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BACKGROUND: Part 1 of the RUBY trial (NCT03981796) evaluated dostarlimab plus carboplatin-paclitaxel compared with placebo plus carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer (EC). At the first interim analysis, the trial met one of its dual primary endpoints with statistically significant progression-free survival benefits in the mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) and overall populations. Overall survival (OS) results are reported from the second interim analysis. PATIENTS AND METHODS: RUBY is a phase III, global, double-blind, randomized, placebo-controlled trial. Part 1 of RUBY enrolled eligible patients with primary advanced stage III or IV or first recurrent EC who were randomly assigned (1 : 1) to receive either dostarlimab (500 mg) or placebo, plus carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab (1000 mg) or placebo every 6 weeks for up to 3 years. OS was a dual primary endpoint. RESULTS: A total of 494 patients were randomized (245 in the dostarlimab arm; 249 in the placebo arm). In the overall population, with 51% maturity, RUBY met the dual primary endpoint for OS at this second interim analysis, with a statistically significant reduction in the risk of death [hazard ratio (HR) = 0.69, 95% confidence interval (CI) 0.54-0.89, P = 0.0020] in patients treated with dostarlimab plus carboplatin-paclitaxel versus carboplatin-paclitaxel alone. The risk of death was lower in the dMMR/MSI-H population (HR = 0.32, 95% CI 0.17-0.63, nominal P = 0.0002) and a trend in favor of dostarlimab was seen in the mismatch repair-proficient/microsatellite stable population (HR = 0.79, 95% CI 0.60-1.04, nominal P = 0.0493). The safety profile for dostarlimab plus carboplatin-paclitaxel was consistent with the first interim analysis. CONCLUSIONS: Dostarlimab in combination with carboplatin-paclitaxel demonstrated a statistically significant and clinically meaningful OS benefit in the overall population of patients with primary advanced or recurrent EC while demonstrating an acceptable safety profile.
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Protocolos de Quimioterapia Combinada Antineoplásica , Carboplatina , Neoplasias do Endométrio , Paclitaxel , Humanos , Feminino , Carboplatina/administração & dosagem , Neoplasias do Endométrio/tratamento farmacológico , Neoplasias do Endométrio/mortalidade , Neoplasias do Endométrio/patologia , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Método Duplo-Cego , Pessoa de Meia-Idade , Idoso , Adulto , Idoso de 80 Anos ou mais , Recidiva Local de Neoplasia/tratamento farmacológico , Recidiva Local de Neoplasia/patologia , Recidiva Local de Neoplasia/mortalidade , Intervalo Livre de Progressão , Anticorpos Monoclonais HumanizadosRESUMO
Identifying patients at risk for readmission after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection could facilitate care planning and prevention. This retrospective cohort study of 60-day readmission included 105 543 COVID-19 patients at 21 US healthcare systems who were discharged alive between February 2020 and November 2021. Generalized linear mixed regression analyses tested predictors of 60-day readmission and severity. The all-cause readmission rate was 15% (95% confidence interval [CI] = 10%-21%), with 22% (95% CI = 18%-26%) of readmitted patients needing intensive care, and 6% (95% CI = 05%-07%) dying. Factors associated with readmission included male sex, government insurance, positive smoking history, co-morbidity burden, longer index admissions, and diagnoses at index admission (e.g., cancer, chronic kidney disease, and liver disease). Death and intensive care rates at readmission declined postvaccine availability. Receiving at least two COVID-19 vaccine doses, which were more common among older patients and those with comorbid conditions, was not independently associated with readmission but predicted a reduced risk of death at readmission. This retrospective cohort study identified factors associated with all-cause readmission for patients re-admitted to the same health system after hospitalization with SARS-CoV-2 infection. Patients who are male, who smoke, who have a higher comorbidity burden, and have government insurance may benefit from additional postacute care planning.
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COVID-19 , Humanos , Masculino , Estados Unidos/epidemiologia , Feminino , COVID-19/epidemiologia , COVID-19/terapia , Readmissão do Paciente , SARS-CoV-2 , Estudos Retrospectivos , Pacientes Internados , Vacinas contra COVID-19 , Fatores de Risco , HospitalizaçãoRESUMO
BACKGROUND: Information on COVID-19 vaccination effects on mortality among patients hospitalized with COVID-19 could inform vaccination outreach efforts and increase understanding of patient risk. OBJECTIVE: Determine the associations of vaccination status with mortality in adult patients hospitalized with COVID-19. DESIGN: This retrospective cohort study assessed the characteristics and mortality rates of adult patients hospitalized with COVID-19 across 21 healthcare systems in the USA from January 1, 2021, to January 31, 2022. PARTICIPANTS: Adult patients admitted to participating hospitals who had COVID-19 diagnoses and/or positive PCR tests and completed their hospital stay via discharge or death. MAIN MEASURE: In-hospital mortality vs. discharge (outcome) and patient age, sex, race, ethnicity, BMI, insurance status, comorbidities, and vaccination status extracted from the electronic health record (EHR). KEY RESULTS: Of 86,732 adult patients hospitalized with COVID-19, 45,082 (52%) were female, mean age was 60 years, 20,800 (24%) were Black, and 22,792 (26.3%) had one or more COVID-19 vaccinations. Statistically adjusted mortality rates for unvaccinated and vaccinated patients were 8.3% (95% CI, 8.1-8.5) and 5.1% (95% CI, 4.8-5.4) respectively (7.9% vs. 4.5% with no immune compromise). Vaccination was associated with especially large reductions in mortality for obese (OR = 0.67; 95% CI 0.56-0.80) and severely obese (OR = 0.52; 95% CI, 0.41-0.67) patients and for older patients (OR = 0.99; 95% CI, 0.98-0.99). Mortality likelihood was higher later in the study period (August 2021-January 31, 2022) than earlier (January 1, 2021-July 30, 2021) (OR = 1.10; 95% CI = 1.04-1.17) and increased significantly for vaccinated patients from 4.6% (95% CI, 3.9-5.2%) to 6.5% (95% CI, 6.2-6.9%). CONCLUSIONS: Patients vaccinated for COVID-19 had reduced mortality, especially for obese/severely obese and older individuals. Vaccination's protective effect against mortality declined over time and hospitalized obese and older individuals may derive especially great benefit from prior vaccination against SARS-CoV-2.
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Vacinas contra COVID-19 , COVID-19 , Adulto , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Estudos Retrospectivos , COVID-19/prevenção & controle , SARS-CoV-2 , Hospitalização , Obesidade/epidemiologia , VacinaçãoRESUMO
INTRODUCTION: Available evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown. METHODS: Electronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission. RESULTS: Current (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97). CONCLUSIONS: Former but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers. IMPLICATIONS: Prior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.
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COVID-19 , Abandono do Hábito de Fumar , Humanos , Nicotina/uso terapêutico , Estudos de Coortes , Mortalidade Hospitalar , Vacinas contra COVID-19/uso terapêutico , Universidades , Wisconsin , COVID-19/epidemiologia , COVID-19/prevenção & controle , SARS-CoV-2 , Dispositivos para o Abandono do Uso de Tabaco , Fumar/epidemiologia , HospitaisRESUMO
INTRODUCTION: Intussusception is one of the commonest causes of bowel obstruction in infants. Most infants in Low- and Middle-Income Countries (LMICs) undergo an invasive operative intervention. Supported by simulation-based education (SBE), the Air Enema (AE) non-operative technique was introduced in 2016 in Myanmar. This study assesses the long-term outcomes. METHODS: Mixed methods study design over 4 years including clinical outcomes and surgeon's attitudes towards the AE technique and SBE. Prospectively collected clinical outcomes and semi-structured interview with reflexive thematic analysis (RTA). Primary outcome measure was a long-term shift to non-operative intervention. SECONDARY OUTCOMES: Length of Stay (LoS), recurrence rates, intestinal resection rates, compared to the operative group. The data was analysed according to intention to treat. Quantitative data analysis with Mann-Whitney U test, Fisher's exact test, Student's T-Test or Wilcoxon Signed-Rank Test utilised. A p-value of <.05 was considered significant. RESULTS: A total of 311 infants with intussusception were included. A sustained shift to AE was revealed with high success rates (86.1-91.2%). AE had a reduced LoS (4 vs. 7 days p ≤ 0.0001), Duration of Symptoms (DoS) was lower with AE (1.9/7 vs. 2.5/7, p = 0.002). Low recurrence rates (0-5.8%) and intestinal resection rates stabilised at 30.5-31.8% vs.15.3% pre-intervention. Four RTA themes were identified: Expanding conceptions of healthcare professional education and training; realising far reaching advantages; promoting critical analysis and reflective practice of clinicians; and adapting clinical practice to local context. RTA revealed an overall positive paradigm shift in attitudes and application of SBE. CONCLUSIONS: A sustained change in clinical outcomes and appreciation of the value of SBE was demonstrated following the intervention.
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Intussuscepção , Procedimentos de Cirurgia Plástica , Criança , Enema , Humanos , Lactente , Intussuscepção/terapia , Tempo de Internação , Pobreza , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Importance: Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness. Objective: To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration). Design, Settings, and Participants: Double-blind, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized. Interventions: All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311). Main Outcomes and Measures: The primary outcome was carbon monoxide-confirmed self-reported 7-day point prevalence abstinence at 52 weeks. Results: Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, -0.4% [95% CI, -5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, -4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups. Conclusions and Relevance: Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration. Trial Registration: ClinicalTrials.gov Identifier: NCT03176784.
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Agonistas Nicotínicos/uso terapêutico , Abandono do Hábito de Fumar/métodos , Dispositivos para o Abandono do Uso de Tabaco , Vareniclina/uso terapêutico , Monóxido de Carbono/análise , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Intervalos de Confiança , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Náusea/epidemiologia , Razão de Chances , Placebos/uso terapêutico , Autorrelato , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Temperança , Fatores de Tempo , WisconsinRESUMO
BACKGROUND: Electronic cigarettes (e-cigarettes) have drastically changed the nicotine and tobacco product landscape. However, their potential public health impact is still unclear. A reliable and valid measure of e-cigarette dependence would likely advance assessment and prognostication of the public health impact of e-cigarettes. The aim of this research was to examine the internal consistency, structure, and validity of three e-cigarette dependence scales. METHODS: Adult dual users (smokers who also vape, N = 256) enrolled in an observational cohort study (45.1% women, 70.7% white). At baseline, participants completed the e-cigarette Fagerström Test of Cigarette Dependence (e-FTCD), the e-cigarette Wisconsin Inventory of Smoking Dependence Motives (e-WISDM), and the Penn State Electronic Cigarette Dependence Index (PS-ECDI). All participants provided a urine sample for cotinine analysis and reported e-cigarette use at 1 year. RESULTS: The e-WISDM subscales had the highest internal consistency (α = .81-.96), then the PS-ECDI (α = .74) and e-FTCD (α = .51). A single-factor structure for the e-FTCD and an 11-factor structure for the e-WISDM were supported, but the PS-ECDI did not have a single-factor structure. All three e-cigarette dependence scales were highly correlated with validation criteria including continued e-cigarette use at 1 year, but not with e-liquid nicotine concentration or cotinine. CONCLUSIONS: The e-WISDM and PS-ECDI had stronger internal consistency than did the e-FTCD, despite the e-FTCD's single-factor structure, but all 3 measures appear to be valid measures of e-cigarette dependence as suggested by their significant relations with self-perceived addiction, heavy use, early use after overnight deprivation, and continued use over time. IMPLICATIONS: This research provides empirical support for three e-cigarette dependence measures: the e-FTCD, the PS-ECDI, and the e-WISDM among dual users of e-cigarettes and combustible cigarettes. The PS-ECDI and e-WISDM are more reliable, but all three measures were strongly correlated with key dependence constructs such as heavy use and continued use over time.
Assuntos
Sistemas Eletrônicos de Liberação de Nicotina/estatística & dados numéricos , Fumantes/psicologia , Abandono do Hábito de Fumar/estatística & dados numéricos , Fumar Tabaco/epidemiologia , Tabagismo/prevenção & controle , Adulto , Comportamento Aditivo , Feminino , Humanos , Estudos Longitudinais , Masculino , Reprodutibilidade dos Testes , Fumar Tabaco/psicologia , Wisconsin/epidemiologiaRESUMO
INTRODUCTION: This study examined relations of two affective vulnerabilities, high anxiety sensitivity (AS) and low distress tolerance (DT), with tobacco dependence, withdrawal, smoking cessation, and pharmacotherapy response. METHODS: Smokers interested in quitting (N = 1067; 52.2% female, 28.1% African American) were randomized to 12 weeks of nicotine patch, nicotine patch plus nicotine lozenge, or varenicline. Baseline questionnaires assessed AS, DT, negative affect, anxiety, and dependence. Withdrawal was assessed the first-week post-quit via ecological momentary assessment. RESULTS: DT, but not AS, predicted biochemically confirmed point-prevalence abstinence at multiple endpoints: weeks 4, 12, 26, and 52 post-quit (ps < .05); relations remained after controlling for pharmacotherapy treatment, AS, baseline negative affect, anxiety, and anxiety disorder history (ps < .05). Additional exploratory analyses examining week 4 abstinence showed DT predicted abstinence (p = .004) even after controlling for baseline dependence, post-quit withdrawal (craving and negative affect), and treatment. DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at week 4 with patch plus lozenge versus patch alone. CONCLUSIONS: DT, but not AS, predicted abstinence over 1 year post-quit (higher DT was associated with higher quit rates), with little overlap with other affective measures. DT also predicted early abstinence independent of dependence and withdrawal symptoms. Results suggest low DT may play a meaningful role in motivation to use tobacco and constitute an additional affective risk factor for tobacco cessation failure beyond negative affect or clinical affective disorders. IMPLICATIONS: People in a stop-smoking study who reported a greater ability to tolerate distress were more likely to quit smoking and remain smoke-free 1 year later. Smokers with high DT were more likely to be smoke-free 4 weeks after their target quit day if they received nicotine patch plus nicotine lozenge rather than nicotine patch alone. TRIAL REGISTRATION: NCT01553084.
Assuntos
Transtornos de Ansiedade/etiologia , Agonistas Nicotínicos/uso terapêutico , Fumantes/psicologia , Abandono do Hábito de Fumar/estatística & dados numéricos , Estresse Psicológico/etiologia , Síndrome de Abstinência a Substâncias/etiologia , Tabagismo/complicações , Adolescente , Adulto , Transtornos de Ansiedade/psicologia , Criança , Avaliação Momentânea Ecológica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Motivação , Nicotina/administração & dosagem , Abandono do Hábito de Fumar/métodos , Estresse Psicológico/psicologia , Síndrome de Abstinência a Substâncias/psicologia , Inquéritos e Questionários , Tabagismo/tratamento farmacológico , Tabagismo/psicologia , Vareniclina/uso terapêutico , Adulto JovemRESUMO
INTRODUCTION: Greater use of nicotine replacement therapy (NRT) is related to smoking cessation success, but the causal direction is unclear. This study characterized the relationship between NRT use and smoking lapse and relapse. METHODS: Participants (N = 416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD). Participants were randomized to counseling and 8 versus 26 weeks of nicotine patch plus nicotine gum post-TQD. Participants carried electronic dispensers that timestamped each gum use. Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with nonlapsers (n = 146 pairs) on multiple variables. We compared lapsers' versus matched nonlapsers' gum use in the 5 days before and after the lapsers' first lapse. RESULTS: By week 6 post-TQD, 63% of participants lapsed. Compared with nonlapsers, lapsers used less gum 1 and 2 days pre-"lapse" and on the 5 days post-lapse. Lapsers used less gum during the 5 days post-lapse than the 5 days pre-lapse. Univariate survival analyses with lapsers showed greater gum use during both pre- and post-lapse periods predicted longer latency to relapse in the first 6 weeks. CONCLUSIONS: In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched nonlapsers used less gum immediately preceding and following their first lapse. Lower mean gum use before and after lapses predicted a more rapid escalation to relapse. Decreased nicotine gum use both precedes and follows returns to smoking during cessation attempts. IMPLICATIONS: This research examined electronically monitored nicotine gum use collected in real time and found that among smokers engaged in a quit attempt, lapsers (vs. matched nonlapsers) tended to decrease their gum use 1-2 days prior to lapsing and to further decrease their gum use from pre- to post-lapse. Decreased gum use pre-lapse may signal heightened lapse risk in 1-2 days, with lower level of gum use predicting a more precipitous course of relapse. These results encourage further exploration of objective measures of smoking medication use patterns to examine their signaling properties and to inform understanding of cessation failure. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01120704.
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Terapia Comportamental , Fumantes/psicologia , Abandono do Hábito de Fumar/métodos , Fumar/psicologia , Dispositivos para o Abandono do Uso de Tabaco/estatística & dados numéricos , Tabagismo/prevenção & controle , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aconselhamento/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nicotina , Recidiva , Fumar/terapia , Tabagismo/psicologia , Adulto JovemRESUMO
BACKGROUND: Low-income smokers experience greater difficulty in quitting smoking than do other smokers. Providing financial incentives for treatment engagement increases smoking cessation success. This study models the cost-effectiveness of varying levels of financial incentives to maximise return on investment (ROI) for engaging low-income Medicaid recipients who smoke to take calls from a tobacco quit line. METHODS: Participants (N=1900) were recruited from May 2013 to June 2015 through quit line-based (n=980), clinic-based (n=444) or community-based referrals (n=476) into the Wisconsin Medicaid Quit Line Incentive project. Incentive (n=948) and control group participants (n=952) received $30 versus $0 per call, respectively, for taking up to five Wisconsin Tobacco Quit Line (WTQL) calls. Cost-effectiveness analyses estimated the incremental cost-effectiveness ratio for alternative financial incentives for engagement with WTQL calls. Probabilistic sensitivity analysis was employed to determine an optimal strategy for financial incentives to minimise the cost per individual who quit smoking. RESULTS: Using fixed payments, the incremental cost-effectiveness ratio of $2316 per smoker who quit in the randomised trial decreased to $2150 per smoker who quit when the incentives were modelled at $20 per each of five WTQL calls taken. Using variable payments, the minimal cost per additional smoker who quit was $2125 when incentives for the first four WTQL calls were set at $20, and the financial payment for the fifth WTQL call was set at $70. CONCLUSIONS: Modelling suggests that financial incentives in the amount of $20 per call for taking the first four quit line calls and $70 for taking a fifth quit line call maximise ROI to engage low-income smokers with evidence-based smoking cessation treatment.
Assuntos
Fumar Cigarros/prevenção & controle , Análise Custo-Benefício , Promoção da Saúde/métodos , Medicaid , Motivação , Pobreza , Abandono do Hábito de Fumar/métodos , Adulto , Aconselhamento/métodos , Feminino , Custos de Cuidados de Saúde , Promoção da Saúde/economia , Humanos , Masculino , Pessoa de Meia-Idade , Fumantes , Nicotiana , Uso de Tabaco , Estados Unidos , WisconsinRESUMO
OBJECTIVES: To determine the cost-effectiveness of an incentive-based stop-smoking intervention that paid Medicaid recipients who smoke to take calls from a tobacco quit line. METHODS: A cost-effectiveness analysis was conducted alongside a randomized controlled trial. The analysis was conducted from a health care systems perspective on the basis of costs and effectiveness over a 6-month follow-up. Participants (n = 1900) were recruited from May 2013 to June 2015 through quit line (n = 980), clinic-based (n = 444), or community-based (n = 476) referrals. Incentive group participants (n = 948) received $30 a call for taking up to five tobacco quit line calls and $40 for biochemically verified tobacco abstinence at 6 months. Control group participants (n = 952) did not receive financial incentives for taking quit line calls. Intervention resource costs included incentive payments to participants, counselor and administrative staff time, and smoking cessation medications. Smoking status at baseline and 6 months was determined for all study participants via carbon monoxide (CO) breath tests (abstinence: CO < 7 ppm). Cost-effectiveness analysis calculated the incremental cost-effectiveness ratio (ICER). RESULTS: Incentive treatment produced higher 6-month CO-confirmed 7-day point-prevalence abstinence than did the control treatment (21.6 vs. 13.8%; P < 0.001). The ICER of the financial incentives intervention was $2316 (95% confidence interval $1582-$4270) per additional person who quit. The study ICER compares favorably with other smoking treatments, such as varenicline combined with proactive telephone counseling, whose ICER has been estimated at $2600 per additional smoker who quits. CONCLUSIONS: Use of financial incentives to engage with tobacco quit line treatment is a cost-effective option to enhance smoking cessation rates for low-income smokers.
Assuntos
Análise Custo-Benefício/métodos , Medicaid/economia , Motivação , Pobreza/economia , Abandono do Hábito de Fumar/economia , Fumar/economia , Adulto , Feminino , Seguimentos , Promoção da Saúde/economia , Promoção da Saúde/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Fumantes , Fumar/terapia , Abandono do Hábito de Fumar/métodos , Estados Unidos/epidemiologiaRESUMO
Carotid artery grayscale ultrasound echogenicity and texture features predict cardiovascular disease events. We evaluated the longitudinal effects of smoking cessation on four grayscale ultrasound measures. This was a secondary analysis of data from 188 age, sex, and body mass index (BMI)-matched smokers (94 eventual abstainers [EA], 94 continued smokers [CS]) from a smoking cessation trial that had carotid ultrasound examinations at baseline and after 3 years. General linear models that included time, smoking group (EA or CS), and a time*smoking interaction term were used to examine the impact of smoking abstinence on carotid artery grayscale marker values at year 3. Participants were mean (SD) 50.3 (11.4) years old (57% female, 86% white). The baseline grayscale median value (GSM) was inversely correlated with age, BMI, insulin resistance, and smoking pack-years (r = -0.20 to -0.30, p < 0.007 for all). There was a significant time*smoking status interaction for predicting GSM at year 3: GSM decreased significantly in the EA group compared to the CS group (-3.63 [13.00] vs CS 0.39 [12.06] units; p = 0.029). BMI increased more in the EA than the CS group (2.42 [3.00] vs CS 0.35 [2.57] kg/m2; p < 0.001). After adjusting for changes in BMI, the time*smoking status interaction no longer was significant (p = 0.138). From baseline to year 3, contrast increased similarly in both groups. Entropy and angular second moment did not change significantly in either group. Changes in carotid ultrasound echogenicity and grayscale texture features during a smoking cessation attempt are modest and mostly related to weight gain. Clinicaltrials.gov Identifier: NCT01553084.
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Artérias Carótidas/diagnóstico por imagem , Doenças das Artérias Carótidas/diagnóstico por imagem , Abandono do Hábito de Fumar , Fumar/efeitos adversos , Ultrassonografia , Remodelação Vascular , Adulto , Doenças das Artérias Carótidas/etiologia , Ensaios Clínicos como Assunto , Ex-Fumantes , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Fatores de Risco , Fumantes , Fatores de Tempo , Aumento de PesoRESUMO
Background: The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings. Purpose: To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST). Methods: Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO <6 ppm) 7-day point-prevalence abstinence. Results: A-OT participants had significantly higher self-reported abstinence rates than R-UC participants at 4, 8, 16, and 26 weeks (ORs: 1.91-3.05; p <. 001). The biochemically confirmed 26-week abstinence rates were lower than the self-reported 26-week rates, but revealed a similar treatment effect size (OR = 2.94, p < .001). There was no moderation of treatment effects on 26-week abstinence by demographic, psychiatric, or nicotine dependence variables. A-OT had an incremental cost-effectiveness ratio for 26-week CO-confirmed abstinence of $7,800. Conclusions: A smoking cessation treatment that is optimized via MOST development meaningfully enhances cessation rates beyond R-UC smoking treatment in smokers seen in primary care. Clinical Trial Registration: NCT02301403.
Assuntos
Fumar Cigarros/terapia , Aconselhamento/métodos , Avaliação de Processos e Resultados em Cuidados de Saúde , Atenção Primária à Saúde/métodos , Abandono do Hábito de Fumar/métodos , Dispositivos para o Abandono do Uso de Tabaco , Adulto , Terapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
INTRODUCTION: The progress achieved in reducing tobacco use has not been consistent across groups of smokers, and health systems are inconsistently implementing best practice guidelines. Guideline implementation could be associated with improved treatment invitation rates. AIMS: To evaluate differences in tobacco treatment invitation rates based on patient characteristics in primary care clinics implementing best practice guidelines. METHODS: A secondary analysis of patients presenting to 11 primary care clinics from 2 Wisconsin health systems from June 2010 to February 2013. The main outcome was whether patients received an invitation to participate in tobacco treatment. Invitation rates were examined by sex, age group (≤ 24 years, 25-44, 45-64, ≥ 64), race (white, black, other), insurance status (private, Medicare, Medicaid, none), and visit diagnosis ("high-risk" [cardiovascular and pulmonary disease, malignancy, pregnancy] vs "low-risk" [all other ICD-9 categories]). Moderation effects of health systems also were examined. RESULTS: Of the 95,471 patients seen, 84,668 (89%) were screened for smoking. Among the 15,193 smokers, 10,242 (67%) were invited to participate. Invited patients were older, white or black, and carried low-risk diagnoses. Invitation rates and patient-level differences varied between the health systems. CONCLUSIONS: Variable treatment invitation rates and health system differences remain evident in the primary care setting employing robust clinical practice guideline recommendations.
Assuntos
Programas de Rastreamento/estatística & dados numéricos , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Atenção Primária à Saúde/organização & administração , Abandono do Uso de Tabaco/estatística & dados numéricos , Adulto , Idoso , Demografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , WisconsinRESUMO
Smokers unwilling to make a quit attempt can still benefit from smoking intervention. However, it is unclear what proportion of smokers will enter such a Motivation phase intervention, and whether such an intervention attracts different types of smokers than does abstinence oriented treatment. We conducted a study from June 2010 to October 2013 based on a chronic care model of tobacco treatment among study eligible primary care patients (N=1579; 58% women, 89% White) presenting for regular health care visits in southern Wisconsin, U.S. Medical assistants, prompted via the electronic health record (EHR), invited smokers (n=10,242) to learn more about treatment options to help them either reduce their smoking or quit. Of those invited to learn more who were then reached by study staff, 10.2% (n=1046) reported interest in reduction treatment and 24% (n=2465) reported interest in cessation treatment. Patients who selected and ultimately entered reduction (n=492) versus cessation (n=1087) were more likely to report: older age; a history of anxiety; lower motivation to quit; lower primary dependence motives; more close friends or family who smoke; and a greater interval since their last quit attempt. Results suggest that Motivation phase treatment aimed at smoking reduction may increase the proportion and range of smokers inducted into tobacco treatment.
Assuntos
Motivação , Atenção Primária à Saúde , Fumantes/estatística & dados numéricos , Abandono do Hábito de Fumar/métodos , Redução do Consumo de Tabaco/métodos , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Pessoa de Meia-Idade , WisconsinRESUMO
IMPORTANCE: Smoking cessation medications are routinely used in health care; it is vital to identify medications that most effectively treat this leading cause of preventable mortality. OBJECTIVE: To compare the efficacies of varenicline, combination nicotine replacement therapy (C-NRT), and the nicotine patch for 26-week quit rates. DESIGN, SETTING, AND PARTICIPANTS: Three-group randomized intention-to-treat clinical trial occurring from May 2012 to November 2015 among smokers recruited in the Madison, Wisconsin, and Milwaukee, Wisconsin, communities; 65.5% of smokers offered the study (2687/4102) refused participation prior to randomization. INTERVENTIONS: Participants were randomized to one of three 12-week open-label smoking cessation pharmacotherapy groups: (1) nicotine patch only (n = 241); (2) varenicline only (including 1 prequit week; n = 424); and (3) C-NRT (nicotine patch + nicotine lozenge; n = 421). Six counseling sessions were offered. MAIN OUTCOMES AND MEASURES: The primary outcome was carbon monoxide-confirmed self-reported 7-day point-prevalence abstinence at 26 weeks. Secondary outcomes were carbon monoxide-confirmed self-reported initial abstinence, prolonged abstinence at 26 weeks, and point-prevalence abstinence at weeks 4, 12, and 52. RESULTS: Among 1086 smokers randomized (52% women; 67% white; mean age, 48 years; mean of 17 cigarettes smoked per day), 917 (84%) provided 12-month follow-up data. Treatments did not differ on any abstinence outcome measure at 26 or 52 weeks, including point-prevalence abstinence at 26 weeks (nicotine patch, 22.8% [55/241]; varenicline, 23.6% [100/424]; and C-NRT, 26.8% [113/421]) or at 52 weeks (nicotine patch, 20.8% [50/241]; varenicline, 19.1% [81/424]; and C-NRT, 20.2% [85/421]). At 26 weeks, the risk differences for abstinence were, for patch vs varenicline, -0.76% (95% CI, -7.4% to 5.9%); for patch vs C-NRT, -4.0% (95% CI, -10.8% to 2.8%); and for varenicline vs C-NRT, -3.3% (95% CI, -9.1% to 2.6%). All medications were well tolerated, but varenicline produced more frequent adverse events than did the nicotine patch for vivid dreams, insomnia, nausea, constipation, sleepiness, and indigestion. CONCLUSIONS AND RELEVANCE: Among adults motivated to quit smoking, 12 weeks of open-label treatment with nicotine patch, varenicline, or C-NRT produced no significant differences in biochemically confirmed rates of smoking abstinence at 26 weeks. The results raise questions about the relative effectiveness of intense smoking pharmacotherapies. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01553084.
Assuntos
Nicotina/administração & dosagem , Agonistas Nicotínicos/administração & dosagem , Fumar/tratamento farmacológico , Dispositivos para o Abandono do Uso de Tabaco , Vareniclina/administração & dosagem , Adulto , Monóxido de Carbono/sangue , Aconselhamento , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Nicotina/efeitos adversos , Agonistas Nicotínicos/efeitos adversos , Avaliação de Resultados em Cuidados de Saúde , Fumar/efeitos adversos , Fumar/sangue , Abandono do Hábito de Fumar/métodos , Síndrome de Abstinência a Substâncias/terapia , Fatores de Tempo , Dispositivos para o Abandono do Uso de Tabaco/efeitos adversos , Vareniclina/efeitos adversosRESUMO
Studies of genomic copy number variants (CNVs) have identified genes associated with autism spectrum disorder (ASD) and intellectual disability (ID) such as NRXN1, SHANK2, SHANK3 and PTCHD1. Deletions have been reported in PTCHD1 however there has been little information available regarding the clinical presentation of these individuals. Herein we present 23 individuals with PTCHD1 deletions or truncating mutations with detailed phenotypic descriptions. The results suggest that individuals with disruption of the PTCHD1 coding region may have subtle dysmorphic features including a long face, prominent forehead, puffy eyelids and a thin upper lip. They do not have a consistent pattern of associated congenital anomalies or growth abnormalities. They have mild to moderate global developmental delay, variable degrees of ID, and many have prominent behavioral issues. Over 40% of subjects have ASD or ASD-like behaviors. The only consistent neurological findings in our cohort are orofacial hypotonia and mild motor incoordination. Our findings suggest that hemizygous PTCHD1 loss of function causes an X-linked neurodevelopmental disorder with a strong propensity to autistic behaviors. Detailed neuropsychological studies are required to better define the cognitive and behavioral phenotype.
Assuntos
Transtorno do Espectro Autista/diagnóstico , Transtorno do Espectro Autista/genética , Deficiência Intelectual/diagnóstico , Deficiência Intelectual/genética , Proteínas de Membrana/genética , Mutação , Fenótipo , Deleção de Sequência , Adolescente , Adulto , Criança , Pré-Escolar , Éxons , Fácies , Feminino , Humanos , Lactente , Masculino , Adulto JovemRESUMO
BACKGROUND: Many smokers are unable to access effective behavioral smoking cessation therapies due to location, financial limitations, schedule, transportation issues or other reasons. We report results from a prospective observational study in which a promising novel behavioral intervention, Mindfulness Training for Smokers was provided via web-based video instruction with telephone-based counseling support. METHODS: Data were collected on 26 low socioeconomic status smokers. Participants were asked to watch eight video-based classes describing mindfulness skills and how to use these skills to overcome various core challenges in tobacco dependence. Participants received eight weekly phone calls from a smoking cessation coach who provided general support and answered questions about the videos. On the quit day, participants received two weeks of nicotine patches. RESULTS: Participants were a mean of 40.5 years of age, smoked 16.31 cigarettes per day for 21.88 years, with a mean of 6.81 prior failed quit attempts. Participants completed a mean of 5.55 of 8 online video classes with a mean of 23.33 minutes per login, completed a mean of 3.19 of 8 phone coach calls, and reported a mean meditation practice time of 12.17 minutes per day. Smoking abstinence was defined as self-reported abstinence on a smoking calendar with biochemical confirmation via carbon monoxide breath-test under 7 parts per million. Intent-to-treat analysis demonstrated 7-day point prevalence smoking abstinence at 4 and 6-months post-quit of 23.1% and 15.4% respectively. Participants showed a significant pre- to post-intervention increase in mindfulness as measured by the Five-Factor Mindfulness Questionnaire, and a significant pre- to post-intervention decrease in the Anxiety Sub-scale of the Depression Anxiety and Stress Scale. CONCLUSIONS: Results suggest that Mindfulness Training for Smokers can be provided via web-based video instruction with phone support and yield reasonable participant engagement on intervention practices and that intervention efficacy and mechanism of effect deserve further study. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02164656 , Registration Date June 13, 2014.
Assuntos
Internet , Meditação , Atenção Plena , Abandono do Hábito de Fumar/métodos , Prevenção do Hábito de Fumar , Telemedicina , Tabagismo/terapia , Adulto , Recursos Audiovisuais , Monóxido de Carbono , Aconselhamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fumar/psicologia , Abandono do Hábito de Fumar/psicologia , Telefone , Nicotiana , Tabagismo/psicologiaRESUMO
We report the results of a randomized trial comparing a novel smoking cessation treatment Mindfulness Training for Smokers (MTS) to a usual care therapy (Controls), which included the availability of a tobacco quit line and nicotine patches. Data were collected from 196 low socioeconomic status smokers in 2010-2011 in Madison, Wisconsin. Participants were randomized to either MTS or a telephonic quit line. The primary outcome was 6-month smoking abstinence measured by carbon monoxide breath testing and Time-Line Follow-Back. Among treatment initiators (randomized participants who participated in the intervention), abstinence rates were significantly different between the MTS (38.7%) and control (20.6%, p = .05) groups. Study limitations are also discussed. Results suggest that further study is warranted.
Assuntos
Atenção Plena , Abandono do Hábito de Fumar/métodos , Fumar/terapia , Tabagismo/terapia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevenção Secundária , Fumar/psicologia , Tabagismo/psicologia , Resultado do Tratamento , Populações VulneráveisRESUMO
This collaborative, community-engaged project developed and tested a Culturally-Tailored Treatment (CTT) for American Indian/Alaska Native (AI/AN) smokers in the Menominee tribal community. One hundred three adult AI/AN smokers were randomized to receive either Standard Treatment (n= 53) or CTT (n = 50) for smoking cessation. Both treatment conditions included 12 weeks of varenicline and four individual counseling sessions but differed in terms of cultural tailoring of the counseling. The primary outcome was 7-day biochemically-confirmed point-prevalence abstinence (PPA) at the 6-month end-of-study visit. Both intention-to-treat (ITT) and responder-only analyses were conducted. There were no statistically significant group differences in 7-day PPA. The overall ITT abstinence rate at 6 months was 20%; the responder-only rate was 42%. The current study represents the first randomized smoking cessation clinical trial testing a culturally-tailored smoking cessation intervention designed for a specific AI/AN tribal community that combined FDA-approved cessation medication (varenicline) and innovative cultural intervention components.