US Clinical Practice Guidelines Research Articles

Do Smartphone Apps Impact Long-Term Smoking Cessation for Sexual and Gender Minority Adults? Exploratory Results from a 2-Arm Randomized Trial Comparing Acceptance and Commitment Therapy with Standard US Clinical Practice Guidelines

ABSTRACT Sexual and gender minority (SGM) adults face unique challenges in accessing smoking cessation care due to stigma tied to their identities and smoking. While cessation apps show promise in the general population, their efficacy for SGM adults is unclear. This study utilized data from a randomized trial to compare two cessation apps, iCanQuit (Acceptance and Commitment Therapy-based) and QuitGuide (US Clinical Practice Guidelines-based) among 403 SGM adults. The primary outcome was self-reported complete-case 30-day abstinence from cigarette smoking at 12 months. Mediation analyses explored whether interventions operated through acceptance of cues to smoke and app engagement. At 12 months, quit rates did not differ between arms (26% iCanQuit vs. 22% QuitGuide, OR = 1.22; 95% CI: 0.74 to 2.00, p = .43). iCanQuit positively impacted cessation via acceptance of cues to smoke (indirect effect = 0.23; 95% CI: 0.06 to 0.50, p < .001) and demonstrated higher engagement (no. logins, 28.4 vs. 12.1; p < .001) and satisfaction (91% vs. 75%, OR = 4.18; 95% CI: 2.12 to 8.25, p < .001) than QuitGuide. Although quit rates did not differ between arms, acceptance of cues to smoke seemed to play a crucial role in helping SGM adults quit smoking. Future interventions should consider promoting acceptance of cues to smoke in this population.

NoFumo+: Mobile Health App to Quit Smoking Using Cognitive-Behavioral Therapy.

This paper describes the development and test of a smartphone application to quit smoking using cognitive behavioral therapy (CBT). The tool includes recommendations from US Clinical Practice Guidelines (USCPG), drawing on the potential of smartphones and complying with the health App (mHealth) assessment standards. The mHealth created, called NoFumo+, is structured by 4 weeks treatment, implements the USCPG 5A recommendations (ask, advise, assess, assist, and arrange) and incorporates a CBT. It also includes complementary information, monitoring of the smoking behavior, social support for users, proposals for alternative activities to smoking, and innovative gamification to encourage and reward adherence. To technical development, a multidisciplinary team was formed (healthcare, research, and software engineers) that made theoretical decisions on both technical issues and the incorporation of therapeutic techniques. The validation was carried out in two phases; the first in the laboratory by a group of experts in information and communication technologies and CBTs (n = 15) and the second, a field study with smokers (n = 10). The standards for the development of mHealth recommended by the Andalusian Healthcare Quality Agency and the App quality evaluation guidelines of the Catalonian ICT Foundation for Social Health were used as assessment protocols by the experts' panel and the smokers' group, respectively. Experts' assessment results were satisfactory and some improving changes were suggested, such as to add more gamification elements. The group of smokers rated the mHealth as 100% easy to use and effective for quit smoking and understandable by the 83.3%. They also found No Fumo + quite useful to have the information available at all times. The obtained evidence after a complete two-phased validation study, with experts and potential users, shows a mHealth with high quality and easy to use. Finally, investigation project registered in ClinicalTrials.gov with reference to this trial is registered with NCT045402004.

Randomized Controlled Trial of Clinical Guidelines Versus Interactive Decision-Support for Improving Medical Trainees' Confidence with Latent Tuberculosis Care.

In order to eliminate tuberculosis (TB) in the USA, primary care providers must take on an expanded role in the diagnosis and management of latent tuberculosis infection (LTBI). Clinical practice guidelines and recommendations exist for LTBI management, but there is a need for innovative tools to improve medical students' and residents' knowledge of evidence-based practices for LTBI testing and treatment. To assess the impact of LTBI-ASSIST, a free online decision support aid, as a novel educational tool and mechanism of delivering clinical practice guidelines for medical trainees. A single site, randomized controlled trial of trainees delivered by electronic survey. Medical students and Internal Medicine residents at the Johns Hopkins University School of Medicine. Participants were randomized in 1:1 ratio to receive the US clinical practice guidelines and recommendations for Latent TB management (control arm) or the guidelines plus an introduction to LTBI-ASSIST (LTBI-ASSIST arm) as they completed a case-based knowledge assessment and reported confidence with domains of LTBI care. (1) Proportion of questions answered correctly on a case-based knowledge assessment; (2) change in reported confidence with domains of LTBI care. One hundred and thirty participants completed the knowledge assessment. Those randomized to receive the LTBI-ASSIST Tool performed better on the case-based knowledge assessment with a mean score of 75.9% (95% CI: 70.6-81.1), compared to 57.4% (52.8-62.0) in the group that received the guidelines only (p <0.001). Similarly, the LTBI-ASSIST group reported a higher change in confidence (measured as post-assessment confidence minus pre-assessment confidence), compared to the control group, in six of the seven domains of LTBI care. LTBI-ASSIST can be an effective supplement to existing guidelines in educating medical trainees and helping providers find evidence-based, guideline-supported answers for questions encountered in clinical practice. NIH Clinical Trial Registry No. NCT05772065.

Acceptance and Commitment Therapy-Based Smartphone Applications for Cessation of Tobacco Use among Adults with High Nicotine Dependence: Results from the iCanQuit Randomized Trial

Background: With 1 in 2 adult tobacco users being highly dependent on nicotine, population-based interventions specifically designed for this group are urgently needed. This study used data from a randomized trial to evaluate whether (1) Acceptance and Commitment Therapy (ACT) delivered via a smartphone application (iCanQuit) would be more efficacious for cessation of nicotine-containing tobacco products than the US Clinical Practice Guidelines (USCPG)-based application (QuitGuide) among highly nicotine-dependent adults, (2) the effect of treatment on cessation was mediated by increases in acceptance of cravings to smoke, and (3) treatment utilization and satisfaction differed by arm. Methods: A total of 1452 highly nicotine-dependent adults received the iCanQuit or QuitGuide application for 12-months. Cessation outcomes were self-reported complete-case 30-day abstinence of nicotine-containing tobacco products (e.g., combustible cigarettes, e-cigarettes, chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks) at 3, 6, and 12-month post-randomization timepoints, missing-as-smoking, and multiple imputation analyses. Acceptance of cues to smoke and satisfaction with the applications was also reported. Results: Participants who received iCanQuit were significantly more likely to report 30-day abstinence of nicotine-containing tobacco products than those who received QuitGuide at 12-months (24% vs. 17%; OR = 1.47 95% CI: 1.11, 1.95). iCanQuit participants utilized their application more frequently and reported greater satisfaction than those who received QuitGuide. Increases in participants’ acceptance of cues to smoke mediated the intervention effect on cessation of nicotine-containing tobacco products. Conclusions: Among nicotine-dependent adults, an application-delivered ACT-based intervention was more engaging and efficacious than a USCPG-based intervention for cessation of nicotine-containing tobacco products.

Development of a WeChat-based Mobile Messaging Smoking Cessation Intervention for Chinese Immigrant Smokers: Qualitative Interview Study.

BackgroundSmoking remains a major public health issue among Chinese immigrants. Smoking cessation programs that focus on this population are scarce and have a limited population-level impact due to their low reach. Mobile messaging interventions have the potential to reach large audiences and expand smokers’ access to smoking cessation treatment.ObjectiveThis study describes the development of a culturally and linguistically appropriate mobile messaging smoking cessation intervention for Chinese immigrant smokers delivered via WeChat, the most frequently used social media platform among Chinese people globally.MethodsThis study had 2 phases. In phase 1, we developed a mobile message library based on social cognitive theory and the US Clinical Practice Guidelines for Treating Tobacco Use and Dependence. We culturally adapted messages from 2 social cognitive theory-based text messaging smoking cessation programs (SmokefreeTXT and Decídetexto). We also developed new messages targeting smokers who were not ready to quit smoking and novel content addressing Chinese immigrant smokers’ barriers to quitting and common misconceptions related to willpower and nicotine replacement therapy. In phase 2, we conducted in-depth interviews with 20 Chinese immigrant smokers (including 7 women) in New York City between July and August 2021. The interviews explored the participants’ smoking and quitting experiences followed by assessment of the text messages. Participants reviewed 17 text messages (6 educational messages, 3 self-efficacy messages, and 8 skill messages) via WeChat and rated to what extent the messages enhanced their motivation to quit, promoted confidence in quitting, and increased awareness about quitting strategies. The interviews sought feedback on poorly rated messages, explored participant preferences for content, length, and format, discussed their concerns with WeChat cessation intervention, and solicited recommendations for frequency and timing of messages.ResultsOverall, participants reported that the messages enhanced their motivation to quit, offered encouragement, and made them more informed about how to quit. Participants particularly liked the messages about the harms of smoking and strategies for quitting. They reported barriers to applying some of the quitting strategies, including coping with stress and staying abstinent at work. Participants expressed strong interest in the WeChat mobile messaging cessation intervention and commented on its potential to expand their access to smoking cessation treatment.ConclusionsMobile messages are well accepted by Chinese immigrant smokers. Research is needed to assess the feasibility, acceptability, and efficacy of WeChat mobile messaging smoking cessation interventions for promoting abstinence among Chinese immigrant smokers.

Efficacy of smartphone applications for smoking cessation in heavy-drinking adults: Secondary analysis of the iCanQuit randomized trial

IntroductionEfficacious smoking cessation treatments are needed for heavy-drinking adults who often have difficulty quitting smoking. In a secondary analysis of a parent randomized controlled trial, we explored the efficacy of an Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) versus a US Clinical Practice Guidelines (USCPG)-based smartphone application (QuitGuide) for smoking cessation among heavy-drinking participants (4 + drinks/day for women; 5 + drinks/day for men). MethodsParticipants were randomized to receive iCanQuit (n = 188) or QuitGuide (n = 160) for 12-months. Smoking cessation outcomes were measured at 3, 6 and 12-months. The primary outcome was self-reported complete-case 30-day point prevalence abstinence (PPA) at 12-months. Secondary outcomes were 7-day PPA at all timepoints; prolonged abstinence; and cessation of all nicotine-containing products at 12-months. Multiple imputation and missing-as-smoking analyses were also conducted. Exploratory outcomes were cessation of both smoking and heavy drinking and change in alcohol use (drinks/day) at 12-months. Treatment engagement and satisfaction and change in ACT-based processes were compared between arms. ResultsRetention rate was 85% at 12-months and did not differ by arm. At 12-months, iCanQuit participants had nearly double the odds of smoking cessation compared to QuitGuide (complete-case 30-day PPA = 24% vs. 15%; OR = 1.87 95% CI: 1.03, 3.42). Findings were similar for the multiple imputation and missing-as-smoking outcomes at 12-months. Combined cessation of smoking and heavy drinking, and alcohol use at 12-months did not differ by arm. iCanQuit was significantly more engaging and satisfying than QuitGuide. Increased acceptance of thoughts about smoking mediated the effect of treatment on cessation of heavy drinking at 12-months. ConclusionsThe iCanQuit smartphone application was more efficacious and engaging for smoking cessation among heavy-drinking adults than a USCPG-based smartphone application.

Efficacy of an acceptance and commitment therapy-based smartphone application for helping rural populations quit smoking: Results from the iCanQuit randomized trial

Limited access to evidence-based smoking cessation interventions among rural populations contributes to high rates of cigarette smoking and poor cessation outcomes. Yet, accessible digital interventions for cessation focusing on rural populations are lacking. In a secondary analysis, we determined the acceptability and efficacy of an Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) relative to a U.S. Clinical Practice Guidelines (USCPG)-based smartphone application (QuitGuide) for smoking cessation among rural participants enrolled in the two-arm randomized iCanQuit trial. Participants were enrolled between May 2017 and September 2018 and randomized to either receive iCanQuit or QuitGuide for 12-months. Rural residence was determined by sub-county level Rural-Urban Commuting Area codes. A total of 550 rural participants were recruited from 43 U.S. states. Self-reported complete-case 30-day point-prevalence abstinence was 15% (33/226) for iCanQuit vs. 9% (22/253) for QuitGuide at 3-months (OR = 1.83; 95% CI: 1.03, 3.25) and 29% (66/231) for iCanQuit vs. 25% (64/288) for QuitGuide at 12-months (OR = 1.19 95% CI: 0.80, 1.79). Retention rate was 89% at 12-months and did not differ by arm. iCanQuit vs. QuitGuide participants were significantly more engaged and satisfied with the iCanQuit application. Increased acceptance of internal cues to smoke mediated the effect of treatment on cessation. Findings suggest that iCanQuit had significantly higher short-term quit rates, descriptively higher long-term quit rates, and operated through its hypothesized mechanisms of action relative to QuitGuide. Future larger studies are needed to further evaluate the efficacy of and methods for disseminating the iCanQuit application for smoking cessation among U.S. rural adults nationwide.Trial registrationClinicalTrials.gov Identifier: NCT02724462

A population-based study of 92 clinically recognized risk factors for heart failure: co-occurrence, prognosis and preventive potential.

AimsPrimary prevention strategies for heart failure (HF) have had limited success, possibly due to a wide range of underlying risk factors (RFs). Systematic evaluations of the prognostic burden and preventive potential across this wide range of risk factors are lacking. We aimed at estimatingevidence, prevalence and co‐occurrence for primary prevention and impact on prognosis of RFs for incident HF.Methods and resultsWe systematically reviewed trials and observational evidence of primary HF prevention across 92 putative aetiologic RFs for HF identified from US and European clinical practice guidelines. We identified 170 885 individuals aged ≥30 years with incident HF from 1997 to 2017, using linked primary and secondary care UK electronic health records (EHR) and rule‐based phenotypes (ICD‐10, Read Version 2, OPCS‐4 procedure and medication codes) for each of 92 RFs. Only 10/92 factors had high quality observational evidence for association with incident HF; 7 had effective randomized controlled trial (RCT)‐based interventions for HF prevention (RCT‐HF), and 6 for cardiovascular disease prevention, but not HF (RCT‐CVD), and the remainder had no RCT‐based preventive interventions (RCT‐0). We were able to map 91/92 risk factors to EHR using 5961 terms, and 88/91 factors were represented by at least one patient. In the 5 years prior to HF diagnosis, 44.3% had ≥4 RFs. By RCT evidence, the most common RCT‐HF RFs were hypertension (48.5%), stable angina (34.9%), unstable angina (16.8%), myocardial infarction (15.8%), and diabetes (15.1%); RCT‐CVD RFs were smoking (46.4%) and obesity (29.9%); and RCT‐0 RFs were atrial arrhythmias (17.2%), cancer (16.5%), heavy alcohol intake (14.9%). Mortality at 1 year varied across all 91 factors (lowest: pregnancy‐related hormonal disorder 4.2%; highest: phaeochromocytoma 73.7%). Among new HF cases, 28.5% had no RCT‐HF RFs and 38.6% had no RCT‐CVD RFs. 15.6% had either no RF or only RCT‐0 RFs.ConclusionOne in six individuals with HF have no recorded RFs or RFs without trials. We provide a systematic map of primary preventive opportunities across a wide range of RFs for HF, demonstrating a high burden of co‐occurrence and the need for trials tackling multiple RFs.

Primary Care-Based Cardiovascular Disease Risk Management After Adverse Pregnancy Outcomes: a Narrative Review.

Several common adverse pregnancy outcomes can reveal subclinical or latent cardiovascular disease (CVD) risk, transiently exposed through the physiologic stress of pregnancy. The year after pregnancy may be a singular opportunity to identify and initiate treatment for CVD risk, even before the onset of traditional CVD risk factors. However, clinical guidance regarding CVD risk management after adverse pregnancy outcomes is lacking. We therefore conducted a systematic review of US clinical practice guidelines and professional society recommendations to inform primary care–based CVD risk management after adverse pregnancy outcomes. We identified 13 relevant publications. While most recommendations were based on limited or weak evidence, we identified several areas of consensus. First, individuals with an adverse pregnancy outcome associated with future CVD are likely to benefit from CVD risk assessment—accompanied by education, counseling, and support for lifestyle modification—beginning within the first postpartum year. Second, among clinicians, clear and consistent documentation about adverse pregnancy outcomes and recommended follow-up is important to coordinate care after pregnancy. In addition, patients need to be informed about their pregnancy complications and associated CVD risks, so that they can make informed health care and lifestyle decisions. Finally, in general, CVD prevention in the year after an adverse pregnancy outcome focuses on lifestyle modification, reserving pharmacotherapy for the highest-risk patients and those with traditional CVD risk factors. While postpartum lifestyle interventions show promise for reducing CVD risk after adverse pregnancy outcomes, continued research to determine the optimal content, timing, and long-term effects of such interventions is needed.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-07149-x.

Efficacy and utilization of smartphone applications for smoking cessation among low-income adults: Secondary analysis of the iCanQuit randomized trial

IntroductionEvidence of digital interventions that are efficacious among low-income populations is scarce. In a secondary analysis, we determined the efficacy and utilization of an Acceptance and Commitment Therapy (ACT)-based smartphone application (iCanQuit) versus a U.S. Clinical Practice Guidelines (USCPG)-based smartphone application (QuitGuide) for smoking cessation in low-income adults enrolled in the iCanQuit randomized trial. MethodsParticipants were randomized to receive iCanQuit (n = 437) or QuitGuide (n = 460) for 12-months. Consistent with the main trial, the primary outcome was self-reported complete-case 30-day point prevalence abstinence (PPA) at 12-months. Secondary outcomes were 7-day PPA, missing-as-smoking and multiple imputation, prolonged abstinence, and cessation of all tobacco products at 12-months. Outcome data retention, utilization, and change in ACT-based processes were compared across arms. ResultsParticipants were recruited from 48 U.S. states. Retention rate was 88% at 12-months and did not differ by arm. At 12-months, iCanQuit was 1.46 times more efficacious than QuitGuide for smoking cessation (27% vs. 20%; OR=1.46 95% CI: 1.04, 2.06). Findings were similar for missing-as-smoking imputation (23% vs. 18%; OR=1.41 95% CI: 1.01, 1.97) and multiple imputation at 12-months (27% vs. 20%; OR=1.51 95% CI: 1.07, 2.14). Treatment utilization was significantly higher among iCanQuit than QuitGuide participants. Increased acceptance of cues to smoke mediated the effect of treatment on cessation. ConclusionsThe iCanQuit smartphone application was more efficacious and engaging for smoking cessation among low-income adults than a USCPG-based smartphone application. A nationwide dissemination trial of iCanQuit is warranted to determine whether iCanQuit may alleviate cessation-related disparities among low-income adults.

Variance between Experts and Oncology Healthcare Providers in Managing Polycythemia Vera and Myelofibrosis: Analysis of an Online Treatment Decision Support Tool

BackgroundThe management of patients with the Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs) polycythemia vera (PV) and myelofibrosis (MF) is evolving. US clinical practice guidelines for MF were published for the first time in late 2016, and those for PV (and essential thrombocythemia) are in development. Clinicians still face substantial challenges in selecting therapy for patients with PV and MF. To assist with patient care and to help healthcare providers (HCPs) make informed decisions in this complex treatment landscape, an online treatment decision support tool was developed. Here we report data comparing expert treatment recommendations from the tool with the intended treatment entered by HCPs using the tool.MethodsIn February 2017, 5 experts in MPN patient care provided specific treatment recommendations for numerous distinct PV and MF case scenarios. These scenarios were defined by key patient and disease characteristics, including the presence of disease symptoms or anemia, previous response to treatment, and eligibility for transplantation and other therapeutic modalities. To use the tool, participating HCPs entered specific patient and disease factors along with their intended treatment plan for their case. When the case entry was completed, the expert treatment recommendations for that specific patient case were shown, followed by a short survey designed to determine if the expert recommendations had changed the HCP's planned course of treatment.ResultsFrom March 20, 2017, to June 9, 2017, 369 patient cases (n = 172 for PV; n = 197 for MF) were entered into the tool by 270 HCPs (83% MDs). Although there was expert consensus (≥ 3 of 5 experts choosing the same treatment course) for the majority of PV and MF cases (table), variance among the experts did exist in select areas: for example, the treatment of anemic patients with intermediate-2-risk/high-risk MF who had significant disease symptoms or splenomegaly but were not candidates for transplantation. A comparison of expert and tool user treatment choices showed substantial variability for several different patient case scenarios (table). For example, compared with expert recommendations for the PV cases, many tool users would potentially overtreat patients at low risk for thrombosis and underuse peginterferon (pegIFN) and ruxolitinib for high-risk patients. Approximately one half of the PV cases entered into the tool involved patients with prior intolerance/inadequate response to hydroxyurea (HU), and the intended treatment for these patients indicated by the majority of HCPs did not match consensus expert recommendations. Compared with expert recommendations for the MF cases, many tool users would potentially overtreat asymptomatic low-risk/intermediate-1-risk patients and underuse ruxolitinib for higher-risk patients. Among the HCPs who reported that their intended treatment plan differed from the experts, 73% indicated that the recommendations provided by the tool would change their previous management plans.ConclusionsAnalysis of cases and intended treatment plans entered into an online PV/MF treatment decision support tool indicated variance in expert and HCP treatment choices for many case scenarios. Expert recommendations in this online tool changed the intended treatment plan of many HCPs and, as such, suggest that online treatment decision tools developed by respected experts can help optimize the care of patients with PV and MF. A full analysis of all cases entered into the tool-including a detailed report of expert and HCP practice trends for PV and MF management-will be presented. [Display omitted] DisclosuresDeininger:Ariad Pharmaceuticals, Bristol Myers Squibb, CTI BioPharma Corp, Gilead, Incyte, Novartis, Pfizer, Celgene, Blue Print, Galena: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Research Funding; ARIAD: Consultancy; Incyte: Consultancy; Celgene: Research Funding; Novartis: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Pfizer: Consultancy. Mascarenhas:Promedior: Research Funding; Incyte: Other: Clinical Trial Steering Committee , Research Funding; CTI Biopharma: Research Funding; Janssen: Research Funding; Merck: Research Funding; Novartis: Other: DSMB member , Research Funding. Mesa:Incyte Corporation: Research Funding; Ariad: Consultancy; Promedico: Research Funding; Celgene Corporation: Research Funding; Galena Biopharma, Inc.: Consultancy; Gilead Sciences, Inc.: Research Funding; CTI BioPharma Corp.: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy. Stein:Incyte: Consultancy. Verstovsek:Lilly Oncology: Research Funding; Promedior: Research Funding; Astrazeneca: Research Funding; Pfizer: Research Funding; Incyte: Research Funding; Bristol Myers Squibb: Research Funding; Pfizer: Research Funding; Gilead: Research Funding; Roche: Research Funding; Astrazeneca: Research Funding; NS Pharma: Research Funding; Galena BioPharma: Research Funding; CTI BioPharma Corp: Research Funding; Bristol Myers Squibb: Research Funding; Seattle Genetics: Research Funding; Gilead: Research Funding; NS Pharma: Research Funding; Celgene: Research Funding; Promedior: Research Funding; Roche: Research Funding; Seattle Genetics: Research Funding; CTI BioPharma Corp: Research Funding; Lilly Oncology: Research Funding; Genentech: Research Funding; Celgene: Research Funding; Genentech: Research Funding; Blueprint Medicines Corp: Research Funding; Blueprint Medicines Corp: Research Funding; Galena BioPharma: Research Funding; Incyte: Research Funding.

Efficacy of Smartphone Applications for Smoking Cessation

Smoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional treatments, yet there is limited evidence for their efficacy. To determine the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy (ACT) vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines (USCPG). A 2-group, stratified, double-blind, individually randomized clinical trial was conducted from May 27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n = 1214 for the ACT-based smoking cessation application group and n = 1201 for the USCPG-based smoking cessation application group) with 3-, 6-, and 12-month postrandomization follow-up. The study was prespecified in the trial protocol. Follow-up data collection started on August 26, 2017, and ended at the last randomized participant's 12-month follow-up survey on December 23, 2019. Data were analyzed from February 25 to April 3, 2020. The primary analysis was performed on a complete-case basis, with intent-to-treat missing as smoking and multiple imputation sensitivity analyses. iCanQuit, an ACT-based smoking cessation application, which taught acceptance of smoking triggers, and the National Cancer Institute QuitGuide, a USCPG-based smoking cessation application, which taught avoidance of smoking triggers. The primary outcome was self-reported 30-day point prevalence abstinence (PPA) at 12 months after randomization. Secondary outcomes were 7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA at 3 and 6 months after randomization, missing data imputed with multiple imputation or coded as smoking, and cessation of all tobacco products (including e-cigarettes) at 12 months after randomization. Participants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states. The 3-month follow-up data retention rate was 86.7% (2093), the 6-month retention rate was 88.4% (2136), and the 12-month retention rate was 87.2% (2107). For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants had 1.49 times higher odds of quitting smoking compared with QuitGuide participants (28.2% [293 of 1040] vs 21.1% [225 of 1067]; odds ratio [OR], 1.49; 95% CI, 1.22-1.83; P < .001). Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001). This trial provides evidence that, compared with a USCPG-based smartphone application, an ACT-based smartphone application was more efficacious for quitting cigarette smoking and thus can be an impactful treatment option. ClinicalTrials.gov Identifier: NCT02724462.

Overall survival of cetuximab administered every two weeks versus weekly in real-world data of U.S. patients with metastatic colorectal cancer.

23 Background: Cetuximab (CET) administered weekly (q1w) at 250 mg/m², after an initial dose of 400 mg/m², is approved in combination with chemotherapy (CT) for the treatment of (K) RAS wild-type metastatic colorectal cancer (mCRC). The use of CET 500 mg/m2 administered with CT every 2 weeks (q2w) is according to US clinical practice guidelines and observed routinely. In this study, we compared q2w vs q1w regimens on overall survival (OS) in a presumed first-line (1L) treatment subcohort and present updated data on the noninferiority of q2w vs q1w in line-agnostic (1L+) treatment using US real-world data. Methods: Using IBM MarketScan, a large US insurance claims database, we classified a cohort of mCRC patients treated between 07/2010 and 12/2016 with CET+CT as q1w or q2w based on observed infusion patterns. Absence of mCRC-related treatment claims preceding CET initiation date (defined as the index date) qualified as CET treated in 1L. A validated algorithm was used to determine patient death. Confounding was accounted for using high-dimensional propensity scoring (hdPS) with inverse probability of treatment weights. OS was compared using Cox proportional hazards regression. Imbalanced confounders after hdPS were added to the Cox model. In 1L+, noninferiority of the q2w regimen was tested with a margin hazard ratio (HR) of 1.25. However, noninferiority could not be tested in 1L due to the small sample size; a test for difference was used instead. Results: Of 2,730 CET-exposed mCRC patients (updated), 1,779 (65.2%) and 951 (34.8%) were classified in q1w and q2w groups, respectively, among which 557 (31.3%) and 316 (33.2%) received CET in 1L. The HR (95% CI) for OS of q2w vs q1w in 1L was 1.10 (0.92-1.31; crude), and 1.05 (0.86-1.29; adjusted; p for difference: 0.625). In 1L+, crude and adjusted HRs were 1.05 (0.94-1.18) and 0.94 (0.85-1.03), respectively, rejecting the inferiority hypothesis at p &lt; 0.001. Conclusions: Only a third of patients received CET in 1L in this study. OS was statistically noninferior in q2w vs q1w in 1L+, and adjusted results in 1L suggest no differences between both treatment schedules. However, more data would be needed to formally test the noninferiority hypothesis in 1L.

A Comprehensive Digital Program for Smoking Cessation: Assessing Feasibility in a Single-Group Cohort Study.

BackgroundCigarette smoking remains the leading cause of preventable death and disease worldwide. Evidence-based approaches are available, but few people access them. Although digital solutions offer great promise for population reach, few multicomponent programs exist. Pivot is a comprehensive digital solution combining a Food and Drug Administration–cleared carbon monoxide (CO) breath sensor; cigarette logging; a 6-phase, app-delivered smoking cessation program based on the US Clinical Practice Guidelines; and dedicated human coaching via text-based chat.ObjectiveThe purpose of this study was to assess program engagement, changes in attitudes toward smoking, self-reported changes in smoking behavior, and program acceptability for the initial phase of Pivot: Explore.MethodsA total of 48 participants enrolled, and 41 completed the study. About half the participants (54%, 22/41) were men, and the mean age was 43 years. Most (85%, 35/41) were daily smokers and smoked an average of 12 cigarettes per day. Explore includes CO breath sensing, logging cigarettes in-app, learning via in-app activities, and dedicated human coaching through a text messaging interface. Participants completed surveys at baseline and exit assessing attitudes toward quitting including readiness, perceived difficulty, and confidence in quit success. At exit, participants also completed a survey of changes in smoking behavior and ratings of program acceptability.ResultsMore than 80% of participants (34-39 of 41) took ≥1 CO breath sample each day, and more than 55% (23-27 of 41) took ≥5 samples each day. More than 65% of participants (27-34 of 41) logged ≥1 cigarette using the in-app logging feature each day. All 9 in-app activities had completion rates ≥80% (33-40 of 41). Response to coach-initiated outreach was also high, with all contacts receiving ≥73% (30-39 of 41) response. In matched pair analyses, significant positive changes in mean attitudes toward quitting (scale 1-10) were evident from baseline (T1) to study exit (T2), including increased readiness to quit (T1 mean=6.1, T2 mean=7.4, P=.005), lower perceived difficulty (T1 mean=3.7, T2 mean=5.6, P=.001), and greater expectations of success (T1 mean=4.5, T2 mean=6.5, P<.001). At exit, 78% (32/41) of participants reported decreasing the number of cigarettes smoked per day during the study. Participants rated program quality and satisfaction very high (mean ≥8 for all items).ConclusionsThese results support the feasibility and acceptability of the initial 9-day phase of Pivot: Explore. Participants had high levels of engagement with sensing, logging, learning, and coaching. Attitudes toward quitting improved significantly, and the majority of users indicated decreasing smoking behavior. Explore was designed to raise smoker awareness and motivation. Additional research is underway to assess how users progress through the full Pivot smoking cessation program and determine the program’s effectiveness for achieving sustained cessation.

Financial Conflicts of Interest in Inflammatory Bowel Disease Guidelines.

Industry payments can lead to financial conflicts of interest (FCOI) among authors of clinical practice guidelines (CPGs). Guidelines for inflammatory bowel disease (IBD) may be at particularly high risk. We determined the prevalence of FCOI in IBD CPGs produced by various gastroenterology societies. We conducted a cross-sectional analysis of FCOI disclosure among CPGs related to the management of IBD. We ascertained the prevalence and types of FCOI for each guideline and determined adherence to National Academy of Medicine (NAM) standards. FCOI disclosures were compared between societies producing CPGs. We identified 11 relevant CPGs with 173 total authors. There were 117 (68%) authors who declared a payment. A total of 107 (62%) authors declared FCOI related to a medication recommended in the guideline. There was a significant difference (P < 0.001) between the proportion of authors with FCOI between countries or regions. Authors of US CPGs had a significantly lower FCOI prevalence (19%) compared with other societies. Authors of UK CPGs had a significantly lower FCOI prevalence (56%) compared with Canadian (84%) and European (94%) CPGs. Three (27%) guidelines adhered to both NAM standards. A substantial portion of authors of IBD CPGs had FCOI. Our study found a significant difference in FCOI prevalence based on CPG sponsor nationality. Most CPGs for IBD did not adhere to NAM standards for FCOI disclosure.

Methodological quality, completeness of reporting and use of systematic reviews as evidence in clinical practice guidelines for paediatric overweight and obesity.

Paediatric obesity rates remain high despite extensive efforts to prevent and treat obesity in children. We investigated the quality of the methodology and reporting within systematic reviews (SRs) underpinning paediatric content in US clinical practice guidelines (CPGs). In June 2016 we searched guideline clearinghouses and professional organization websites for guidelines published by national or professional organizations in the United States from January 2007 onwards. In our primary, a priori analysis, we used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR (A Measurement Tool to Assess Systematic Reviews) instruments to score SRs and meta-analyses that included paediatric populations and were cited by included CPGs. In a secondary, post hoc analysis, we determined the extent to which US CPGs use available, relevant SRs and meta-analyses compared with non-US CPGs. Eight US-based CPGs with 27 references to 22 unique SRs were found. AMSTAR and PRISMA scores were low overall, with only three SRs having 'high' methodological quality. Items dealing with bias assessments and search strategies had especially low scores. US CPGs were also older on average and cited fewer SRs than their international counterparts. Low quality scores and dated guidelines should be a cause for concern among practicing clinicians and a call to action for future guideline developers, publishers and research institutions.

Are Chinese pediatricians missing the opportunity to help parents quit smoking?

BackgroundSecondhand smoke (SHS) exposure of children due to parental tobacco use is a particularly prevalent health issue and is associated with adverse health outcomes. Following the US Clinical Practice guidelines, pediatricians in the United States deliver 5A’s (ask, advise, assess, assist, and arrange) counseling to smoking parents which has proven to be effective. We examined Chinese pediatricians’ adherence to the clinical practice guidelines for smoking cessation (i.e. 5A’s counseling practices) with smoking parents, and identified factors associated with these practices.MethodsA cross-sectional paper-and-pencil survey of pediatricians was conducted in twelve conveniently selected southern Chinese hospitals. Factors associated with any of the 5A’s smoking cessation counseling practices were identified by logistic regression.ResultsOf respondents (504/550), only 26 % routinely provided 5A’s smoking cessation counseling to smoking parents. More than 80 % of pediatricians didn’t receive formal training in smoking cessation and had not read China smoking cessation guidelines; 24 % reported being “very confident” in discussing smoking or SHS reduction with parents. Pediatricians who had never smoked (OR: 2.29, CI:1.02-5.12), received training in smoking cessation (OR: 2.50, CI:1.40-4.48), had read China smoking cessation guidelines (OR: 2.17, CI:1.10-4.26), and felt very (OR: 7.12, CI:2.45-20.70) or somewhat (OR: 3.05, CI:1.11-8.37) confident in delivering cessation counseling were more likely to practice 5A’s. Pediatricians who reported “it is hard to find a time to talk with parents” (OR: 0.32, CI: 0.11-0.92) or “lack of a standard of care requiring pediatricians to provide smoking cessation or SHS exposure reduction intervention” (OR: 0.45, CI: 0.21-0.98) as a barrier were less likely to follow the 5A’s guidelines.ConclusionsSmoking cessation counseling to address parental smoking is infrequent among Chinese pediatricians. There is a need to develop and test intervention strategies to improve the delivery of 5A’s smoking cessation counseling to parental smokers.

New Treatment Guidelines for Sjögren's Disease.

Sjögren's disease is associated with a high burden of illness, diminished quality of life, and increased health care costs. The Sjögren's Syndrome Foundation developed the first US clinical practice guidelines for management of the oral, ocular, and rheumatologic or systemic manifestations. Guideline recommendations were reviewed by a consensus expert panel using a modified Delphi process. This initiative should improve the quality and consistency of care for Sjögren's disease in the United States, guide insurance reimbursement, and define areas for future study. Guidelines will be periodically reviewed and revised as new information becomes available.

Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy

BackgroundThere is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy (ACT) application for smoking cessation vs. an application following US Clinical Practice Guidelines. MethodAdult participants were recruited nationally into the double-blind randomized controlled pilot trial (n=196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). ResultsWe recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p<0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8–10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n=88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6–20.7). ConclusionsACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed.

Systemic therapy of hepatocellular carcinoma: Current status and future perspectives

The management of hepatocellular carcinoma (HCC) has substantially changed in the past few decades, the introduction of novel therapies (such as sorafenib) have improved patient survival. Nevertheless, HCC remains the third most common cause of cancer-related deaths worldwide. Decision-making largely relies on evidence-based criteria, as showed in the US and European clinical practice guidelines, which endorse five therapeutic recommendations:resection; transplantation; radiofrequency ablation; chemoembolization; and sorafenib. Many molecularly targeted agents that inhibit angiogenesis, epidermal growth factor receptor, and mammalian target of rapamycin are at different stages of clinical development in advanced HCC. Future research should continue to unravel the mechanism of hepatocarcinogenesis and to identify key relevant molecular targets for therapeutic intervention. Identification and validation of potential surrogate and predictive biomarkers hold promise to individualize patient's treatment to maximize clinical benefit and minimize the toxicity and cost of targeted agents.