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Beyond intention-to-treat: The effect of brief counseling for tobacco cessation in secondary analyses of a cluster randomized controlled trial in Swedish dental clinics.

ABSTRACT: In experimental studies the assigned intervention measures the received intervention if full protocol adherence is achieved, but this is rarely the case in public health. The objective of this study was to estimate the effect of a brief counseling intervention delivered in Swedish dental clinics on tobacco use cessation, taking non-adherence into account. We conducted three secondary analyses. In a per-protocol analysis the experimental counseling delivered as intended was contrasted to usual care (control). In an as-treated analysis individuals were compared according to the counseling components actually received, disregarding randomization. In an instrumental variable analysis the effect of the intervention among those who would always be treated as assigned was estimated. Logistic regression was used to examine the association between tobacco cessation outcomes (seven-day abstinence, three-month abstinence, half-reduction, quit attempts) and the defined exposure to the intervention. Protocol adherence in the intervention group was 73.4%. The per-protocol analysis closely replicated the results of the intention-to-treat analysis, showing a statistically significant effect of the brief counseling on the reduction in tobacco consumption OR = 1.81, 95% CI [1.06, 3.07], but no significant effect for other outcomes. In the as-treated analysis, receiving more counseling components compared with no tobacco counseling increased the likelihood of half-reduction. The instrumental variable yielded biased results. We conclude that despite application problems, conducting per-protocol, as-treated and instrumental variable analyses in randomized trials where experimental conditions are not strictly standardized strengthens and puts in context the inference based on intention-to-treat analysis.

SUBMITTER: Oncioiu SI

PROVIDER: S-EPMC5936699 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Beyond intention-to-treat: The effect of brief counseling for tobacco cessation in secondary analyses of a cluster randomized controlled trial in Swedish dental clinics.

Oncioiu Sinziana I SI Franchetti-Pardo Livia L Virtanen Suvi E SE Faggiano Fabrizio F Galanti Maria R MR

Contemporary clinical trials communications 20170118

In experimental studies the assigned intervention measures the received intervention if full protocol adherence is achieved, but this is rarely the case in public health. The objective of this study was to estimate the effect of a brief counseling intervention delivered in Swedish dental clinics on tobacco use cessation, taking non-adherence into account. We conducted three secondary analyses. In a per-protocol analysis the experimental counseling delivered as intended was contrasted to usual ca ...[more]

PMID: 29740626

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Project description:BackgroundDecreases in smoking prevalence from recent decades have slowed, and national goals to reduce tobacco use remain unmet. Healthcare providers, including those in physician and dental teams, have access to evidence-based guidelines to help patients quit smoking. Translation of those guidelines into practice, however, remains low. Approaches that involve screening for drug use, brief intervention, and referral to treatment (SBIRT) are a promising, practical solution.PurposeThis study examined whether dentists and dental hygienists would assess interest in quitting, deliver a brief tobacco intervention, and refer to a tobacco quitline more frequently as reported by patients if given computer-assisted guidance in an electronic patient record versus a control group providing usual care.DesignA blocked, group-randomized trial was conducted from November 2010 to April 2011. Randomization was conducted at the clinic level. Patients nested within clinics represented the lowest-level unit of observation.Setting/participantsParticipants were patients in HealthPartners dental clinics.InterventionIntervention clinics were given a computer-assisted tool that suggested scripts for patient discussions. Usual care clinics provided care without the tool.Main outcome measuresPrimary outcomes were post-appointment patient reports of the provider assessing interest in quitting, delivering a brief intervention, and referring them to a quitline.ResultsPatient telephone surveys (72% response rate) indicated that providers assessed interest in quitting (control 70% vs intervention 87%, p=0.0006); discussed specific strategies for quitting (control 26% vs intervention 47%, p=0.003); and referred the patient to a tobacco quitline (control 17% vs intervention 37%, p=0.007) more frequently with the support of a computer-assisted tool integrated into the electronic health record.ConclusionsClinical decision support embedded in electronic health records can effectively help providers deliver tobacco interventions. These results build on evidence in medical settings supporting this approach to improve provider-delivered tobacco cessation.Trial registrationThis study is registered at ClinicalTrials.govNCT01584882.

Project description:BackgroundThis study estimated the cost-effectiveness of four strategies enhancing the quality and accessibility of Brief Intervention (BI) service for smoking cessation in Thailand during 2022-2030: (1) current-BI (status quo), (2) the effective-training standard-BI, (3) the current-BI plus the village health volunteers (VHV) mobilization, and (4) the effective-training BI plus VHV mobilization.MethodsBy interviewing five public health officers, nine healthcare professionals aiding these services, and fifteen BI service experts, we explored the status quo situation of the Thai smoking cessation service system, including main activities, their quantity assumptions, and activities' unit prices needed to operate the current cessation service system. Then, we modeled additional activities needed to implement the other three simulated scenarios. We estimated the costs and impacts of implementing these strategies over a nine-year operating horizon (2022-2030), covering 3 years of service system preparation and 6 years of full implementation. The modeled costs of these four strategies included intervention and program costs. The study focused on current smokers age 15 years or older. The assessed impact parameters encompassed smoking prevalence, deaths averted, and healthy life-years gained. An Incremental Cost-Effectiveness Analysis compared the four simulated strategies was employed. Data analysis was performed using the One Health Tool software, which the World Health Organization developed.ResultsThe findings of this investigation reveal that all three intervention strategies exhibited cost-effectiveness compared to the prevailing status quo. Among these strategies, Strategy 2, enhancing BI service quality, emerged as the most efficient and efficacious option. Therefore, the expansion of quality services should be synergistically aligned with augmented training, service delivery optimization, and managerial enhancements.ConclusionThis approach is particularly poised to enhance accessibility to and the efficacy of smoking cessation interventions across Thailand.

Project description:IntroductionCombined efforts to encompass different aspects of tobacco control have been in place for some time. Despite the recognition of the need to offer support to tobacco users to quit tobacco use, such support remains highly inadequate in India. However, little is known about the practice of oral health professionals (OHP) and the experiences and expectations of dental patients in the context of tobacco cessation (TC) services. In this article, we describe the protocol of a doctoral research project that explores OHPs and their patients in an Indian city. The aims are (A) to understand the functioning of the oral healthcare system towards TC and what changes to it will be needed to benefit TC and (B) to capture the views of dental patients on TC services provided by OHPs.Methods and analysisA cross-sectional qualitative study based on individual interviews with OHPs and dental patients will be carried out in the city of Ahmedabad, Gujarat, India. The OHP will be purposively selected from two major organisation types: (1) single-doctor dental clinics and (2) dental hospital attached to teaching institutions. The sample population will be divided into two subgroups: general OHP (dentists practising general dentistry irrespective of their qualification) and prosthodontists (dentists with a specialisation in prosthodontics). We will sample dental patients through convenient sampling from a public teaching hospital and select private dental care facilities. The sampling of OHPs and dental patients will continue until we reach data saturation. Interviews will be audio recorded, transcribed verbatim and coded by hand. The interview transcript will subsequently be analysed using thematic content analysis.Ethics and disseminationThe study received ethical approval from the Institutional Ethical Committee of the Government Dental College and Hospital, Ahmedabad. The findings will be disseminated through conference presentations, peer-reviewed publications and to the study participants.

Dataset Information

Beyond intention-to-treat: The effect of brief counseling for tobacco cessation in secondary analyses of a cluster randomized controlled trial in Swedish dental clinics.

Publications

Beyond intention-to-treat: The effect of brief counseling for tobacco cessation in secondary analyses of a cluster randomized controlled trial in Swedish dental clinics.

Similar Datasets

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