Flourishing together: research protocol for developing methods to better include disabled people's knowledge in health policy development.

BACKGROUND: To positively impact the social determinants of health, disabled people need to contribute to policy planning and programme development. However, they report barriers to engaging meaningfully in consultation processes. Additionally, their recommendations may not be articulated in ways that policy planners can readily use. This gap contributes to health outcome inequities. Participatory co-production methods have the potential to improve policy responsiveness. This research will use innovative methods to generate tools for co-producing knowledge in health-related policy areas, empowering disabled people to articulate experience, expertise and insights promoting equitable health policy and programme development within Aotearoa New Zealand. To develop these methods, as an exemplar, we will partner with both tangata whaikaha Maori and disabled people to co-produce policy recommendations around housing and home (kainga)-developing a nuanced understanding of the contexts in which disabled people can access and maintain kainga meeting their needs and aspirations. METHODS: Participatory co-production methods with disabled people, embedded within a realist methodological approach, will develop theories on how best to co-produce and effectively articulate knowledge to address equitable health-related policy and programme development-considering what works for whom under what conditions. Theory-building workshops (Phase 1) and qualitative surveys (Phase 2) will explore contexts and resources (i.e., at individual, social and environmental levels) supporting them to access and maintain kainga that best meets their needs and aspirations. In Phase 3, a realist review with embedded co-production workshops will synthesise evidence and co-produce knowledge from published literature and non-published reports. Finally, in Phase 4, co-produced knowledge from all phases will be synthesised to develop two key research outputs: housing policy recommendations and innovative co-production methods and tools empowering disabled people to create, synthesise and articulate knowledge to planners of health-related policy. DISCUSSION: This research will develop participatory co-production methods and tools to support future creation, synthesis and articulation of the knowledge and experiences of disabled people, contributing to policies that positively impact their social determinants of health.

Social determinants and inequitable maternal and perinatal outcomes in Aotearoa New Zealand.

OBJECTIVES: Aotearoa New Zealand has demonstrable maternal and perinatal health inequity. We examined the relationships between adverse outcomes in a total population sample of births and a range of social determinant variables representing barriers to equity. METHODS: Using the Statistics New Zealand Integrated Data Infrastructure suite of linked administrative data sets, adverse maternal and perinatal outcomes (mortality and severe morbidity) were linked to socio-economic and health variables for 97% of births in New Zealand between 2003 and 2018 (~970,000 births). Variables included housing, economic, health, crime and family circumstances. Logistic regression examined the relationships between adverse outcomes and social determinants, adjusting for demographics (socio-economic deprivation, education, parity, age, rural/urban residence and ethnicity). RESULTS: Maori (adjusted odds ratio = 1.21, 95% confidence interval = 1.18-1.23) and Asian women (adjusted odds ratio 1.39, 95% confidence interval = 1.36-1.43) had poorer maternal or perinatal outcomes compared to New Zealand European/European women. High use of emergency department (adjusted odds ratio = 2.68, 95% confidence interval = 2.53-2.84), disability (adjusted odds ratio = 1.98, 95% confidence interval = 1.83-2.14) and lack of engagement with maternity care (adjusted odds ratio = 1.89, 95% confidence interval = 1.84-1.95) had the strongest relationship with poor outcomes. CONCLUSION: Maternal health inequity was strongly associated with a range of socio-economic and health determinants. While some of these factors can be targeted for interventions, the study highlights larger structural and systemic issues that affect maternal and perinatal health.

Do maternity services in New Zealand's public healthcare system deliver on equity? Findings from structural equation modelling of national maternal satisfaction survey data.

BACKGROUND: Birthing outcomes in New Zealand are demonstrably inequitable based on governmental reports and research. However, the last Ministry of Health maternal satisfaction survey in 2014 indicated that 77% of women were satisfied or very satisfied with care. This study used data from the maternal satisfaction survey to examine aspects of inequity in reported satisfaction with care. METHODS: Structural Equation Modelling (SEM) was used to infer latent variables of satisfaction with equity domains from responses to the satisfaction survey. Additional data (residential location and deprivation score), not used in the Ministry of Health primary analysis, were provided and included in this modelling. RESULTS: SEM showed that satisfaction was not equitably distributed. Younger women, those from areas of high socio-economic deprivation, and remote rural women were most likely to be affected by dissatisfaction associated with physical access, cultural care, information provided, and/or barriers to equity associated with additional costs (all p<0.05). Financial burden of additional costs was also unevenly distributed. CONCLUSION: While these findings are congruent with other research on the association between social determinants and maternal satisfaction, it is concerning that they remain sources of inequity in New Zealand twenty years after they were first identified as priorities to address. On the basis of this study, urgent attention needs to be paid to removing sources of inequity within the health system and maternity care in particular.

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Barriers to equitable maternal health in Aotearoa New Zealand: an integrative review.

BACKGROUND: The purpose of this review was to examine the literature for themes of underlying social contributors to inequity in maternal health outcomes and experiences in the high resource setting of Aotearoa New Zealand. These 'causes of the causes' were explored and compared with the international context to identify similarities and New Zealand-specific differences. METHOD: A structured integrative review methodology was employed to enable a complex cross disciplinary analysis of data from a variety of published sources. This method enabled incorporation of diverse research methodologies and theoretical approaches found in the literature to form a unified overall of the topic. RESULTS: Six integrated factors - Physical Access, Political Context, Maternity Care System, Acceptability, Colonialism, and Cultural factors - were identified as barriers to equitable maternal health in Aotearoa New Zealand. The structure of the maternal health system in New Zealand, which includes free maternity care and a woman centred continuity of care structure, should help to ameliorate inequity in maternal health and yet does not appear to. A complex set of underlying structural and systemic factors, such as institutionalised racism, serve to act as barriers to equitable maternity outcomes and experiences. Initiatives that appear to be working are adapted to the local context and involve self-determination in research, clinical outreach and community programmes. CONCLUSIONS: The combination of six social determinants identified in this review that contribute to maternal health inequity is specific to New Zealand, although individually these factors can be identified elsewhere; this creates a unique set of challenges in addressing inequity. Due to the specific social determinants in Aotearoa New Zealand, localised solutions have potential to further maternal health equity.

Effectiveness and cost-effectiveness randomised controlled trial of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL (optimising pelvic floor exercises to achieve long-term benefits) trial mixed methods longitudinal qualitative case study and process evaluation.

INTRODUCTION: Female urinary incontinence (UI) is common affecting up to 45% of women. Pelvic floor muscle training (PFMT) is the first-line treatment but there is uncertainty whether intensive PFMT is better than basic PFMT for long-term symptomatic improvement. It is also unclear which factors influence women's ability to perform PFMT long term and whether this has impacts on long-term outcomes. OPAL (optimising PFMT to achieve long-term benefits) trial examines the effectiveness and cost-effectiveness of basic PFMT versus biofeedback-mediated PFMT and this evaluation explores women's experiences of treatment and the factors which influence effectiveness. This will provide data aiding interpretation of the trial findings; make recommendations for optimising the treatment protocol; support implementation in practice; and address gaps in the literature around long-term adherence to PFMT for women with stress or mixed UI. METHODS AND ANALYSIS: This evaluation comprises a longitudinal qualitative case study and process evaluation (PE). The case study aims to explore women's experiences of treatment and adherence and the PE will explore factors influencing intervention effectiveness. The case study has a two-tailed design and will recruit 40 women, 20 from each trial group; they will be interviewed four times over 2 years. Process data will be collected from women through questionnaires at four time-points, from health professionals through checklists and interviews and by sampling 100 audio recordings of appointments. Qualitative analysis will use case study methodology (qualitative study) and the framework technique (PE) and will interrogate for similarities and differences between the trial groups regarding barriers and facilitators to adherence. Process data analyses will examine fidelity, engagement and mediating factors using descriptive and interpretative statistics. ETHICS AND DISSEMINATION: Approval from West of Scotland Research Ethics Committee 4 (16/LO/0990). Findings will be published in journals, disseminated at conferences and through the final report. TRIAL REGISTRATION NUMBER: ISRCTN57746448.

Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial.

INTRODUCTION: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. METHODS AND ANALYSIS: This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. ETHICS AND DISSEMINATION: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review. TRIAL REGISTRATION NUMBER: ISRCTN57746448; Pre-results.