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      The LEAD trial - the effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: study protocol for a randomized controlled trial

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          Abstract

          Background

          Colorectal cancer screening participation is a preference-sensitive choice, in which trade-offs between benefits and harms must be made by individual citizens. Often the decision is made without any contact with healthcare professionals. Citizens with lower educational attainment tend to participate less in colorectal cancer screening than citizens with average educational attainment. Further, they tend to have lower levels of knowledge about colorectal cancer screening. Providing lower educational attainment citizens with a targeted decision aid embracing their diverse information needs might increase these citizens’ ability to make informed decisions. The aim of this trial is to test the effectiveness of such a newly developed self-administered decision aid.

          Methods

          The LEAD (Lower Educational Attainment Decision aid) trial will be conducted as a two-arm randomized controlled trial among 10,000 50–74-year-old citizens, resident in the Central Denmark Region not yet invited to take up colorectal cancer screening. Citizens will receive a baseline questionnaire. Respondents will be allocated into the intervention or the control groups. Citizens in the intervention group will receive the decision aid whereas the control group will not. Those who return a stool sample within 45 days after receiving the screening invitation and those with medium or higher educational attainment are excluded. Both groups will receive a follow-up questionnaire 90 days after being invited to colorectal cancer screening.

          A historic cohort consisting of 5000 50–74-year-old citizens resident in the Central Denmark Region, having received their screening invitation in the beginning of 2017 will be included. This cohort will receive a follow-up questionnaire 6–9 months after they received the screening invitation.

          Informed choice will be evaluated by assessing levels of knowledge, attitudes, and screening uptake. Analyses will be conducted as intention-to-treat analyses. Additionally, differences between levels of worry and decisional conflict between groups will be assessed as secondary outcomes.

          Discussion

          This trial will evaluate whether a targeted decision aid is a feasible way of enhancing informed choice among lower educational attainment citizens in colorectal cancer screening. Further, it may guide decisions about providing information material in cancer screening in general.

          Trial registration

          ClinicalTrials.gov, NCT03253888. Registered on 17 August 2017.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2921-z) contains supplementary material, which is available to authorized users.

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          Most cited references24

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          A systematic development process for patient decision aids

          Background The original version of the International Patient Decision Aid Standards (IPDAS) recommended that patient decision aids (PtDAs) should be carefully developed, user-tested and open to scrutiny, with a well-documented and systematically applied development process. We carried out a review to check the relevance and scope of this quality dimension and, if necessary, to update it. Methods Our review drew on three sources: a) published papers describing PtDAs evaluated in randomised controlled trials and included in the most recent Cochrane Collaboration review; b) linked papers cited in the trial reports that described how the PtDAs had been developed; and c) papers and web reports outlining the development process used by organisations experienced in developing multiple PtDAs. We then developed an extended model of the development process indicating the various steps on which documentation is required, as well as a checklist to assess the frequency with which each of the elements was publicly reported. Results Key features common to all patient decision aid (PtDA) development processes include: scoping and design; development of a prototype; ‘alpha’ testing with patients and clinicians in an iterative process; ‘beta’ testing in ‘real life’ conditions (field tests); and production of a final version for use and/or further evaluation. Only about half of the published reports on the development of PtDAs that we reviewed appear to have been field tested with patients, and even fewer had been reviewed or tested by clinicians not involved in the development process. Very few described a distribution strategy, and surprisingly few (17%) described a method for reviewing and synthesizing the clinical evidence. We describe a model development process that includes all the original elements of the original IPDAS criterion, expanded to include consideration of format and distribution plans as well as prototype development. Conclusions The case for including each of the elements outlined in our model development process is pragmatic rather than evidence-based. Optimal methods for ensuring that each stage of the process is carried out effectively require further development and testing.
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            Assessing the Quality of Decision Support Technologies Using the International Patient Decision Aid Standards instrument (IPDASi)

            Objectives To describe the development, validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies (decision aids). Design Scale development study, involving construct, item and scale development, validation and reliability testing. Setting There has been increasing use of decision support technologies – adjuncts to the discussions clinicians have with patients about difficult decisions. A global interest in developing these interventions exists among both for-profit and not-for-profit organisations. It is therefore essential to have internationally accepted standards to assess the quality of their development, process, content, potential bias and method of field testing and evaluation. Methods Scale development study, involving construct, item and scale development, validation and reliability testing. Participants Twenty-five researcher-members of the International Patient Decision Aid Standards Collaboration worked together to develop the instrument (IPDASi). In the fourth Stage (reliability study), eight raters assessed thirty randomly selected decision support technologies. Results IPDASi measures quality in 10 dimensions, using 47 items, and provides an overall quality score (scaled from 0 to 100) for each intervention. Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sampled (n = 30), enabling discrimination. The inter-rater intraclass correlation for the overall quality score was 0.80. Correlations of dimension scores with the overall score were all positive (0.31 to 0.68). Cronbach's alpha values for the 8 raters ranged from 0.72 to 0.93. Cronbach's alphas based on the dimension means ranged from 0.50 to 0.81, indicating that the dimensions, although well correlated, measure different aspects of decision support technology quality. A short version (19 items) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 (CI 0.79 to 0.92). Conclusions This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies. The existing IPDASi provides an assessment of the quality of a DST's components and will be used as a tool to provide formative advice to DSTs developers and summative assessments for those who want to compare their tools against an existing benchmark.
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              Psychological and behavioral implications of abnormal mammograms.

              To evaluate women's psychological responses to abnormal mammograms and the effect on mammography adherence. To identify psychological responses and other factors that predict mammography adherence in women with normal or abnormal mammograms. Survey study with prospective analysis of factors associated with mammography adherence. Health Maintenance Organization of Pennsylvania and New Jersey (HMO PA/NJ). Study patients, members of HMO PA/NJ who were 50 years of age or older, and who had had mammography done 3 months earlier, included women with normal mammograms (n = 121), women with low-suspicion mammograms (n = 119), and women with high-suspicion mammograms (n = 68), but not women with breast cancer. Psychological responses 3 months after mammography and adherence to subsequent annual mammography were assessed. Women with high-suspicion mammograms had substantial mammography-related anxiety (47%) and worries about breast cancer (41%). Such worries affected the moods (26%) and daily functioning (17%) of these women, despite diagnostic evaluation excluding malignancy. For each variable, a consistent trend (P greater than 0.05) was seen with degree of mammogram abnormality. Sixty-eight percent of women with normal results, 78% of women with low-suspicion results, and 74% of women with high-suspicion results obtained their subsequent annual mammograms (P greater than 0.05). The number of previous mammograms (odds ratio, 3.2; 95% CI, 1.6 to 6.2) and the effect of the previous results on concerns about breast cancer (odds ratio, 0.5; CI, 0.2 to 1.0) were independent predictors of adherence in logistic regression analyses (P less than 0.05). A substantial proportion of women with suspicious mammograms have psychological difficulties, even after learning that they do not have cancer. Such sequelae do not appear to interfere with subsequent adherence.
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                Author and article information

                Contributors
                +45 8742 0185 , pergab@rm.dk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                10 October 2018
                10 October 2018
                2018
                : 19
                : 543
                Affiliations
                [1 ]Department of Public Health Programmes, Randers Regional Hospital, Central Denmark Region, Skovlyvej 15, 8930 Randers NØ, Denmark
                [2 ]ISNI 0000 0001 1956 2722, GRID grid.7048.b, Faculty of Health, , Aarhus University, ; Aarhus, Denmark
                [3 ]ISNI 0000 0001 0807 5670, GRID grid.5600.3, Division of Population Medicine, , Cardiff University School of Medicine, ; Cardiff, UK
                Author information
                http://orcid.org/0000-0001-8828-2505
                Article
                2921
                10.1186/s13063-018-2921-z
                6180588
                30305114
                44f5044b-35b2-4fd9-823c-7c166ed02d0b
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 6 November 2017
                : 17 September 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100007437, TrygFonden;
                Award ID: ID: 113925
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100008363, Kr&x00E6;ftens Bek&x00E6;mpelse;
                Award ID: R146-A9555-16-S2
                Award Recipient :
                Funded by: Health Research Fund of Central Denmark Region
                Funded by: Health, Aarhus University
                Funded by: FundRef http://dx.doi.org/10.13039/501100005860, Helsefonden;
                Award ID: 16-B-0100
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100005940, Dansk Kræftforsknings Fond;
                Award ID: 49/1
                Award Recipient :
                Funded by: The Family Spogaard Fund (DK)
                Funded by: Ringgaard-Bohn foundation (DK)
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                colorectal cancer,cancer screening,decision aid,lower educational attainment,randomized controlled trial

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