Obstetrics & Gynaecology - Doctoral Theses
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Item Developing a patient-reported outcome measure (PROM) for postpartum care in Ireland(University College Cork, 2024) O'Byrne, Laura; Maher, Gillian; Khashan, Ali; Greene, Richard; Browne, John P.; McCarthy, Fergus; Health Research Board; National Perinatal Epidemiology CentreBackground and Aims: Patient-reported outcome measures (PROMs) are validated tools completed by patients to assess the impact of an intervention or therapy on them. In recent years, PROMs have gained attention for their patient-centred focus. However, there is no gold standard for assessing maternity care quality through PROM. The aim of this thesis was to examine the construction, feasibility, and validity of a comprehensive postnatal PROM, created as a combination of existing validated PROMs. This was achieved by systematically reviewing existing literature and conducting a range of analyses using recruited patient data from a postnatal population. Methods: This thesis includes an introductory chapter and a comprehensive methods section detailing the study designs, methodological choices, and statistical analyses. Chapters Three and Four present the systematic review and meta-analysis of existing postnatal PROMs. Chapter Five explores the feasibility of using a combination PROM based on the recommended findings from the systematic review. Chapters Six and Seven assess the content validity and construct validity of this approach. Chapter Eight discusses the overall findings, evaluates the strengths and limitations of the thesis, and offers recommendations for future studies. Results: The systematic review identified 10,324 records and 41 eligible studies evaluating 29 individual tools. Their psychometric properties were assessed according to the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN). Twenty-one postnatal PROMs were recommended with 17 covering mental health, 4 addressing health-related quality of life, 4 focusing on breastfeeding and 3 on role transition. Gaps were found in postpartum urinary incontinence and pain with sexual intercourse coverage. The feasibility study assessed combining the identified psychometric tools with two bespoke sexual health inquiries to create a comprehensive postpartum PROM. Using the International Consortium for Health Outcomes Measurement (ICHOM) domains as a framework, the study tested the Postpartum Quality of Life (PQoL) and International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF) questionnaires with additional sexual health questions on 86 women within the first week postpartum (T1), at 6 weeks after delivery (T2) and at 12 weeks post-partum (T3). High participation and favourable response rates were achieved: 69% (n=59) at T1, 67% (n=57) at T2, and 48% (n=41) at T3. There was high concordance between self-reported and clinician-reported delivery complications, providing a foundation for further validity studies. The content validity section examined the ability of the combination PROM in addressing ICHOM’s framework for postpartum care. 534 women agreed to participate, with observed response rates of 63% (n=334) at T1, 53% (n=283) at T2, and 45% (n=240) at T3. This analysis highlighted gaps in the coverage of mental health, early postpartum trauma related to childbirth, feeding challenges beyond breastfeeding, and evolving comprehensive physical health concerns throughout the postpartum period. The construct validity assessed how well the comprehensive PROM aligned with theoretical hypotheses regarding postpartum health. There were longitudinal changes in scores over time, with significant changes observed in PQoL and ICIQ-UI SF scores but not in pelvic pain scores. PQoL T1: 128 [±9.67], T2: 125 [±8.47], and T3: 126 [±8.51] p= 0.002. The ICIQ-UI SF had a median score and interquartile ranges of T1: 7.7 (IQR=6), T2: 9 (IQR=7), and T3: 9 (IQR=7), p = <0.001. No significant differences in scores were found between women with and without maternal morbidity, or across different morbidity types, neonatal unit admissions, or delivery types. Conclusion: This thesis evaluated the use of a comprehensive postpartum PROM, created as a combination of the best available instruments. The data suggests that current tools, including our comprehensive PROM, despite good psychometric properties, do not adequately cover postpartum health and wellbeing or discern between clinically distinct groups and outcomes.Item Implementation of a national electronic health record in the specialised setting of neonatal intensive care units(University College Cork, 2024) Sheehan, Orla Maria; Greene, Richard A.; Murphy, Brendan; Corcoran, Paul; National Perinatal Epidemiology CentreElectronic Health Records (EHRs) are being introduced worldwide and are necessary to update modern healthcare. The introduction of EHRs however is complex and is dependent on a myriad of factors. One key factor in successful EHR implementations is workflows and workflow compliance. Through acceptable workflow designs, clinicians can document appropriate clinical information at source which can be used for clinical decision making and contribute to patient care improvements. In the Republic of Ireland, a national EHR is being introduced for women and their babies- the Maternal and Newborn - Clinical Management System (MN-CMS) EHR provides the research environment for this thesis. This thesis aims to (1) To assess the role workflows play in the successful implementation of an EHR (2) Explore the potential aspects of Implementation Science - using the Normalisation Process Theory (NPT) for evaluation of a successful implementation of an EHR and (3) Can EHR user interfaces be improved with clinician engagement to better facilitate input and management of healthcare data? Primarily quantitative methods, with some qualitative methods, were used for the research contained in this thesis. From exploration of implementation science literature, the Normalisation Process Theory was identified as being useful in complex and technological changes and the various implementation strategies and outcomes are explored. A retrospective document review was undertaken of the MN-CMS Phase One Closure Report to identify the key lessons learned. A retrospective document review was also undertaken to analyse the MN-CMS workflows. The process of workflow design was outlined and evaluated using the AACTT Framework (Actor, Action, Context, Time, Target). Healthcare clinicians (nurses n=76; doctors n=29) workflow compliance was quantifiably measured using background system audit logs and system reports to gain a comprehensive analysis of the workflow compliance. Data were analysed using means and standard deviations. Pre – Post mean differences, and their 95% confidence intervals were calculated and their statistical significant was assessed based on p-values derived from paired t-tests (nurses) and independent t-tests (doctors). The final study of this thesis was improving data quality of newborn feeding in the EHR. Firstly, an expert multidisciplinary group (n=38) were used to design the changes to feeding data entry and review components. Then a quantitative pre-post design was used to assess feeding documentation from newborns electronic records (n= 322). Descriptive statistics and Pearson’s Chi-Square were used to assess pre-post differences and statistical significance. A focus group (n=5) was conducted post implementation and data were analysed using reflexive thematic analysis. This thesis has focused on the Normalisation Process Theory as providing a useful framework for complex changes such as EHR implementation. The use of the AACTT framework is specifically useful in guiding workflow developments. This research has identified key lessons learned and recommendations for a large scale EHR implementation in terms of the planning, implementation and optimisation phases. The key role workflows play in EHR implementation was identified through a retrospective assessment of patient focused workflows from the MN-CMS with modifications and a new workflow successfully implemented using the AACTT framework. Quantifiably measuring workflow compliance identified that the introduction of a new patient summary page demonstrated some very positive changes and adoption of the EHR. Finally, following a collaborative approach to redesigning newborn feeding within an EHR, data completeness significantly improved. This thesis has explored the benefits of the Normalisation Process Theory and the AACTT Framework in implementing EHRs and the key role of workflow development and evaluation. Appropriately designed workflows can underpin the EHR and encourage appropriate and accurate data entry. This thesis has also identified that the EHR system design can be improved with clinician user engagement to improve data input in the EHR.Item Digitalisation in healthcare: the future of surgical training(University College Cork, 2023) Galvin, Daniel; O'Reilly, Barry A.Introduction The impact of digital technology and artificial intelligence (AI) has a daily impact on our lives. Healthcare as an industry is at the forefront of technological innovation. The application of novel technology to aid performance and enhance training in surgery is key. Challenges in surgical training owing to an increase in trainee numbers, a reduction in working hours, increase in complexity and variety of surgeries performed have become major issues in surgical education. The COVID-19 pandemic further compounded these concerns between 2020 and 2022 where there was significant disruption and reduction in elective surgical activity. Methods Five studies examining the challenges in surgical training in gynaecology and their potential solutions were designed. These comprised of a national cross-sectional trainee and trainer survey on the current challenges of surgical training in gynaecology and in training during the COVID-19 pandemic. Potential solutions examined were a trial of the application of artificial intelligence to the grading of surgical performance and two randomised controlled trails of the application of transcranial direct current stimulation (tDCS) to enhance surgical performance in laparoscopic and robotic surgery. Results Our results showed significant challenges in surgical training over the last decade with a significant reduction in trainee confidence and experience in operative gynaecology. The COVID-19 pandemic had a significant impact on operative volumes of both trainees and trainers. Trainees failed to increase their self-reported confidence in performing common gynaecology procedures over the pandemic period. AI grading of operative performance was shown to be a potential means of enhancing trainee feedback and reducing workload for trainers. tDCS was shown to decrease rates of excessive velocity events during novice laparoscopic training setting it out as a potential solution to maximise training opportunities. tDCS was not shown to enhance robotic surgical performance. Conclusion While the current training environment is challenging in operative gynaecology, potential solutions to augment and accelerate training exist. Further study is required to assess the best means of implementing these solutions to ensure continued access to high quality surgical training.Item Infertility and recurrent miscarriage: an examination of pregnancy outcomes, services and patient experience(University College Cork, 2024) Linehan, Laura Aoife; O'Donoghue, Keelin; Hennessy, MaritaBackground Miscarriage and infertility are distinct reproductive health conditions which profoundly impact the lives of women and men affected. Although miscarriage is the most common complication of pregnancy affecting an estimated 23 million women globally a year, it remains poorly understood (1). There is a limited evidence base for investigation and treatments for miscarriage or recurrent miscarriage (RM), and approximately half of women/couples will have unexplained RM (2). Similarly, up to one in six couples are affected by infertility, this is an estimated 48.5 million people, with 30% having unexplained infertility (2,3). Miscarriage and infertility share a number of risk factors and are reciprocally associated, in addition to being associated with adverse pregnancy outcomes. The impacts of RM and infertility are also in parallel, with both experiences bearing psychological sequelae, economic burdens and isolation as a consequence of stigmatisation. Despite these commonalities, the dual experience of RM and infertility is not widely described in the literature or clinical practice guidelines and the optimal management of women/couples is unclear. RM and infertility are separately receiving greater attention from policy makers, nationally and internationally, therefore greater evidence is needed to inform policy and practice. Thus, the overall objective of this thesis is to examine the dual experience of RM and infertility and to add to the knowledge base on the current care issues, reproductive outcomes and lived experiences to inform improvements in care. Methods To meet this objective, a number of quantitative and qualitative studies were conducted. A narrative review of the literature was undertaken to determine what is known of the dual experience of RM and infertility and to identify the knowledge gaps (Chapter 2). A National Clinical Guideline was developed to provide evidence-based guidance for the management of RM in the Republic of Ireland (Chapter 3). A retrospective cohort study of women with three consecutive first-trimester miscarriages was undertaken to examine reproductive outcomes after RM, including women with a history of RM and infertility (Chapter 4). For this study descriptive and inferential statistics were utilised. A national service evaluation was conducted using key performance indicators (KPIs) for RM to establish how care for women/couples with RM and infertility compares to international recommendations (Chapter 5). These KPIs were also employed in an audit of RM and infertility care in a tertiary referral maternity hospital to examine how care compared to international recommendations (chapter 6). A qualitative semi-structured interview study of women with lived experience of RM and infertility and healthcare professionals working in these areas was also undertaken, utilising reflexive thematic analysis (Chapter 8). Results The narrative review (Chapter 2) demonstrated that women with RM and infertility are not well studied in the wider literature and feature predominantly within sub-groups of investigations or treatments, and their experiences are underexplored within qualitative studies. These findings are reflected in the exclusion of women with RM and infertility in international Clinical Practice Guidelines, thus it is unclear how best to manage and support this complex cohort. The National Clinical Practice Guideline for the management of RM (Chapter 3) sets out evidence-based recommendations for the structure of care, supportive care, investigation and treatment of RM, including subsequent pregnancy management. The retrospective cohort study of 748 women with RM (Chapter 4) found a subsequent pregnancy rate of 77%, with a cumulative live-birth rate of 63%. The multinomial regression analysis demonstrated that maternal age, smoking and parental karyotype were associated with reproductive outcomes. Additionally, there was a lower live-birth rate in women age over 40 years (44%) or with a history of infertility (54%). The national service evaluation (Chapter 5) found that while care is largely in line with international clinical practice guidelines, there is variation in counselling, imaging and surgical treatments offered. Areas for education identified included fertility counselling and resources for information provision and supportive care. Importantly, clinical outcomes were seldom audited. The audit of care for 128 women with RM and infertility (Chapter 6) found that alongside good clinical practice there are several areas for improvement: Counselling regarding risk factors and treatments, availability of genetic counselling, access to ultrasound and cytogenetic investigation should be improved. The subsequent pregnancy rate was 70% with a live-birth rate of 63% and a preterm birth rate of 11%, with 36% of women conceiving with assisted reproductive technologies. For the qualitative study (Chapter 7), 33 individuals were interviewed: 17 women with lived experience of RM and infertility and 16 healthcare professionals. Four themes were actively generated: “exploring all avenues”, “exhausting all resources”, “separateness” and “no woman is an island”, which captured this complex experience. The themes encompassed the challenges in seeking care and the many personal burdens of RM and infertility, which were compounded by stigmatisation, a lack of knowledge and awareness, the divisions within the healthcare system and the limited availability of supports. Conclusions This doctoral work has examined the dual experience of RM and infertility in the ROI and has provided meaningful insights into the difficulties within current service provision and the management of RM and infertility. This work has also provided guidance for evidence-based management for the care of women/couples with RM. It has made an important contribution to the literature in describing the reproductive outcomes for women following RM and RM and infertility. This thesis has also distinctly depicted the lived experiences of women with RM and infertility and also of relevant healthcare professionals. Through analysis of these findings, this thesis identified three overarching themes: 1) the dual experience of RM and infertility needs greater recognition; 2) there is a need for equity and balance in the care provided to women with RM and infertility; 3) information is central to improving care. Several recommendations for practice and policy are made. There is a need for greater education and training for healthcare professionals regarding reproductive health, which must be supplemented by increased availability of high-quality and accessible information resources for women and their families. Improvements in knowledge and awareness of RM and infertility must be accompanied by improved data collection to inform and develop services, identify inequities in care and better direct resources to improve access to RM and fertility care. There must be increased investment in supportive care for women/couples experiencing RM and infertility, with better acknowledgement of the life impacts of this experience on both partners. Recommendations from the Clinical Practice Guidelines for RM and for fertility must be appropriately resourced and implemented to facilitate standardisation of care, alongside implementation of the Assisted Human Reproduction legislation to ensure better regulation within fertility services. Future research must prioritise the inclusion of women with a dual experience of RM and infertility in investigations, treatments, and outcome studies, thereby enriching the evidence base for management. Moreover, there is a need to explore factors contributing to delayed childbearing in Irish society and develop strategies to enhance and disseminate reproductive health knowledge effectively. Facilitators and barriers to accessing fertility and RM care across all levels of society must be examined to address the current inequities in care. Further patient and public involvement in research are also necessary to identify the optimal supportive care and resources for women/couples with RM and infertility. Addressing these issues can promote a more compassionate, informed, and equitable approach to reproductive healthcare for individuals dealing with RM and infertility in the Republic of Ireland.Item Axis of placental ageing in adverse pregnancy outcomes(University College Cork, 2023) Manna, Samprikta; McCarthy, Fergus; McCarthy, Cathal; European Chiropractors' UnionBackground: Pre-eclampsia (PE), an adverse pregnancy outcome affects 2-5% pregnancies worldwide and significantly adversely impacts both maternal and fetal outcomes. Intrauterine growth restriction (IUGR) is defined as the inability of the fetus to reach normal growth potential within the uterus as a result of various genetic, environmental, or placental factors. Premature ageing of the placenta in pregnancy outcomes such as PE and IUGR is associated with the persistent presence of oxidative stress and placental insufficiency reducing its functional capacity. Placental proteomics has been instrumental in improving our understanding of molecular mechanisms involved in the pathophysiology of placental insufficiency as well as identifying biomarkers to predict and diagnose pregnancy outcomes. In this study, we investigated cellular senescence phenotypes of PE and IUGR pregnancies by simultaneously measuring several biomarkers of senescence, as well as the proteomic signature of the placenta in healthy and adverse pregnancy outcomes PE and IUGR. Method: Maternal plasma and placental samples were collected at term (>37 weeks) and preterm (<37 weeks) gestation from nulliparous women undergoing prelabour elective Caesarean section with PE without intrauterine growth restriction (PE; n=5), PE associated with intrauterine growth restriction (n=8), intrauterine growth restriction (IUGR <10th centile) (n=6) and age-matched controls (n=20) from Cork University Maternity Hospital, Cork, Ireland. To assess cellular senescence absolute telomere length (aTL) and senescence associated genes in the placentas was performed by RTqPCR. Cyclin-dependent kinase inhibitors (p21 and p16) expression were determined by Western blotting. Senescence Associated Secretory Phenotype (SASP) were evaluated in maternal plasma by multiplex ELISA assay. Proteomic analysis of placental samples dissected into 3 sub-anatomical regions (maternal, middle, fetal) taken from 3 nulliparous healthy placentas was performed by mass-spectrometry and pathway analysis was conducted. Based on the differentially expressed proteins (DEPs), a placenta specific disease map using NaviCenta focusing on functional analysis to include the placenta specific context for healthy (n=4) compared to PE affected (n=4) and IUGR affected (n=4) placentas. Results: Placental expression of senescence associated genes CHEK1, PCNA, PTEN, CDKN2A, CCNB-1 was significantly upregulated in PE, while TBX-2, PCNA, ATM and CCNB-1 expression were significantly decreased in IUGR compared to controls. Moreover, placental p16 protein expression was significantly decreased in PE only when compared to controls placentas. We also observed that IL-6 was significantly increased in maternal circulation in PE when compared to controls; while IFN-γ was significantly increased in maternal circulation in women affected with IUGR when compared to controls. Proteomic profiling of healthy placentas divided into three sub-anatomical regions identified 1081, 1086, and 1101 proteins in maternal, middle, and fetal sub-anatomical regions respectively. Depending on sample site location and sub-anatomical regions, 374 differentially expressed proteins (DEP) were identified. When we investigated the proteomic variations between PE and IUGR placentas when compared to controls we observed 314, 391, and 378 proteins in healthy control, PE, and IUGR placenta, respectively. We performed functional analysis by combining ClusterCompare and NaviCenta to analyse a placenta-centric context, and observed regulatory elements predominantly involved in the immune regulation, complement cascade and antioxidant activities in PE and IUGR compared to control placentas. Conclusion: This thesis provides evidence of premature senescence in IUGR, while in PE, evidence of activated cell cycle checkpoint regulators is suggestive of cellular repair and proliferation rather than progression to cellular senescence. The heterogeneity within senescence molecular markers of these phenotypes highlights the complexity and disparity between pathophysiological insults unique to each obstetric complication. Proteomic profiling of sub-anatomical placental regions highlighted the variabilities between regions particularly providing evidence of senescence in these regions. Placental proteomic mapping of healthy placentas compared to adverse pregnancy outcomes PE and IUGR revealed the importance of complement system, inflammatory response, and antioxidant activity in placental function in PE placentas. The identification of novel targets such as transcription factor activity and synergistic miRNAs elements within the core regulatory network, might enlighten future placental research within adverse pregnancy outcomes.