Evidence map›Paper›PMID 38772891›Full record

ArticleBMJ open2024

Protocol for cost-effectiveness analysis of a randomised trial of mHealth coaching (Bump2Baby and Me) compared with usual care for healthy gestational weight gain and postnatal outcomes in at-risk women and their offspring in the UK, Australia, Ireland and Spain.

Laura Pirhonen Nørmark, Fionnuala McAuliffe, Helle Terkildsen Maindal, Sharleen O'Reilly, Anna Davies, Christy Burden, Timothy C Skinner, Karsten Vrangbæk, Emily Callander

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Laura Pirhonen NørmarkDepartment of Public Health, University of Copenhagen Faculty of Health and Medical Sciences, Kobenhavn, Denmark laura.pirhonen@sund.ku.dk.ORCID 0000-0002-7371-2215
Fionnuala McAuliffeUCD Perinatal Research Centre, University College Dublin, Dublin, Ireland.
Helle Terkildsen MaindalAarhus University, Aarhus, UK.
Sharleen O'ReillyInstitute of Food and Health, University College Dublin, Dublin, Ireland.
Anna DaviesCentre for Academic Child Health, University of Bristol, Bristol, UK.ORCID 0000-0003-0743-6547
Christy BurdenUniversity of Bristol Faculty of Health Sciences, Bristol, UK.
Timothy C SkinnerRural Health School, La Trobe University, Bendigo, Victoria, Australia.
Karsten VrangbækDepartment of Public Health, University of Copenhagen Faculty of Health and Medical Sciences, Kobenhavn, Denmark.
Emily CallanderSchool of Public Health, University of Technology Sydney, Sydney, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs as well as reduced health and well-being in women and infants. This protocol presents the health economic evaluation to investigate the cost-effectiveness of Bump2Baby and Me (B2B&Me), which is a health coaching intervention delivered via smartphone to women at risk of gestational diabetes. METHODS AND ANALYSIS: Using data from the B2B&Me randomised controlled trial, this economic evaluation compares costs and health effects between the intervention and control group as an incremental cost-effectiveness ratio. Direct healthcare costs, costs of pharmaceuticals and intervention costs will be included in the analysis, body weight and quality-adjusted life-years for the mother will serve as the effect outcomes. To investigate the long-term cost-effectiveness of the trial, a Markov model will be employed. Deterministic and probabilistic sensitivity analysis will be employed. ETHICS AND DISSEMINATION: The National Maternity Hospital Human Research and Ethics Committee was the primary approval site (EC18.2020) with approvals from University College Dublin HREC-Sciences (LS-E-20-150-OReilly), Junta de Andalucia CEIM/CEI Provincial de Granada (2087-M1-22), Monash Health HREC (RES-20-0000-892A) and National Health Service Health Research Authority and Health and Care Research Wales (HCRW) (21/WA/0022). The results from the analysis will be disseminated in scientific papers, through conference presentations and through different channels for communication within the project. TRIAL REGISTRATION NUMBER: ACTRN12620001240932.

Indexed as

Diabetes, GestationalGestational Weight GainTelemedicineAustraliaCost-Effectiveness AnalysisFemaleHumansInfant, NewbornIrelandMentoringPregnancyQuality-Adjusted Life YearsRandomized Controlled Trials as TopicSpainUnited KingdomDiabetes in pregnancyHEALTH ECONOMICSRandomized Controlled Trial

Identifiers

PMID38772891
PMCPMC11110546

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Registered trials

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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.