There is a need for a concise questionnaire to allow ante- and postnatal women to signal bothersome symptoms of bladder or bowel dysfunction including incontinence, vaginal prolapse or sexual dysfunction. The development of the new Perinatal Pelvic Health Self-Assessment Questionnaire (PPHSAQ) will enable women to report their symptoms before and after the birth of their baby, to allow early identification of pelvic floor dysfunction (PFD) symptoms and ensure rapid referral for treatment. This study describes the stages undertaken in developing a draft version of PPHSAQ, prior to its psychometric testing. It is anticipated that this questionnaire will be situated with the existing International Consultation in Incontinence Questionnaire (ICIQ) modular group of questionnaires (www.iciq.net).

The study adopted a qualitative design over four developmental stages:

1) Literature Review
A scoping review mapped existing literature about perinatal women’s experiences of PFD symptoms and existing self-assessment questionnaires. Literature published in English from 2011 was collected from CINAHL, Web of Science, Ovid Medline, PubMed and grey literature. Findings were summarised and presented narratively.

2) Qualitative Interviews
Qualitative interviews sought to identify and understand participant-centred concepts of greatest importance to perinatal women with regard to pelvic health issues, impact, and expectations of care. Purposive sampling was undertaken to identify women with a range of PFD symptoms on the perinatal pathway across NHS Trusts in England. Semi-structured interviews were undertaken using MS Teams or by telephone, and thematically analysed using NVivo 12 QSR. 

3) Professional stakeholder panel
A panel of multidisciplinary professional stakeholders (including nurses/midwives, senior clinicians, allied health professionals) was convened to prioritise concepts drawn from literature and qualitative interviews for inclusion in the PPHSAQ. An online three-round modified Delphi survey technique was used to reach consensus on the concepts that clinicians deemed essential for comprehensive assessment of perinatal PFD. The survey was hosted on Qualtrics. Consensus definitions were as follows: Concepts scored ‘critically important’ (7-9) by ≥70% of participants, and ‘limited importance’ (1-3) by ≤15% of participants were defined as ‘consensus in’. Concepts scored 1-3 by ≥70% and 7-9 by ≤15% of participants were defined as ‘consensus out’. Concepts not fulfilling criteria for consensus in or out were defined as ‘no consensus’. 

4) Cognitive debriefing interviews
Cognitive debriefing interviews were undertaken to evaluate aspects of the questionnaire such as comprehension of questions and response options within the target population. Purposeful sampling was used to identify ante- and postnatal women in England, and interviews were undertaken using MS Teams.  Data were summarised and systematically compared across questionnaire items to identify differences between the intended interpretation and that of respondents. Iterative revisions were made to the questionnaire over three consecutive rounds until no further changes were necessary.

1) Literature Review
From an original 3,283 records screened by title, 3,011 records were excluded, leaving 272 records to be assessed for eligibility. Of these, seven studies from Brazil, China, Sweden, Turkey, Germany, and Italy met eligibility criteria. One study aimed to develop and validate a questionnaire for the assessment of pelvic floor disorders, their symptoms and risk factors in pregnancy and after birth; five others were a translation, validation and/or cultural adaptation of this; one study aimed to test a translated assessment questionnaire. No self-assessment questionnaires in English that were validated for the comprehensive assessment of PFD throughout the antenatal and postnatal periods were identified.

2) Qualitative interviews
Perinatal women who were experiencing bothersome PFD symptoms (N=27) participated. The most bothersome PFD symptom was Urinary Incontinence (n=10, 37%), closely followed by Pelvic Organ Prolapse (n=9, 33%).  Fifteen participants had more than one symptom, with many describing a negative impact on their physical and mental wellbeing. Nine participants reported no recent treatment, while specialist women’s health physiotherapy was the most common treatment. Data were analysed thematically, with four overarching themes identified: 1) Strategies to adapt to the physical impact, and cope with the emotional impact of PFD; 2) Factors that underpinned women’s help-seeking behaviour for PFD symptoms; 3) Unmet expectations of perinatal care for PFD symptoms; and 4) Importance of timely referral and personalised care.

3) Professional Stakeholder Panel
Of 56 professionals invited to participate, a total of 38, 24 and 19 individuals participated in rounds 1 (R1), 2 (R2), and 3 (R3) respectively. Representation of physiotherapists, midwives, urogynaecologists, and urologists was achieved in each round. All concepts were carried forward from R1 to R2. In R2, from a total of 81 concepts, 36 reached consensus and 45 concepts were deemed ‘no consensus’. A third round was undertaken (R3) where a further 16 concepts reached consensus. A total of 52 concepts were therefore accepted for inclusion in PPHSAQ. These included 35 symptom concepts, and 17 risk factor concepts. 

4) Cognitive debriefing interviews
Three rounds of cognitive debriefing interviews were undertaken (N=13). Interviews lasted between 23-79 minutes, and identified issues related to interpretation of questions and response options; item order; and question instructions. Iterative testing resulted in modifications to terminology within nine questions to improve respondent understanding; an additional response option was added to two questions; and one item was repositioned. Tables 1 and 2 outline concepts within the developmental questionnaire. Table 1 contains Risk Factors for PFD; Table 2 contains PFD symptoms.

The results summarise the developmental stages of the PPHSAQ – a questionnaire to enable women to monitor themselves at specific time points during the maternity pathway, to allow early identification of PFD symptoms and ensure rapid referral for treatment. Although many questionnaires have been developed to assess PFD, no self-assessment questionnaire in English exists that is validated for the comprehensive assessment of PFD throughout the antenatal and postnatal periods. No single questionnaire comes highly recommended by the ICI for the complete assessment of these issues in an integrated way. Results of the qualitative interviews demonstrate that PFD symptoms have negative physical and psychological consequences for women, and often women’s experiences of timely referral for clinical care are suboptimal. These results underpin the need for a robust questionnaire to assess the range and severity of perinatal PFD in an integrated way, along with a measure of perceived impact on QoL. The Delphi process elicited multidisciplinary expert opinion on the concepts that clinicians deem essential for comprehensive assessment. These data along with items from existing high-quality PROMs informed the content of the PPHSAQ. The resultant developmental PPHSAQ was confirmed to be interpreted and understood as intended by the target population.

Despite the reported increase of PFD, clinical practice lacks an assessment questionnaire to monitor and assess the severity of symptoms and risk factors in an integrated way for the perinatal population of women. This study provides a robust evidence base for the development of a patient centred assessment questionnaire (PPHSAQ). The developmental stages were crucial in providing insight to the lived experience of PFD, and also to improve understanding of key concepts to be included in the contents of the questionnaire. Quantitative testing of the psychometric capabilities of the PPHSAQ will also enable item reduction where required, and a suitable scoring system to be derived. The introduction of a new pelvic health assessment questionnaire will raise awareness of symptoms and improve rates of early referral for treatment. Empowering more women to address and report pregnancy and childbirth related PFD symptoms expeditiously will support improved perinatal outcomes.