Evidence map›Paper›PMID 37321807›Full record

ArticleBMJ open2023

Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial.

Melissa Pearson, Andrew Dawson, Jacques Raubenheimer, Lalith Senerathna, Katherine Conigrave, K S Kylie Lee, Thilini Rajapakse, Pahala Hangidi Gedara Janaka Pushpakumara, Sisira Siribaddana, Jane Brandt Soerensen and 11 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 29% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

21 authors at 5 institutions in 4 countries.

Melissa PearsonCentre for Pesticide Suicide Prevention, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK Melissa.Pearson@ed.ac.uk.ORCID 0000-0001-6683-3628
Andrew DawsonCentral Clinical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
Jacques RaubenheimerBiomedical Informatics and Digital Health, University of Sydney, Sydney, New South Wales, Australia.
Lalith SenerathnaSouth Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka.
Katherine ConigraveSydney Medical School, Royal Prince Albert Hospital, Camperdown, New South Wales, Australia.ORCID 0000-0002-6428-1441
K S Kylie LeeNHMRC Centre of Research Excellence in Indigenous Health and Alcohol, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
Thilini RajapakseSouth Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka.
Pahala Hangidi Gedara Janaka PushpakumaraSouth Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka.
Sisira SiribaddanaDepartment of Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka.ORCID 0000-0001-5821-2557
Jane Brandt SoerensenGlobal Health Section, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-1702-280X
Flemming KonradsenGlobal Health Section, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Stephen JanThe George Institute for Global Health, Sydney, New South Wales, Australia.
Angela J DawsonFaculty of Health, World Health Collaborating Centre, University of Technology, Sydney, Sydney, New South Wales, Australia.
Nicholas BuckleySouth Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka.
Ranil AbeysingheDepartment of Psychiatry, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
Prabash SiriwardhanaSouth Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka.
Chamil PriyadarshanaSouth Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka.
Paul S HaberSydney Medical School, Royal Prince Albert Hospital, Camperdown, New South Wales, Australia.
Monika DzidowskaNHMRC Centre of Research Excellence in Indigenous Health and Alcohol, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
Palitha AbeykoonNational Authority on Tobacco and Alcohol, Colombo, Sri Lanka.
Nick GlozierBrain and Mind Research Institute, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-0476-9146
University of Peradeniya · LKThe University of Sydney · AUUniversity of Copenhagen · DKRajarata University of Sri Lanka · LKThe George Institute for Global Health · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAlcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We designed a mixed-methods stepped wedge cluster randomised control trial of a complex alcohol intervention. This paper describes the initial trial protocol and subsequent modifications following COVID-19. METHODS AND ANALYSIS: We aimed to recruit 20 villages (approximately n=4000) in rural Sri Lanka. The proposed intervention consisted of health screening clinics, alcohol brief intervention, participatory drama, film, and public health promotion materials to be delivered over 12 weeks.Following disruptions to the trial resulting from the Easter bombings in 2019, COVID-19 and a national financial crisis, we adapted the study in two main ways. First, the interventions were reconfigured for hybrid delivery. Second, a rolling pre-post study evaluating changes in alcohol use, mental health, social capital and financial stress as the primary outcome and implementation and ex-ante economic analysis as secondary outcomes. ETHICS AND DISSEMINATION: The original study and amendments have been reviewed and granted ethical approval by Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and February 2022) and the University of Sydney (2019/006). Findings will be disseminated locally in collaboration with the community and stakeholders.The new hybrid approach may be more adaptable, scalable and generalisable than the planned intervention. The changes will allow a closer assessment of individual interventions while enabling the evaluation of this discontinuous event through a naturalistic trial design. This may assist other researchers facing similar disruptions to community-based studies.

trial registrationThe trial is registered with the Sri Lanka Clinical Trials Registry; https://slctr.lk/trials/slctr-2018-037.

Indexed as

COVID-19Alcohol DrinkingCounselingHealth EducationHumansRandomized Controlled Trials as TopicSri LankaDepression & mood disordersPREVENTIVE MEDICINEPUBLIC HEALTHSubstance misuse

Identifiers

PMID37321807
PMCPMC10276966
OpenAlexW4380871937

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.