Evidence map›Paper›PMID 26582386›Full record

Trial reportBMC medical research methodology2015

The feasibility and acceptability of using the Mother-Generated Index (MGI) as a Patient Reported Outcome Measure in a randomised controlled trial of maternity care.

Andrew Symon, Soo Downe, Kenneth William Finlayson, Rebecca Knapp, Peter Diggle, SHIP trial team

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medical research methodology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 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.

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

11 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

6 authors.

Andrew SymonMother and Infant Research Unit, University of Dundee, 11 Airlie Place, Dundee, DD1 4HJ, UK. a.g.symon@dundee.ac.uk.
Soo DowneMidwifery Studies, School of Health, Brook Building, University of Central Lancashire, Preston, PR1 2HE, UK. sdowne@uclan.ac.uk.
Kenneth William FinlaysonSchool of Health, Brook Building, University of Central Lancashire, Preston, PR1 2HE, UK. KWFinlayson1@uclan.ac.uk.
Rebecca KnappSharoe Green Unit, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, PR2 9HT, UK. rebecca.knapp@lthtr.nhs.uk.
Peter DiggleLancaster Medical School, Lancaster University, Lancaster, LA1 4YB, UK. p.diggle@lancaster.ac.uk.
SHIP trial team

Funding

Department of Health PB-PG-0808-16234
6 · The paper itself

Abstract

backgroundUsing patient-reported outcome measures (PROMs) to assess Quality of Life (QoL) is well established, but commonly-used PROM item-sets do not necessarily capture what all respondents consider important. Measuring complex constructs is particularly difficult in randomised controlled trials (RCTs). The Mother-Generated Index (MGI) is a validated antenatal and postnatal QoL instrument in which the variables and scores are completely respondent-driven. This paper reports on the feasibility and acceptability of the MGI in an RCT, and compares the resulting variables and QoL scores with more commonly used instruments.

methodsThe single-page MGI was included at the end of a ten page questionnaire pack and posted to the RCT participants at baseline (28-32 weeks' gestation) and follow-up (six weeks postnatal). Feasibility and acceptability were assessed by ease of administration, data entry and completion rates. Variables cited by women were analysed thematically. MGI QoL scores were compared with outcomes from the EQ-5D-3 L; Edinburgh Postnatal Depression Scale; Satisfaction With Life Scale; and State Trait Anxiety Inventory.

resultsSix hundred and seventy eight pregnant women returned the pack at baseline; 668 completed the MGI (98.5%); 383/400 returns at follow up included a completed MGI (95.7%). Quantitative data were scanned into SPSS using a standard data scanning system, and were largely error-free; qualitative data were entered manually. The variables recorded by participants on the MGI forms incorporated many of those in the comparison instruments, and other outcomes commonly used in intrapartum trials, but they also revealed a wider range of issues affecting their quality of life. These included financial and work-related worries; moving house; and concerns over family illness and pets. The MGI scores demonstrated low-to-moderate correlation with other tools (all r values p < .01).

conclusionsWithout face-to-face explanation and at the end of a long questionnaire, the MGI was feasible to use, and acceptable to RCT participants. It allowed individual participants to include issues that were important to them, but which are not well captured by existing tools. The MGI unites the explanatory power of qualitative research with the comparative power of quantitative designs, is inexpensive to administer, and requires minimal linguistic and conceptual translation.

trial registrationISRCTN27575146 (date assigned 23 March 2011).

Indexed as

Health StatusPatient Outcome AssessmentPersonality InventorySurveys and QuestionnairesAdultAnxietyDepressionFemaleHumansMothersPatient SatisfactionPregnancyQuality of Life

Identifiers

PMID26582386
PMCPMC4652369

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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.