Jean Hay-Smith

Background: One major methodological challenge faced by researchers when conducting randomised controlled trials (RCTs) of complex interventions is blinding. Given the nature of complex interventions, trial participants and intervention providers often cannot be blinded to the intervention. This lack of blinding may result in a lower evidence rating for the trial, potentially hindering the implementation of its findings. One option to mitigate this issue is to single blind studies, with the blinding only of outcome assessors to group allocation. Despite the potential advantages, outcome assessment blinding is frequently underutilised. The challenges behind its limited adoption in this field are not clearly understood. This study aimed to explore the attitudes and practices of UK researchers regarding blinding, particularly outcome assessment blinding, in complex intervention RCTs. Methods: We conducted an online survey targeting researchers affiliated with the UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs), the National Institute for Health and Care Research (NIHR), Trials Methodology Research Partnership (TMRP) and National Health Service (NHS)-NIHR research units. Results: A total of 63 researchers participated in the survey. Most were affiliated with UKCRC (49/63, 77%), TMRP (6/63, 8%) or NHS-NIHR research units (8/63, 12%). The majority (57/63, 91%) agreed that complex interventions pose significant challenges to adequate blinding. Concerns about compromised internal validity due to lack of blinding were noted by 45% of respondents (28/63), and 67% (42/63) expressed dissatisfaction with existing quality assessment tools for complex intervention RCTs. Although 66% of respondents (41/63) found outcome assessment blinding often feasible, 52% (33/63) identified limited resources as a primary obstacle. Free-text responses highlighted practical constraints and additional costs associated with blinding. Furthermore, two-thirds of respondents (43/63, 68%) reported a lack of specific recommendations on blinding, which may exacerbate these challenges. Opinions on the influence of the new Medical Research Council (MRC)-NIHR Framework 2021 were mixed. However, most respondents 76% (48/63)) agreed that NIHR plays a role in improving blinding strategies in complex intervention RCTs and 79% (50/63) agreed that a wider stakeholder engagement is necessary to overcome blinding challenges. Conclusion: This survey offers insights into the views of experienced UK-based researchers on blinding in complex intervention RCTs. Four key findings emerged: (1) the challenges of blinding due to the inherent complexity of these interventions, (2) the essential role of blinding in reducing bias, (3) the variability in the feasibility of outcome assessment blinding due to practical and resource constraints and (4) the positive impact of stakeholder involvement in addressing blinding challenges. However, respondents expressed dissatisfaction with current quality assessment tools and held divergent views on outcome assessment blinding, highlighting the need for more definitive methodological guidance on blinding in complex intervention trials.

Background Pelvic floor muscle training (PFMT), compared to no treatment, is effective for treating urinary incontinence (UI) in women. Feedback and biofeedback are additional resources that give women more information about their pelvic floor muscle contraction. The extra information could improve training performance by increasing capability or motivation for PFMT. The Committee on Conservative Management from the 7th International Consultation on Incontinence states that the benefit of adding biofeedback to PFMT is unclear. This review is an update of a Cochrane review last published in 2011. Objectives The primary objective was to assess the effects of PFMT with feedback or biofeedback, or both, for UI in women. We considered the following research questions. Are there differences in the effects of PFMT with feedback, biofeedback, or both versus PFMT without these adjuncts in the management of stress, urgency or mixed UI in women? Are there differences in the effects of feedback versus biofeedback as adjuncts to PFMT for women with UI? Are there differences in the effects of different types of biofeedback? Search methods We searched the Cochrane Incontinence Specialised Register (searched 27 September 2023), which includes searches of CENTRAL, MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP as well as handsearching of journals and conference proceedings, and the reference lists of relevant articles. Selection criteria We included only randomised controlled trials (RCTs), cluster‐RCTs and quasi‐RCTs in women with UI. We excluded studies that recruited women with neurological conditions, who were pregnant or less than six months postpartum. Eligible studies made one of the following comparisons: PFMT plus feedback versus PFMT alone, PFMT plus biofeedback versus PFMT alone, PFMT plus feedback or biofeedback versus PFMT alone, PFMT plus feedback versus PFMT plus biofeedback, and one type of biofeedback versus another. Data collection and analysis Two review authors independently assessed studies for eligibility, extracted data onto a prepiloted form, and assessed risk of bias using RoB 1. We used the GRADE approach to assess the certainty of evidence in each comparison by outcome. Our primary outcome was lower urinary tract symptom‐specific quality of life. We pooled data using a standardised mean difference (SMD). Secondary outcomes were leakage episodes in 24 hours (mean difference (MD)), leakage severity (MD), subjective cure or improvement (odds ratio (OR)), satisfaction (OR), and adverse events (descriptive summary). Main results We included 41 completed studies with 3483 women. Most (33 studies, 3031 women) investigated the effect of PFMT with biofeedback versus PFMT alone. Eleven studies were at low risk of bias overall, 27 at unclear risk of bias, and three at high risk. Only one study reported leakage severity, with no usable data. Comparison 1. PFMT with feedback versus PFMT alone: one eligible study reported no outcome of interest. Comparison 2. PFMT with biofeedback versus PFMT alone: there was little or no difference in incontinence quality of life (SMD 0.07 lower, 95% confidence interval (CI) 0.18 lower to 0.05 higher; 11 studies, 1169 women; high‐certainty evidence). Women randomised to biofeedback had 0.29 fewer leakage episodes in 24 hours versus PFMT alone (MD 0.29 lower, 95% CI 0.42 lower to 0.16 lower; 12 studies, 932 women; moderate‐certainty evidence), but this slight reduction in leakage episodes may not be clinically important. Women in biofeedback arms report that there is probably little to no difference in cure or improvement (OR 1.26, 95% CI 1.00 to 1.58; 14 studies, 1383 women; moderate‐certainty evidence) but may report greater satisfaction with treatment outcomes (OR 2.41, 95% CI 1.56 to 3.7; 6 studies, 390 women; low‐certainty evidence). None of these outcomes were blinded. Eight studies (711 women) assessed severe adverse events but reported that there were no events. Comparison 3. PFMT with feedback or biofeedback versus PFMT alone: a single study contributed very‐low certainty evidence regarding leakage episodes in 24 hours, subjective cure or improvement, and satisfaction. Comparison 4. PFMT with feedback versus PFMT with biofeedback: the evidence is very uncertain about any difference in effect between biofeedback versus feedback for incontinence‐related quality of life. Not only is the evidence certainty very low, the confidence interval is very wide and there could be a more than small effect in favour of biofeedack or feedback (SMD 0.14 lower, 95% CI 0.56 lower to 0.28 higher; 2 studies, 91 women; very‐low certainty evidence). There may be fewer leakage episodes in 24 hours for women receiving biofeedback verus feedback but the difference may not be clinically important and the evidence certainty is low (MD 0.28 lower, 95% CI 0.62 lower to 0.07 higher; 2 studies, 120 women; low‐certainty evidence). There were no data for subjective cure, improvement or satisfaction. One study measured adverse events and none were reported. Comparison 5. PFMT with biofeedback versus PFMT with another type of biofeedback: five studies assessed this comparison, with individual studies contributing data for separate outcomes. There was low‐ or very‐low certainty evidence about the benefits of one type of biofeedback versus another for leakage episodes in 24 hours or subjective cure or improvement, respectively. One study reported adverse events from two of nine women receiving electromyography biofeedback versus six of 10 receiving pressure biofeedback. Authors' conclusions PFMT with biofeedback results in little to no difference in incontinence quality of life. The addition of biofeedback to PFMT likely results in a small unimportant difference in leakage episodes in 24 hours, and likely little to no difference in patient‐reported cure...

Objectives To assess the feasibility of an intervention of midwifery support for antenatal pelvic floor muscle exercises (PFME) to prevent postnatal urinary incontinence (UI). Design Feasibility and pilot cluster randomised controlled trial. Clusters were community midwifery teams. Setting Community maternity antenatal care. Participants One hundred seventy-five women; 186 midwives. Intervention Midwifery training and resources for midwives and women to support antenatal PFME. Control clusters continued standard care. Outcomes Women reporting: that their midwife explained how to do PFME, PFME adherence and postpartum UI. Midwives reporting: pre-post-training PFME confidence, intervention acceptability. Fidelity of training delivery and implementation. Results Ninety-five midwives in intervention clusters; 91 midwives in control clusters. Of 998 women sent questionnaires, 175 responded: 15.8% in intervention, 16.4% in control clusters. Women’s characteristics in both trial arms were similar and characteristics of respondents and non-respondents were similar. Sixty-five percent (95% CI 56.9% to 72.4%) of women in intervention clusters reported their midwife explained how to do PFME vs 38% (95% CI 24.6% to 51.2%) in control clusters. Fifty percent (95% CI 24.1% to 77.1%) of women in intervention clusters vs 38% (95% CI 12.4% to 67.1%) in control clusters reported doing enough PFME to potentially prevent UI. Fourty-four percent (95% CI 32.0% to 56.1%) of women in intervention clusters reported UI vs 54% (95% CI 42.2% to 65.8%) in control clusters. Intervention training was delivered with fidelity and received positively. Midwives reported improvements in PFME confidence/knowledge (median increase of at least 1 point on a 0–4 scale for each of eight questions). Midwives (26%) most frequently reported insufficient time as an implementation barrier. Conclusions This pilot trial produced consistent new findings that training and resourcing midwives to teach and support pregnant women to undertake PFME is acceptable and feasible for women and midwives. It increased the number of women who are informed about PFME, with potential to improve PFME adherence and reduce postpartum UI. Recent changes to the National Health Service perinatal pelvic healthcare means a full trial is not possible. Trial registration number ISRCTN10833250.

Background Pelvic floor muscle training (PFMT) is a recommended treatment for female stress, urgency, and mixed urinary incontinence. Training varies in exercise type (pelvic floor muscles contracting with and without other muscles), dose, and delivery (e.g. amount and type of supervision). Objectives To assess the effects of alternative approaches (exercise type, dose, and delivery) to pelvic floor muscle training (PFMT) in the management of urinary incontinence (stress, urgency, and mixed) in women. Search methods We searched the Cochrane Incontinence Specialised Register (searched 27 September 2023; which contains CENTRAL, MEDLINE, ClinicalTrials.gov, and World Health Organization ICTRP), handsearched journals and conference proceedings, and reviewed reference lists of relevant articles. Selection criteria Randomised, quasi‐randomised, or cluster‐randomised trials in female stress, urge, or mixed urinary incontinence where one trial arm included PFMT and another was an alternative approach to PFMT type, dose, or intervention delivery. We excluded studies with participants with neurological conditions or pregnant or recently postpartum. Data collection and analysis Two review authors independently assessed trials for eligibility and methodological quality using the Cochrane RoB 1 tool. We extracted and cross‐checked data and resolved disagreements by discussion. Data processing was as described in the Cochrane Handbook for Systematic Reviews of Interventions (Version 6). Synthesis was completed in intervention subgroups. Main results This is a review update. The analysis included 63 trials with 4920 women; the previous version included 21 trials with 1490 women. Samples sizes ranged from 11 to 362. Overall, study participants were mid‐age (45 to 65 years) parous women with stress or stress‐predominant mixed urinary incontinence (46 trials), who had no prior incontinence treatment or pelvic surgery, or appreciable pelvic floor dysfunction. Trials were conducted in countries around the world, mostly in middle‐ or high‐income settings (53 trials). All trials had one or more arms using 'direct' PFMT, defined as repeated, isolated, voluntary pelvic floor muscle contractions. Trials were categorised as comparisons of exercise type (27 trials, 3 subgroups), dose (11 trials, 5 subgroups, 1 with no data), and delivery (25 trials, 5 subgroups). Incontinence quality of life data are reported here as the primary outcome. Adverse event data were summarised narratively. Comparison 1: exercise type Co‐ordinated training (body movements with concurrent pelvic floor muscle contraction) versus direct PFMT Co‐ordinated training may slightly improve quality of life (standardised mean difference (SMD) −0.22, 95% confidence interval (CI) −0.44 to −0.01; I² = 81%; 8 trials, 356 women; low‐certainty evidence). Indirect training (exercises that are not contractions of the pelvic floor muscles) versus direct PFMT Direct PFMT may moderately improve quality of life (SMD 0.70, 95% CI 0.38 to 1.02; I² = 78%; 4 trials, 170 women; low‐certainty evidence). Indirect training combined with direct PFMT versus direct PFMT Combining indirect training with direct PFMT may make little to no difference in quality of life (SMD −0.08, 95% CI −0.26 to 0.10; I² = 33; 7 trials, 482 women; low‐certainty evidence). Comparison 2: exercise dose PFMT with resistance device versus PFMT without resistance device PFMT without a resistance device may slightly improve incontinence quality of life, but the evidence is very uncertain (SMD 0.22, 95% CI −0.04 to 0.48; I² = 32%; 3 trials, 227 women; very low‐certainty evidence). Maximal pelvic floor muscle contractions versus submaximal pelvic floor muscle contractions No data reported. PFMT more days per week versus PFMT fewer days per week PFMT more days per week may greatly improve incontinence quality of life (SMD −1.60, 95% CI −2.15 to −1.05; 1 trial, 68 women; low‐certainty evidence). PFMT in upright body positions versus PFMT when lying down No data reported. Comparison 3: exercise intervention delivery PFMT supervised in clinic versus PFMT at home Clinic supervision may slightly improve incontinence quality of life, but the evidence is very uncertain (SMD −0.30, 95% CI −0.65 to 0.05; I² = 89%; 3 trials, 137 women; very low‐certainty evidence). More clinician contact for PFMT supervision versus less clinician contact No usable data reported. Individual supervision of PFMT versus group supervision Individually supervised PFMT probably results in little to no difference in quality of life (SMD −0.18, 95% CI −0.35 to −0.01; I² = 0%; 5 trials, 544 women; moderate‐certainty evidence). PFMT supervised in clinic versus supervision using e‐health (mobile app communication with clinicians) Clinic supervision may make little to no difference in incontinence quality of life, but the evidence is very uncertain (SMD −0.11, 95% CI −0.41 to 0.19; 1 trial, 173 women; very low‐certainty evidence). PFMT instruction delivered via e‐health versus written instruction E‐health delivery may slightly improve quality of life (SMD −0.21, 95% CI −0.43 to 0.01; I² = 25%; 3 studies, 318 women; low‐certainty evidence). Adverse events Nine trials collected adverse event data; 66/1083 (6%) women had an adverse event. Almost all events were associated with use of an intravaginal or intrarectal training device. The adverse events were vaginal discharge, spotting, or discomfort. Limitations in the evidence Four main factors influenced our certainty in the evidence: 44 trials were at unclear or high risk of selection bias; data were sparse in some subgroups with few trials, trials that did not measure outcomes of interest, or did not report usable data; results were inconsistent; and many trials were small (imprecise). Authors' conclusions Although there is low‐ to moderate‐certainty evidence that some approaches to PFMT are better than others, for some there was little or no difference. The 7th International Consultation on Incontinence recommends PFMT as first‐line therapy for women with urinary incontinence. Direct PFMT (sets of repeated, isolated, voluntary pelvic floor muscle contractions) may result in a small improvement in incontinence quality of life compared to indirect training. In terms of improved quality of life, PFMT can be supervised individually or in a group because it probably makes little to no difference in achieving this outcome. Many comparisons had low‐ or very low‐certainty evidence, often because there was only one trial or several small trials with methodological limitations. More, better designed and reported trials, directly comparing PFMT approaches are needed, especially trials investigating exercise dose.

Background: Antenatal pelvic floor muscle exercises are effective in reducing postnatal urinary incontinence. Midwives, however, lack training and confidence to promote these exercises and often do not provide information or support to women to do the exercises. Objectives: Objectives were to: (1) investigate current antenatal care in relation to pelvic floor muscle exercise support from midwives for women; (2) develop an intervention to increase the likelihood of midwives supporting women to do pelvic floor muscle exercises during pregnancy; and (3) test the intervention in a feasibility and pilot cluster randomised controlled trial with numerous trial and process evaluation outcomes. Design: Study designs included critical interpretive synthesis, ethnography and other methods (interviews, focus groups, behaviour change theory mapping, stakeholder and patient/public involvement activities) and piloting questionnaires to develop an intervention to test in a feasibility and pilot cluster randomised controlled trial. Clusters were community midwife teams. Setting: Main setting: two National Health Service hospital trusts providing maternity care in Birmingham. Participants: Participants included pregnant women and midwives. Pilot trial participants included women who gave birth during a prespecified month in study maternity units. Midwives participated in trial process evaluation. Interventions: Midwives in teams randomised to the intervention were trained how to teach pelvic floor muscle exercises to women and support them in undertaking these exercises throughout pregnancy. Midwife teams allocated to control provided standard antenatal care. Main outcome measures: Early-phase outcomes were whether current antenatal midwife care supported women to undertake pelvic floor muscle exercises, and a midwife pelvic floor muscle exercise training intervention. Main feasibility and pilot trial outcomes included return rates and associated intraclass correlation coefficient; whether midwives provided pelvic floor muscle exercise support to women during antenatal care; women’s adherence to undertaking pelvic floor muscle exercises antenatally; and prevalence estimates of urinary incontinence at 10–12 weeks post partum. Other process outcomes included intervention midwives’ confidence in pelvic floor muscle exercise knowledge and views on intervention delivery; women’s views on pelvic floor muscle exercise support received; and control midwives’ views on pelvic floor muscle exercises in standard care. Results: The critical interpretive literature synthesis showed that current antenatal pelvic floor muscle support was constrained by numerous factors including women’s and healthcare professionals’ capacity to implement pelvic floor muscle exercises. Reform of healthcare policy and service delivery was recommended to provide opportunity to genuinely support women and healthcare professionals. Main findings of early-phase qualitative research showed that women and midwives ‘know’ that pelvic floor muscle exercises are important, but that midwives infrequently communicate to women the large ‘gains’ available from undertaking these exercises. There was lack of confidence among women and midwives on when and how to initiate discussion on pelvic floor muscle exercises and urinary incontinence. A systematic review of diagnostic tests for midwives to use to support women’s practice of pelvic floor muscle exercises identified no available studies. Qualitative research with women and midwives, mapping to behaviour change theory, and stakeholder and patient/public involvement activities followed by a practice training event showed that the intervention should consist of five steps: raising the topic of incontinence and pelvic floor muscle exercises; screening for symptoms; teaching the exercises; reminding and supporting women to do the exercises; and knowing when and how to refer. Midwife training evaluation findings showed median positive change following training of 1 point (0–5 scale) for each of eight questions related to confidence about pelvic floor muscle exercise knowledge and teaching the exercises. In the cluster trial, 17 clusters were randomised and 95 midwives in intervention clusters were trained. Of 998 women included in the trial, 175 returned a questionnaire: 15.8% in intervention and 16.4% in control clusters. Based on women’s responses to the post-partum postal questionnaire, 65% of those in intervention clusters said their midwife explained how to do pelvic floor muscle exercises compared to 38% of those in control clusters. Among women in intervention clusters, 50% undertook the exercises in a manner likely to improve symptoms compared to 38% of women in control clusters, and 44% of women in intervention clusters reported urinary incontinence compared to 54% in control clusters. Interviews with midwives and women generally supported trial findings and emphasised the importance of service change for ensuring time to implement the Antenatal Preventative Pelvic floor Exercises And Localisation intervention into antenatal appointments. Limitations: There was a low questionnaire return rate. A definitive trial, which would have provided evidence of effectiveness not possible from a pilot trial, could not be undertaken because of changes to standard midwife antenatal care due to National Health Service England’s new perinatal pelvic health service. Conclusions: Training midwives to appropriately support women to undertake pelvic floor muscle exercises in pregnancy is feasible, acceptable and could improve exercise adherence and reduce post-partum urinary incontinence. Future work: Implementation work with National Health Service England has begun. Study registration: This study is registered as ISRCTN10833250. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0514-20002) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 9. See the NIHR Funding and Awards website for further award information.

Learning to work collaboratively requires opportunities to practice and acquire interprofessional competencies. These can be gained through interprofessional education learning activities (IPE). A key interprofessional competency is learning to constructively resolve difference or conflict, but how to do this is less frequently described than with other competencies. A brief educational intervention about how to resolve difference or conflict was delivered to pre-registration IPE students engaged in small group activities in Aotearoa, New Zealand. A pre/post design study examined qualitative data retained from a student peer assessment tool administered before and after the educational intervention. The intervention was delivered in 2021 and data was compared with an otherwise comparable 2019 student cohort. In 2021, the small groups described fewer instances of poor teamwork in their peer assessments than the 2019 student cohort who did not receive the intervention. 2021 groups who did experience poor teamwork described repair attempts. There are indications that a brief conflict resolution intervention can support most student groups (but not necessarily all) to resolve difference or conflict in small group work.

Purpose: Evidence-based practice (EBP) is considered central to ethical, effective service delivery in rehabilitation, and the implementation of the World Health Organisation's Rehabilitation Strategy 2030. This study aimed to explore and compare the experiences of health professionals regarding the application of EBP for stroke rehabilitation in each participant's region and country, which provided perspectives from low, middle, and high-income countries.Methods and materials: Interviews were conducted with 12 experienced rehabilitation professionals from 12 different countries (5 high-income, 2 upper-middle income, 3 lower-middle income, and 2 low-income countries) and interpreted using qualitative descriptive analysis.Results: Nine factors influencing evidence-based stroke rehabilitation were: 1) the complexity of rehabilitation research; 2) the (ir)relevance of research to local context; 3) lack of time for EBP; 4) minimal training in EBP; 5) changing health professional behaviours; 6) poor access to resources for developing EBP; 7) influence of culture, patients, and families; 8) language barriers; and 9) lack of access to research evidence. Economic constraints contributed to many challenges; but not all challenges related to the country's economic classification.Conclusion: A global approach is needed to share knowledge about EBP, especially scientific evidence and innovative thinking about its application to clinical practice. Implications for rehabilitationRehabilitation professional groups should contribute to a global network to improve informal knowledge sharing and training around evidence-based practice.Support for training in evidence-based practice and its application needs to be developed and accessible in all countries, including low and middle-income countries.It is imperative that policymakers prioritise practical, evidence-based solutions for rehabilitation research in low and middle-income countries that can be effectively implemented within local settings.There must be solutions and increased accessibility of journal articles for those working in low and middle-income countries including those whose first language is not English.

Objectives One in two women experiencing pelvic floor (PF) symptoms stop playing sport or exercising. The study examines the perspective of women with PF symptoms to inform acceptable screening practices within sport and exercise settings. Methods Explanatory, sequential, mixed-methods design. Phase 1: survey of 18–65 years, symptomatic, Australian women (n=4556). Phase 2: semistructured interviews with a subset of survey participants (n=23). Integration occurred through connection of phases (study design, sampling) and joint display of data. Results Findings are represented in three threads: (1) ‘women (not) telling’; a majority of women had told no-one within a sport or exercise setting about their PF symptoms due to shame/embarrassment, lack of pelvic health knowledge and not wanting to initiate the conversation, (2) ‘asking women (screening for PF symptoms)’; women endorsed including PF symptom questions within existing sport and exercise screening practices but only when conducted in a respectful and considered manner and (3) ‘creating safety’; professionals can assist women to disclose by demonstrating expertise, trustworthiness and competency. If health and exercise professionals are provided with appropriate training, they could raise pelvic health awareness and promote a supportive and safe sport and exercise culture. Conclusion Women with PF symptoms support health and exercise professionals initiating conversations about PF health to normalise the topic, and include PF symptoms among other pre-exercise screening questions. However, women should be informed on the relevance and potential benefits of PF screening prior to commencing. Safe screening practices require building trust by providing information, gaining consent, displaying comfort and genuine interest, and being knowledgeable within one’s scope of practice to the provision of advice, exercise modifications and referral as appropriate.