Evidence map›Paper›PMID 29102982›Full record

ArticleBMJ open2017

Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website.

Paul Wallace, Pierliugi Struzzo, Roberto Della Vedova, Francesca Scafuri, Costanza Tersar, Charilaos Lygidakis, Richard McGregor, Emanuele Scafato, Rachael Hunter, Nick Freemantle

Registry-linked trialAbstract readEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01638338 (Optimizing and Integrating the Delivery of Primary Care Services for Risky Drinkers in Region Friuli-Venezia Giulia), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01638338 nacompletednot on this map

Optimizing and Integrating the Delivery of Primary Care Services for Risky Drinkers in Region Friuli-Venezia Giulia

TypeinterventionalSponsorAzienda Per I Servizi Sanitari N. 2 IsontinaRan2012 to 2015Enrolled674ConditionsExcessive DrinkingArmsWeb assisted brief motivational interview on risky drinking, Face to Face
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. 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

10 authors.

Paul WallaceDepartment of Primary Care and Population Health, University College London, London, UK.
Pierliugi StruzzoRegional Centre for Training in Primary Care, Monfalcone, Italy.
Roberto Della VedovaCentro Studi e Ricerca Medicina Generale, Udine, Italy.
Francesca ScafuriRegional Centre for Training in Primary Care, Monfalcone, Italy.
Costanza TersarDepartment of Life Sciences, University of Trieste, Trieste, Italy.
Charilaos LygidakisResearch Unit INSIDE, Institute for Health and Behaviour, University of Luxembourg, Luxembourg City, Luxembourg.
Richard McGregorCodeface Ltd, Hove, UK.
Emanuele ScafatoWHO Collaborating Centre for Research and Health Promotion on Alcohol and Alcohol-Related Health Problems, Istituto Superiore di Sanita, Roma, Lazio, Italy.
Rachael HunterRegional Centre for Training in Primary Care, Monfalcone, Italy.ORCID http://orcid.org/0000-0002-7447-8934
Nick FreemantleRegional Centre for Training in Primary Care, Monfalcone, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBrief interventions (BIs) delivered in primary care have been shown to be effective in reducing risky drinking, but implementation is limited. Facilitated access to a digital application offers a novel alternative to face-to-face intervention, but its relative effectiveness is unknown.

methodsPrimary care-based, non-inferiority, randomised controlled trial comparing general practitioner (GP) facilitated access to an interactive alcohol reduction website (FA) with face-to-face BI for risky drinking. Patients screening positive on the short Alcohol Use Disorders Identification Test (AUDIT-C) were invited to participate in the trial. Assessment at baseline, 3 months and 12 months was carried out using AUDIT and EQ-5D-5L questionnaires.

findings58 participating GPs approached 9080 patients of whom 4529 (49.9%) logged on, 3841 (84.8%) undertook screening, 822 (21.4%) screened positive and 763 (19·9%) were recruited. 347 (45.5%) were allocated to FA and 416 (54.5%) to BI. At 3 months, subjects in FA group with an AUDIT score of ≥8 reduced from 95 (27.5%) to 85 (26.8%) while those in BI group increased from 123 (20.6%) to 141 (37%). Differences between groups were principally due to responses to AUDIT question 10. Analysis of primary outcome indicated non-inferiority of FA compared with BI, and prespecified subgroup analysis indicated benefits for older patients and those with higher levels of computer literacy and lower baseline severity. Additional analyses undertaken to take account of bias in response to AUDIT question 10 failed to support non-inferiority within the prespecified 10% boundary.

interpretationPrespecified protocol-driven analyses of the trial indicate that FA is non-inferior to BI; however, identified bias in the outcome measure and further supportive analyses question the robustness of this finding. It is therefore not possible to draw firm conclusions from this trial, and further research is needed to determine whether the findings can be replicated using more robust outcome measures. TRIAL REGISTRATION NUMBER: NCT01638338; Results.

Indexed as

InternetRisk Reduction BehaviorAdultAlcohol DrinkingAlcoholismFemaleGeneral PractitionersHumansItalyMaleMiddle AgedPrimary Health CareQuality of LifeSurveys and QuestionnairesTreatment OutcomeHealth informaticsMental healthPublic health

Identifiers

PMID29102982
PMCPMC5722079

What OpenQuestion holds

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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.