Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties.

Laura J. O'Byrne; Gillian M. Maher; Ali S. Khashan; Richard A. Greene; John Browne; Fergus P. McCarthy

doi:10.12688/hrbopenres.13445.1

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Study Protocol

Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties.

[version 1; peer review: 1 approved, 1 approved with reservations]

Laura J. O'Byrne ^1,2, Gillian M. Maher¹, Ali S. Khashan³, Richard A. Greene², John Browne³, Fergus P. McCarthy^1,2

Laura J. O'Byrne ^1,2, Gillian M. Maher¹, [...] Ali S. Khashan³, Richard A. Greene², John Browne³, Fergus P. McCarthy^1,2

PUBLISHED 03 Nov 2021

Author details Author details

¹ INFANT Research Centre, Cork, Ireland
² Department of Obstetrics and Gynaecology, Cork University Maternity Hospital, Wilton, Cork, Ireland
³ Department of Epidemiology and Public Health, University College Cork, Cork, Ireland

Laura J. O'Byrne
Roles: Investigation, Methodology, Visualization, Writing – Original Draft Preparation

Gillian M. Maher
Roles: Writing – Review & Editing

Ali S. Khashan
Roles: Supervision, Writing – Review & Editing

Richard A. Greene
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

John Browne
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Fergus P. McCarthy
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Maternal and Child Health collection.

Abstract

Background: Patient centred healthcare is the corner stone to many healthcare strategies. Patient specific health needs should be at the fore of healthcare improvements and quality measurements. Patient reported outcome measures (PROM) that support real world clinical effectiveness assessments are increasingly being used to highlight domains where there is the greatest scope for change.
Objectives: This systematic review aims to identify and evaluate existing patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women. We will assess and evaluate their measurement properties in a transparent and structured way in accordance with the COSMIN guidelines.
Methods: Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed and EMBASE from inception to the present day. Two reviewers independently will judge eligibility, conduct data extraction and assess the methodological quality of each study as per COSMIN guidelines. Inclusion criteria: studies should concern PROM with an aim to evaluate measurement properties in the development or the evaluation of a PROM of interest. Included PROMS will focus upon postpartum women assessing morbidity and quality of care. All peer reviewed studies with an assessment tool designed for patient completion will be considered. Exclusion criteria; abstract, letters and non-peer reviewed publications. Studies will be graded on measurement properties and quality of evidence as laid out by COSMIN. All studies and characteristics eligible for inclusion will be summarised and a recommendation to the most suitable measurement tool(s) will be given.
Discussion: We will provide a comprehensive description of all available patient reported assessment tools available for childbirth and postpartum quality of life and recommend based on COSMIN guidelines the most suitable instrument(s) available for use.

Keywords

Maternity care, Patient reported outcome measure, postpartum, quality of life, quality of care, validity, Reliability, responsiveness

Corresponding author: Laura J. O'Byrne

Competing interests: No competing interests were disclosed.

Grant information: Health Research Board [SDAP-2019-017].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2021 O'Byrne LJ et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: O'Byrne LJ, Maher GM, Khashan AS et al. Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties. [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2021, 4:117 (https://doi.org/10.12688/hrbopenres.13445.1) First published: 03 Nov 2021, 4:117 (https://doi.org/10.12688/hrbopenres.13445.1) Latest published: 06 Jun 2024, 4:117 (https://doi.org/10.12688/hrbopenres.13445.3)

Introduction

Patient-centric quality healthcare can only be developed with reliable information. Patient reported outcome measures (PROM) provide an insight into the impact that an intervention or therapy has on the patient, this is particularly important when striving for improvements in maternity care. PROM’s support real world clinical effectiveness assessment for different care models and interventions, describe variation across sociodemographic and clinical groups, highlight domains where there is greatest scope for improvement, and detect variation between providers and institutions that cannot be explained by differences in case mix. There are no current means of capturing outcomes from the perspective of women receiving maternity care. The need for patient-reported outcome measures that can be used in maternity care has been gaining attention in the literature over the past decade. The CROWN initiative, an international initiative led by research journal editors which was established to standardise core outcomes reporting in women’s health research has been calling for supporting PROM sets to be developed in tandem to their core outcome sets, but currently no maternity PROMs exist^1–3.

PROMs are a means of assessing the impact that health events, and interventions have had on constructs such as quality of life. It is important to differentiate PROMs from patient-reported experience measures (PREMs). PREMs are assessments of the patients’ experience of the care they received including whether certain standards of care were met, and their subjective satisfaction with care. There are multiple maternity-specific PREMs in Ireland and the UK: the Irish national maternity experience survey⁴ and two in the UK, the national maternity services survey⁵ and ‘You and Your Baby’ survey⁶.

The ideal PROM should have validity, reliability and be able to measure change over time³. Recent systematic reviews ascertained there are no PROMs currently suitable for a maternity system, but many previously validated tools could be considered when designing a specific PROM for pregnancy and childbirth^2,7,8. The development of a maternity PROM that covers antenatal, intra-partum, postpartum and neonatal care is challenging. There have been studies recently focusing on measures of recovery and recovery post Caesarean Section^9,10. This project will focus on the generation of a maternity PROM focusing on delivery outcomes which can be applied to all women postpartum. Postpartum quality of life (QoL) will be examined across multiple domains. This includes, but is not limited to the conceptual model of patient outcomes by Wilson and Cleary¹¹; symptom status → functional status → general health perception → overall QoL. This will allow new insights into women’s perspectives of the healthcare they have received and ultimately driving the service into a more patient centred response.

The COnsensus-based Standards for the selection of health Measurement INstruments initiative has improved the selection and assessment of outcome measurement instruments. The COSMIN guidelines will allows us to select the best outcome measurements in a methodological and consistent way¹².

The aim of this review is to identify potential tool(s)/measurement that can be used to produce a PROM for postpartum women who have been given care within a maternity system.

Methods

Protocol and registration

The present paper is reported in accordance with the recommendations from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) statement¹³ (see extended data)¹⁴. The review will follow COSMIN guidelines for systematic reviews¹². This protocol has been submitted for registration with PROSPERO (submission number 283472). Details of the PROSPERO protocol registration will be provided in the final systematic review.

Search strategy

A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital based maternity care will be performed using the following bibliographic databases: PubMed and EMBASE. Databases will be searched from inception to present and there will be no language restrictions set. Additionally, hand searching of the reference lists of the studies included and key articles on this topic will be searched.

Using the comprehensive PROM filter developed for COSMIN¹⁵ and with the assistance of a librarian a search thread was constructed as follows in order to identify all relevant publications (see extended data)¹⁶. The search thread included construct search, population search with a measurement properties filter and exclusion filter as recommended by COSMIN. We chose to not included a ‘type of instrument’ in our search strategy as it may possibly exclude potential tools of interest.

Selection of abstracts and full-text articles will be performed by two reviewers independently using Rayyan software. If there is a study that has been deemed relevant by at least one reviewer the full -text article will be retrieved and screened. If a consensus cannot be reached a third senior review will consult.

Eligibility criteria

The eligibility criteria are in agreement with the COSMIN guidelines for systematic review, namely the PROM(s) should aim to measure the construct of interest QoL. The study sample should represent the population of interest, in our case postpartum women after maternity care. The study should concern PROMS and finally the aim should be the evaluation of one or more measurement properties, the development of a prom or the evaluation of the interpretability of the PROM of interest.

Following the PICO (population, intervention, comparator and outcome) framework our population is postpartum women, Intervention is childbirth, comparator is not required but may include differing modes of birth, Neonatal Intensive Care Unit admission, morbidity and outcome is quality of care. All peer reviewed studies with an assessment tool designed for patient completion will be considered.

Exclusion criteria: abstract, letters and non-peer reviewed publications.

COSMIN recommend the exclusion of studies that only use the PROM as an outcome measurement instrument or in studies in which the PROM is used in a validation study of another instrument. We will examine the possibility of excluding these studies from our search if there are other appropriate tools available. We may consider the inclusion of these studies if there are limited.

Data extraction

PRISMA-P guidelines and COSMIN guidelines for systematic reviews will be followed with the following steps being used to evaluate potential PROM¹⁷. These are a ten-step process as described in Figure 1.

Figure 1. The 10 steps for conducting a systematic review from the COSMIN manual for systematic reviews of patient reported outcome measures (PROMs)¹².

The data to be extracted as recommended by the COSMIN systematic review guidelines¹² include the characteristics of the tool, characteristics about the population assessed, results on the measurement properties and information on the interpretability and feasibility if available. This information will be extracted independently and presented in an overview table. If any information is missing the reviewers will contact the author for additional information.

Each study will we rated as very good, adequate, doubtful or inadequate quality for the methodology used to assess the psychometric properties of that study. The overall rating of the quality of each study is determined by taking the lowest rating of any standard in the box (i.e. “the worst score counts” principle). The results of each study on measurement property are rated against the criteria for a good measurement property. Each result is then rated as either sufficient (+), insufficient (-), or indeterminant (?) The results will be summarised using the modified GRADE approach. A modified GRADE approach will be used specifically for evaluating measurement properties in systematic reviews of PROMs, the following four factors should be taken into account: (1) risk of bias (i.e. the methodological quality of the studies), (2) inconsistency (i.e. unexplained inconsistency of results across studies), (3) imprecision (i.e. total sample size of the available studies), and (4) indirectness (i.e. evidence from different populations than the population of interest in the review)

The results on all available measurement properties will be quantitatively pooled or qualitatively summarised and against the criteria for good measurement properties to determine whether an overall measurement property is sufficient (+) insufficient (-) inconsistent (±) or indeterminant (?).

Generating recommendations for the use of a PROM

The data to be extracted as recommended by the COSMIN systematic review guidelines¹² include the characteristics of the tool, characteristics about the population assessed, results on the measurement properties and information on the interpretability and feasibility if available. This Information will be extracted independently and presented in an overview table. If any information is missing the reviewers will contact the author for additional information.

A. PROMs with evidence for sufficient content validity (any level) AND at least low-quality evidence for sufficient internal consistency: recommended for use.
B. PROMs where further validation is needed.
C. PROMs with high-quality evidence for an insufficient measurement property: should not be recommended for use.

Dissemination of information

Publication in a leading journal.

Study status

Not started.

Discussion

A complete systematic assessment of the literature to examine available measurement properties is the first step toward developing a usable postpartum PROM. The COSMIN initiative aims to improve the selection of outcome measurement instruments in research and clinical practice by developing tools for selecting the most suitable instrument for the situation at issue and will be followed throughout this review

Our aim is to recommend the best PROM or of combination of self-reported tool(s)/assessment measures to evaluate maternity care postpartum. Each step of the process will be reported on in a systematic and transparent way accompanied by clear recommendations for the most suitable outcome measurement instrument.

Data availability

Underlying data

No data are associated with this article.

Extended data

Harvard Dataverse: Search thread: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties. https://doi.org/10.7910/DVN/WMHKXG¹⁶.

Reporting guidelines

Harvard Dataverse: PRISMA-P checklist for ‘Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties’. https://doi.org/10.7910/DVN/IXX1EG¹⁴.

Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

Faculty Opinions recommended

References

1. Devane D, Begley CM, Clarke M, et al.: Evaluating Maternity Care: A Core Set of Outcome Measures. Birth. 2007; 34(2): 164–172. PubMed Abstract | Publisher Full Text
2. Dickinson F, McCauley M, Smith H, et al.: Patient reported outcome measures for use in pregnancy and childbirth: A systematic review. BMC Pregnancy Childbirth. 2019; 19(1): 155. PubMed Abstract | Publisher Full Text | Free Full Text
3. Mahmud A, Morris E, Johnson S, et al.: Developing core patient-reported outcomes in maternity: PRO-Maternity. BJOG. 2014; 121 Suppl 4: 15–19. PubMed Abstract | Publisher Full Text
4. Health Service Executive, Health Information and Quality Authority, Department of Health: National Maternity Experience Survey. Published online 2020; 4–80. Reference Source
5. NHS Maternity Survey 2021. Reference Source
6. You and Your baby survey. Reference Source
7. Beecher C, Greene R, O’Dwyer L, et al.: Measuring women’s experiences of maternity care: A systematic review of self-report survey instruments. Women Birth. 2021; 34(3): 231–241. PubMed Abstract | Publisher Full Text
8. Korst LM, Fridman M, Saeb S, et al.: The Development of a Conceptual Framework and Preliminary Item Bank for Childbirth-Specific Patient-Reported Outcome Measures. Health Serv Res. 2018; 53(5): 3373–3399. PubMed Abstract | Publisher Full Text | Free Full Text
9. Sultan P, Sharawi N, Blake L, et al.: Use of Patient-Reported Outcome Measures to Assess Outpatient Postpartum Recovery: A Systematic Review. JAMA Netw open. 2021; 4(5): e2111600. PubMed Abstract | Publisher Full Text | Free Full Text
10. Sharawi N, Klima L, Shah R, et al.: Evaluation of patient-reported outcome measures of functional recovery following caesarean section: a systematic review using the consensus-based standards for the selection of health measurement instruments (COSMIN) checklist. Anaesthesia. 2019; 74(11): 1439–1455. PubMed Abstract | Publisher Full Text
11. Wilson IB, Paul D: Health-Related Quality of Life. Published online 2021.
12. Mokkink LB, Prinsen CAC, Patrick DL, et al.: COSMIN manual for systematic reviews of PROMs, user manual. 2018; (February): 1–78. Reference Source
13. Shamseer L, Moher D, Clarke M, et al.: Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015; 350: g7647. PubMed Abstract | Publisher Full Text
14. O’Byrne L: PRISMA-P for Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties. 2021. http://www.doi.org/10.7910/DVN/IXX1EG
15. Terwee CBI, Jansma EP, Riphagen II, et al.: Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res. 2009; 18(8): 1115–1123. PubMed Abstract | Publisher Full Text | Free Full Text
16. O’Byrne L: Search thread: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties. 2021. http://www.doi.org/10.7910/DVN/WMHKXG
17. Prinsen CAC, Bouter LB, Bouter LM, et al.: COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018; 27(5): 1147–1157. PubMed Abstract | Publisher Full Text | Free Full Text

Comments on this article Comments (0)

Version 3

VERSION 3 PUBLISHED 03 Nov 2021

Author details Author details

Laura J. O'Byrne
Roles: Investigation, Methodology, Visualization, Writing – Original Draft Preparation

Gillian M. Maher
Roles: Writing – Review & Editing

Ali S. Khashan
Roles: Supervision, Writing – Review & Editing

Richard A. Greene
Roles: Conceptualization, Funding Acquisition, Supervision, Writing – Review & Editing

John Browne
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Fergus P. McCarthy
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

Health Research Board [SDAP-2019-017].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (3)

version 3

Revised

Published: 06 Jun 2024, 4:117

https://doi.org/10.12688/hrbopenres.13445.3

version 2

Revised

Published: 13 Jan 2023, 4:117

https://doi.org/10.12688/hrbopenres.13445.2

version 1

Published: 03 Nov 2021, 4:117

https://doi.org/10.12688/hrbopenres.13445.1

© 2021 O'Byrne LJ et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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O'Byrne LJ, Maher GM, Khashan AS et al. Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties. [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2021, 4:117 (https://doi.org/10.12688/hrbopenres.13445.1)

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Version 1

VERSION 1

PUBLISHED 03 Nov 2021

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Reviewer Report 23 Sep 2022

Christine Newman, National University of Ireland, Galway, Ireland

Approved with Reservations

https://doi.org/10.21956/hrbopenres.14653.r32819

This is an interesting and novel piece which aims to review existing PROMs and patient reported assessment measures and use this to develop a PROM for the post-partum period.

There are some small spelling errors that can be addressed through proofreading.

Only 2 databases will be searched - at least 3 are generally advised for a systematic review. Can the authors comment on this?

There is no sample search strategy given keywords, MESH headings, etc. This should be included in the protocol.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Diabetes in pregnancy and Patient-Reported Outcomes

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 17 Nov 2023

Laura O'Byrne, Department of Obstetrics and Gynaecology, Cork University Maternity Hospital, Wilton, Ireland

17 Nov 2023

Author Response

Thank you to the two reviewers for taking the time to review this protocol and for their comments.

Reviewer 2, comment 1 ‘Only 2 databases will be searched - ... Continue reading Thank you to the two reviewers for taking the time to review this protocol and for their comments.

Reviewer 2, comment 1 ‘Only 2 databases will be searched - at least 3 are generally advised for a systematic review. Can the authors comment on this?’
Response: Thank you, we increased the search strategy to include searching on the CINAHL database. The search, therefore, included three databases PubMed, EMBASE and CINAHL which yielded 10,324 studies identified in the initial search, of which 29 tools were identified from 41 eligible studies included in the review. This has been added to the manuscript search strategy line 52 ‘A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital-based maternity care will be performed using the following bibliographic databases: PubMed, CINHAL and EMBASE.’ The Abstract methods section has also been amended to include ‘Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day.’

Reviewer 2, comment 2: ‘There is no sample search strategy given keywords, MESH headings, etc. This should be included in the protocol.’
Response: The search strategy is included in the extended data held within the Harvard Dataverse: Search thread: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for the systematic review of measurement properties. https://doi.org/10.7910/DVN/WMHKXG 16.
We thank you for your helpful comments that have improved the quality of the paper and thank you for re-considering this manuscript for review and publication.
Thank you to the two reviewers for taking the time to review this protocol and for their comments.

Reviewer 2, comment 1 ‘Only 2 databases will be searched - at least 3 are generally advised for a systematic review. Can the authors comment on this?’
Response: Thank you, we increased the search strategy to include searching on the CINAHL database. The search, therefore, included three databases PubMed, EMBASE and CINAHL which yielded 10,324 studies identified in the initial search, of which 29 tools were identified from 41 eligible studies included in the review. This has been added to the manuscript search strategy line 52 ‘A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital-based maternity care will be performed using the following bibliographic databases: PubMed, CINHAL and EMBASE.’ The Abstract methods section has also been amended to include ‘Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day.’

Reviewer 2, comment 2: ‘There is no sample search strategy given keywords, MESH headings, etc. This should be included in the protocol.’
Response: The search strategy is included in the extended data held within the Harvard Dataverse: Search thread: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for the systematic review of measurement properties. https://doi.org/10.7910/DVN/WMHKXG 16.
We thank you for your helpful comments that have improved the quality of the paper and thank you for re-considering this manuscript for review and publication.
Competing Interests: No competing interest Close
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Author Response 17 Nov 2023

Laura O'Byrne, Department of Obstetrics and Gynaecology, Cork University Maternity Hospital, Wilton, Ireland

17 Nov 2023

Author Response

Thank you to the two reviewers for taking the time to review this protocol and for their comments.

Reviewer 2, comment 1 ‘Only 2 databases will be searched - ... Continue reading Thank you to the two reviewers for taking the time to review this protocol and for their comments.

Reviewer 2, comment 1 ‘Only 2 databases will be searched - at least 3 are generally advised for a systematic review. Can the authors comment on this?’
Response: Thank you, we increased the search strategy to include searching on the CINAHL database. The search, therefore, included three databases PubMed, EMBASE and CINAHL which yielded 10,324 studies identified in the initial search, of which 29 tools were identified from 41 eligible studies included in the review. This has been added to the manuscript search strategy line 52 ‘A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital-based maternity care will be performed using the following bibliographic databases: PubMed, CINHAL and EMBASE.’ The Abstract methods section has also been amended to include ‘Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day.’

Reviewer 2, comment 2: ‘There is no sample search strategy given keywords, MESH headings, etc. This should be included in the protocol.’
Response: The search strategy is included in the extended data held within the Harvard Dataverse: Search thread: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for the systematic review of measurement properties. https://doi.org/10.7910/DVN/WMHKXG 16.
We thank you for your helpful comments that have improved the quality of the paper and thank you for re-considering this manuscript for review and publication.
Thank you to the two reviewers for taking the time to review this protocol and for their comments.

Reviewer 2, comment 1 ‘Only 2 databases will be searched - at least 3 are generally advised for a systematic review. Can the authors comment on this?’
Response: Thank you, we increased the search strategy to include searching on the CINAHL database. The search, therefore, included three databases PubMed, EMBASE and CINAHL which yielded 10,324 studies identified in the initial search, of which 29 tools were identified from 41 eligible studies included in the review. This has been added to the manuscript search strategy line 52 ‘A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital-based maternity care will be performed using the following bibliographic databases: PubMed, CINHAL and EMBASE.’ The Abstract methods section has also been amended to include ‘Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day.’

Reviewer 2, comment 2: ‘There is no sample search strategy given keywords, MESH headings, etc. This should be included in the protocol.’
Response: The search strategy is included in the extended data held within the Harvard Dataverse: Search thread: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for the systematic review of measurement properties. https://doi.org/10.7910/DVN/WMHKXG 16.
We thank you for your helpful comments that have improved the quality of the paper and thank you for re-considering this manuscript for review and publication.
Competing Interests: No competing interest Close
Report a concern

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Reviewer Report 18 Aug 2022

Fiona Dickinson, Liverpool School of Tropical Medicine, Liverpool, UK

Approved

https://doi.org/10.21956/hrbopenres.14653.r32545

Thank you for this interesting and timely paper describing your systematic review protocol, to identify and evaluate PROMs for postnatal women. On the whole, the protocol seems appropriate and achievable. The rationale and objectives are clearly described, the proposed study design seems appropriate, and the proposed methods are described in detail.

There are however, a few typos and it would be good to be consistent in the use of the acronym PROM/S/s. Also, the 3 paragraphs under the headings 'Data extraction' and 'Generating recommendations for the use of a PROM', seem to be a direct repeat. Good luck with the review and I look forward to seeing the results.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Development of PROMs for use in maternity services in low and middle-income countries; Emergency obstetric care in LMIC; Care of mothers and newborns in LMIC.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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VERSION 3 PUBLISHED 03 Nov 2021

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Version 2 (revision) 13 Jan 23	read		read
Version 1 03 Nov 21	read	read

Fiona Dickinson, Liverpool School of Tropical Medicine, Liverpool, UK
Christine Newman, National University of Ireland, Galway, Ireland
Joanna Leaviss, University of Sheffield, Sheffield, UK
Susanna Carmona Cañabate, Instituto de Investigación Sanitaria Gregorio Marañón, Instituto de Salud Carlos III, Madrid, Spain

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10 Views

26 Feb 2025 | for Version 3

Susanna Carmona Cañabate, Instituto de Investigación Sanitaria Gregorio Marañón, Instituto de Salud Carlos III, Madrid, Spain

10 Views Cite this report Responses(0)

Approved

This manuscript describes the protocol for conducting a systematic review of “Patient Reported Outcome Measures” (PROM). According to the authors, “currently no maternity PROM exists.”
The objective of this study is to identify and evaluate patient-reported assessment tools or measures that could contribute to the development of a PROM for postpartum women. The study will systematically assess the measurement properties of these tools, following the COSMIN guidelines to ensure a rigorous and transparent evaluation.
The findings from this review will be used to generate recommendations on the most reliable and well-supported PROMs, highlighting those with sufficient evidence and consistency for use in postpartum care. I believe that this protocol can significantly improve maternity services by providing a standardized and evidence-based approach to assessing patient-reported outcomes.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Neuroscience of pregnancy and postpartum, Neuroimaging.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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50 Views

02 Oct 2023 | for Version 2

Joanna Leaviss, University of Sheffield, Sheffield, UK

50 Views Cite this report Responses(1)

Approved With Reservations

The protocol describes planned methods for a systematic review of PROMs for maternity care using COSMIN methodology. The authors state that there are currently no maternity specific PROMs.

The stated aim is to ‘identify potential tool(s)/measurement that can be used to produce a PROM for postpartum women who have been given care within a maternity system’. This will be used to develop a maternity specific PROM with multiple domains.

Review question: This needs further clarification (and see comments on inclusion criteria below). Is the aim of the review to identify tools, or is the aim of the review to evaluate the psychometric properties of tools used to assess various measures of QoL in postpartum women? Is this specific part of the project to develop a new tool, or is this specific part of the project to assess what already exists, to take forward to produce a new tool? The review question should reflect this very specific aim.

Search strategy: 3 databases is very much the minimum expected for a systematic review. I would generally expect to see more databases searched, and to include the Cochrane library, plus PsychInfo as this is a review of psychometric properties. More supplementary searching should be included, for example, citation searching.

Inclusion criteria: Much more detail is need here. PICO isn’t appropriate as childbirth isn’t an ‘intervention’. You could include it as an ‘exposure’, but as there is really no comparator - a PEO structure would be more relevant.

A section on ‘types of study’ would also be informative here. The protocol states that ‘The study should concern PROM and finally the aim should be the evaluation of one or more measurement properties, the development of a prom or the evaluation of the interpretability of the PROM of interest.’ I think further detail is needed on the types of PROM that are of interest. The authors have stated in the abstract that there are no maternity specific PROMs. Presumably these will still be searched for however – recent PROMs may have been published. In addition, more clarification is needed on what type of PROMs are expected to be included in light of the anticipated lack of condition-specific PROMs – i.e. generic PROMs such as EQ5D, SF-36 etc. So will the authors be retrieving studies which include the development/validation of generic tools, but only where they have been applied to maternity-specific populations?

For ‘outcomes’ – the authors state outcome is quality of care. Do they mean quality of life? However, isn’t the outcome the psychometric properties of the tools that are being used to assess QoL? These properties as described in the COSMIN methodology should be briefly listed e.g. content validity; structural validity; internal consistency etc.

Finally, will the COSMIN ratings be ratified by subject experts and patients at the end of the process?

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Evidence synthesis methodology.

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Author Response

06 Jun 2024

Laura O'Byrne, Department of Obstetrics and Gynaecology, Cork University Maternity Hospital, Wilton, Ireland

Systematic review protocol: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties.
Thank you to the third reviewer for taking the time to review the protocol and for their comments.

Review comment 1: Is the aim of the review to identify tools, or is the aim of the review to evaluate the psychometric properties of tools used to assess various measures of QoL in postpartum women? Is this specific part of the project to develop a new tool, or is this specific part of the project to assess what already exists, to take forward to produce a new tool? The review question should reflect this very specific aim.
Response 1:
Thank you, this systematic review aimed to both identify the tools available and to evaluate their psychometric properties. The objectives in the abstract read ‘This systematic review aims to identify and evaluate existing patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women. We will assess and evaluate their measurement properties in a transparent and structured way in accordance with the COSMIN guidelines.’
The aim in introduction originally read ‘The aim of this review is to identify potential tool(s)/measurement that can be used to produce a PROM for postpartum women who have been given care within a maternity system’. We have now edited it to read ‘This study aims to identify and evaluate patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women. Their measurement properties will be assessed in a transparent and structured way in accordance with the COSMIN guidelines.’

Reviewer comment 2: Search strategy: 3 databases is very much the minimum expected for a systematic review. I would generally expect to see more databases searched, and to include the Cochrane library, plus PsychInfo as this is a review of psychometric properties. More supplementary searching should be included, for example, citation searching.
Response 2: The search strategy states ‘A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital based maternity care will be performed using the following bibliographic databases: PubMed, CINHAL and EMBASE. Databases will be searched from inception to present and there will be no language restrictions set. Additionally, hand searching of the reference lists of the studies included and key articles on this topic will be searched.’
By searching these three databases we were hopeful that any articles on Cochrane or PsycInfo of relevance would be indexed in the above. This search strategy yields over 10,000 studies. Citation search will be included ‘Additionally, hand searching of the reference lists of the studies included and key articles on this topic will be searched.’

Reviewer comment 3: Inclusion criteria: Much more detail is need here. PICO isn’t appropriate as childbirth isn’t an ‘intervention’. You could include it as an ‘exposure’, but as there is really no comparator - a PEO structure would be more relevant.
Response 3:Thank you – we have changed the inclusion criteria section to read – ‘The eligibility criteria for this review followed the COSMIN guidelines for systematic reviews of PROM recommendations. Eligible studies included generic and specific PROM that assessed postpartum women’s health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN. The aim of the eligible study should be evaluation of one or more measurement properties of the tool, or the evaluation of the interpretability of the PROMs of interest. Studies that only use the PROM as a measurement instrument for the outcome of interest or in which the PROM was used for the validation of another instrument were excluded. Only full-text articles were included. All peer reviewed studies with an assessment tool designed for patient completion were considered.’

Reviewer Comment 4: A section on ‘types of study’ would also be informative here. The protocol states that ‘The study should concern PROM and finally the aim should be the evaluation of one or more measurement properties, the development of a prom or the evaluation of the interpretability of the PROM of interest.’ I think further detail is needed on the types of PROM that are of interest.
Response 4: Thank you – we have changed the text in the Eligibility criteria to read – ‘Eligible studies included generic and specific PROM that assessed postpartum women’s health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN. The aim of the eligible study should be evaluation of one or more measurement properties of the tool, or the evaluation of the interpretability of the PROMs of interest. Studies that only use the PROM as a measurement instrument for the outcome of interest or in which the PROM was used for the validation of another instrument were excluded. Only full-text articles were included. All peer reviewed studies with an assessment tool designed for patient completion were considered.’

Reviewer Comment 5: The authors have stated in the abstract that there are no maternity specific PROMs. Presumably these will still be searched for however – recent PROMs may have been published. In addition, more clarification is needed on what type of PROMs are expected to be included in light of the anticipated lack of condition-specific PROMs – i.e. generic PROMs such as EQ5D, SF-36 etc. So will the authors be retrieving studies which include the development/validation of generic tools, but only where they have been applied to maternity-specific populations?
Response 5: Thank you, any tool (generic or condition-specific) examining women’s health and well-being postpartum will be included. The new Eligibility criteria text now reads ‘Eligible studies included generic and specific PROM that assessed postpartum women’s health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN.’

Reviewer Comment 6 For ‘outcomes’ – the authors state outcome is quality of care. Do they mean quality of life? However, isn’t the outcome the psychometric properties of the tools that are being used to assess QoL? These properties as described in the COSMIN methodology should be briefly listed e.g. content validity; structural validity; internal consistency etc.
Response 6:Thank you – we have changed the inclusion criteria section to read – ‘Eligible studies included generic and specific PROM that assessed postpartum women’s health and wellbeing, where the study sample included >50% postpartum women as advised by COSMIN.’
The data extraction section reads ‘The data to be extracted as recommended by the COSMIN systematic review guidelines include the characteristics of the tool, characteristics about the population assessed, results on the measurement properties’ We have now added ‘which includes: structural validity, internal consistency, cross-cultural validity/measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness.’

Reviewer Comment 7:Finally, will the COSMIN ratings be ratified by subject experts and patients at the end of the process?
Response 7: Thank you. The review will be conducted by subject matter experts, including obstetricians and gynaecologists actively involved in providing care at a tertiary-level maternity hospital and authors who have experience in designing and implementing PROM. The results of this systematic review will be Piloted by patients to better comprehend the recommended tools' content and validity, but patients will not be involved in the systematic review itself.

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Competing Interests

No competing interests were disclosed.

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Reviewer Report

29 Views

16 Jan 2023 | for Version 2

Fiona Dickinson, Liverpool School of Tropical Medicine, Liverpool, UK

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Approved

No new comments.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Development of PROMs for use in maternity services in low and middle-income countries; Emergency obstetric care in LMIC; Care of mothers and newborns in LMIC.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report

51 Views

23 Sep 2022 | for Version 1

Christine Newman, National University of Ireland, Galway, Ireland

51 Views Cite this report Responses(1)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Diabetes in pregnancy and Patient-Reported Outcomes

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Author Response

17 Nov 2023

Laura O'Byrne, Department of Obstetrics and Gynaecology, Cork University Maternity Hospital, Wilton, Ireland

Thank you to the two reviewers for taking the time to review this protocol and for their comments.

Reviewer 2, comment 1 ‘Only 2 databases will be searched - at least 3 are generally advised for a systematic review. Can the authors comment on this?’
Response: Thank you, we increased the search strategy to include searching on the CINAHL database. The search, therefore, included three databases PubMed, EMBASE and CINAHL which yielded 10,324 studies identified in the initial search, of which 29 tools were identified from 41 eligible studies included in the review. This has been added to the manuscript search strategy line 52 ‘A systematic literature review to examine all available objective tools for patient assessment of QoL and health assessment after hospital-based maternity care will be performed using the following bibliographic databases: PubMed, CINHAL and EMBASE.’ The Abstract methods section has also been amended to include ‘Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day.’

Reviewer 2, comment 2: ‘There is no sample search strategy given keywords, MESH headings, etc. This should be included in the protocol.’
Response: The search strategy is included in the extended data held within the Harvard Dataverse: Search thread: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for the systematic review of measurement properties. https://doi.org/10.7910/DVN/WMHKXG 16.
We thank you for your helpful comments that have improved the quality of the paper and thank you for re-considering this manuscript for review and publication.

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Competing Interests

No competing interest

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Reviewer Report

33 Views

18 Aug 2022 | for Version 1

Fiona Dickinson, Liverpool School of Tropical Medicine, Liverpool, UK

33 Views Cite this report Responses(0)

Approved

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Development of PROMs for use in maternity services in low and middle-income countries; Emergency obstetric care in LMIC; Care of mothers and newborns in LMIC.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (0)

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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[10] 10. Sharawi N, Klima L, Shah R, et al.: Evaluation of patient-reported outcome measures of functional recovery following caesarean section: a systematic review using the consensus-based standards for the selection of health measurement instruments (COSMIN) checklist. Anaesthesia. 2019; 74(11): 1439–1455. PubMed Abstract | Publisher Full Text

[11] 11. Wilson IB, Paul D: Health-Related Quality of Life. Published online 2021.

[12] 12. Mokkink LB, Prinsen CAC, Patrick DL, et al.: COSMIN manual for systematic reviews of PROMs, user manual. 2018; (February): 1–78. Reference Source

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[14] 14. O’Byrne L: PRISMA-P for Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties. 2021. http://www.doi.org/10.7910/DVN/IXX1EG

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[16] 16. O’Byrne L: Search thread: Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties. 2021. http://www.doi.org/10.7910/DVN/WMHKXG

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Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties.

Abstract

Keywords

Introduction

Methods

Protocol and registration

Search strategy

Eligibility criteria

Data extraction

Figure 1. The 10 steps for conducting a systematic review from the COSMIN manual for systematic reviews of patient reported outcome measures (PROMs)¹².

Generating recommendations for the use of a PROM

Dissemination of information

Study status

Discussion

Data availability

Underlying data

Extended data

Reporting guidelines

References

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Patient reported outcome measures in childbirth and postpartum maternal quality of life: a protocol for systematic review of measurement properties.

Abstract

Keywords

Introduction

Methods

Protocol and registration

Search strategy

Eligibility criteria

Data extraction

Figure 1. The 10 steps for conducting a systematic review from the COSMIN manual for systematic reviews of patient reported outcome measures (PROMs)12.

Generating recommendations for the use of a PROM

Dissemination of information

Study status

Discussion

Data availability

Underlying data

Extended data

Reporting guidelines

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

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Figure 1. The 10 steps for conducting a systematic review from the COSMIN manual for systematic reviews of patient reported outcome measures (PROMs)¹².