Evidence map›Paper›PMID 30305114›Full record

ArticleTrials2018

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.

Pernille Gabel, Mette Bach Larsen, Pia Kirkegaard, Adrian Edwards, Berit Andersen

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03253888, which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03253888 no registry record found
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. Systematic Development of Patient Decision Aids: An Update from the IPDAS Collaboration.Medical decision making : an international journal of the Society for Medical Decision Making · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 2 countries.

Pernille GabelDepartment of Public Health Programmes, Randers Regional Hospital, Central Denmark Region, Skovlyvej 15, 8930, Randers NØ, Denmark. pergab@rm.dk.ORCID http://orcid.org/0000-0001-8828-2505
Mette Bach LarsenDepartment of Public Health Programmes, Randers Regional Hospital, Central Denmark Region, Skovlyvej 15, 8930, Randers NØ, Denmark.
Pia KirkegaardDepartment of Public Health Programmes, Randers Regional Hospital, Central Denmark Region, Skovlyvej 15, 8930, Randers NØ, Denmark.
Adrian EdwardsDivision of Population Medicine, Cardiff University School of Medicine, Cardiff, UK.
Berit AndersenDepartment of Public Health Programmes, Randers Regional Hospital, Central Denmark Region, Skovlyvej 15, 8930, Randers NØ, Denmark.
Central Denmark Region · DKAarhus University · DKCardiff University · GB

Funding

Dansk Kræftforsknings Fond 49/1Helsefonden 16-B-0100Kr&x00E6;ftens Bek&x00E6;mpelse R146-A9555-16-S2TrygFonden ID: 113925
6 · The paper itself

Abstract

backgroundColorectal 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.

methodsThe 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 registrationClinicalTrials.gov, NCT03253888 . Registered on 17 August 2017.

Indexed as

Decision Support TechniquesEducational StatusImmunohistochemistryPatient PreferenceAgedBiomarkers, TumorChoice BehaviorColorectal NeoplasmsDenmarkEarly Detection of CancerFeasibility StudiesFecesFemaleHealth Knowledge, Attitudes, PracticeHealth LiteracyHumansBiomarkers, TumorCancer screeningColorectal cancerDecision aidLower educational attainmentRandomized controlled trial

Identifiers

PMID30305114
PMCPMC6180588
OpenAlexW2969807380

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.