomised, active-controlled trial, obstetric practices across Massachusetts (USA) were allocated (1:1) via covariate adaptive randomisation to either continue participating in the MCPAP for Moms intervention, a state-wide, population-based programme, or to participate in the PRISM intervention, which involved MCPAP for Moms plus a proactive, multifaceted, obstetric practice-level intervention with intensive implementation support. English-speaking women (aged ≥18 years) who screened positive for depression (Edinburgh Postnatal Depression Scale [EPDS] score ≥10) were recruited from the practices. Patients were followed up at 4-25 weeks of gestation, 32-40 weeks of gestation, 0-3 months postpartum, 5-7 months postpartum, and 11-13 months postpartum via telephone interview. Participants were masked to the intervention; investigators were not masked. The primary outcome was change in depression symptoms (EPDS score) between baseline assessment and 11-13 months postpartum. Analysis was done by intention to treat, fitting generalised linear mixed models adjusting for age, insurance status, education, and race, and accounting for clustering of patients within practices. This trial is registered with ClinicalTrials.gov, NCT02760004. FINDINGS: Between July 29, 2015, and Sept 20, 2021, ten obstetric practices were recruited and retained; five (50%) practices were randomly allocated to MCPAP for Moms and five (50%) to PRISM. 1265 participants were assessed for eligibility and 312 (24·7%) were recruited, of whom 162 (51·9%) were enrolled in MCPAP for Moms practices and 150 (48·1%) in PRISM practices. Comparing baseline to 11-13 months postpartum, EPDS scores decreased by 4·2 (SD 5·2; p<0·0001) among participants in MCPAP for Moms practices and by 4·3 (SD 4.5; p<0·0001) among those in PRISM practices (estimated difference between groups 0·1 [95% CI -1·2 to 1·4]; p=0·87). INTERPRETATION: Both the MCPAP for Moms and PRISM interventions were equally effective in improving depression symptoms. This finding is important because the 4-point decrease in EPDS score is clinically significant, and MCPAP for Moms has a lower intensity and greater population-based reach than does PRISM. FUNDING: US Centers for Disease Control and Prevention.

Prognostic heterogeneity and clonal dynamics within distinct subgroups of myelodysplastic syndrome and acute myeloid leukemia with TP53 disruptions.

TP53 aberrations constitute the highest risk subset of myelodysplastic neoplasms (MDS) and acute myeloid leukemia (AML). The International Consensus Classification questions the blast threshold between MDS and AML. In this study, we assess the distinction between MDS and AML for 76 patients with TP53 aberrations. We observed no significant differences between MDS and AML regarding TP53 genomics. Median overall survival (OS) was 223 days for the entire group, but prognostic discrimination within subgroups showed the most inferior OS (46 days) for AML with multihit allelic state plus TP53 variant allele frequency (VAF) > 50%. In multivariate analysis, unadjusted Cox models revealed the following variables as independent risk factors for mortality: AML (vs. MDS) (hazard ratio [HR]: 2.50, confidence interval [CI]: 1.4-4.4, p = 0.001), complex karyotype (HR: 3.00, CI: 1.4-6.1, p = 0.003), multihit status (HR: 2.30, CI 1.3-4.2, p = 0.005), and absence of hematopoietic cell transplant (HCT) (HR: 3.90, CI: 1.8-8.9, p = 0.0009). Clonal dynamic modeling showed a significant reduction in TP53 VAF with front-line hypomethylating agents. These findings clarify the impact of specific covariates on outcomes of TP53-aberrant myeloid neoplasms, irrespective of the diagnosis of MDS versus AML, and may influence HCT decisions.

Understanding Perinatal Depression Care Gaps by Examining Care Access and Barriers in Perinatal Individuals With and Without Psychiatric History.

Background: Depression affects one in seven perinatal individuals and remains underdiagnosed and undertreated. Individuals with a psychiatric history are at an even greater risk of perinatal depression, but it is unclear how their experiences with the depression care pathway may differ from individuals without a psychiatric history. Methods: We conducted a secondary analysis evaluating care access and barriers to care in perinatal individuals who screened positive for depression using the Edinburgh Postnatal Depression Scale (N = 280). Data were analyzed from the PRogram in Support of Moms (PRISM) study, a cluster randomized controlled trial of two interventions for perinatal depression. Results: Individuals with no prepregnancy psychiatric history (N = 113), compared with those with a history (N = 167), were less likely to be screened for perinatal depression, and less likely to be offered a therapy referral, although equally likely to attend if referred. When examining how these differences affected outcomes, those without a psychiatric history had 46% lower odds of attending therapy (95% confidence interval [CI]: 0.19-1.55), 79% lower odds of taking medication (95% CI: 0.08-0.54), and 80% lower odds of receiving any depression care (95% CI: 0.08-0.47). Barriers were similar across groups, except for concerns regarding available treatments and beliefs about self-resolution of symptoms, which were more prevalent in individuals without a psychiatric history. Conclusions: Perinatal individuals without a prepregnancy psychiatric history were less likely to be screened, referred, and treated for depression. Differences in screening and referrals resulted in missed opportunities for care, reinforcing the urgent need for universal mental health screening and psychoeducation during the perinatal period. Clinical Trial Registration No.: NCT02935504.

Wound Care Adherence in Mohs Micrographic Surgery: A Prospective Cohort Study.

BACKGROUND: Patients undergoing Mohs micrographic surgery (MMS) are given detailed wound care instructions to prevent postoperative complications. Previous studies have revealed low treatment adherence in general dermatology, but adherence to postoperative wound care and its potential association with poor surgical outcomes remain largely unstudied. OBJECTIVE: To determine the frequency and causes of wound care nonadherence in patients who underwent MMS. MATERIALS AND METHODS: A questionnaire containing a modified Eight-Item Morisky Medication Adherence Measure Scale was administered to Mohs patients at their 1 to 2 weeks postoperative visit. RESULTS: Sixty-three patients were solicited and consented to completing the questionnaire. The average modified Eight-Item Morisky Medication Adherence Measure Scale score was 7.4 of 8, indicating high adherence. Old age and wound care assistance were associated with increased adherence. Factors contributing to nonadherence included feeling well, being too busy, wound care causing discomfort, and being with friends or family. One patient (1.6%) with high adherence developed an epidermal inclusion cyst within the scar. No other complications were observed. CONCLUSION: Most MMS patients demonstrated high adherence to wound care instructions, and nonadherence was not associated with postoperative complications.

Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed Newborns.

Background and purpose: Conventional measures of withdrawal in newborns with prenatal opioid exposure (POE) rely on nursing assessments, including the subjective judgment of infant irritability. This study investigated limb movement actigraphy as a tool for providing an objective, quantifiable measure of underlying distress. Methods: Correlational analyses compared continuous physiological-detected movement actigraphy and clinical intervallic-scored symptomology (modified Finnegan system) obtained from a control cohort of 37 term neonates with POE studied in their crib in the newborn unit (1-8 days). Results: Infants spent 15% crib time in high movement activity (>100 movements/minute; index irritability) and 38% crib time in low activity (0-5 movements/minute; index calm). There was a significant positive association between actigraphy and Finnegan composite score (r = .28, P = .001) and between actigraphy and subcomponent scores (i.e., central nervous system, gastrointestinal, and metabolic-vasomotor-respiratory). Conclusion: Movement activity via actigraphy captures underlying distress and calm not measured by conventional assessments. Such objective, quantifiable measures can serve to promote equitable assessment and treatment of hospitalized newborns with POE.

Effect of a Machine Learning Recommender System and Viral Peer Marketing Intervention on Smoking Cessation: A Randomized Clinical Trial.

Importance: Novel data science and marketing methods of smoking-cessation intervention have not been adequately evaluated. Objective: To compare machine learning recommender (ML recommender) computer tailoring of motivational text messages vs a standard motivational text-based intervention (standard messaging) and a viral peer-recruitment tool kit (viral tool kit) for recruiting friends and family vs no tool kit in a smoking-cessation intervention. Design, Setting, and Participants: This 2 ×2 factorial randomized clinical trial with partial allocation, conducted between July 2017 and September 2019 within an online tobacco intervention, recruited current smokers aged 18 years and older who spoke English from the US via the internet and peer referral. Data were analyzed from March through May 2022. Interventions: Participants registering for the online intervention were randomly assigned to the ML recommender or standard messaging groups followed by partially random allocation to access to viral tool kit or no viral tool kit groups. The ML recommender provided ongoing refinement of message selection based on user feedback and comparison with a growing database of other users, while the standard system selected messages based on participant baseline readiness to quit. Main Outcomes and Measures: Our primary outcome was self-reported 7-day point prevalence smoking cessation at 6 months. Results: Of 1487 participants who smoked (444 aged 19-34 years [29.9%], 508 aged 35-54 years [34.1%], 535 aged ≥55 years [36.0%]; 1101 [74.0%] females; 189 Black [12.7%] and 1101 White [78.5%]; 106 Hispanic [7.1%]), 741 individuals were randomly assigned to the ML recommender group and 746 individuals to the standard messaging group; viral tool kit access was provided to 745 participants, and 742 participants received no such access. There was no significant difference in 6-month smoking cessation between ML recommender (146 of 412 participants [35.4%] with outcome data) and standard messaging (156 of 389 participants [40.1%] with outcome data) groups (adjusted odds ratio, 0.81; 95% CI, 0.61-1.08). Smoking cessation was significantly higher in viral tool kit (177 of 395 participants [44.8%] with outcome data) vs no viral tool kit (125 of 406 participants [30.8%] with outcome data) groups (adjusted odds ratio, 1.48; 95% CI, 1.11-1.98). Conclusions and Relevance: In this study, machine learning-based selection did not improve performance compared with standard message selection, while viral marketing did improve cessation outcomes. These results suggest that in addition to increasing dissemination, viral recruitment may have important implications for improving effectiveness of smoking-cessation interventions. Trial Registration: ClinicalTrials.gov Identifier: NCT03224520.

Splenic Artery Embolization for Unstable Patients with Splenic Injury: A Retrospective Cohort Study.

PURPOSE: To compare the outcomes of splenic artery embolization (SAE) for acute splenic injury (ASI) between patients who are hemodynamically stable (HDS) and hemodynamically unstable (HDU). Nonoperative management with SAE has become an accepted practice for patients who are HDS with ASI; however, SAE for the treatment of patients who are HDU with ASI has not been well studied. MATERIALS AND METHODS: A retrospective cohort study was performed, including 52 patients who were HDU and HDS who underwent SAE for ASI at a Level 1 trauma center. HDU was defined as the lowest recorded systolic blood pressure prior to intervention <90 mm Hg. Utilizing the American Association for Surgery of Trauma (AAST) splenic injury scale, AAST Grades 1-3 were defined as low grade, and Grades 4-5 were defined as high grade. The primary outcomes were survival at 30 days and the need for subsequent splenectomy. RESULTS: Seventy-five percent (n = 39) of the patients were HDS, and 25% (n = 13) were HDU. The majority (69%) of patients who were HDU who underwent SAE did not require splenectomy, compared with 95% of patients who were HDS (P = .03). No significant difference in 30-day survival between patients who were HDU and HDS was noted. No major adverse events were recorded. There was no significant difference in 30-day patient survival or the rate of subsequent splenectomy between high-grade and low-grade splenic injuries. CONCLUSIONS: In this retrospective cohort study, there was no statistically significant difference in the adverse events or 30-day post-SAE survival rates between patients who were HDS and HDU with ASI. The authors conclude that SAE can be a safe and effective treatment option for patients who are HDU with ASI, including high-grade splenic injury.

Comparison of Rapid Antigen Tests' Performance Between Delta and Omicron Variants of SARS-CoV-2 : A Secondary Analysis From a Serial Home Self-testing Study.

BACKGROUND: It is important to document the performance of rapid antigen tests (Ag-RDTs) in detecting SARS-CoV-2 variants. OBJECTIVE: To compare the performance of Ag-RDTs in detecting the Delta (B.1.617.2) and Omicron (B.1.1.529) variants of SARS-CoV-2. DESIGN: Secondary analysis of a prospective cohort study that enrolled participants between 18 October 2021 and 24 January 2022. Participants did Ag-RDTs and collected samples for reverse transcriptase polymerase chain reaction (RT-PCR) testing every 48 hours for 15 days. SETTING: The parent study enrolled participants throughout the mainland United States through a digital platform. All participants self-collected anterior nasal swabs for rapid antigen testing and RT-PCR testing. All Ag-RDTs were completed at home, whereas nasal swabs for RT-PCR were shipped to a central laboratory. PARTICIPANTS: Of 7349 participants enrolled in the parent study, 5779 asymptomatic persons who tested negative for SARS-CoV-2 on day 1 of the study were eligible for this substudy. MEASUREMENTS: Sensitivity of Ag-RDTs on the same day as the first positive (index) RT-PCR result and 48 hours after the first positive RT-PCR result. RESULTS: A total of 207 participants were positive on RT-PCR (58 Delta, 149 Omicron). Differences in sensitivity between variants were not statistically significant (same day: Delta, 15.5% [95% CI, 6.2% to 24.8%] vs. Omicron, 22.1% [CI, 15.5% to 28.8%]; at 48 hours: Delta, 44.8% [CI, 32.0% to 57.6%] vs. Omicron, 49.7% [CI, 41.6% to 57.6%]). Among 109 participants who had RT-PCR-positive results for 48 hours, rapid antigen sensitivity did not differ significantly between Delta- and Omicron-infected participants (48-hour sensitivity: Delta, 81.5% [CI, 66.8% to 96.1%] vs. Omicron, 78.0% [CI, 69.1% to 87.0%]). Only 7.2% of the 69 participants with RT-PCR-positive results for shorter than 48 hours tested positive by Ag-RDT within 1 week; those with Delta infections remained consistently negative on Ag-RDTs. LIMITATION: A testing frequency of 48 hours does not allow a finer temporal resolution of the analysis of test performance, and the results of Ag-RDTs are based on self-report. CONCLUSION: The performance of Ag-RDTs in persons infected with the SARS-CoV-2 Omicron variant is not inferior to that in persons with Delta infections. Serial testing improved the sensitivity of Ag-RDTs for both variants. The performance of rapid antigen testing varies on the basis of duration of RT-PCR positivity. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute of the National Institutes of Health.

Predicting mortality in moderate-severe TBI patients without early withdrawal of life-sustaining treatments including ICU complications: The MYSTIC-score.

PURPOSE: To develop and internally validate the MortalitY in Moderate-Severe TBI plus ICU Complications (MYSTIC)-Score to predict in-hospital mortality of msTBI patients without early (<24 h) withdrawal-of-life-sustaining treatments. METHODS: We analyzed data from a Neuro-Trauma Intensive Care Unit prospectively collected between 11/2009-5/2019. Consecutive adult msTBI patients were included if Glasgow Coma Scale≤12, and neither died nor had withdrawal-of-life-sustaining treatments within 24 h of admission (n = 485). Using univariate and multivariable logistic regression in a random-split cohort approach (2/3 derivation;1/3 validation), we identified independent predictors of in-hospital mortality while adjusting for validated predictors of mortality (IMPACT-variables). We constructed the MYSTIC-Score and examined discrimination and calibration. RESULTS: The MYSTIC-Score included the ICU complications brain edema, herniation, systemic inflammatory response syndrome, sepsis, acute kidney injury, cardiac arrest, and urinary tract infection. In the derivation cohort(n = 324), discrimination and calibration were excellent (area-under-the-receiver-operating-curve [AUC-ROC] = 0.95;Hosmer-Lemeshow p-value = 0.09, with p > 0.05 indicating good calibration). Internal validation revealed an AUC-ROC = 0.93 and Hosmer-Lemeshow-p-value = 0.76 (n = 161). CONCLUSIONS: Certain ICU complications are independent predictors of in-hospital mortality and strengthen outcome prediction in msTBI when combined with validated admission predictors of mortality. However, external validation is needed to determine robustness and practical applicability of our model given the high potential for residual confounders.

A Pilot Randomized Clinical Trial of a Goals-of-Care Decision Aid for Surrogates of Severe Acute Brain Injury Patients.

BACKGROUND AND OBJECTIVES: Breakdowns in clinician-family communication in neurologic intensive care units (neuroICUs) are common, particularly for goals-of-care decisions to continue or withdraw life-sustaining treatments while considering long-term prognoses. Shared decision-making interventions (decision aids [DAs]) may prevent this problem and increase patient-centered care, yet none are currently available. We assessed the feasibility, acceptability, and perceived usefulness of a DA for goals-of-care communication with surrogate decision-makers for critically ill severe acute brain injury (SABI) patients after hemispheric acute ischemic stroke, intracerebral hemorrhage, or traumatic brain injury. METHODS: We conducted a parallel-arm, unblinded, patient-level randomized, controlled pilot trial at two tertiary-care U.S. neuroICUs and randomized surrogate participants 1:1 to a tailored paper-based DA provided to surrogates prior to clinician-family goals-of-care meetings or usual care (no intervention prior to clinician-family meetings). The primary outcomes were feasibility of deploying the DA (recruitment, participation, retention), acceptability, and perceived usefulness of the DA among surrogates. Exploratory outcomes included outcome of surrogate goals-of-care decision, code-status changes during admission, patients' 3-month functional outcome, and surrogates' 3-month validated psychological outcomes. RESULTS: We approached 83 surrogates of 58 patients and enrolled 66 surrogates of 41 patients (80% consent rate). Of 66 surrogates, 45 remained in the study at 3 months (68% retention). Of the 33 surrogates randomized to intervention, 27 were able to receive the DA, and 25 subsequently read the DA (93% participation). 82% rated the DA's acceptability as good or excellent (median Acceptability score 2 [IQR 2;3]); 96% found it useful for goals-of-care decision-making. In the DA group, there was a trend towards fewer comfort-care decisions (27% vs. 56%, p=0.1) and fewer code-status changes (no change, 73% vs. 44%, p=0.02). At 3 months, fewer patients in the DA group had died (33% vs. 69%, p=0.05; median GOS 3 vs.1, p=0.05). Regardless of intervention, 3-month psychological outcomes were significantly worse among surrogates who had chosen continuation-of-care. DISCUSSION: A goals-of-care DA to support ICU shared decision-making for patients with SABI is feasible to deploy and well-perceived by surrogates. A larger trial is feasible to conduct, although surrogates who select continuation-of-care deserve additional psychosocial support. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov NCT03833375 CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that the use of a DA explaining the goals-of-care decision and the treatment options is acceptable and useful to surrogates of incapacitated critically ill patients with ischemic stroke, intracerebral hemorrhage, or traumatic brain injury.

Comparison of Rapid Antigen Tests' Performance between Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) Variants of SARS-CoV-2: Secondary Analysis from a Serial Home Self-Testing Study.

Background: There is a need to understand the performance of rapid antigen tests (Ag-RDT) for detection of the Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) SARS-CoV-2 variants. Methods: Participants without any symptoms were enrolled from October 18, 2021 to January 24, 2022 and performed Ag-RDT and RT-PCR tests every 48 hours for 15 days. This study represents a non-pre-specified analysis in which we sought to determine if sensitivity of Ag-RDT differed in participants with Delta compared to Omicron variant. Participants who were positive on RT-PCR on the first day of the testing period were excluded. Delta and Omicron variants were defined based on sequencing and date of first RT-PCR positive result (RT-PCR+). Comparison of Ag-RDT performance between the variants was based on sensitivity, defined as proportion of participants with Ag-RDT+ results in relation to their first RT-PCR+ result, for different duration of testing with rapid Ag-RDT. Subsample analysis was performed based on the result of participants' second RT-PCR test within 48 hours of the first RT-PCR+ test. Results: From the 7,349 participants enrolled in the parent study, 5,506 met the eligibility criteria for this analysis. A total of 153 participants were RT-PCR+ (61 Delta, 92 Omicron); among this group, 36 (23.5%) tested Ag-RDT+ on the same day, and 84 (54.9%) tested Ag-RDT+ within 48 hours as first RT-PCR+. The differences in sensitivity between variants were not statistically significant (same-day: Delta 16.4% [95% CI: 8.2-28.1] vs Omicron 28.2% [95% CI: 19.4-38.6]; and 48-hours: Delta 45.9% [33.1-59.2] vs. Omicron 60.9% [50.1-70.9]). This trend continued among the 86 participants who had consecutive RT-PCR+ result (48-hour sensitivity: Delta 79.3% [60.3-92.1] vs. Omicron: 89.5% [78.5-96.0]). Conversely, the 38 participants who had an isolated RT-PCR+ remained consistently negative on Ag-RDT, regardless of the variant. Conclusions: The performance of Ag-RDT is not inferior among individuals infected with the SARS-CoV-2 Omicron variant as compared to the Delta variant. The improvement in sensitivity of Ag-RDT noted with serial testing is consistent between Delta and Omicron variant. Performance of Ag-RDT varies based on duration of RT-PCR+ results and more studies are needed to understand the clinical and public health significance of individuals who are RT-PCR+ for less than 48 hours.

Effect of Technology-Assisted Brief Abstinence Game on Long-term Smoking Cessation in Individuals Not Yet Ready to Quit: A Randomized Clinical Trial.

IMPORTANCE: Most trials of behavioral or pharmaceutical interventions for people who smoke are limited to individuals reporting they are ready to quit smoking. Engaging individuals who initially report they are not yet ready to quit in brief, precessation, skills-building interventions (eg, practice quit attempts or nicotine replacement therapy [NRT] sampling) is challenging. OBJECTIVE: To test an integrated behavioral plus NRT-sampling intervention using a gamification approach supported by mobile health. DESIGN, SETTING, AND PARTICIPANTS: A multisite randomized clinical trial with site-level 1-to-1 allocation into 2 conditions was conducted in 4 US health care systems. A total of 433 individuals who were currently smoking and reported at enrollment that they were not ready to quit smoking were enrolled. The study was conducted from November 7, 2016, to July 31, 2020. INTERVENTIONS: Take a Break (TAB) was a 3-week game experience and included 5 behavioral components (motivational messaging, challenge quizzes, brief abstinence goal setting, mobile health apps for cravings management, and reward points for participation) integrated with NRT sampling. TAB draws on social cognitive theory and game mechanics concepts to engage participants in health behavior change. The comparison included NRT sampling only. MAIN OUTCOMES AND MEASURES: Time to first quit attempt (duration from TAB experience to primary outcome) and carbon monoxide level-verified smoking cessation at 6-month follow-up. All analyses used an intention-to-treat approach. RESULTS: Of the 433 individuals included in the trial, 223 were women (52%); mean (SD) age was 54 (13) years. More than half (53% [112 of 213]) of the TAB participants completed 100% of the daily challenge quizzes in the first week, 73% (145 of 199) of participants who completed the goal-setting call set a brief abstinence goal (most frequently 1-2 days of abstinence from cigarettes), and 75% (159 of 213) of participants used the mobile health apps to manage nicotine cravings. Time to the first quit attempt was lower for the TAB vs comparison group (hazard ratio, 1.68; 95% CI, 1.09-2.60; P = .02). At the 6-month follow-up, 18% (28 of 160) of TAB participants and 10% (17 of 171) of the comparison (χ2 test, P = .045) participants obtained carbon monoxide level-verified smoking cessation (accounting for clustering of outcomes by site; odds ratio, 1.92; 95% CI, 1.01-3.68; P = .048). CONCLUSIONS AND RELEVANCE: The findings of this randomized clinical trial demonstrate that individuals not yet ready to quit smoking could be engaged in a brief abstinence game. Six months later, the TAB group had nearly double the rate of smoking cessation vs the NRT sampling comparison group. Integrating a skills-building game experience with brief NRT sampling can enhance long-term cessation among those not yet ready to quit smoking. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02973425.

Survivorship care planning, quality of life, and confidence to transition to survivorship: A randomized controlled trial with women ending treatment for breast cancer.

PURPOSE: The Polaris Oncology Survivorship Transition (POST) system is a computer-based program that integrates information from the electronic health record, oncology team, and the patient to produce a personalized Survivorship Care Plan. The purpose of this study was to compare the POST to treatment as usual on confidence, quality of life, and interest in mental health referrals in women ending treatment for breast cancer. SAMPLE: Two hundred women (100 POST, 100 treatment as usual) ending treatment for breast cancer were enrolled in a randomized controlled trial. DESIGN: Women randomized to the POST condition received a personalized care plan during a baseline/intervention appointment. At enrollment and baseline/intervention, a number of outcomes were examined in this study, including confidence to enter survivorship measured by the Confidence in Survivorship Index (CSI) and Quality of Life (QOL). One, three, and six month follow up assessments were also conducted. FINDINGS: Treatment groups did not differ in terms of QOL scores at any time points. Mean CSI scores were statistically different between POST and treatment as usual at baseline for the total CSI score and both subscales, but only for confidence in knowledge about prevention and treatment at the 1-month follow-up. All significant differences were in favor of the POST intervention as mean CSI scores were higher for participants who received the POST intervention as opposed to treatment as usual. These findings disappeared at the 3 and 6 month follow up assessments. Finally, patients who received the POST intervention were twice as likely to request mental health/social services referrals compared to women who received treatment as usual. IMPLICATIONS: Oncologists may use the POST to build personalized care plans for women ending treatment for cancer, which may enhance patients' confidence in the short term as well as encourage use of mental health resources.

Safety and Efficacy of Triple Therapy With Ticagrelor or Prasugrel Versus Clopidogrel After Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction.

BACKGROUND: Patients on dual antiplatelet therapy following percutaneous coronary intervention often have indications for concomitant oral anticoagulation, known as triple antithrombotic therapy. Majority of literature evaluating triple antithrombotic therapy fails to adequately represent patients with ST-elevation myocardial infarction and those prescribed potent P2Y12 inhibitors, ticagrelor or prasugrel. The purpose of this study was to evaluate the safety and efficacy of triple antithrombotic regimens containing ticagrelor or prasugrel versus clopidogrel after percutaneous coronary intervention in the setting of ST-elevation myocardial infarction. METHODS: This was a single-center, retrospective cohort trial. The primary endpoint was net adverse clinical event, defined as the primary efficacy endpoint of death, myocardial infarction, or cerebrovascular accident and the primary safety endpoint of any bleeding event. RESULTS: Between October 2017 and October 2019, a total of 65 patients with ST-elevation myocardial infarction were initiated on triple therapy. Forty-six patients were included in the primary analysis, of which 26 were discharged on triple antithrombotic therapy with clopidogrel and 20 discharged on potent P2Y12 inhibitors (ticagrelor or prasugrel). The primary endpoint occurred in 27% of the clopidogrel group and 40% of the potent P2Y12 inhibitor group (P = 0.35). Bleeding occurred in 23% of the clopidogrel group and 35% of the potent P2Y12 inhibitor group (P = 0.37). CONCLUSIONS: This small cohort study suggests, in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention, the net adverse clinical event rate does not differ between clopidogrel and potent P2Y12 inhibitors in the setting of triple antithrombotic therapy. The results of this exploratory analysis warrant confirmation in a larger, randomized study.

Effect of Levodopa Initiation on the Gut Microbiota in Parkinson's Disease.

Background: The impact of Levodopa on the gut microbiota of Parkinson's disease (PD) patients has not been sufficiently addressed. Methods: We conducted a longitudinal study to examine the impact of Levodopa initiation on the gut microbiota composition of 19 PD patients who had not previously been exposed to Levodopa. Patients provided two stool samples prior to and two samples 90 days after starting Levodopa. Motor impairment (MDS-UPDRS Part III), diet, and other patient characteristics were assessed. 16S rRNA gene amplicon sequencing was used to characterize the microbiota. We examined, cross-sectionally and longitudinally, the associations between Levodopa use and alpha and beta diversity and performed feature-wise, multivariate modeling to identify taxa associated longitudinally with Levodopa use and with improvement in motor function after Levodopa administration. Results: We did not observe significant differences in alpha or beta diversity before vs. after initiation of Levodopa. In longitudinal feature-wise analyses, at the genus level, no taxa were significantly associated with Levodopa use after false discovery rate (FDR) correction (q < 0.05). We observed a marginally lower relative abundance of bacteria belonging to Clostridium group IV in PD patients who experienced a medium or large improvement in motor impairment in response to Levodopa compared to those with a small response [ß = -0.64 (SE: 0.18), p-trend: 0.00015 p-FDR: 0.019]. Conclusions: In this study, Levodopa was not associated with changes in microbiota composition in this longitudinal analysis. The association between abundance of Clostridium group IV and short-term motor symptom response to Levodopa is preliminary and should be investigated in larger, longer-term studies, that include a control group.

Improving Early Identification and Access to Diagnosis of Autism Spectrum Disorder in Toddlers in a Culturally Diverse Community with the Rapid Interactive screening Test for Autism in Toddlers.

The objective of this study was to test a screening model that employs the Rapid Interactive Screening Test for Autism in Toddlers (RITA-T), in an underserved community to improve ASD detection. We collaborated with a large Early Intervention (EI) program and trained 4 providers reliably on the RITA-T. Toddlers received the Modified Checklist for Autism in Toddlers (MCHAT-R/F), the RITA-T, developmental and autism testing, and a best-estimate clinical diagnosis. Eighty-One toddlers were enrolled: 57 with ASD and 24 with Developmental Delay (DD) non-ASD. Wait-time for diagnosis was on average 6 weeks. The RITA-T correlated highly with autism measures and EI staff integrated this model easily. The RITA-T significantly improved the identification and wait time for ASD in this underserved community.

The contributions of focused attention and open monitoring in mindfulness-based cognitive therapy for affective disturbances: A 3-armed randomized dismantling trial.

OBJECTIVE: Mindfulness-based cognitive therapy (MBCT) includes a combination of focused attention (FA) and open monitoring (OM) meditation practices. The aim of this study was to assess both short- and long-term between- and within-group differences in affective disturbance among FA, OM and their combination (MBCT) in the context of a randomized controlled trial. METHOD: One hundred and four participants with mild to severe depression and anxiety were randomized into one of three 8-week interventions: MBCT (n = 32), FA (n = 36) and OM (n = 36). Outcome measures included the Inventory of Depressive Symptomatology (IDS), and the Depression Anxiety Stress Scales (DASS). Mixed effects regression models were used to assess differential treatment effects during treatment, post-treatment (8 weeks) and long-term (20 weeks). The Reliable Change Index (RCI) was used to translate statistical findings into clinically meaningful improvements or deteriorations. RESULTS: All treatments demonstrated medium to large improvements (ds = 0.42-1.65) for almost all outcomes. While all treatments were largely comparable in their effects at post-treatment (week 8), the treatments showed meaningful differences in rapidity of response and pattern of deteriorations. FA showed the fastest rate of improvement and the fewest deteriorations on stress, anxiety and depression during treatment, but a loss of treatment-related gains and lasting deteriorations in depression at week 20. OM showed the slowest rate of improvement and lost treatment-related gains for anxiety, resulting in higher anxiety in OM at week 20 than MBCT (d = 0.40) and FA (d = 0.36), though these differences did not reach statistical significance after correcting for multiple comparisons (p's = .06). MBCT and OM showed deteriorations in stress, anxiety and depression at multiple timepoints during treatment, with lasting deteriorations in stress and depression. MBCT showed the most favorable pattern for long-term treatment of depression. CONCLUSIONS: FA, OM and MBCT show different patterns of response for different dimensions of affective disturbance. TRIAL REGISTRATION: This trial is registered at (v NCT01831362); www.clinicaltrials.gov.