Pelvic floor muscle training for female urinary incontinence: development of a programme theory from a longitudinal qualitative case study.

BACKGROUND: Urinary incontinence (UI) negatively affects the well-being of women globally. Pelvic Floor Muscle Training (PFMT) is a complex intervention that aims to decrease UI symptoms. Information about how the multiple complex components involved in PFMT achieve and maintain the desired effect are rarely studied as a whole. The evidence base lacks data about how women experience PFMT over time and in the longer-term. This study explored women's experiences of biofeedback-assisted PFMT and PFMT alone, to identify and understand what influenced self-reported adherence to PFMT, and UI outcomes over time. METHODS: This rigorous longitudinal qualitative case study, nested within a randomised controlled trial, recruited forty cases (women with stress or mixed UI; 20 in biofeedback-assisted and 20 in PFMT alone group). A case included up to four semi-structured interviews with each woman (prior to starting PFMT, end of treatment [6 months], 12 months, 24 months). Analysis followed case study analytic traditions, resulting in a Programme Theory about PFMT from the perspectives of women with UI. FINDINGS: The theory demonstrates factors that motivated women to seek UI treatment, and how these influenced long-term adherence. Therapists who delivered PFMT played a crucial role in supporting women to know how to undertake PFMT (to have capability). Some, but not all, women developed self-efficacy for PFMT. Where women did not have PFMT self-efficacy, adherence tended to be poor. When women had PFMT self-efficacy, the conditions to support adherence were present, but contextual factors could still intercede to inhibit adherence. The intercession of contextual factors was individual to a woman and her life, meaning any particular contextual factor had inconsistent influences on PFMT adherence over time for individual women and exerted varying influences across different women. CONCLUSION: Long term adherence to PFMT is a complex interaction between many different factors. Enquiring about an individual woman's motivation to seek treatment and understanding the contextual factors that affect an individual woman will enable a practitioner to support longer-term adherence.

Exploring In-Session Engagement in Equine-Assisted Services for Children and Youth Experiencing Disability: A Scoping Review.

Aims: The purpose of this review was to identify and describe the evidence about children and youth engagement during equine-assisted services (EAS). Methods: Five databases (Scopus, Web of Science, PsycINFO, CINAHL, and MEDLINE) were systematically searched. Included studies reported research about EAS conducted in children and youth and presented findings about in-session engagement or associated concepts such as motivation, involvement, and participation. Extracted data (study type, equine intervention, population, and the studies' key focus) were summarized descriptively, followed by inductive content analysis of the main mechanisms proposed to influence engagement. Results: In total, 30 studies were identified; however, only three centered on rider engagement as the primary focus of research. Other publications addressed in-session engagement within service descriptions or results and discussion sections. Three mechanisms that influence engagement within EAS were derived: (1) the unique EAS landscape, (2) the horse-child relationship and (3) the provider-child relationship. The literature primarily referred to horses as the most important factor influencing child and youth engagement in EAS sessions. Little attention was given to the influence of service providers', parents', or child preferences on engagement. Conclusions: The child/youth-parent-provider relational triad and specific strategies to improve rider engagement within EAS sessions warrants further investigation.

Prevalence of urinary incontinence in New Zealand women from the cross-sectional Sexual and Reproductive Health module of the New Zealand Health Survey 2014/2015.

AIMS: To describe urinary incontinence prevalence for New Zealand women. METHODS: The New Zealand Health Survey Adult Sexual and Reproductive Health module 2014/2015 was used to estimate urinary incontinence prevalence. Associations between urinary incontinence and age, body mass index (BMI), parity and ethnicity were estimated by logistic regression adjusted for sampling weights. RESULTS: There were 2,472/5,685 (43.5%) of women aged between and 16 and 74 who responded to the urinary incontinence question and reported at least some incontinence. The sample survey weight-adjusted prevalence (95% confidence interval) was 41.7% (40.0-43.4). An increased prevalence of incontinence was seen with older age, increased BMI and greater parity. The association between BMI and parity was complex, with the lower prevalence with lower BMI attenuated with increasing parity. After adjustment for these variables there was no association with incontinence prevalence for Maori versus non-Maori or European versus non-European. CONCLUSIONS: Urinary incontinence is highly prevalent in New Zealand women. There was no association with ethnicity after adjusting for older age, increased BMI and parity. The prevalence identified in the New Zealand Health Survey is higher than that reported in older surveys based on the electoral roll.

Experience of Playing Sport or Exercising for Women with Pelvic Floor Symptoms: A Qualitative Study.

BACKGROUND: Women participate in sport at lower rates than men, and face unique challenges to participation. One in three women across all sports experience pelvic floor (PF) symptoms such as urinary incontinence during training/competition. There is a dearth of qualitative literature on women's experiences of playing sport/exercising with PF symptoms. The purpose of this study was to explore the lived experience of symptomatic women within sports/exercise settings and the impact of PF symptoms on sports/exercise participation using in-depth semi-structured interviews. RESULTS: Twenty-three women (age 26-61 years) who had experienced a breadth of PF symptom type, severity and bother during sport/exercise participated in one-one interviews. Women played a variety of sports and levels of participation. Qualitative content analysis was applied leading to identification of four main themes: (1) I can't exercise the way I would like to (2) it affects my emotional and social well-being, (3) where I exercise affects my experience and (4) there is so much planning to be able to exercise. Women reported extensive impact on their ability to participate in their preferred type, intensity and frequency of exercise. Women experienced judgement from others, anger, fear of symptoms becoming known and isolation from teams/group exercise settings as a consequence of symptoms. Meticulous and restrictive coping strategies were needed to limit symptom provocation during exercise, including limiting fluid intake and careful consideration of clothing/containment options. CONCLUSION: Experiencing PF symptoms during sport/exercise caused considerable limitation to participation. Generation of negative emotions and pain-staking coping strategies to avoid symptoms, limited the social and mental health benefits typically associated with sport/exercise in symptomatic women. The culture of the sporting environment influenced whether women continued or ceased exercising. In order to promote women's participation in sport, co-designed strategies for (1) screening and management of PF symptoms and (2) promotion of a supportive and inclusive culture within sports/exercise settings are needed.

Screening for pelvic floor symptoms in exercising women: a survey of 636 health and exercise professionals.

OBJECTIVES: This study aimed to establish health and exercise professionals' (i) current practice of screening for pelvic floor (PF) symptoms in women within sports/exercise settings (ii) between-professional group differences in screening practice (iii) confidence and attitudes towards screening for PF symptoms and (iv) barrier/enablers towards engagement in future screening practice. DESIGN: Observational, cross-sectional survey. METHODS: Australian health and exercise professionals (n = 636) working with exercising women participated in a purpose-designed and piloted, online survey about PF symptom screening in professional practice. Data were analysed descriptively and groups compared using Chi-square/Kruskal-Wallis tests. RESULTS: Survey respondents included physiotherapists (39%), personal trainers/fitness instructors (38%) and exercise physiologists (12%), with a mean of 12 years of practice (SD: 9.7, range: 0-46). One in two participants never screened women for PF symptoms; 23% screened when indicated. Pregnant/recently post-natal women (44%) were more commonly screened for PF symptoms than younger women (18-25 years:28%) and those competing in high-impact sports (32%). Reasons for not screening included waiting for patients to disclose symptoms (41%) and an absence of PF questions on screening tools (37%). Most participants were willing to screen PF symptoms but cited a lack of knowledge, training and confidence as barriers. CONCLUSIONS: Screening for PF symptoms in exercising women is not common practice, especially in at-risk groups such as young, high-impact athletes. Including PF questions in existing pre-exercise questionnaires and providing professional development to improve knowledge of indications for screening and evidence-based management options may facilitate early symptom identification and prevent secondary exercise cessation.

Getting to know our patients and what matters: exploring the elicitation of patient values, preferences, and circumstances in neurological rehabilitation.

PURPOSE: Patient values, preferences, and circumstances are critical to decision-making in both patient-centred and evidence-based practice models of healthcare. Despite the established importance of integrating these patient attributes, the ways they are elicited in rehabilitation remain unclear. This study aimed to explore how health professionals elicit and share patients' 'values', 'preferences', and 'circumstances', and what they understand by the terms. METHODS: This exploratory qualitative descriptive study used interviews with 13 clinicians from interprofessional teams in inpatient neurological rehabilitation. Data were analysed using a general inductive approach. RESULTS: Participants understood 'values' to mean what is important and meaningful; 'preferences' as likes/dislikes and choices; and 'circumstances' as the social, physical, and environmental context surrounding the person. Formal and informal strategies were used to gather information directly from patients or indirectly from other sources. The processes of eliciting and communicating this information were influenced by relationships and relied on contributions from many people. Elicitation involved a flexible approach tailored to the individual and considering each unique context. CONCLUSION: The strategies used and the approach used to implement these strategies were both essential to eliciting patient values, preferences, and circumstances in neurological rehabilitation. These findings offer insights into the practices of interprofessional rehabilitation clinicians. Implications for rehabilitationEliciting patient values, preferences, and circumstances involves a combination of strategies and approaches that are applied gradually throughout the continuum of rehabilitation.These processes are flexible, and strategies should be tailored to individual patients/families and phases of rehabilitation.Clinicians should be attentive to informal opportunities to gather valuable information throughout rehabilitation.Establishing positive relationships and using effective communication is foundational to these processes.

Interventions to improve access to care for abnormal uterine bleeding: A systematic scoping review.

BACKGROUND: Women with abnormal uterine bleeding (AUB) experience barriers to accessing healthcare services. OBJECTIVES: To identify and describe the evidence on interventions to improve healthcare access of women with AUB. SEARCH STRATEGY: A systematic search of databases including Medline, CINAHL, EMBASE, Scopus, and Cochrane register for clinical trials on February 26, 2021. SELECTION CRITERIA: Studies including women with AUB and investigating an intervention to improve access at the levels of individual patient, community, organization, health system, or medical education. DATA COLLECTION AND ANALYSIS: Data extraction and descriptive analysis of the country, study design, settings, participant characteristics, intervention, outcome measures, and key findings. MAIN RESULTS: We identified 20 studies and most interventions (13 studies) targeted organizational changes. Creating a multidisciplinary team, bringing services together and developing a care pathway improved the availability of services. Management of AUB in an outpatient setting improved the affordability. The use of decision aids improved patient engagement in consultations. There is a lack of interventions at an individual or community level targeting health literacy, health beliefs, social acceptability, and opportunity to reach and pay for services. CONCLUSIONS: Community-based culturally-adapted interventions focusing on access to women with different socio-economic and cultural backgrounds should be investigated.

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.

Managing fatigue at work after traumatic brain injury: a qualitative descriptive study.

Fatigue is a common sequela of traumatic brain injury (TBI) and adversely impacts on the ability to return to work. To the authors' knowledge, no prior studies have investigated how people manage TBI-related fatigue at work. This qualitative descriptive study explored how people managed fatigue attributed to TBI when returning to and maintaining paid work. Eight employed adults, who sustained a recent TBI and experienced TBI-related fatigue, participated in a semi-structured interview. Transcripts were analysed using a general inductive approach. Participants learned through trial and error to recognise 'change points' - fatigue symptom awareness that prompted fatigue management. At each change point, participants selected the most effective strategy from a continuum of options to minimise the impact on productivity at work. This continuum may provide useful guidance to other people returning to and maintaining paid work while managing post-TBI fatigue symptoms.

Pelvic Floor Symptoms Are an Overlooked Barrier to Exercise Participation: A Cross-Sectional Online Survey of 4556 Women Who Are Symptomatic.

OBJECTIVE: This study aimed to: (1) investigate barriers to exercise in women with pelvic floor (PF) symptoms (urinary incontinence [UI], anal incontinence [AI], and pelvic organ prolapse [POP]); (2) determine factors associated with reporting PF symptoms as a substantial exercise barrier; and (3) investigate the association between reporting PF symptoms as an exercise barrier and physical inactivity. METHODS: In this cross-sectional survey, Australian women who were 18 to 65 years of age and had PF symptoms completed an anonymous online survey (May-September 2018) containing validated PF and physical activity questionnaires: Questionnaire for Female Urinary Incontinence Diagnosis, Incontinence Severity Index, Pelvic Floor Bother Questionnaire, and International Physical Activity Questionnaire. Participants reported exercise barriers and the degree to which the barriers limited participation. Binary logistic regression was used to identify variables associated with (1) identifying PF symptoms as a substantial exercise barrier and (2) physical inactivity. RESULTS: In this cohort (N = 4556), 31% (n = 1429) reported PF symptoms as a substantial exercise barrier; UI was the most frequently reported barrier. Two-thirds of participants who identified POP and UI as exercise barriers had stopped exercising. The odds of reporting PF symptoms as a substantial exercise barrier were significantly higher for women with severe UI (odds ratio [OR] = 4.77; 95% CI = 3.60-6.34), high symptom bother (UI OR = 10.19; 95% CI = 7.24-14.37; POP OR = 22.38; 95% CI = 13.04-36.60; AI OR = 29.66; 95% CI = 7.21-122.07), those who had a vaginal delivery (1 birth OR = 2.04; 95% CI = 1.63-2.56), or those with a third- or fourth-degree obstetric tear (OR = 1.47; 95% CI = 1.24-1.76). The odds of being physically inactive were greater in women who identified PF symptoms as an exercise barrier than in those who did not (OR = 1.33; 95% CI = 1.1-1.59). CONCLUSION: One in 3 women reported PF symptoms as a substantial exercise barrier, and this was associated with increased odds of physical inactivity. IMPACT: Physical inactivity is a major cause of mortality and morbidity in women. Pelvic floor symptoms stop women participating in exercise and are associated with physical inactivity. Screening and management of PF symptoms could allow women to remain physically active across their life span. LAY SUMMARY: Pelvic floor symptoms are a substantial barrier to exercise in women of all ages, causing them to stop exercising and increasing the odds of being physical inactive. Physical therapists can screen and help women manage their PF symptoms so that they remain physically active.

Pelvic floor disorders stop women exercising: A survey of 4556 symptomatic women.

OBJECTIVES: To establish the impact of pelvic floor (PF) symptoms (urinary incontinence [UI], anal incontinence [AI] and pelvic organ prolapse [POP]) on exercise participation in women. DESIGN: Observational, cross-sectional survey. METHODS: Australian, 18- to 65-year-old women with self-identified PF symptoms during exercise (current, past or fear of) were included. This survey included validated questionnaires: Questionnaire for female Urinary Incontinence Diagnosis, Incontinence Severity Index, Pelvic Floor Bother Questionnaire, International Physical Activity Questionnaire and purpose-designed questions on the impact of PF symptoms on sport/exercise participation. Analysis utilised descriptive statistics. Chi-square tests for independence and t-tests were used to explore differences between groups. RESULTS: Of 4556 women, 46% stopped exercise they had previously participated in due to their PF symptoms. Urinary incontinence had the largest impact; 41% with UI, followed by 37% with POP and 26% with AI stopped at least one form of exercise. Forty-two percent of women who experienced symptoms in high-impact sports stopped participation (versus low-impact: 21%). Sports commonly ceased included volleyball (63%), racquet-sports (57%) and basketball (54%). Exercise cessation was reported amongst younger (18-25 years: 35%) and nulliparous women (31%). Common exercise modifications included lowering the intensity (58%) or frequency (34%) of participation or changing to a low-impact form of sport/exercise (45%). CONCLUSIONS: Pelvic floor symptoms stop women of all ages and levels of participation from exercising. High-impact sports were most affected but low-impact sports were also ceased. Symptomatic women also modify exercise to less vigorous/frequent participation, which may place them at risk of physical inactivity, and chronic illness.

Women report sustained benefits from attending group-based education about pelvic floor muscles: a longitudinal qualitative study.

QUESTION: Among women who have participated in group-based education about the pelvic floor, what are their perceptions of the program and the group format? DESIGN: Exploratory longitudinal qualitative study. PARTICIPANTS: Community-dwelling women aged ≥ 18 years who participated in three or four sessions of pelvic floor education in a group format at a university clinic. DATA EXTRACTION AND ANALYSIS: Semi-structured group or individual interviews were conducted at three time points: 1 week, 3 months and ≥ 5 months after the education activity. Data were inductively content analysed and independently coded, with iterative theme development. RESULTS: Women considered the content and delivery appropriate and useful. New knowledge was assimilated and shared with others, and many tried to adopt pelvic floor muscle training in daily life. The women felt that the education sessions might benefit other women, with and without pelvic floor dysfunction symptoms, and that such education would ideally be more widely available. A perception of the value of the education persisted over time, even though maintenance of some health-promoting behaviours, such as pelvic floor muscle training, decreased. CONCLUSION: The pelvic floor group education sessions appeared to fulfil the purpose of increasing knowledge about pelvic floor (dys)function and applying this in daily life. Overall, the participants, who had completed three or four of the four sessions, found the program to be useful. A unique feature of this study was longitudinal data collection and it seemed that the perception of value persisted over time.

Comprehensive reporting of pelvic floor muscle training for urinary incontinence: CERT-PFMT.

AIM: To produce a pelvic floor muscle training variation of the Consensus on Exercise Reporting Template (CERT-PFMT). METHODS: Qualitative methods were used to explore the perspectives of physiotherapists who have postgraduate continence and pelvic floor rehabilitation qualifications on using research evidence to implement pelvic floor muscle training for urinary incontinence. The same experienced facilitator guided the discussions with questions derived from systematic reviews and content experts. The face-to-face focus groups were audio-recorded and verbatim transcripts were thematically analysed. For each CERT item the authors collated participant quotations that identified required explanation or elaboration for the CERT-PFMT. Systematic reviews of pelvic floor muscle training for urinary incontinence were searched by the research team for examples of good reporting. RESULTS: Twenty- nine continence physiotherapists participated in one of seven focus groups. Participants agreed that all key elements they needed for replicating pelvic floor muscle training interventions from a research report were provided in the published CERT checklist. CERT items 2 (qualifications), 6 (motivation), 7 (progression rules), 8 (exercise description), 13 (intervention description) and 15 (starting level) required additional explanations for pelvic floor muscle training. Clinicians reported that original CERT explanations for items 1, 3-5, 8-12, 14 and 16 could be used without modification. CONCLUSIONS: The CERT-PFMT reporting guideline has been designed with clinician input to inform how to document pelvic floor muscle training to enable replication in clinical practice. It can be used for research protocols, to construct manuscripts reporting pelvic floor muscle training for urinary incontinence and by journal editors and reviewers.

Effect of Pelvic Floor Symptoms on Women's Participation in Exercise: A Mixed-Methods Systematic Review With Meta-analysis.

OBJECTIVE: To (1) review the effect of pelvic floor (PF) symptoms (urinary incontinence [UI], pelvic organ prolapse, and anal incontinence) on exercise participation in women, and (2) explore PF symptoms as a barrier to exercising. DESIGN: Mixed-methods systematic review with meta-analysis. LITERATURE SEARCH: Eight databases were systematically searched up to September 2020. STUDY SELECTION CRITERIA: We included full-text, peer-reviewed observational, experimental, or qualitative studies in adult, community-dwelling women with PF symptoms. Outcomes included the participant-reported effect on exercise or the perception of PF symptoms as an exercise barrier. Study quality was assessed using a modified version of the Mixed Methods Appraisal Tool. DATA SYNTHESIS: Meta-analysis was performed where possible. Deductive and inductive content analysis was used to synthesize qualitative data. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework and the GRADE-Confidence in the Evidence from Reviews of Qualitative research (CERQual) guided interpretation of the certainty of evidence. RESULTS: Thirty-three studies were included. In 47% (95% confidence interval [CI]: 37%, 56%; I2 = 98.6%) of women with past, current, or fear of PF symptoms, UI symptoms adversely affected exercise participation (21 studies, n = 14 836 women). Thirty-nine percent (95% CI: 22%, 57%; I2 = 93.0%; 6 studies, n = 426) reported a moderate or great effect on exercise. Pelvic organ prolapse affected exercise for 28% of women (95% CI: 24%, 33%; I2 = 0.0%; 2 studies, n = 406). There were no quantitative studies of anal incontinence. CONCLUSION: For 1 in 2 women, UI symptoms negatively affect exercise participation. Half of women with UI reported either stopping or modifying exercise due to their symptoms. Limited data on pelvic organ prolapse also demonstrated adverse exercise effect. J Orthop Sports Phys Ther 2021;51(7):345-361. Epub 10 May 2021. doi:10.2519/jospt.2021.10200.

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.

Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.

OBJECTIVE: To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN: Parallel group randomised controlled trial. SETTING: 23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS: 600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. INTERVENTIONS: Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. MAIN OUTCOME MEASURES: The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. RESULTS: Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. CONCLUSIONS: At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated. TRIAL REGISTRATION: ISRCTN57756448.

Issues in reporting of systematic review methods in health app-focused reviews: A scoping review.

No guidelines exist for the conduct and reporting of manuscripts with systematic searches of app stores for, and then appraisal of, mobile health apps ('health app-focused reviews'). We undertook a scoping review including a systematic literature search for health app-focused reviews describing systematic app store searches and app appraisal, for apps designed for patients or clinicians. We created a data extraction template which adapted data elements from the PRISMA guidelines for systematic literature reviews to data elements operationalised for health app-focused reviews. We extracted the data from included health app-focused reviews to describe: (1) which elements of the adapted 'usual' methods of systematic review are used; (2) methods of app appraisal; and (3) reporting of clinical efficacy and recommendations for app use. From 2798 records, the 26 included health app-focused reviews showed incomplete or unclear reporting of review protocol registration; use of reporting guidelines; processes of screening apps; data extraction; and appraisal tools. Reporting of clinical efficacy of apps or recommendations for app use were infrequent. The reporting of methods in health app-focused reviews is variable and could be improved by developing a consensus reporting standard for health app-focused reviews.