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      An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial

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          Abstract

          Background

          Decision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness.

          Objective

          We describe the development process of an online DA (called “VISOR”) that helps smokers to choose evidence-based cessation assistance. Additionally, we provide a description of the protocol of an ongoing randomized controlled trial in which the DA containing an explicit value clarification method (VCM) and tailored advice is compared with a DA without an explicit VCM and tailored advice.

          Methods

          The development of “VISOR” was based on the International Patient Decision Aid Standards guidelines. Viewpoints of end users (collected through 20 interviews with smokers) and clinical and scientific experts (assessed using 2 Delphi studies with 24 scientists and 38 clinicians) were assessed regarding cessation tool decision making and preferred DA content. These findings, together with principles from the Self-Determination Theory, served as input for the development of the online DA. A first DA prototype was alpha-tested in September 2019 and beta-tested for usability in December 2019; feedback was incorporated and resulted in a final version. The final DA contains (1) an information section, (2) an optional knowledge quiz, (3) a brief smoking assessment, (4) intuitive decision, (5) intermediate advice, (6) an explicit VCM, (7) tailored advice, and (8) access information. A randomized controlled trial is currently being conducted to assess the DA’s (cost-)effectiveness compared to a DA that does not include the explicit VCM and the tailored advice; specifically, the DA’s effect on smoking abstinence, uptake of evidence-based cessation assistance, smoking abstinence mediated through uptake of evidence-based cessation assistance, and decisional conflict are investigated. Participants are randomly allocated to receive access to 1 of the 2 DAs and are asked to complete 5 questionnaires (including the baseline questionnaire) over a period of 12 months. To evaluate the effects of the DA on the outcome measures, logistic and linear regression analyses as well as mediation analyses will be carried out. An economic evaluation will be performed to assess the cost-effectiveness.

          Results

          Data regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021.

          Conclusions

          By making use of an iterative process that integrated different stakeholders’ perspectives (including end users), we were able to systematically design an evidence-based DA. The study will contribute to the current knowledge regarding smoking cessation DA application, the added value of explicit VCMs, and the effect of behavioral and informed decision-making outcomes.

          Trial Registration

          Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/21772

          Related collections

          Most cited references67

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          lavaan: AnRPackage for Structural Equation Modeling

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            From alpha to omega: a practical solution to the pervasive problem of internal consistency estimation.

            Coefficient alpha is the most popular measure of reliability (and certainly of internal consistency reliability) reported in psychological research. This is noteworthy given the numerous deficiencies of coefficient alpha documented in the psychometric literature. This mismatch between theory and practice appears to arise partly because users of psychological scales are unfamiliar with the psychometric literature on coefficient alpha and partly because alternatives to alpha are not widely known. We present a brief review of the psychometric literature on coefficient alpha, followed by a practical alternative in the form of coefficient omega. To facilitate the shift from alpha to omega, we also present a brief guide to the calculation of point and interval estimates of omega using a free, open source software environment. © 2013 The British Psychological Society.
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              Decision aids for people facing health treatment or screening decisions.

              Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                December 2020
                15 December 2020
                : 9
                : 12
                : e21772
                Affiliations
                [1 ] Department of Health Promotion Care and Public Health Research Institute Maastricht University Maastricht Netherlands
                [2 ] Department of Communication Science Amsterdam School of Communication Research University of Amsterdam Amsterdam Netherlands
                [3 ] Netherlands Institute for Health Services Research (Nivel) Utrecht Netherlands
                [4 ] Department of Family Medicine Care and Public Health Research Institute Maastricht University Maastricht Netherlands
                [5 ] Department of Clinical Epidemiology and Medical Technology Assessment Care and Public Health Research Institute Maastricht University Medical Centre Maastricht Netherlands
                Author notes
                Corresponding Author: Thomas Gültzow thomas.gultzow@ 123456maastrichtuniversity.nl
                Author information
                https://orcid.org/0000-0002-9268-1880
                https://orcid.org/0000-0001-8588-6194
                https://orcid.org/0000-0001-9656-3665
                https://orcid.org/0000-0002-0621-585X
                https://orcid.org/0000-0003-2742-4543
                https://orcid.org/0000-0002-0377-3389
                https://orcid.org/0000-0003-1357-863X
                Article
                v9i12e21772
                10.2196/21772
                7772073
                33320096
                7fbb390e-39eb-47c0-9bf3-1e8faf85f88c
                ©Thomas Gültzow, Eline Suzanne Smit, Raesita Hudales, Vera Knapen, Jany Rademakers, Carmen D Dirksen, Ciska Hoving. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 15.12.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 6 July 2020
                : 22 August 2020
                : 15 October 2020
                : 17 November 2020
                Categories
                Protocol
                Protocol

                digital health,decision making,decision support technique,decision aids,smoking,smoking cessation,informed decision making

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