Co-Design of a website for women with pelvic organ prolapse: A study protocol

Maria-Louise Carroll; Catherine Doody; Cliona O' Sullivan; Carla Perrotta; Brona M Fullen

doi:10.12688/hrbopenres.13742.4

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Study Protocol

Revised

Co-Design of a website for women with pelvic organ prolapse: A study protocol

[version 4; peer review: 3 approved]

Maria-Louise Carroll ^1-3, Catherine Doody^1,2, Cliona O' Sullivan¹, Carla Perrotta¹, Brona M Fullen^1,2

Maria-Louise Carroll ^1-3, Catherine Doody^1,2, [...] Cliona O' Sullivan¹, Carla Perrotta¹, Brona M Fullen^1,2

PUBLISHED 29 May 2025

Author details Author details

¹ University College Dublin, Dublin, Leinster, D04C7X2, Ireland
² UCD Centre for Translational Pain Research, Dublin, D04C7X2, Ireland
³ Physiotherapy Department, Tipperary University Hospital, Clonmel, Co. Tipperary, E91VY40, Ireland

Maria-Louise Carroll
Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Catherine Doody
Roles: Conceptualization, Methodology, Writing – Review & Editing

Cliona O' Sullivan
Roles: Conceptualization, Methodology, Writing – Review & Editing

Carla Perrotta
Roles: Conceptualization, Methodology, Writing – Review & Editing

Brona M Fullen
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Public and Patient Involvement collection.

Abstract

Background

Despite high reported prevalence of pelvic organ prolapse (POP), women report difficulties accessing evidence-based and reliable information about the condition. Many rely on social media and other popular and highly visible internet platforms which have been found to contain poor quality information that is difficult for the average patient to understand. The aim of the study is to co-design an information website for premenopausal women with POP. The website design will be based on the Website Developmental Model for the Healthcare Consumer (WDMHC) framework.

Methods

A four phase process will be utilised as per the WDMHC framework: 1) User, task and environmental analysis; 2) Functional and representational analysis; 3) Cognitive walkthrough, keystroke level model, heuristic testing; 4) Content based testing, expert testing and user-based testing.

Ethics approval has been obtained (LS-23-19-Carroll-Ful). Two groups of stakeholders will be recruited (i) patient group (ii) healthcare professional (HCP) group. Patient participants will be recruited from an online pelvic floor dysfunction (PFD) support group (n=950 members). A website designer and HCP stakeholders involved in the multidisciplinary team caring for women with POP will be invited to participate.

Both groups will participate in separate co-design online workshops. Focus group workshops will be video-recorded, transcribed and imported into NVivo. Themes and subthemes will be developed.

The website will be designed and disseminated to all participants for feedback. Cognitive walkthrough and heuristic testing will be undertaken. Following this, necessary modifications will be made to the website. Participants will then complete a modified System Usability Scale (SUS) and the eHealth Impact Questionnaire, while five HCPs will complete the DISCERN instrument.

Conclusion

This study will inform the design and testing of an information website for women with POP. The website design and content will be informed by patient and HCP stakeholder voices and the health literacy literature.

Keywords

pelvic organ prolapse, physiotherapy, co-design, health literacy, gynaecology

Corresponding author: Maria-Louise Carroll

Competing interests: No competing interests were disclosed.

Grant information: Maria-Louise Carroll is a recipient of University College Dublin Centre for Translational Pain Research grant funding. Grant number: N/A
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 Carroll ML 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: Carroll ML, Doody C, O' Sullivan C et al. Co-Design of a website for women with pelvic organ prolapse: A study protocol [version 4; peer review: 3 approved]. HRB Open Res 2025, 6:37 (https://doi.org/10.12688/hrbopenres.13742.4) First published: 26 Jul 2023, 6:37 (https://doi.org/10.12688/hrbopenres.13742.1) Latest published: 29 May 2025, 6:37 (https://doi.org/10.12688/hrbopenres.13742.4)

Revised Amendments from Version 3

A wording change was made to reflect that the term cognitive walkthrough testing was twice used in error to describe the process of think aloud testing. No other changes were made.

See the authors' detailed response to the review by Sara Cichowski
See the authors' detailed response to the review by Rohna Kearney and Rebecca Helliwell
See the authors' detailed response to the review by Louise Brennan

Background

Female pelvic organ prolapse (POP) is defined by the International Urogynecological Association (IUGA) and International Continence Society (ICS) as a departure from normal sensation, structure, or function, experienced by the woman in reference to the position of her pelvic organs¹.

More than 30 million women worldwide are affected by POP², with some epidemiological research suggesting a rapid increase in prevalence of the condition in the next 25-30 years, particularly in high income countries³.

It is associated with a range of physical symptoms, including a feeling of vaginal bulge, dragging, pain and other bladder, bowel, and sexual issues³. These symptoms result in significant psychological and social impact including fear, regret, sadness hypervigilance and fear avoidance of certain activities^4–6. These impacts appear to be compounded for women by a lack of knowledge about POP and difficulty sourcing reliable and evidence-based information about the condition^3,4.

The provision of adequate information and counselling for women with POP has been highlighted as important for women to facilitate increased understanding of the condition, to promote active self-management where possible and increase shared decision-making between patients and their healthcare professionals (HCPs)^4,7–11.

Despite this, women have reported difficulty accessing evidence based, trustworthy and accurate information about POP¹². Moreover, women report HCPs as often lacking the time or expertise to provide adequate and detailed answers to their questions, or to offer health education or counselling when they present with symptoms or are diagnosed with POP^4,8–10,13. The lack of accessibility to best practice information leads women to access other popular and highly visible web resources such as Wikipedia, Google and YouTube. However these are often reported as being difficult to read, biased, omitting important information or including misleading or incorrect information about the condition^13–21.

Also a consideration is that most information on PFD accessible on the internet is at a reading level that is too difficult to understand for the average person²². Health literacy research has consistently found that health information on PFD and POP is well above the recommended reading level of grades 5–8 recommended by the US National Institute of Health (NIH) and Centre for Disease Control, the Joint Commission and the American Medical Association (AMA)^23,24.

Expert-designed health information is often overly generic and not adequately aligned with the abilities, preferences and life situations of the audience. It is suggested that participatory design of health information may improve health literacy and health promotion interventions²⁵.

This study is informed by our previous work in this field; utilising a systematic review to investigate the biopsychosocial profile of women POP and a qualitative investigation of the lived experience of women with POP⁴. Lack of information about POP (among both women and HCPs) and high levels of anxiety and fear was highlighted in this research as a major problem for women. They reported significant concerns regarding inadvertently worsening their condition by undertaking activities they perceived as risky. As a consequence, women described fear avoidance behaviours, particularly related to physical activity⁴.

Therefore, we propose a participatory action research framework to inform the development of a national information website for women with POP and other stakeholders.

Study aims

To develop and design a national evidence-based information website for women with POP using a participatory action research approach.

Study design framework

The study design will be based on the applicable principles of the Website Developmental Model for the Healthcare Consumer (WDMHC)²⁶. This model is a comprehensive, user-centred framework for the design and development of healthcare websites and has been shown to result in the delivery of a product that is likely to meet the expectations of end users and have minimal usability issues during end user testing^27,28.

The WDMHC model (Figure 1) provides recommendations for website design in three main areas (i) user/environmental/task/functional analysis (part A), (ii) visual-graphic representation and (iii) comparative analysis (part B). Parts C and D provide recommendations for (i) usability, (ii) heuristic testing and content and (iii) expert and user based testing.

Figure 1. Website Development Model for the Healthcare Consumer.

Incorporating the Noorbergen guidelines, which aim to address commonly encountered challenges in co-design during each step of the WDMHC will ensure a robust, standardised approach to the co-design process. They include: consideration of the circumstances of the health promotion context; consultation of behaviour change literature; engaging co-design facilitators with an understanding of the problem; immersion in the underlying health context to identify and understand stakeholders; identification of potential post-design advocates; ‘real world’ feasibility testing and analysis of intervention impact^26,29. This is to ensure that the resulting intervention prioritizes and includes the perspectives of all major stakeholders, in particular the target end-user (women with POP), is evidence-based, pragmatic and applicable to multiple health service areas.

Methods

Step 1: User, task & environmental analysis

1.1 Contextual enquiry

The study will be informed by our earlier research exploring the biopsychosocial profile and lived experience of premenopausal Irish women with POP seeking healthcare⁴. Additionally, end user characteristics such as age, race, ethnicity, computer skill level and information goals, as well as environmental analysis including physical, social and cultural context will be explored using focus group questions, the current literature and clinician experience. Task and functional analysis will be informed by the literature and patient and clinician experience with additional input from a website design expert.

1.2 Forming a planning/development team

The development team will include four physiotherapists, including a specialist pelvic health physiotherapist with fifteen years of experience in the field, and three with backgrounds in qualitative research and health literacy, a GP with a background in research and women’s health and an obstetrics and gynaecology consultant. A website designer will also be included on the research team.

1.3 Ethics approval

Ethical approval has been granted by the University College Dublin Human Research Ethics Committee (HREC) (REF: LS-23-19-Carroll-Ful). The study will be performed in accordance with the Declaration of Helsinki.

1.4 Participant selection

Two groups of stakeholders will be recruited (i) patient group (n=10 participants) (ii) HCP group (n=6 participants).

Patient inclusion criteria will be adult women (>18 years) with POP diagnosed and staged by a HCP, at least one year post-partum, premenopausal, not currently pregnant and able and willing to give informed consent. Sampling will be undertaken to ensure a range of POP stages (I-IV).

Relevant HCP stakeholders will include individuals from several involved disciplines including GPs, midwives, practice nurses/smear takers, gynaecologist/obstetricians and pelvic health physiotherapists.

Recruitment

Patient participants will be recruited from an online PFD support group (n=950 members). This group was set up by the principle investigator (MLC) on the social media platform Facebook in 2018 to provide a discussion forum and peer support for women with PFD.

Members will be invited to participate by an advertisement on the support group website outlining the study and patient inclusion criteria. Potential participants can contact the researcher (MLC) by phone or email. The participant information leaflet will be provided and after allowing a period of 1 week reflection the participant will be contacted by email by the researcher MLC to confirm their participation and provide the consent, demographic and eHealth Literacy questionnaires.

HCPs will be purposefully recruited by the development team including general practitioners (GPs), midwives, practice nurses/smear takers, gynaecologist/obstetricians and pelvic health physiotherapists. The development team will invite these HCPs to participate. HCPs will also be given 1 week to consider their participation and then contacted by the researcher (MLC) and if agreeing to participation, the HCP consent, demographic and eHealth Literacy Questionnaires will be provided.

1.5 Development of preparatory materials

Prior to the workshop patient participants will complete:

(i) a consent form
(ii) a patient demographic form
(iii) eHealth Literacy Questionnaire

HCPs will complete:

(i) a consent form
(ii) a HCP demographic form detailing their clinical experience and exposure to management of POP
(iii) eHealth Literacy Questionnaire.

Preparatory materials will be developed by the research team including:

(i) Participant instruction leaflets for using the Zoom & JamBoard platforms
(ii) Questions for workshop discussions
(iii) Patient vignettes to promote participant exploration of the ‘ideal’ scenario rather than a problem-solving approach
(iv) Details of other publicly available websites that will be discussed for comparative analysis to the proposed website

1.6 Technology tests

The online focus groups will be held on Zoom and the JamBoard platform, and will be tested with participants prior to the workshops to ensure familiarity with both platforms.

Step 2: Functional & representational analysis & creation of the prototype

2.1 Framing the issue

This study will build on previous research by the authors exploring Irish women’s experiences of accessing care for POP and their recommendations for improvements. The development team have also conducted a systematic review exploring the biopsychosocial profile of Irish women with POP and qualitative research examining the lived experience of POP from a biopsychosocial perspective⁴.

Access to information about their condition as an important facet of self –management and shared decision making was highlighted by the participants in this research. One researcher has extensive clinical experience working in the area of women’s pelvic health which will contribute to an understanding of the various stakeholder perspectives.

2.2 Defining the goal of the intervention

Patients and HCPs will be sent pre-workshop packs (see Extended data) for questions related to the workshop activities). These will include aims of the workshop and details of activities that they will participate in during the workshop. Content will include background information on POP and findings from qualitative research, details of similar publicly available information websites for comparative analysis, At the beginning of each workshop the aim of the intervention will again be explained and clarified where necessary.

2.3 Generating ideas

The co-design process will consist of separate patient and HCP workshops. This aims to eliminate any potential perceived power imbalance which may affect patient or HCP ability to share their views within their groups. Workshops will be carried out online, via Zoom. Zoom has been chosen as a platform with which many people are familiar and where interviews can be recorded and auto-transcribed.

Online workshops are favoured because of their accessibility, reducing the need for participants to travel, take time off work or source childcare to attend. This format will also allow the inclusion of a range of participants from across the country.

Workshop activities will aim to outline the ideal website content and design from both a patient and HCP perspective. Planned activities and goals for the workshops are shown in Figure 2 below.

Figure 2. Planned activities and goals for patient and HCP workshops.

Patient workshops

Patient co-design workshops will be longer, reflecting the need to place patients at the centre of their care. They will run for approximately 2.5 hours and comprise of four activities; (i) semi-structured discussion in two smaller groups. During this discussion participants willing to share stories of their experiences and difficulties faced in the current state will be encouraged to do so; this will help the development team and participants in understanding what must change (see Appendix A at 10.6084/m9.figshare.22923290 for guiding questions). The development team will facilitate these conversations using questions designed to identify strengths, weaknesses and opportunities for improvement to the current state, leading to a clear overall concept for the website content, (ii) comparative analysis of similar websites (see Appendix C under Extended data), (iii) patient vignettes – this generative technique aims to imagine a future state where personas can receive the ideal resources and information. To distil details of this ideal future state, guiding questions will be used to direct group discussion (see Appendix B under Extended data) (iv) draft layout design for website (see section 2.5 for questions)

Healthcare Professional Workshops

HCP workshops will run for a period of approximately one hour. The HCP session will consist of one group session and will use the same four activities as in the patient workshops. The same two patient vignettes will be used for patient journey mapping in order to observe differences in the HCP and patient perspective of the information needs of patients with POP.

After the workshops a list of topics for the website content will be compiled. The development team will consult the POP literature for evidence-based information under each topic heading. The development team will also use information from the comparative analysis and the draft layout workshop activities to inform the layout and design of the prototype website. The website developer will attend both the patient and HCP focus group workshops.

2.4 Sharing ideas

A sharing of ideas session bringing each group together to present the smaller group ideas will take place after the semi-structured discussion and patient vignettes activities. During this session the facilitator (a member of the development team) will also enquire about their thoughts on findings from qualitative research on women’s experiences of accessing care for POP and their recommendations for improvement. This information will be provided in the pre-workshop packs.

The sharing ideas session after the semi-structured discussion will further frame the issue for the development team and workshop participants, as well as highlighting challenges which may need to be overcome. The patient vignette is designed to encourage participant view of a future ‘ideal’ scenario rather than solutions to existing problems. The sharing of these vignettes from both a HCP and patient perspective may help to expose tacit knowledge or latent information needs that may be unconscious or difficult for participants to express in words²⁷.

The sessions will end with participants organising agreed topics into a draft layout design for the website.

2.5 Comparative analysis to similar websites

Comparative analysis will be carried out to similar websites during both the patient and HCP workshops. The details of these websites will be included in the pre-workshop packs and shared again during the workshops.

Participants will be asked several questions about the websites regarding the content: (i) what did you feel as regards the relevance of the content (ii) What did you think about the usefulness of the content? (iii) How reliable would you perceive the content of this website to be? (iv) Did the site contain all the information you were looking for? (v) Was there anything about the content of the website that you disliked? (vi) Is there any way you feel the content of the website could be improved upon?’ and design: (vii) ‘What are your thoughts on how the information on the website is organised? (viii) How easy or convenient did you find navigating the website? (ix) Where you satisfied with the website speed (how quickly it retrieved the information you were looking for)? (x) What is your opinion of the website’s layout? (xi) What did you think of the way information was presented (the format the information is given in, eg videos, multimedia)?

These questions are based on a hierarchical framework developed by Moustakis et al. which supports website quality assessment²⁸.

2.6 Intervention development

Requirements Translation/Focus Group Analysis

The focus group workshops will be video-recorded, transcribed verbatim and imported into NVivo. The lead researcher (MLC) will complete a descriptive synthesis of the workshop activities and focus group transcripts. Developed themes and subthemes will be communicated to the focus group participants via email to ensure agreement with summary views.

Once themes and subthemes have been reviewed and approved by participants, the required elements of the website will be devised (content to be included, draft website layout, sorting the information into logical sections, the evidence-based POP literature all considered, using a health literate-sensitive approach). This work will inform the content and design for each section of the website by the development team including a website designer.

Priorities will be developed for the website design and action items and timelines assigned to each theme and subtheme. Tasks will then be assigned to the appropriate research team member. Focus group participants will be informed via email of the plans and timeline for the intervention design.

Step 3: Cognitive walkthrough & heuristic testing

Participants from the original focus group workshops will be invited to participate in testing of the website to ensure the usability, impact and quality of the end product aligns with the goals of the development team and study participants.

3.1 Usability testing & think aloud testing

Research has found that at least five participants are necessary in any usability testing cycle to detect up to 80% of issues^30,31. Once the platform has been fully developed, two approaches will be used:

(i) Modified Usability Scale (SUS)
Five participants from the patient focus group will be recruited to complete a modified SUS. This instrument has been validated as useful and robust and produces a single score, which can be compared against standardized acceptability scores³².
(ii) Think aloud testing
This will be used to gather deeper insight into patient experience and usability of the intervention^33,34. This will be done via Zoom with the tester sharing their screen through the Zoom platform while the researcher observes. These meetings are recorded. Tasks will be identified such as the seeking of health-related information or finding information about HCPs and steps for each task will be documented. Each task within the website will then be assessed using the standardized questions outlined by Taylor et al.³⁵: (i). What are the users’ goals?; (ii). Is the action obviously available?; (iii) Does the action or label match the goal?; (iv) Is there good feedback?

3.2 Heuristic evaluation

Heuristic evaluation of the intervention on computer and mobile devices will be carried out in line with Nielsen’s ten usability heuristic principles by five development team members including a website designer³⁶. One patient and one HCP from the focus groups will also be asked to carry out heuristic testing. The areas of focus will include search, navigation, forms and data entry, information architecture, writing and content quality, trust and credibility, page layout and visual design.

The development team members will independently rate each website page using the following criteria: +1 (complies), -1 (does not comply), or 0 (partially complies). These reviewers will provide comments to justify their scoring. For items deemed not relevant, they will note ‘not applicable’. The development team will meet to discuss the ratings and reach an agreement regarding the items to be addressed before usability testing.

The results of the usability and heuristic testing will inform modifications to the website. Following these modifications content-based assessment, including expert-based and user-based testing will be carried out.

Step 4: Content based testing

4.1 Standards of practice

Standards of practice to ensure quality and credibility of internet health information have been established in many countries.

(i) The development of the study intervention will be informed by The Health on the Net Foundation Code of Conduct (HONcode)³⁷ While HONcode certification is no longer available, the HONcode principles which promote transparent and reliable health information online will be adhered to. For websites, it consists of eight principles, with detailed guidelines for each principle. It is used and approved by the Economic and Social Council and the WHO.

4.2 Expert based testing

(i) The DISCERN instrument³⁸ will be used by the HCPs involved in the HCP focus group. The 16 item instrument will peer-review the content of the website for quality, accuracy and reliability using the DISCERN instrument, a 16-item rating scale, to Once these steps are complete the prototype will be disseminated to the patient focus group participants who will be asked to complete a modified System Usability Scale (SUS) and the eHealth Impact Questionnaire. Following this, any necessary modifications will be made to the website.

4.3 Readability

It is recommended that patient educational information should not exceed the reading level of an 11 to 12-year old (or approximately 5th-8th grade level^39–42. The website’s content will thus be assessed and adjusted as necessary to achieve an average Flesch-Kincaid grade level of between five and eight. The development team will also consult the National Adult Literacy Agency (NALA) Plain English Guidelines, as well as the Health Service Executive (HSE) Guidelines on Communicating Clearly Using Plain English With Our Patients and Service Users^43,44.

4.5 User based testing

The same five patient participants recruited from the focus group will be asked to complete the eHealth Impact Questionnaire (e-HIQ)⁴⁵. This instrument assesses the impact of using websites containing health information. It consists of two distinct categories (eHIQ-Part 1 and eHIQ-Part 2). eHIQ-Part 1 is an eleven item scale assessing general attitude towards using the internet to access health information. eHIQ-Part 2 is a 26 item score assessing a participant’s experience of using a specific website.

Following content-based, including expert-based and user-based testing, modifications to the website will again be made as necessary.

Study status

This study is currently at recruitment stage.

Conclusions

Social media and the internet are ubiquitously used to search for and share medical information. According to the literature women are more likely to search online for diagnoses than men⁴⁶. Given the difficulties expressed by women with POP in obtaining reliable and complete information regarding their condition, this study aims to design and develop an evidence-based information website for this cohort. In the current project, there will be collaboration between patient users, health professionals, researchers and a website developer to develop a website based heavily on feedback from real patient users. The use of this participatory action research design aims to ensure a user-centred, reliable and evidence-based design.

Data availability

Underlying data

No data are associated with this article.

Extended data

Figshare: Appendices Co-design Protocol.docx. https://doi.org/10.6084/m9.figshare.22923290.v1⁴⁷.

- Appendices Co-design Protocol.docx

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Faculty Opinions recommended

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33. Lewis C, Polson PG, Wharton C, et al.: Testing a walkthrough methodology for theory-based design of walk-up-and-use interfaces. In: Proceedings of the SIGCHI Conference on Human Factors in Computing Systems. 1990; 235–242. Publisher Full Text
34. Khajouei R, Zahiri Esfahani M, Jahani Y: Comparison of heuristic and cognitive walkthrough usability evaluation methods for evaluating health information systems. J Am Med Inform Assoc. 2017; 24(e1): e55–60. PubMed Abstract | Publisher Full Text | Free Full Text
35. Taylor HA, Sullivan D, Mullen C, et al.: Implementation of a user-centered framework in the development of a web-based health information database and call center. J Biomed Inform. 2011; 44(5): 897–908. PubMed Abstract | Publisher Full Text
36. Nielsen J: Ten usability heuristics. Reference Source
37. Health on the net Foundation: The HON code of conduct for medical and health Web sites (HONcode). 1997.
38. Charnock D, Shepperd S, Needham G, et al.: DISCERN: an instrument for judging the quality of written consumer health information on treatment choices. J Epidemiol Community Health. 1999; 53(2): 105–11. PubMed Abstract | Publisher Full Text | Free Full Text
39. Kelly L, Jenkinson C, Ziebland S: Measuring the effects of online health information for patients: item generation for an e-health impact questionnaire. Patient Educ Couns. 2013; 93(3): 433–8. PubMed Abstract | Publisher Full Text | Free Full Text
40. Joint Commission: Advancing effective communication, cultural competence, and patient-and family-centered care: a roadmap for hospitals. Joint Commission; 2010. Reference Source
41. Weiss BD: Health literacy: a manual for clinicians. Chicago, IL: American Medical Association, American Medical Foundation. National Institutes of Health. How to Write Easy to Read Health Materials: National Library of Medicine Website, 2003. Reference Source
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47. Carroll ML: Appendices Co-design Protocol.docx. figshare. Preprint, 2023. http://www.doi.org/10.6084/m9.figshare.22923290.v1

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Version 4

VERSION 4 PUBLISHED 26 Jul 2023

Author details Author details

Maria-Louise Carroll
Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Catherine Doody
Roles: Conceptualization, Methodology, Writing – Review & Editing

Cliona O' Sullivan
Roles: Conceptualization, Methodology, Writing – Review & Editing

Carla Perrotta
Roles: Conceptualization, Methodology, Writing – Review & Editing

Brona M Fullen
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

Maria-Louise Carroll is a recipient of University College Dublin Centre for Translational Pain Research grant funding. Grant number: N/A
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (4)

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Carroll ML, Doody C, O' Sullivan C et al. Co-Design of a website for women with pelvic organ prolapse: A study protocol [version 4; peer review: 3 approved]. HRB Open Res 2025, 6:37 (https://doi.org/10.12688/hrbopenres.13742.4)

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Reviewer Report 27 Jan 2024

Rohna Kearney, Manchester University NHS Foundation Trust, Manchester, UK

Rebecca Helliwell, Gynaecology, Manchester University NHS Trust, Manchester, Lancashire, UK

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https://doi.org/10.21956/hrbopenres.15181.r37727

The authors have addressed the suggestions in our previous review. I have ... Continue reading

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Sara Cichowski, Oregon Health & Sciences, Portland, Oregon, USA

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Reviewer Report 13 Oct 2023

Sara Cichowski, Oregon Health & Sciences, Portland, Oregon, USA

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15102.r36483

This is a prospective study to develop a patient-friendly website for women with pelvic organ prolapse.

Background: no concerns

Aim: No concerns

Study Design:

My primary concern is the anticipated recruitment (n=10) for the patient focus group. POP is experienced and impacts life in unique ways. Additionally the information a young, premenopausal woman needs/wants may vary from an elderly, post-menopausal woman. Likewise there may be differing cultural, contextual beliefs that require specific educational needs. I think the anticipated sample size is well below what will be needed to make this website applicable to a generalizable population. Even in qualitative approaches there can be power estimations for thematic saturation. Do the researchers have a group size estimate for thematic saturation? Would the authors considers creating a table of intentional sampling? Usually for qualitative research it's not a random pick but an intentional selection so that a broad, diverse group is selected ideally representing many viewpoints/needs/perspectives. I would consider intentionally sampling based on age, desire for future childbearing, menopausal status, overall health status, prior experience versus no prior experience with POP, etc. This intentional sample should be described, well thought out and based on current evidence about varying populations with POP.

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: Pelvic floor disorders

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 15 Jan 2024

Louise Carroll, University College Dublin, Dublin, D04C7X2, Ireland

15 Jan 2024

Author Response

My primary concern is the anticipated recruitment (n=10) for the patient focus group. POP is experienced and impacts life in unique ways. Additionally the information a young, premenopausal woman needs/wants ... Continue reading My primary concern is the anticipated recruitment (n=10) for the patient focus group. POP is experienced and impacts life in unique ways. Additionally the information a young, premenopausal woman needs/wants may vary from an elderly, post-menopausal woman. Likewise there may be differing cultural, contextual beliefs that require specific educational needs. I think the anticipated sample size is well below what will be needed to make this website applicable to a generalizable population.

The authors’ previous work has been specifically focused on younger premenopausal women with POP. This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed. The authors agree that the information needs of a younger premenopausal woman are likely to differ from those of older post-menopausal women. Therefore the authors intend to focus on information provision primarily for this younger premenopausal cohort. We envisage carrying out future research with the aim of further developing the website to meet the requirements of a broader population of women e.g. older women, women from specific minority populations.

Even in qualitative approaches there can be power estimations for thematic saturation. Do the researchers have a group size estimate for thematic saturation? Would the authors considers creating a table of intentional sampling? Usually for qualitative research it's not a random pick but an intentional selection so that a broad, diverse group is selected ideally representing many viewpoints/needs/perspectives. I would consider intentionally sampling based on age, desire for future childbearing, menopausal status, overall health status, prior experience versus no prior experience with POP, etc. This intentional sample should be described, well thought out and based on current evidence about varying populations with POP.

Thank you for this valuable suggestion. As suggested, the authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.
My primary concern is the anticipated recruitment (n=10) for the patient focus group. POP is experienced and impacts life in unique ways. Additionally the information a young, premenopausal woman needs/wants may vary from an elderly, post-menopausal woman. Likewise there may be differing cultural, contextual beliefs that require specific educational needs. I think the anticipated sample size is well below what will be needed to make this website applicable to a generalizable population.

The authors’ previous work has been specifically focused on younger premenopausal women with POP. This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed. The authors agree that the information needs of a younger premenopausal woman are likely to differ from those of older post-menopausal women. Therefore the authors intend to focus on information provision primarily for this younger premenopausal cohort. We envisage carrying out future research with the aim of further developing the website to meet the requirements of a broader population of women e.g. older women, women from specific minority populations.

Even in qualitative approaches there can be power estimations for thematic saturation. Do the researchers have a group size estimate for thematic saturation? Would the authors considers creating a table of intentional sampling? Usually for qualitative research it's not a random pick but an intentional selection so that a broad, diverse group is selected ideally representing many viewpoints/needs/perspectives. I would consider intentionally sampling based on age, desire for future childbearing, menopausal status, overall health status, prior experience versus no prior experience with POP, etc. This intentional sample should be described, well thought out and based on current evidence about varying populations with POP.

Thank you for this valuable suggestion. As suggested, the authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.
Competing Interests: No competing interests were disclosed. Close
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Author Response 15 Jan 2024

Louise Carroll, University College Dublin, Dublin, D04C7X2, Ireland

15 Jan 2024

Author Response

My primary concern is the anticipated recruitment (n=10) for the patient focus group. POP is experienced and impacts life in unique ways. Additionally the information a young, premenopausal woman needs/wants ... Continue reading My primary concern is the anticipated recruitment (n=10) for the patient focus group. POP is experienced and impacts life in unique ways. Additionally the information a young, premenopausal woman needs/wants may vary from an elderly, post-menopausal woman. Likewise there may be differing cultural, contextual beliefs that require specific educational needs. I think the anticipated sample size is well below what will be needed to make this website applicable to a generalizable population.

The authors’ previous work has been specifically focused on younger premenopausal women with POP. This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed. The authors agree that the information needs of a younger premenopausal woman are likely to differ from those of older post-menopausal women. Therefore the authors intend to focus on information provision primarily for this younger premenopausal cohort. We envisage carrying out future research with the aim of further developing the website to meet the requirements of a broader population of women e.g. older women, women from specific minority populations.

Even in qualitative approaches there can be power estimations for thematic saturation. Do the researchers have a group size estimate for thematic saturation? Would the authors considers creating a table of intentional sampling? Usually for qualitative research it's not a random pick but an intentional selection so that a broad, diverse group is selected ideally representing many viewpoints/needs/perspectives. I would consider intentionally sampling based on age, desire for future childbearing, menopausal status, overall health status, prior experience versus no prior experience with POP, etc. This intentional sample should be described, well thought out and based on current evidence about varying populations with POP.

Thank you for this valuable suggestion. As suggested, the authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.
My primary concern is the anticipated recruitment (n=10) for the patient focus group. POP is experienced and impacts life in unique ways. Additionally the information a young, premenopausal woman needs/wants may vary from an elderly, post-menopausal woman. Likewise there may be differing cultural, contextual beliefs that require specific educational needs. I think the anticipated sample size is well below what will be needed to make this website applicable to a generalizable population.

The authors’ previous work has been specifically focused on younger premenopausal women with POP. This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed. The authors agree that the information needs of a younger premenopausal woman are likely to differ from those of older post-menopausal women. Therefore the authors intend to focus on information provision primarily for this younger premenopausal cohort. We envisage carrying out future research with the aim of further developing the website to meet the requirements of a broader population of women e.g. older women, women from specific minority populations.

Even in qualitative approaches there can be power estimations for thematic saturation. Do the researchers have a group size estimate for thematic saturation? Would the authors considers creating a table of intentional sampling? Usually for qualitative research it's not a random pick but an intentional selection so that a broad, diverse group is selected ideally representing many viewpoints/needs/perspectives. I would consider intentionally sampling based on age, desire for future childbearing, menopausal status, overall health status, prior experience versus no prior experience with POP, etc. This intentional sample should be described, well thought out and based on current evidence about varying populations with POP.

Thank you for this valuable suggestion. As suggested, the authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.
Competing Interests: No competing interests were disclosed. Close
Report a concern

Views

Reviewer Report 13 Oct 2023

Rohna Kearney, Manchester University NHS Foundation Trust, Manchester, UK

Rebecca Helliwell, Gynaecology, Manchester University NHS Trust, Manchester, Lancashire, UK

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15102.r36210

This is a well written study protocol to co-design a website with patients and healthcare providers to provide information on pelvic organ prolapse for women. The case for website creation is well made.

Women will be recruited from an existing online forum. Previous work published from this online group, referenced in this protocol, reported an age range of 32-41 years. All women included in that study (reference 6) were reported of fair to good health. How will the researchers ensure the study produces an online resource that also meets the needs of older women, those less engaged with internet and online media and those with medical co-morbidities? If the focus is on information provision for premenopausal women, this should be explicitly stated.

As 10 women will be recruited, how will the authors ensure appropriate representation of the population of women with prolapse. Will the website be accessible to women who do not speak English? Is 10 women sufficient for theme saturation?

I suggest discussing the strengths and limitations of the approach proposed.

It would be helpful to reference the HSE/NALA guidelines discussed for readers not familiar with these.

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

Yes
Is the study design appropriate for the research question?

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

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

Not applicable

Competing Interests: I am a co-chief investigator for a NIHR funded RCT on self-management of vaginal pessaries for prolapse compared with clinic based care

Reviewer Expertise: Urogynaecology, pelvic floor, self-management, pelvic floor imaging, obstetric childbirth injury

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

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Author Response 15 Jan 2024

Louise Carroll, University College Dublin, Dublin, D04C7X2, Ireland

15 Jan 2024

Author Response

How will the researchers ensure the study produces an online resource that also meets the needs of older women, those less engaged with internet and online media and those with ... Continue reading How will the researchers ensure the study produces an online resource that also meets the needs of older women, those less engaged with internet and online media and those with medical co-morbidities? If the focus is on information provision for premenopausal women, this should be explicitly stated.

The authors’ previous work has been specifically focused on younger premenopausal women with pelvic organ prolapse (POP). This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed.
The literature to date shows that POP symptom bother is not always explained by level of anatomic prolapse. In our previous work (Carroll et al 2023) and in other research, it has been suggested that the aetiology of POP in younger women differs from that in older women, in whom POP symptoms tend to more closely reflect anatomic POP (Alcalay 2015, Rinne 1999).
This younger cohort tend to report more symptom bother which in many cases levels off around menopause (Miedel et al 2008). Central sensitization and/or myofascial pain have been proposed as a possible explanation for this, with Vij et al finding a 30% rate of central sensitization in a sample of women with POP from a general GOPD (Vij et al 2019, Dixon et al 2019, Adams et al 2014).
The prevalence of POP in premenopausal women in Ireland and elsewhere is uncertain; however Durnea et al reported a 90% incidence of anatomic POP in primparous women 1 year after childbirth. 20% of these women were symptomatic.
Research to date has found that neuroscience education, cognition-targeted exercise therapy, sleep management, stress management, and/or dietary intervention to be important facets for the treatment of central sensitization (Nijs et al 2019). If central sensitization is an important factor, it would be interesting to see how a biopsychosocial approach to POP including the information proposed through this intervention would affect experience of this cohort of women with POP.
Therefore the authors intent is to focus on information provision for premenopausal women primarily. This has been clarified in the article.

_{Carroll L, Sullivan CO, Doody C, Perrotta C, Fullen BM. Pelvic organ prolapse: Women’s experiences of Accessing Care & Recommendations for improvement. BMC Women's Health. 2023 Dec;23(1):1-3.

Alcalay M, Stav K, Eisenberg VH. Family history associated with pelvic organ prolapse in young women. International urogynecology journal. 2015 Dec;26:1773-6.

Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse?. European Journal of Obstetrics & Gynecology and Reproductive Biology. 1999 May 1;84(1):23-5.

Miedel A, Tegerstedt G, Mörlin B, Hammarström M. A 5-year prospective follow-up study of vaginal surgery for pelvic organ prolapse. International Urogynecology Journal. 2008 Dec;19:1593-601.

Vij M, Davies A, Dua A, Freeman R. The proportion of women with central sensitivity syndrome in gynecology outpatient clinics (GOPDs). International Urogynecology Journal. 2019 Mar 4;30:483-8.

Dixon AM, Fitzgerald CM, Brincat C. Severity and bother of prolapse symptoms in women with pelvic floor myofascial pain. International Urogynecology Journal. 2019 Nov;30:1829-34.

Adams K, Osmundsen B, Gregory WT. Does fibromyalgia influence symptom bother from pelvic organ prolapse?. International urogynecology journal. 2014 May;25:677-82.

Durnea CM, Khashan AS, Kenny LC, Durnea UA, Smyth MM, O’Reilly BA. Prevalence, etiology and risk factors of pelvic organ prolapse in premenopausal primiparous women. International urogynecology journal. 2014 Nov;25:1463-70.

Nijs J, Leysen L, Vanlauwe J, Logghe T, Ickmans K, Polli A, Malfliet A, Coppieters I, Huysmans E. Treatment of central sensitization in patients with chronic pain: time for change?. Expert Opinion on Pharmacotherapy. 2019 Nov 2;20(16):1961-70.}

As 10 women will be recruited, how will the authors ensure appropriate representation of the population of women with prolapse?

The authors acknowledge that representation of the population of all women with POP will not be fully addressed as focus of the authors research is on the impact of POP on premenopausal women. The authors will use a sampling grid to ensure recruitment of pre-menopausal women with stages I-IV prolapse, of varying parity and those who do and do not desire more children. To increase impact and applicability, we would envisage after the website is complete that more research will be carried out to further develop the website with the requirements of a broader population of women e.g. older women, women from specific minority populations including a broader range of recruitment strategies taken into account.

Will the website be accessible to women who do not speak English?

The website will be developed in English but will be enabled to allow auto-translation to multiple languages.

Is 10 women sufficient for theme saturation?

The authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.

It would be helpful to reference the HSE/NALA guidelines discussed for readers not familiar with these.

The authors have added this information to the reference section.
How will the researchers ensure the study produces an online resource that also meets the needs of older women, those less engaged with internet and online media and those with medical co-morbidities? If the focus is on information provision for premenopausal women, this should be explicitly stated.

The authors’ previous work has been specifically focused on younger premenopausal women with pelvic organ prolapse (POP). This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed.
The literature to date shows that POP symptom bother is not always explained by level of anatomic prolapse. In our previous work (Carroll et al 2023) and in other research, it has been suggested that the aetiology of POP in younger women differs from that in older women, in whom POP symptoms tend to more closely reflect anatomic POP (Alcalay 2015, Rinne 1999).
This younger cohort tend to report more symptom bother which in many cases levels off around menopause (Miedel et al 2008). Central sensitization and/or myofascial pain have been proposed as a possible explanation for this, with Vij et al finding a 30% rate of central sensitization in a sample of women with POP from a general GOPD (Vij et al 2019, Dixon et al 2019, Adams et al 2014).
The prevalence of POP in premenopausal women in Ireland and elsewhere is uncertain; however Durnea et al reported a 90% incidence of anatomic POP in primparous women 1 year after childbirth. 20% of these women were symptomatic.
Research to date has found that neuroscience education, cognition-targeted exercise therapy, sleep management, stress management, and/or dietary intervention to be important facets for the treatment of central sensitization (Nijs et al 2019). If central sensitization is an important factor, it would be interesting to see how a biopsychosocial approach to POP including the information proposed through this intervention would affect experience of this cohort of women with POP.
Therefore the authors intent is to focus on information provision for premenopausal women primarily. This has been clarified in the article.

_{Carroll L, Sullivan CO, Doody C, Perrotta C, Fullen BM. Pelvic organ prolapse: Women’s experiences of Accessing Care & Recommendations for improvement. BMC Women's Health. 2023 Dec;23(1):1-3.

Alcalay M, Stav K, Eisenberg VH. Family history associated with pelvic organ prolapse in young women. International urogynecology journal. 2015 Dec;26:1773-6.

Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse?. European Journal of Obstetrics & Gynecology and Reproductive Biology. 1999 May 1;84(1):23-5.

Miedel A, Tegerstedt G, Mörlin B, Hammarström M. A 5-year prospective follow-up study of vaginal surgery for pelvic organ prolapse. International Urogynecology Journal. 2008 Dec;19:1593-601.

Vij M, Davies A, Dua A, Freeman R. The proportion of women with central sensitivity syndrome in gynecology outpatient clinics (GOPDs). International Urogynecology Journal. 2019 Mar 4;30:483-8.

Dixon AM, Fitzgerald CM, Brincat C. Severity and bother of prolapse symptoms in women with pelvic floor myofascial pain. International Urogynecology Journal. 2019 Nov;30:1829-34.

Adams K, Osmundsen B, Gregory WT. Does fibromyalgia influence symptom bother from pelvic organ prolapse?. International urogynecology journal. 2014 May;25:677-82.

Durnea CM, Khashan AS, Kenny LC, Durnea UA, Smyth MM, O’Reilly BA. Prevalence, etiology and risk factors of pelvic organ prolapse in premenopausal primiparous women. International urogynecology journal. 2014 Nov;25:1463-70.

Nijs J, Leysen L, Vanlauwe J, Logghe T, Ickmans K, Polli A, Malfliet A, Coppieters I, Huysmans E. Treatment of central sensitization in patients with chronic pain: time for change?. Expert Opinion on Pharmacotherapy. 2019 Nov 2;20(16):1961-70.}

As 10 women will be recruited, how will the authors ensure appropriate representation of the population of women with prolapse?

The authors acknowledge that representation of the population of all women with POP will not be fully addressed as focus of the authors research is on the impact of POP on premenopausal women. The authors will use a sampling grid to ensure recruitment of pre-menopausal women with stages I-IV prolapse, of varying parity and those who do and do not desire more children. To increase impact and applicability, we would envisage after the website is complete that more research will be carried out to further develop the website with the requirements of a broader population of women e.g. older women, women from specific minority populations including a broader range of recruitment strategies taken into account.

Will the website be accessible to women who do not speak English?

The website will be developed in English but will be enabled to allow auto-translation to multiple languages.

Is 10 women sufficient for theme saturation?

The authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.

It would be helpful to reference the HSE/NALA guidelines discussed for readers not familiar with these.

The authors have added this information to the reference section.
Competing Interests: No competing interests were disclosed. Close
Report a concern
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COMMENTS ON THIS REPORT

Author Response 15 Jan 2024

Louise Carroll, University College Dublin, Dublin, D04C7X2, Ireland

15 Jan 2024

Author Response

How will the researchers ensure the study produces an online resource that also meets the needs of older women, those less engaged with internet and online media and those with ... Continue reading How will the researchers ensure the study produces an online resource that also meets the needs of older women, those less engaged with internet and online media and those with medical co-morbidities? If the focus is on information provision for premenopausal women, this should be explicitly stated.

The authors’ previous work has been specifically focused on younger premenopausal women with pelvic organ prolapse (POP). This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed.
The literature to date shows that POP symptom bother is not always explained by level of anatomic prolapse. In our previous work (Carroll et al 2023) and in other research, it has been suggested that the aetiology of POP in younger women differs from that in older women, in whom POP symptoms tend to more closely reflect anatomic POP (Alcalay 2015, Rinne 1999).
This younger cohort tend to report more symptom bother which in many cases levels off around menopause (Miedel et al 2008). Central sensitization and/or myofascial pain have been proposed as a possible explanation for this, with Vij et al finding a 30% rate of central sensitization in a sample of women with POP from a general GOPD (Vij et al 2019, Dixon et al 2019, Adams et al 2014).
The prevalence of POP in premenopausal women in Ireland and elsewhere is uncertain; however Durnea et al reported a 90% incidence of anatomic POP in primparous women 1 year after childbirth. 20% of these women were symptomatic.
Research to date has found that neuroscience education, cognition-targeted exercise therapy, sleep management, stress management, and/or dietary intervention to be important facets for the treatment of central sensitization (Nijs et al 2019). If central sensitization is an important factor, it would be interesting to see how a biopsychosocial approach to POP including the information proposed through this intervention would affect experience of this cohort of women with POP.
Therefore the authors intent is to focus on information provision for premenopausal women primarily. This has been clarified in the article.

_{Carroll L, Sullivan CO, Doody C, Perrotta C, Fullen BM. Pelvic organ prolapse: Women’s experiences of Accessing Care & Recommendations for improvement. BMC Women's Health. 2023 Dec;23(1):1-3.

Alcalay M, Stav K, Eisenberg VH. Family history associated with pelvic organ prolapse in young women. International urogynecology journal. 2015 Dec;26:1773-6.

Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse?. European Journal of Obstetrics & Gynecology and Reproductive Biology. 1999 May 1;84(1):23-5.

Miedel A, Tegerstedt G, Mörlin B, Hammarström M. A 5-year prospective follow-up study of vaginal surgery for pelvic organ prolapse. International Urogynecology Journal. 2008 Dec;19:1593-601.

Vij M, Davies A, Dua A, Freeman R. The proportion of women with central sensitivity syndrome in gynecology outpatient clinics (GOPDs). International Urogynecology Journal. 2019 Mar 4;30:483-8.

Dixon AM, Fitzgerald CM, Brincat C. Severity and bother of prolapse symptoms in women with pelvic floor myofascial pain. International Urogynecology Journal. 2019 Nov;30:1829-34.

Adams K, Osmundsen B, Gregory WT. Does fibromyalgia influence symptom bother from pelvic organ prolapse?. International urogynecology journal. 2014 May;25:677-82.

Durnea CM, Khashan AS, Kenny LC, Durnea UA, Smyth MM, O’Reilly BA. Prevalence, etiology and risk factors of pelvic organ prolapse in premenopausal primiparous women. International urogynecology journal. 2014 Nov;25:1463-70.

Nijs J, Leysen L, Vanlauwe J, Logghe T, Ickmans K, Polli A, Malfliet A, Coppieters I, Huysmans E. Treatment of central sensitization in patients with chronic pain: time for change?. Expert Opinion on Pharmacotherapy. 2019 Nov 2;20(16):1961-70.}

As 10 women will be recruited, how will the authors ensure appropriate representation of the population of women with prolapse?

The authors acknowledge that representation of the population of all women with POP will not be fully addressed as focus of the authors research is on the impact of POP on premenopausal women. The authors will use a sampling grid to ensure recruitment of pre-menopausal women with stages I-IV prolapse, of varying parity and those who do and do not desire more children. To increase impact and applicability, we would envisage after the website is complete that more research will be carried out to further develop the website with the requirements of a broader population of women e.g. older women, women from specific minority populations including a broader range of recruitment strategies taken into account.

Will the website be accessible to women who do not speak English?

The website will be developed in English but will be enabled to allow auto-translation to multiple languages.

Is 10 women sufficient for theme saturation?

The authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.

It would be helpful to reference the HSE/NALA guidelines discussed for readers not familiar with these.

The authors have added this information to the reference section.
How will the researchers ensure the study produces an online resource that also meets the needs of older women, those less engaged with internet and online media and those with medical co-morbidities? If the focus is on information provision for premenopausal women, this should be explicitly stated.

The authors’ previous work has been specifically focused on younger premenopausal women with pelvic organ prolapse (POP). This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed.
The literature to date shows that POP symptom bother is not always explained by level of anatomic prolapse. In our previous work (Carroll et al 2023) and in other research, it has been suggested that the aetiology of POP in younger women differs from that in older women, in whom POP symptoms tend to more closely reflect anatomic POP (Alcalay 2015, Rinne 1999).
This younger cohort tend to report more symptom bother which in many cases levels off around menopause (Miedel et al 2008). Central sensitization and/or myofascial pain have been proposed as a possible explanation for this, with Vij et al finding a 30% rate of central sensitization in a sample of women with POP from a general GOPD (Vij et al 2019, Dixon et al 2019, Adams et al 2014).
The prevalence of POP in premenopausal women in Ireland and elsewhere is uncertain; however Durnea et al reported a 90% incidence of anatomic POP in primparous women 1 year after childbirth. 20% of these women were symptomatic.
Research to date has found that neuroscience education, cognition-targeted exercise therapy, sleep management, stress management, and/or dietary intervention to be important facets for the treatment of central sensitization (Nijs et al 2019). If central sensitization is an important factor, it would be interesting to see how a biopsychosocial approach to POP including the information proposed through this intervention would affect experience of this cohort of women with POP.
Therefore the authors intent is to focus on information provision for premenopausal women primarily. This has been clarified in the article.

_{Carroll L, Sullivan CO, Doody C, Perrotta C, Fullen BM. Pelvic organ prolapse: Women’s experiences of Accessing Care & Recommendations for improvement. BMC Women's Health. 2023 Dec;23(1):1-3.

Alcalay M, Stav K, Eisenberg VH. Family history associated with pelvic organ prolapse in young women. International urogynecology journal. 2015 Dec;26:1773-6.

Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse?. European Journal of Obstetrics & Gynecology and Reproductive Biology. 1999 May 1;84(1):23-5.

Miedel A, Tegerstedt G, Mörlin B, Hammarström M. A 5-year prospective follow-up study of vaginal surgery for pelvic organ prolapse. International Urogynecology Journal. 2008 Dec;19:1593-601.

Vij M, Davies A, Dua A, Freeman R. The proportion of women with central sensitivity syndrome in gynecology outpatient clinics (GOPDs). International Urogynecology Journal. 2019 Mar 4;30:483-8.

Dixon AM, Fitzgerald CM, Brincat C. Severity and bother of prolapse symptoms in women with pelvic floor myofascial pain. International Urogynecology Journal. 2019 Nov;30:1829-34.

Adams K, Osmundsen B, Gregory WT. Does fibromyalgia influence symptom bother from pelvic organ prolapse?. International urogynecology journal. 2014 May;25:677-82.

Durnea CM, Khashan AS, Kenny LC, Durnea UA, Smyth MM, O’Reilly BA. Prevalence, etiology and risk factors of pelvic organ prolapse in premenopausal primiparous women. International urogynecology journal. 2014 Nov;25:1463-70.

Nijs J, Leysen L, Vanlauwe J, Logghe T, Ickmans K, Polli A, Malfliet A, Coppieters I, Huysmans E. Treatment of central sensitization in patients with chronic pain: time for change?. Expert Opinion on Pharmacotherapy. 2019 Nov 2;20(16):1961-70.}

As 10 women will be recruited, how will the authors ensure appropriate representation of the population of women with prolapse?

The authors acknowledge that representation of the population of all women with POP will not be fully addressed as focus of the authors research is on the impact of POP on premenopausal women. The authors will use a sampling grid to ensure recruitment of pre-menopausal women with stages I-IV prolapse, of varying parity and those who do and do not desire more children. To increase impact and applicability, we would envisage after the website is complete that more research will be carried out to further develop the website with the requirements of a broader population of women e.g. older women, women from specific minority populations including a broader range of recruitment strategies taken into account.

Will the website be accessible to women who do not speak English?

The website will be developed in English but will be enabled to allow auto-translation to multiple languages.

Is 10 women sufficient for theme saturation?

The authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.

It would be helpful to reference the HSE/NALA guidelines discussed for readers not familiar with these.

The authors have added this information to the reference section.
Competing Interests: No competing interests were disclosed. Close
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Version 1

VERSION 1

PUBLISHED 26 Jul 2023

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Reviewer Report 18 Aug 2023

Louise Brennan, Discipline of Physiotherapy, School of Medicine, Trinity College Dublin, Dublin, Ireland

Approved

https://doi.org/10.21956/hrbopenres.15032.r35508

A well-written, detailed protocol for the co-design of a website for women with pelvic organ prolapse. The introduction clearly describes the problem the website aims to solve and this is important work which will support an under-served population. The methodology is guided by a very appropriate framework (WDMHC) which will enable comprehensive input from stakeholders and should result in a highly user-friendly website.

Is the context for this website local, national or international? Providing some context for this will help provide background to the study for the reader, will guide website design and will help identify if participant representatives in focus groups appropriately represent target population. If the website is for a national / local audience, consider including appropriate references re health literacy (e.g. HSE/NALA).

Focus groups: Can you report why participants with advanced POP are not included in the focus groups? Family members and spouses will provide insightful input to this project - could they be included at some stage? Will the website developer attend any part of these sessions?

Heuristics will ideally be assessed by someone external to the development team - could a patient rep and HCP complete this assessment also? Will you make further adjustments to the website based on the feedback from content-based testing?

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?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Digital health, website co-design, physical rehabilitation

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.

CITE

Report a concern

Author Response 17 Nov 2023

Louise Carroll, University College Dublin, Dublin, D04C7X2, Ireland

17 Nov 2023

Author Response

Dear Dr. Brennan,
Thank you very much for your time and expertise in reviewing our study protocol. We have addressed your feedback below and also in the updated version of ... Continue reading Dear Dr. Brennan,
Thank you very much for your time and expertise in reviewing our study protocol. We have addressed your feedback below and also in the updated version of the study article.
Kind regards,
Louise Carroll, Brona Fullen, Catherine Doody, Cliona O’ Sullivan & Carla Perrotta

Is the context for this website local, national or international? Providing some context for this will help provide background to the study for the reader, will guide website design and will help identify if participant representatives in focus groups appropriately represent target population. If the website is for a national / local audience, consider including appropriate references re health literacy (e.g. HSE/NALA).
The context for this website is national. As such, we will consult the NALA ‘Literacy audit for healthcare settings’ and HSE ‘Guidelines for Communicating Clearly using Plain English with our Patients and Service Users’ to inform the design.

Focus groups: Can you report why participants with advanced POP are not included in the focus groups?
We have amended the study inclusion/exclusion criteria to include women with Stage IV POP. As many women have corrective surgery as a matter of urgency with this level of advanced POP and as it is relatively rare, recruitment of women with Stage IV POP would be challenging; to date we do not have anyone with Stage IV POP enrolled in the study.

Family members and spouses will provide insightful input to this project - could they be included at some stage?
For the current project we have no plan to include family members and spouses; however we may explore this perspective in future work.

Will the website developer attend any part of these sessions?
Yes, the developer will attend both the patient and HCP workshops.

Heuristics will ideally be assessed by someone external to the development team - could a patient rep and HCP complete this assessment also?
We have amended the study methodology to reflect this recommendation.

Will you make further adjustments to the website based on the feedback from content-based testing?
Yes the website will be adjusted based to content-based testing feedback.
Dear Dr. Brennan,
Thank you very much for your time and expertise in reviewing our study protocol. We have addressed your feedback below and also in the updated version of the study article.
Kind regards,
Louise Carroll, Brona Fullen, Catherine Doody, Cliona O’ Sullivan & Carla Perrotta

Is the context for this website local, national or international? Providing some context for this will help provide background to the study for the reader, will guide website design and will help identify if participant representatives in focus groups appropriately represent target population. If the website is for a national / local audience, consider including appropriate references re health literacy (e.g. HSE/NALA).
The context for this website is national. As such, we will consult the NALA ‘Literacy audit for healthcare settings’ and HSE ‘Guidelines for Communicating Clearly using Plain English with our Patients and Service Users’ to inform the design.

Focus groups: Can you report why participants with advanced POP are not included in the focus groups?
We have amended the study inclusion/exclusion criteria to include women with Stage IV POP. As many women have corrective surgery as a matter of urgency with this level of advanced POP and as it is relatively rare, recruitment of women with Stage IV POP would be challenging; to date we do not have anyone with Stage IV POP enrolled in the study.

Family members and spouses will provide insightful input to this project - could they be included at some stage?
For the current project we have no plan to include family members and spouses; however we may explore this perspective in future work.

Will the website developer attend any part of these sessions?
Yes, the developer will attend both the patient and HCP workshops.

Heuristics will ideally be assessed by someone external to the development team - could a patient rep and HCP complete this assessment also?
We have amended the study methodology to reflect this recommendation.

Will you make further adjustments to the website based on the feedback from content-based testing?
Yes the website will be adjusted based to content-based testing feedback.
Competing Interests: No competing interests were disclosed. Close
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Respond or Comment

COMMENTS ON THIS REPORT

Author Response 17 Nov 2023

Louise Carroll, University College Dublin, Dublin, D04C7X2, Ireland

17 Nov 2023

Author Response

Dear Dr. Brennan,
Thank you very much for your time and expertise in reviewing our study protocol. We have addressed your feedback below and also in the updated version of ... Continue reading Dear Dr. Brennan,
Thank you very much for your time and expertise in reviewing our study protocol. We have addressed your feedback below and also in the updated version of the study article.
Kind regards,
Louise Carroll, Brona Fullen, Catherine Doody, Cliona O’ Sullivan & Carla Perrotta

Is the context for this website local, national or international? Providing some context for this will help provide background to the study for the reader, will guide website design and will help identify if participant representatives in focus groups appropriately represent target population. If the website is for a national / local audience, consider including appropriate references re health literacy (e.g. HSE/NALA).
The context for this website is national. As such, we will consult the NALA ‘Literacy audit for healthcare settings’ and HSE ‘Guidelines for Communicating Clearly using Plain English with our Patients and Service Users’ to inform the design.

Focus groups: Can you report why participants with advanced POP are not included in the focus groups?
We have amended the study inclusion/exclusion criteria to include women with Stage IV POP. As many women have corrective surgery as a matter of urgency with this level of advanced POP and as it is relatively rare, recruitment of women with Stage IV POP would be challenging; to date we do not have anyone with Stage IV POP enrolled in the study.

Family members and spouses will provide insightful input to this project - could they be included at some stage?
For the current project we have no plan to include family members and spouses; however we may explore this perspective in future work.

Will the website developer attend any part of these sessions?
Yes, the developer will attend both the patient and HCP workshops.

Heuristics will ideally be assessed by someone external to the development team - could a patient rep and HCP complete this assessment also?
We have amended the study methodology to reflect this recommendation.

Will you make further adjustments to the website based on the feedback from content-based testing?
Yes the website will be adjusted based to content-based testing feedback.
Dear Dr. Brennan,
Thank you very much for your time and expertise in reviewing our study protocol. We have addressed your feedback below and also in the updated version of the study article.
Kind regards,
Louise Carroll, Brona Fullen, Catherine Doody, Cliona O’ Sullivan & Carla Perrotta

Is the context for this website local, national or international? Providing some context for this will help provide background to the study for the reader, will guide website design and will help identify if participant representatives in focus groups appropriately represent target population. If the website is for a national / local audience, consider including appropriate references re health literacy (e.g. HSE/NALA).
The context for this website is national. As such, we will consult the NALA ‘Literacy audit for healthcare settings’ and HSE ‘Guidelines for Communicating Clearly using Plain English with our Patients and Service Users’ to inform the design.

Focus groups: Can you report why participants with advanced POP are not included in the focus groups?
We have amended the study inclusion/exclusion criteria to include women with Stage IV POP. As many women have corrective surgery as a matter of urgency with this level of advanced POP and as it is relatively rare, recruitment of women with Stage IV POP would be challenging; to date we do not have anyone with Stage IV POP enrolled in the study.

Family members and spouses will provide insightful input to this project - could they be included at some stage?
For the current project we have no plan to include family members and spouses; however we may explore this perspective in future work.

Will the website developer attend any part of these sessions?
Yes, the developer will attend both the patient and HCP workshops.

Heuristics will ideally be assessed by someone external to the development team - could a patient rep and HCP complete this assessment also?
We have amended the study methodology to reflect this recommendation.

Will you make further adjustments to the website based on the feedback from content-based testing?
Yes the website will be adjusted based to content-based testing feedback.
Competing Interests: No competing interests were disclosed. Close
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Version 4

VERSION 4 PUBLISHED 26 Jul 2023

Open Peer Review

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Version 4 (revision) 29 May 25
Version 3 (revision) 11 Jan 24		read	read
Version 2 (revision) 15 Sep 23		read	read
Version 1 26 Jul 23	read

Louise Brennan, Trinity College Dublin, Dublin, Ireland
Rohna Kearney, Manchester University NHS Foundation Trust, Manchester, UK

Rebecca Helliwell, Manchester University NHS Trust, Manchester, UK
Sara Cichowski, Oregon Health & Sciences, Portland, USA

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27 Views

27 Jan 2024 | for Version 3

Rohna Kearney, Manchester University NHS Foundation Trust, Manchester, UK

Rebecca Helliwell, Gynaecology, Manchester University NHS Trust, Manchester, Lancashire, UK

27 Views Cite this report Responses(0)

Approved

The authors have addressed the suggestions in our previous review. I have no further comments and wish them the best of luck in their study.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Urogynaecology, pelvic floor, self-management, pelvic floor imaging, obstetric childbirth injury

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

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22 Views

27 Jan 2024 | for Version 3

Sara Cichowski, Oregon Health & Sciences, Portland, Oregon, USA

22 Views Cite this report Responses(0)

Approved

I agree that the revisions address my concerns.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Pelvic floor disorders

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

55 Views

13 Oct 2023 | for Version 2

Sara Cichowski, Oregon Health & Sciences, Portland, Oregon, USA

55 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?

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

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Pelvic floor disorders

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Author Response

15 Jan 2024

Louise Carroll, University College Dublin, Dublin, D04C7X2, Ireland

My primary concern is the anticipated recruitment (n=10) for the patient focus group. POP is experienced and impacts life in unique ways. Additionally the information a young, premenopausal woman needs/wants may vary from an elderly, post-menopausal woman. Likewise there may be differing cultural, contextual beliefs that require specific educational needs. I think the anticipated sample size is well below what will be needed to make this website applicable to a generalizable population.

The authors’ previous work has been specifically focused on younger premenopausal women with POP. This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed. The authors agree that the information needs of a younger premenopausal woman are likely to differ from those of older post-menopausal women. Therefore the authors intend to focus on information provision primarily for this younger premenopausal cohort. We envisage carrying out future research with the aim of further developing the website to meet the requirements of a broader population of women e.g. older women, women from specific minority populations.

Even in qualitative approaches there can be power estimations for thematic saturation. Do the researchers have a group size estimate for thematic saturation? Would the authors considers creating a table of intentional sampling? Usually for qualitative research it's not a random pick but an intentional selection so that a broad, diverse group is selected ideally representing many viewpoints/needs/perspectives. I would consider intentionally sampling based on age, desire for future childbearing, menopausal status, overall health status, prior experience versus no prior experience with POP, etc. This intentional sample should be described, well thought out and based on current evidence about varying populations with POP.

Thank you for this valuable suggestion. As suggested, the authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.

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Competing Interests

No competing interests were disclosed.

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Reviewer Report

65 Views

13 Oct 2023 | for Version 2

Rohna Kearney, Manchester University NHS Foundation Trust, Manchester, UK

Rebecca Helliwell, Gynaecology, Manchester University NHS Trust, Manchester, Lancashire, UK

65 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?

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

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

Not applicable

Competing Interests

I am a co-chief investigator for a NIHR funded RCT on self-management of vaginal pessaries for prolapse compared with clinic based care

Reviewer Expertise

Urogynaecology, pelvic floor, self-management, pelvic floor imaging, obstetric childbirth injury

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Responses (1)

Author Response

15 Jan 2024

Louise Carroll, University College Dublin, Dublin, D04C7X2, Ireland

How will the researchers ensure the study produces an online resource that also meets the needs of older women, those less engaged with internet and online media and those with medical co-morbidities? If the focus is on information provision for premenopausal women, this should be explicitly stated.

The authors’ previous work has been specifically focused on younger premenopausal women with pelvic organ prolapse (POP). This research aims to build on these findings, in particular the recommendations of this cohort with respect to information needed.
The literature to date shows that POP symptom bother is not always explained by level of anatomic prolapse. In our previous work (Carroll et al 2023) and in other research, it has been suggested that the aetiology of POP in younger women differs from that in older women, in whom POP symptoms tend to more closely reflect anatomic POP (Alcalay 2015, Rinne 1999).
This younger cohort tend to report more symptom bother which in many cases levels off around menopause (Miedel et al 2008). Central sensitization and/or myofascial pain have been proposed as a possible explanation for this, with Vij et al finding a 30% rate of central sensitization in a sample of women with POP from a general GOPD (Vij et al 2019, Dixon et al 2019, Adams et al 2014).
The prevalence of POP in premenopausal women in Ireland and elsewhere is uncertain; however Durnea et al reported a 90% incidence of anatomic POP in primparous women 1 year after childbirth. 20% of these women were symptomatic.
Research to date has found that neuroscience education, cognition-targeted exercise therapy, sleep management, stress management, and/or dietary intervention to be important facets for the treatment of central sensitization (Nijs et al 2019). If central sensitization is an important factor, it would be interesting to see how a biopsychosocial approach to POP including the information proposed through this intervention would affect experience of this cohort of women with POP.
Therefore the authors intent is to focus on information provision for premenopausal women primarily. This has been clarified in the article.

_{Carroll L, Sullivan CO, Doody C, Perrotta C, Fullen BM. Pelvic organ prolapse: Women’s experiences of Accessing Care & Recommendations for improvement. BMC Women's Health. 2023 Dec;23(1):1-3.

Alcalay M, Stav K, Eisenberg VH. Family history associated with pelvic organ prolapse in young women. International urogynecology journal. 2015 Dec;26:1773-6.

Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse?. European Journal of Obstetrics & Gynecology and Reproductive Biology. 1999 May 1;84(1):23-5.

Miedel A, Tegerstedt G, Mörlin B, Hammarström M. A 5-year prospective follow-up study of vaginal surgery for pelvic organ prolapse. International Urogynecology Journal. 2008 Dec;19:1593-601.

Vij M, Davies A, Dua A, Freeman R. The proportion of women with central sensitivity syndrome in gynecology outpatient clinics (GOPDs). International Urogynecology Journal. 2019 Mar 4;30:483-8.

Dixon AM, Fitzgerald CM, Brincat C. Severity and bother of prolapse symptoms in women with pelvic floor myofascial pain. International Urogynecology Journal. 2019 Nov;30:1829-34.

Adams K, Osmundsen B, Gregory WT. Does fibromyalgia influence symptom bother from pelvic organ prolapse?. International urogynecology journal. 2014 May;25:677-82.

Durnea CM, Khashan AS, Kenny LC, Durnea UA, Smyth MM, O’Reilly BA. Prevalence, etiology and risk factors of pelvic organ prolapse in premenopausal primiparous women. International urogynecology journal. 2014 Nov;25:1463-70.

Nijs J, Leysen L, Vanlauwe J, Logghe T, Ickmans K, Polli A, Malfliet A, Coppieters I, Huysmans E. Treatment of central sensitization in patients with chronic pain: time for change?. Expert Opinion on Pharmacotherapy. 2019 Nov 2;20(16):1961-70.}

As 10 women will be recruited, how will the authors ensure appropriate representation of the population of women with prolapse?

The authors acknowledge that representation of the population of all women with POP will not be fully addressed as focus of the authors research is on the impact of POP on premenopausal women. The authors will use a sampling grid to ensure recruitment of pre-menopausal women with stages I-IV prolapse, of varying parity and those who do and do not desire more children. To increase impact and applicability, we would envisage after the website is complete that more research will be carried out to further develop the website with the requirements of a broader population of women e.g. older women, women from specific minority populations including a broader range of recruitment strategies taken into account.

Will the website be accessible to women who do not speak English?

The website will be developed in English but will be enabled to allow auto-translation to multiple languages.

Is 10 women sufficient for theme saturation?

The authors have created a sampling table to ensure women with a range of prolapse stages, ages, parity and desire for no or more pregnancies are represented in the sample. Further recruitment is ongoing to ensure saturation is reached across all categories.

It would be helpful to reference the HSE/NALA guidelines discussed for readers not familiar with these.

The authors have added this information to the reference section.

View more View less

Competing Interests

No competing interests were disclosed.

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Reviewer Report

54 Views

18 Aug 2023 | for Version 1

Louise Brennan, Discipline of Physiotherapy, School of Medicine, Trinity College Dublin, Dublin, Ireland

54 Views Cite this report Responses(1)

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?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Digital health, website co-design, physical rehabilitation

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 (1)

Author Response

17 Nov 2023

Louise Carroll, University College Dublin, Dublin, D04C7X2, Ireland

Dear Dr. Brennan,
Thank you very much for your time and expertise in reviewing our study protocol. We have addressed your feedback below and also in the updated version of the study article.
Kind regards,
Louise Carroll, Brona Fullen, Catherine Doody, Cliona O’ Sullivan & Carla Perrotta

Is the context for this website local, national or international? Providing some context for this will help provide background to the study for the reader, will guide website design and will help identify if participant representatives in focus groups appropriately represent target population. If the website is for a national / local audience, consider including appropriate references re health literacy (e.g. HSE/NALA).
The context for this website is national. As such, we will consult the NALA ‘Literacy audit for healthcare settings’ and HSE ‘Guidelines for Communicating Clearly using Plain English with our Patients and Service Users’ to inform the design.

Focus groups: Can you report why participants with advanced POP are not included in the focus groups?
We have amended the study inclusion/exclusion criteria to include women with Stage IV POP. As many women have corrective surgery as a matter of urgency with this level of advanced POP and as it is relatively rare, recruitment of women with Stage IV POP would be challenging; to date we do not have anyone with Stage IV POP enrolled in the study.

Family members and spouses will provide insightful input to this project - could they be included at some stage?
For the current project we have no plan to include family members and spouses; however we may explore this perspective in future work.

Will the website developer attend any part of these sessions?
Yes, the developer will attend both the patient and HCP workshops.

Heuristics will ideally be assessed by someone external to the development team - could a patient rep and HCP complete this assessment also?
We have amended the study methodology to reflect this recommendation.

Will you make further adjustments to the website based on the feedback from content-based testing?
Yes the website will be adjusted based to content-based testing feedback.

View more View less

Competing Interests

No competing interests were disclosed.

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

[1] 1. Haylen BT, Maher CF, Barber MD, et al.: An International Urogynecological Association (IUGA) / International Continence Society (ICS) joint report on the terminology for female Pelvic Organ Prolapse (POP). Neurourol Urodyn. 2016; 35(2): 137–68. PubMed Abstract | Publisher Full Text

[2] 2. Herbert AS, Nemirovsky A, Hess DS, et al.: An evaluation of the readability and content-quality of Pelvic Organ Prolapse YouTube transcripts. Urology. 2021; 154: 120–126. PubMed Abstract | Publisher Full Text

[3] 3. Wu JM, Hundley AF, Fulton RG, et al.: Forecasting the prevalence of Pelvic Floor Disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009; 114(6): 1278–1283. PubMed Abstract | Publisher Full Text

[4] 4. Carroll L, O’Sullivan C, Doody C, et al.: Pelvic Organ Prolapse: the lived experience. PLoS One. 2022; 17(11): e0276788. PubMed Abstract | Publisher Full Text | Free Full Text

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Co-Design of a website for women with pelvic organ prolapse: A study protocol

Abstract

Background

Methods

Conclusion

Keywords

Revised Amendments from Version 3

Background

Study aims

Study design framework

Figure 1. Website Development Model for the Healthcare Consumer.

Methods

Step 1: User, task & environmental analysis

Step 2: Functional & representational analysis & creation of the prototype

Figure 2. Planned activities and goals for patient and HCP workshops.

Step 3: Cognitive walkthrough & heuristic testing

Step 4: Content based testing

Study status

Conclusions

Data availability

Underlying data

Extended data

References

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Open Peer Review

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Reviewer Reports

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Co-Design of a website for women with pelvic organ prolapse: A study protocol

Abstract

Background

Methods

Conclusion

Keywords

Revised Amendments from Version 3

Background

Study aims

Study design framework

Figure 1. Website Development Model for the Healthcare Consumer.

Methods

Step 1: User, task & environmental analysis

Step 2: Functional & representational analysis & creation of the prototype

Figure 2. Planned activities and goals for patient and HCP workshops.

Step 3: Cognitive walkthrough & heuristic testing

Step 4: Content based testing

Study status

Conclusions

Data availability

Underlying data

Extended data

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Competing Interests Policy

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