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 (Lead / Corresponding author), Soo Downe, Kenneth William Finlayson, Rebecca Knapp, Peter Diggle, SHIP trial team

Research output: Contribution to journalArticle

4 Citations (Scopus)
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Abstract

Background: Using 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. Methods: The 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. Results: Six 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). Conclusions: Without 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 registration: ISRCTN27575146 (date assigned 23 March 2011)

Original languageEnglish
Article number100
Number of pages9
JournalBMC Medical Research Methodology
Volume15
DOIs
Publication statusPublished - 18 Nov 2015

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Randomized Controlled Trials
Mothers
Quality of Life
Patient Reported Outcome Measures
Postpartum Depression
Qualitative Research
Pets
Linguistics
Information Systems
Pregnant Women
Anxiety
Equipment and Supplies
Pregnancy
Surveys and Questionnaires

Keywords

  • Acceptability
  • Antenatal
  • Feasibility
  • Patient-reported outcome measure
  • Postnatal
  • Pregnancy
  • Quality of life
  • Randomised controlled trial

Cite this

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title = "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",
abstract = "Background: Using 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. Methods: The 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. Results: Six 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). Conclusions: Without 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 registration: ISRCTN27575146 (date assigned 23 March 2011)",
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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. / Symon, Andrew (Lead / Corresponding author); Downe, Soo; Finlayson, Kenneth William; Knapp, Rebecca; Diggle, Peter; SHIP trial team.

In: BMC Medical Research Methodology, Vol. 15, 100, 18.11.2015.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Symon, Andrew

AU - Downe, Soo

AU - Finlayson, Kenneth William

AU - Knapp, Rebecca

AU - Diggle, Peter

AU - SHIP trial team

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Y1 - 2015/11/18

N2 - Background: Using 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. Methods: The 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. Results: Six 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). Conclusions: Without 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 registration: ISRCTN27575146 (date assigned 23 March 2011)

AB - Background: Using 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. Methods: The 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. Results: Six 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). Conclusions: Without 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 registration: ISRCTN27575146 (date assigned 23 March 2011)

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KW - Antenatal

KW - Feasibility

KW - Patient-reported outcome measure

KW - Postnatal

KW - Pregnancy

KW - Quality of life

KW - Randomised controlled trial

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