Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift.

Bayesian adaptive designs with response adaptive randomization (RAR) have the potential to benefit more participants in a clinical trial. While there are many papers that describe RAR designs and results, there is a scarcity of works reporting the details of RAR implementation from a statistical point exclusively. In this paper, we introduce the statistical methodology and implementation of the trial Changing the Default (CTD). CTD is a single-center prospective RAR comparative effectiveness trial to compare opt-in to opt-out tobacco treatment approaches for hospitalized patients. The design assumed an uninformative prior, conservative initial allocation ratio, and a higher threshold for stopping for success to protect results from statistical bias. A particular emerging concern of RAR designs is the possibility that time trends will occur during the implementation of a trial. If there is a time trend and the analytic plan does not prespecify an appropriate model, this could lead to a biased trial. Adjustment for time trend was not pre-specified in CTD, but post hoc time-adjusted analysis showed no presence of influential drift. This trial was an example of a successful two-armed confirmatory trial with a Bayesian adaptive design using response adaptive randomization.

Hospital-Initiated Smoking Cessation Among Patients Admitted with Behavioral Health Conditions.

BACKGROUND: Smoking rates among people living with behavioral health conditions (BHC) range from 30 to 65% and are 2-4 times higher than rates found in the general population. Starting tobacco treatment during a hospital stay is effective for smoking cessation, but little is known regarding treatment response among inpatients with BHC. OBJECTIVE: This study pooled data across multiple clinical trials to determine the relative success in quitting among participants with BHC compared to other study participants. PARTICIPANTS: Adults who smoke (≥ 18 years old) from five hospital-based smoking cessation randomized clinical trials. DESIGN: A retrospective analysis using data from the electronic health record to identify participants with primary diagnoses related to BHC. Recruitment and data analysis were conducted from 2011 to 2016. We used propensity score matching to pair patients with BHC to those with similar characteristics and logistic regression to determine differences between groups. MEASURES: The main outcome was self-reported 30-day abstinence 6 months post-discharge. RESULTS: Of 6612 participants, 798 patients had a BHC-related primary diagnosis. The matched sample included 642 pairs. Nearly 1 in 3 reported using tobacco medications after hospitalization, with no significant difference between patients with and without BHC (29.3% vs. 31.5%; OR (95% CI) = 0.90 (0.71, 1.14), p = 0.40). Nearly 1 in 5 patients with BHC reported abstinence at 6 months; however, their odds of abstinence were 30% lower than among people without BHC (OR (95% CI) = 0.70 (0.53,0.92), p = 0.01). CONCLUSION: When offered tobacco treatment, hospitalized patients with BHC were as likely as people without BHC to accept and engage in treatment. However, patients with BHC were less likely to report abstinence compared to those without BHC. Hospitals are a feasible and promising venue for tobacco treatment among inpatients with BHC. More studies are needed to identify treatment approaches that help people with BHC achieve long-term abstinence.

Leveraging National Data and Regional Innovations to Right-Size Tobacco Treatment Policy for Behavioral Health in a Midwestern State.

BACKGROUND: People with mental health (MH) and substance use disorders (SUD) have high rates of tobacco use and tobacco-related mortality. They want to stop smoking and studies have shown they can quit, but few behavioral health facilities provide tobacco treatment. The purpose of this paper is to describe how a midwestern statewide behavioral health collaboration used regional data to pinpoint strengths and weaknesses in tobacco treatment trends, identified policies in neighboring states that were associated with high rates of tobacco treatment, and worked with state leaders to implement these policies to enhance treatment. METHODS: We used publicly available data from 2 SAMHSA annual national surveys of MH/SUD facilities to describe tobacco treatment services and policies in behavioral health facilities in Kansas and 3 neighboring states (Missouri, Nebraska and Oklahoma). We interviewed neighboring state leaders to identify policies they had implemented to boost tobacco recovery services in behavioral health. We collaborated with our state behavioral health agency to encourage adoption of similar policies. RESULTS: Using 7 years of survey data (2014-2020), rates for screening, counseling, and medications for tobacco dependence were highest in Oklahoma and Missouri facilities. Oklahoma had the highest percentages of facilities reporting smoke-free campuses. In all states, rates of tobacco service provision and smoke-free campuses were lower among SUD facilities than in MH facilities. State leaders associated several policies with high performance, including (a) requiring programs contracting with the state to conduct screening, provide counseling, and adopt smoke-free campuses (Oklahoma and Missouri); (b) state-based collection of tobacco treatment service provision data (Oklahoma); (c) providing facilities with free NRT for clients (Oklahoma); (d) setting benchmarks for service provision (Oklahoma); (e) comprehensive Medicaid coverage of cessation medications (Missouri). Upon review of these findings, Kansas behavioral health officials adopted a 2-year process to implement similar policies and are integrating tobacco treatment requirements into the state Certified Community Behavioral Health Clinic program. CONCLUSIONS: Summarizing and sharing freely-available data across states laid the groundwork for cross-border networking and policy change. State and federal agencies should integrate these policies into contracts and block grants to reduce tobacco-related disparities among individuals with behavioral health conditions.

Using Bayesian hierarchical models for controlled post hoc subgroup analysis of clinical trials: application to smoking cessation treatment in American Indians and Alaska Natives.

Clinical trials powered to detect subgroup effects provide the most reliable data on heterogeneity of treatment effect among different subpopulations. However, pre-specified subgroup analysis is not always practical and post hoc analysis results should be examined cautiously. Bayesian hierarchical modelling provides grounds for defining a controlled post hoc analysis plan that is developed after seeing outcome data for the population but before unblinding the outcome by subgroup. Using simulation based on the results from a tobacco cessation clinical trial conducted among the general population, we defined an analysis plan to assess treatment effect among American Indians and Alaska Natives (AI/AN) enrolled in the study. Patients were randomized into two arms using Bayesian adaptive design. For the opt-in arm, clinicians offered a cessation treatment plan after verifying that a patient was ready to quit. For the opt-out arm, clinicians provided all participants with free cessation medications and referred them to a Quitline. The study was powered to test a hypothesis of significantly higher quit rates for the opt-out arm at one-month post randomization. Overall, one-month abstinence rates were 15.9% and 21.5% (opt-in and opt-out arm, respectively). For AI/AN, one-month abstinence rates were 10.2% and 22.0% (opt-in and opt-out arm, respectively). The posterior probability that the abstinence rate in the treatment arm is higher is 0.96, indicating that AI/AN demonstrate response to treatment at almost the same probability as the whole population.

Development and Demonstration of Tobacco Treatment Measures for Cancer Registries: Novel Metrics for Quality Improvement.

BACKGROUND: Individuals undergoing cancer treatment have better outcomes when they discontinue tobacco use. Few cancer centers systematically provide evidence-based cessation services. As part of a national quality improvement initiative [Cancer Center Cessation Initiative (C3i)], we collaborated with our cancer registry to develop and implement two tobacco treatment metrics for tracking the provision of behavioral support and pharmacotherapy. METHODS: Post-development, the tobacco treatment metrics were integrated into the registry for all future patients. We used means and frequencies to summarize tobacco treatment for cases treated between 2017 and 2019, coinciding with the timeframe of C3i participation. RESULTS: Of 17,735 cancer cases reviewed, both measures were captured on 17,654 (99.5%) of patients, with 3,091 (17.4%) identified as users of tobacco. Across the 3 years, 557 (18%) of individuals who used tobacco received either tobacco cessation pharmacotherapy or behavioral support; with 478 (15.5%) receiving behavioral counseling, 352 (11.4%) receiving pharmacotherapy, and 273 (8.8%) receiving both-considered gold standard care. Tobacco treatment varied substantially across cancer types. The odds of receiving gold standard care were 2.37 times greater in 2019 compared with 2017. (OR, 2.37; 95% confidence interval, 1.63-3.46; P < 0.0001). CONCLUSIONS: The new metrics demonstrated high completion rates and their potential to track quality improvement efforts over time. They identified suboptimal treatment reach, but a potential increase in treatment over time and greater treatment among tobacco-related versus nontobacco-related cancers. IMPACT: Continued tobacco use worsens cancer care outcomes. Integrating measures into cancer registries is a viable option for tracking tobacco treatment and cessation in the context of cancer care.

The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial.

Importance: Tobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries. Objective: To evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco. Design, Setting, and Participants: In Changing the Default (CTD), a Bayesian adaptive population-based randomization trial, eligible patients were randomized into study groups, treated according to group assignment, and debriefed and consented for participation at 1-month follow-up. A total of 1000 adult patients were treated at a tertiary care hospital in Kansas City. Patients were randomized from September 2016 to September 2020; final follow-up was in March 2021. Interventions: At bedside, counselors screened for eligibility, conducted baseline assessment, randomized patients to study group, and provided opt-out care or opt-in care. Counselors and medical staff provided opt-out patients with inpatient nicotine replacement therapy, prescriptions for postdischarge medications, a 2-week medication starter kit, treatment planning, and 4 outpatient counseling calls. Patients could opt out of any or all elements of care. Opt-in patients willing to quit were offered each element of treatment described previously. Opt-in patients who were unwilling to quit received motivational counseling. Main Outcomes and Measures: The main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization. Results: Of a total of 1000 eligible adult patients who were randomized, most consented and enrolled (270 [78%] of opt-in patients; 469 [73%] of opt-out patients). Adaptive randomization assigned 345 (64%) to the opt-out group and 645 (36%) to the opt-in group. The mean (SD) age at enrollment was 51.70 (14.56) for opt-out patients and 51.21 (14.80) for opt-out patients. Of 270 opt-in patients, 123 (45.56%) were female, and of 469 opt-out patients, 226 (48.19%) were female. Verified quit rates for the opt-out group vs the opt-in group were 22% vs 16% at month 1 and 19% vs 18% at 6 months. The Bayesian posterior probability that opt-out care was better than opt-in care was 0.97 at 1 month and 0.59 at 6 months. Treatment use for the opt-out group vs the opt-in group was 60% vs 34% for postdischarge cessation medication (bayesian posterior probability of 1.0), and 89% vs 37% for completing at least 1 postdischarge counseling call (bayesian posterior probability of 1.0). The incremental cost-effectiveness ratio was $678.60, representing the cost of each additional quit in the opt-out group. Conclusions and Relevance: In this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients' sense of agency and alliance with practitioners. Stronger and longer treatment could increase cessation. Trial Registration: ClinicalTrials.gov Identifier: NCT02721082.

Quitting Smoking before and after Pregnancy: Study Methods and Baseline Data from a Prospective Cohort Study.

Smoking during pregnancy and postpartum remains an important public health problem. No known prior study has prospectively examined mutual changes in risk factors and women's smoking trajectory across pregnancy and postpartum. The objective of this study was to report methods used to implement a prospective cohort (Msgs4Moms), present participant baseline characteristics, and compare our sample characteristics to pregnant women from national birth record data. The cohort study was designed to investigate smoking patterns, variables related to tobacco use and abstinence, and tobacco treatment quality across pregnancy through 1-year postpartum. Current smokers or recent quitters were recruited from obstetrics clinics. Analyses included Chi-square and independent sample t-tests using Cohen's d. A total of 62 participants (41 smokers and 21 quitters) were enrolled. Participants were Black (45.2%), White (35.5%), and multiracial (19.3%); 46.8% had post-secondary education; and most were Medicaid-insured (64.5%). Compared with quitters, fewer smokers were employed (65.9 vs 90.5%, Cohen's d = 0.88) and more reported financial strain (61.1% vs 28.6%; Cohen's d = 0.75). Women who continue to smoke during pregnancy cope with multiple social determinants of health. Longitudinal data from this cohort provide intensive data to identify treatment gaps, critical time points, and potential psychosocial variables warranting intervention.

Effectiveness of Recruitment Strategies of Latino Smokers: Secondary Analysis of a Mobile Health Smoking Cessation Randomized Clinical Trial.

BACKGROUND: Latinos remain disproportionately underrepresented in clinical trials, comprising only 2%-3% of research participants. In order to address health disparities, it is critically important to increase enrollment of Latino smokers in smoking cessation trials. There is limited research examining effective recruitment strategies for this population. OBJECTIVE: The purpose of this study was to compare the effectiveness of direct versus mass and high- versus low-effort recruitment strategies on recruitment and retention of Latino smokers to a randomized smoking cessation trial. We also examine how the type of recruitment might have influenced the characteristics of enrolled participants. METHODS: Latino smokers were enrolled into Decídetexto from 4 states-New Jersey, Kansas, Missouri, and New York. Participants were recruited from August 2018 until March 2021. Mass recruitment strategies included English and Spanish advertisements to the Latino community via flyers, Facebook ads, newspapers, television, radio, church bulletins, and our Decídetexto website. Direct, high-effort strategies included referrals from clinics or community-based organizations with whom we partnered, in-person community outreach, and patient registry calls. Direct, low-effort strategies included texting or emailing pre-existing lists of patients who smoked. A team of trained bilingual (English and Spanish) recruiters from 9 different Spanish-speaking countries of origin conducted recruitment, assessed eligibility, and enrolled participants into the trial. RESULTS: Of 1112 individuals who were screened, 895 (80.5%) met eligibility criteria, and 457 (457/895, 51.1%) enrolled in the trial. Within the pool of screened individuals, those recruited by low-effort recruitment strategies (both mass and direct) were significantly more likely to be eligible (odds ratio [OR] 1.67, 95% CI 1.01-2.76 and OR 1.70, 95% CI 0.98-2.96, respectively) and enrolled in the trial (OR 2.60, 95% CI 1.81-3.73 and OR 3.02, 95% CI 2.03-4.51, respectively) compared with those enrolled by direct, high-effort strategies. Among participants enrolled, the retention rates at 3 months and 6 months among participants recruited via low-effort strategies (both mass and direct) were similar to participants recruited via direct, high-effort methods. Compared with enrolled participants recruited via direct (high- and low-effort) strategies, participants recruited via mass strategies were less likely to have health insurance (44.0% vs 71.2% and 71.7%, respectively; P<.001), lived fewer years in the United States (22.4 years vs 32.4 years and 30.3 years, respectively; P<.001), more likely to be 1st generation (92.7% vs 76.5% and 77.5%, respectively; P=.007), more likely to primarily speak Spanish (89.3% vs 65.8% and 66.3%, respectively), and more likely to be at high risk for alcohol abuse (5.8 mean score vs 3.8 mean score and 3.9 mean score, respectively; P<.001). CONCLUSIONS: Although most participants were recruited via direct, high-effort strategies, direct low-effort recruitment strategies yielded a screening pool more likely to be eligible for the trial. Mass recruitment strategies were associated with fewer acculturated enrollees with lower access to health services-groups who might benefit a great deal from the intervention. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03586596; https://clinicaltrials.gov/ct2/show/NCT03586596. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-DOI: 10.1016/j.cct.2020.106188.

Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment.

Background: Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen's design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial. Methods: At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus those who did not enroll. We also compared the characteristics of participants who consented and those who were reached and explicitly refused consent at one-month follow-up. We used the Cohen's d measure of effect size to evaluate differences. Results: Of the 1,000 randomized, 741 (74.1%) consented to continue in the study at one-month follow-up. One hundred and twenty-seven (12.7%) refused consent and 132 (13.2%) were unreachable. Cohen's d effect size differences between those who consented/enrolled (n = 741) and those who were not enrolled (n = 259) were negligible (<0.2) for age, gender, race/ethnicity, and most forms of insurance. The effect size was small for Medicaid (0.36), and other public insurance (0.48). After excluding those unreached at 1 month (12.7%), there were medium Cohen's d effect size differences between those who consented to participate (n = 741) and those who explicitly refused (n = 127) with respect to age (0.55) and self-pay or no insurance (0.51). There were small to negligible effect size differences with respect to sex, race/ethnicity, and other forms of health insurance. Conclusions: The modified Zelen's design resulted in successful enrollment of most participants who were initially randomized into the trial, including those not motivated to quit.

Vaping, Perceptions of Vaping, and Plans to Quit Among E-cigarette Users in the United States and the United Kingdom.

INTRODUCTION: Government and health organizations in the United States and the United Kingdom have taken different stances on e-cigarettes policy. To explore the potential effects of these policies, we describe e-cigarette user characteristics, intentions to quit, and perceived attitudes toward vaping. METHODS: We used the online crowdsourcing platform Prolific to conduct a cross-sectional survey of current vapers in both countries. Measures were drawn from international surveys. RESULTS: The sample included 1044 vapers (524 United Kingdom; 520 United States) with a mean age of 34. Samples differed by gender (United States: 57% male vs 45% in United Kingdom), race (United States: 79% White vs 90% in United Kingdom) and employment (United States: 73% employed vs 79% in United Kingdom). UK respondents were more likely than US respondents to be ever smokers (89% vs 71%, p < .0001); be daily vapers (69% vs 53%, p < .0001) and to use e-cigarettes to quit smoking (75% vs 65%, p < .0007). Most vapers in the United Kingdom and the United States want to stop vaping (62% vs 61%; p < .9493), but US respondents plan to quit significantly sooner (odds ratio 0.47, p < .0004). Attitudes differed as well. Over half (56%) of UK respondents reported their government-approved e-cigarette use, and 24% felt health care providers had positive views on e-cigarettes versus 29% and 13% from the United States, respectively (p < .0004 for both). CONCLUSIONS: Plans for quitting and perceptions regarding e-cigarettes differ markedly between demographically similar groups of vapers in the two countries. Future research should determine whether e-cigarette cessation for adults should be a public health goal, and if so, identify effective ways to stop. IMPLICATIONS: The contribution of this study is that it describes differences in behaviors and attitudes of vapers recruited through the same research platform and adjusted to account for minor demographic differences across country samples. For clinicians, these findings suggest that most vapers would welcome assistance in quitting. For researchers and policymakers, findings suggest that government policy regarding nicotine devices might influence behaviors and attitudes related to use and also that future research is needed to determine effective ways to quit.

Institutional Tobacco Policy and Tobacco Use Among Kansas Sheriffs' Staff and Individuals Incarcerated in Jail.

This article describes the factors that contribute to Kansas county jails' tobacco culture to identify reasons for high tobacco use and intervention opportunities. Kansas sheriffs' offices were asked to complete a novel 26-item survey from August through November 2019, and 40% responded. A few reported that tobacco cessation counseling was available to staff (31%) or incarcerated individuals (12%). Seventy-nine percent reported that staff were permitted to use tobacco in designated places outside, whereas 24% reported that tobacco use by incarcerated individuals was permitted in designated places outside. In the jails' commissaries, 5% reported selling nicotine gum or nicotine lozenges and 26% reported selling e-cigarettes. The lack of tobacco cessation counseling and nicotine replacement therapy, weak policies, and availability of tobacco all contribute to Kansas county jails' prevalent tobacco culture.

Text messaging interventions to support smoking cessation among hospitalized patients in Brazil: a randomized comparative effectiveness clinical trial.

OBJECTIVE: A clinical trial carried out in patients hospitalized for clinical and surgical conditions. This study evaluated the effectiveness of text messaging interventions (TM) versus telephone counseling (TC) to promote smoking cessation among hospitalized smokers in a middle-income country. Seven-day abstinence was measured during follow-up phone calls one month after discharge. The comparative cost of the two interventions considered the cost of calls, time spent on phone calls and sending SMS and cost of the professional involved in the approaches. RESULTS: Past 7-day tobacco abstinence was not statistically different between groups (30.5% in TM group and 26% in TC, p = 0.318). Costs were significantly lower in the TM group (U$9.28 × U$19.45- p < 0,001). Continuous abstinence was reported by 26% of TM participants and 24.5% of TC participants (p = 0.730). In the 3-month follow-up, 7-day abstinence was 23% in the TMI and 27% in the TC (p = 0.356) group. Continuous abstinence was reported by 20% of TM participants and 24% of TC participants (p = 0.334). TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03237949 Registred on: 30th May 2017.

Hospital-based tobacco treatment for inpatients with a history of cancer.

OBJECTIVE: To describe treatment engagement and outcomes of patients who smoke with cancer and received tobacco cessation treatment during hospitalization. METHOD: We analyzed treatment engagement and cessation outcomes for hospitalized patients who smoke with a current or former history of cancer receiving treatment from an inpatient tobacco treatment service between July, 2018 to October, 2019. RESULTS: The service treated 407 inpatients. Patients had an overall high level of interest in quitting (7.6, 0-10 scale). One in three accepted cessation pharmacotherapies during hospitalization or at discharge (35%) and/or referral to the state tobacco quitline (37%). Of 189 patients reached at one-month post-discharge, 73 (39%) reported tobacco abstinence (18% intent to treat-ITT-quit rate); 35.5% had used cessation pharmacotherapy and 6.5% had engaged in quitline counseling. Of 151 patients reached at 6 months post-discharge, 29% reported abstinence (11%, ITT). CONCLUSION: Inpatients with a history of cancer are interested in quitting. Post-discharge quit rates and pharmacotherapy use were high but quitline use was low. Hospitalization is an under-utilized, prime treatment opportunity and teachable moment for people with a history of cancer who continue to use tobacco.

The impact of COVID-19 on income and employment and willingness to become vaccinated among African Americans enrolled in a smoking cessation randomized trial.

Given vulnerability to COVID-19 among smokers and vaccine hesitancy among populations disproportionately burdened with COVID-19, it's important to understand concerns about vaccines and the impact of COVID-19 on these subgroups. Among our all African American (AA) sample of smokers (N = 172) enrolled in alargersmoking cessation clinical trial, results demonstrated an intensive burden from COVID-19; 42 (24.4%) lost employment, 56 (32.6%) lost household income, and 66 (38.4%) reportedinability to pay bills and buy food due to COVID. Most, 103 (64.4%), were willing to get vaccinated. Among the vaccine-hesitant, 57 (35.6%), concerns about COVID-19 vaccine development and mistrust in vaccines were primary reasons for unwillingness to get vaccinated. Few identified doctor's advice as most valued in deciding if the vaccine was the best option. Findings highlight high openness to the vaccine among smokers impacted by COVID but reiterate the need for community-engaged versus health system-driven approaches to improve vaccine hesitancy among racial/ethnic minorities.

Association between tobacco and alcohol use among hospital inpatients / Associação do uso de álcool e tabaco entre pacientes hospitalizados

We aimed to evaluate concurrent use of alcohol and tobacco among hospitalized patients as well as to compare the use of both substances among people living with Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome and those with other diagnoses. A cross-sectional study took place in a hospital in Minas Gerais (Brazil). Structured surveys were used to evaluate tobacco and alcohol use. Data analysis was conducted using descriptive statistics and chi-square test. We interviewed 972 patients, in which 20.3% were hazardous drinkers and 14.9% tobacco users. Almost half of the smokers (47.6%) were hazardous drinkers, while 15.5% of nonsmokers engaged in harmful consumption of alcohol (p < 0.001). Tobacco use was higher among people living with Human Immunodeficiency Virus when compared with patients that did not have an Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome diagnosis (32.1% vs 14.4%, p = 0.009). Our findings showed the association of tobacco use and hazardous drinking among hospitalized patients in Brazil and a higher prevalence of tobacco use among patients living with Human Immunodeficiency Virus. These findings can be used to develop smoking cessation interventions that address the comorbidities associated with substance use.

O presente estudo teve como objetivo avaliar a associação do uso de álcool e tabaco entre pacientes internados em um hospital geral e comparar o uso das duas substâncias entre pacientes que vivem com o Vírus da Imunodeficiência Humana/Síndrome de Imunodeficiência Adquirida e outros diagnósticos. Realizou-se um estudo observacional em um hospital público para avaliação do uso de tais substâncias. Entre 972 pacientes, 20,3% fizeram uso prejudicial de álcool e 14,9% de tabaco. Quase metade dos tabagistas (47,6%) fizeram uso prejudicial do álcool, enquanto 15,5% dos não tabagistas relataram uso excessivo da substância (p < 0,001). A porcentagem de fumantes foi significativamente mais alta no grupo de pacientes que vivem com o Virus da Imunodeficiência Humana do que nos demais diagnósticos (32,1% vs 14,4%, p = 0,009). Percebe-se a associação do uso de tabaco e uso prejudicial de álcool entre pacientes hospitalizados e alta prevalência do uso de tabaco entre pacientes que vivem com o Vírus da Imunodeficiência Humana/Síndrome de Imunodeficiência Adquirida. Esses dados podem direcionar o planejamento de intervenções para cessação do consumo de tabaco que consigam direcionar as comorbidades relacionadas ao uso da substância

Eficácia de um protocolo hospitalar para cessação do tabagismo no pós-alta: um estudo longitudinal / Efficacy of a hospital protocol for post-discharge smoking cessation: a longitudinal study

Introdução: Na literatura nacional, são escassos os trabalhos que avaliam intervenções hospitalares para promoção da cessação do tabagismo. Objetivo: Avaliar a eficácia de um protocolo hospitalar na promoção da cessação do tabagismo segundo grau de dependência nicotínica. Método: Estudo longitudinal realizado em hospital universitário, com 146 participantes dividido em dois grupos segundo grau de dependência à nicotina. Ambos receberam abordagem motivacional, material informativo, terapia de reposição de nicotina (quando indicado) e ligações telefônicas semanais por 30 dias pós alta. Resultados: Noventa e dois participantes (63%) apresentaram maior dependência nicotínica (Fagerström ≥ 5). Os sintomas de ansiedade e depressão foram mais frequentes no grupo de maior dependência (p=0,018). A autoeficácia, foi maior no grupo com menor dependência (p=0,008). O percentual de cessação um mês após a alta foi três vezes maior nos pacientes com menor dependência (p=0,001). Conclusão: Os resultados reforçam que as estratégias devem ser aprimoradas para pacientes com maior dependência e que um protocolo estruturado favorece o alcance da cessação em pacientes hospitalizados. [au]

Introduction: In the national literature, studies which evaluates hospital interventions are still shortages to promote smoking cessation. Objective: To evaluate the effectiveness of a hospital smoking cessation program in promoting cessation, according degree of nicotine dependence. Methods: This longitudinal study evaluated 146 hospitalized smokers, divided into two groups according to their degree of nicotine dependence. During hospitalization, patients received motivational/behavioral counseling, printed educational materials, nicotine replacement for 30 days. Post-discharge, patients received weekly telephone calls for one month. Results: Ninety-two participants (63%) had an FTND score ≥ 5 indicating higher levels of nicotine dependence. Depression/anxiety was significantly more prevalent in the high-dependent group (p=0,018). The low-dependent group had higher mean self-efficacy (0-worst to 10-best) compared to the high dependence group (median of 8 and 6 respectively, p=0.008). Cessation one month after discharge was nearly three times higher in the low-dependent group, compared to the high-dependent group (p=0.001). Conclusions: In the sample studied, patients more dependent on nicotine exhibited higher depression/anxiety and lower self-efficacy­elements that negatively influence the achievement of cessation. Quit rates were much lower in the high-dependent group. Strategies that increase self-efficacy and address mental disorders could address underlying risks that hinder cessation among patients with higher nicotine dependence. A structured protocol favors the achievement of cessation in hospitalized patients. [au]

Physician perceived barriers and facilitators for self-measured blood pressure monitoring- a qualitative study.

INTRODUCTION: Improving hypertension management is a national priority that can decrease morbidity and mortality. Evidence-based hypertension management guidelines advocate self-measured BP (SMBP), but widespread implementation of SMBP is lacking. The purpose of this study was to describe the perspective of primary care physicians (PCPs) on SMBP to identify the barriers and facilitators for implementing SMBP. METHODS: We collected data from PCPs from a large health system using semi-structured interviews based on the Theoretical Domains Framework (TDF). Responses were recorded, transcribed, and qualitatively analyzed into three overarching TDF domains based on the Behavior Change Wheel (BCW): 1) Motivation 2) Opportunity and 3) Capabilities. The sample size was based on theme saturation. RESULTS: All 17 participating PCPs believed that SMBP is a useful, but underutilized tool. Although individual practices varied, most physicians felt that the increased data points from SMBP allowed for better hypertension management. Most felt that overcoming existing barriers would be difficult, but identified several facilitators: physician support of SMBP, the possibility of having other trained health professionals to assist with SMBP and patient education; improving patient engagement and empowerment with SMBP, and the interest of the health system in using technology to improve hypertension management. CONCLUSION: PCPs believe that SMBP can improve hypertension management. There are numerous barriers and facilitators for implementing SMBP. Successful implementation in clinical practice will require implementation strategies targeted at increasing patient acceptability and reducing physician workload. This may need a radical change in the current methods of managing hypertension.

Stress, Depression and Quit Attempt Outcomes among Unmotivated Smokers.

INTRODUCTION: Stress and depressive symptoms have been linked to a reduced likelihood of sustaining smoking cessation. Because stress and depressive symptoms may negatively affect motivation to quit, stress and depression may also be important for whether or not smokers make a quit attempt. OBJECTIVE: To examine the relationship between perceived stress and depressive symptoms and initiating a quit attempt in a smoking cessation induction trial. METHODS: We conducted a secondary analysis of existing data from a randomized clinical trial (N = 255) comparing motivational interviewing to health education and brief advice for smoking cessation induction in smokers with low motivation to quit. RESULTS: We observed positive associations between baseline predictors and quit attempts at week 12 (r = 0.192, p < 0.01 for depressive symptoms and r = 0.136, p < 0.05 for perceived stress). Logistic regression models revealed similar significant positive associations between baseline perceived stress and baseline depressive symptoms and making a quit attempt by week 12 (OR = 1.5, CI:1.03, 2.19 and OR = 1.03, 95% CI: 1.01, 1.06; respectively). CONCLUSION: Unexpectedly, this study found generally small but consistently positive associations between baseline depressive symptoms and baseline perceived stress and making a quit attempt by week 12. The results can be viewed as encouraging in that interventions to encourage quit attempts do not appear counter-productive for individuals higher in stress and depressive symptoms, but these patients very likely will need additional supports to sustain abstinence.

Differential mechanisms of change in motivational interviewing versus health education for smoking cessation induction.

Objective: To determine if Motivational Interviewing (MI) versus health education (HE) elicited different types of client language and whether these differences were associated with outcomes in a randomized clinical trial (RCT) for cessation induction among people who smoke with low motivation to quit. Methods: A secondary data analysis was conducted using data from the MI and HE arms of a trial in which people who smoke (N = 202) with low desire to quit were randomly assigned to four sessions of MI, HE or brief advice. Mediation analyses examined two types of client language: change talk (CT) and a novel form of client speech called "learning talk" (LT). Outcomes were assessed at baseline, 3 and 6 months. Results: With HE as the reference group, MI resulted in greater CT (OR = 3.0, 95% CI: 1.7-5.5) which was associated with better outcomes (average d = .34, SD = .13) and HE resulted in greater LT (OR = .05, 95% CI: .02-.10) which was also associated with better outcomes (average d = .42, SD = .08). Indirect parallel mediation effects on quit attempts were significant for both MI-CT (OR = 1.4, 95% CI: 1.1-1.7) and HE-LT (OR = .4, 95% CI: .2-.7). Conclusions: MI and HE were both efficacious via different pathways to change, confirming the utility of MI in this RCT as well as highlighting the potential of HE based on the "5R's" for smoking cessation. These findings emphasize the value of exploring theorized mechanisms of action of interventions evaluated in RCTs. (PsycInfo Database Record (c) 2021 APA, all rights reserved).