Identifying a framework for hope in order to establish the Importance of generalised hopes for individuals who have suffered a stroke

Hope and hopelessness are important psychological constructs that physiotherapists should consider when working with patients who have experienced a stroke. The view of hope in rehabilitation is often focused around the concept of goals and how hope works within this framework. However, the current paper proposes a broader framework for hope and the importance of a more generalised view of understanding why a certain hope exists or is identified by a patient. A narrative review using an a priori thematic analysis was undertaken to consider how more generalised hopes are expressed by individuals who have suffered a stroke. An electronic search of 4 databases from inception until April 2014 was undertaken. Qualitative articles were included if they considered the concept of hope for patients who had suffered a stroke. The results identified three themes which included (1) consideration of the patient’s identity/identities, (2) meaningful activities, experiences, and interactions, and (3) the experience of suffering and need for relief. An awareness of patients’ generalised hopes should be a priority for HCPs. Detailed implications for HCPs are identified within the discussion

Survival time and differences between dementia with Lewy bodies and Alzheimer's disease following diagnosis: A meta-analysis of longitudinal studies.

OBJECTIVE: To synthesize the evidence across longitudinal studies comparing survival in dementia with Lewy bodies (DLB) and Alzheimer's disease (AD). METHODS: We conducted a systematic review and meta-analysis of studies comparing survival in clinically diagnosed DLB to AD. Longitudinal cohort studies were identified through a systematic search of major electronic databases from inception to May 2018. A random effects meta-analysis was performed to calculate survival time and relative risk of death. RESULTS: Overall, 11 studies were identified including 22,952 patients with dementia: 2029 with DLB (mean diagnosis age 76.3; 47% female) compared with 20,923 with AD (mean diagnosis age 77.2; 65.1% female). Average survival time in DLB from diagnosis was 4.11 years (SD ± 4.10) and in AD 5.66 (SD ± 5.32) years, equating to a 1.60 (95% CI: -2.44 to -0.77) years shorter survival in DLB (p < 0.01). Relative risk of death was increased by 1.35 (95%CI: 1.17-1.55) in DLB compared to AD (p < 0.01). Differences in survival were not explained by follow-up time, age at diagnosis, gender, or cognitive score. CONCLUSIONS: There is consistent evidence for higher and earlier mortality in DLB compared to AD. This is important for all stakeholders and underlines the importance of expanding research into DLB.NIH

WILL (When to Induce Labour to Limit risk in pregnancy hypertension): a multicentre randomised controlled trial - adaptations to deliver a timing-of-birth trial during the COVID-19 international pandemic.

BACKGROUND: As a pragmatic randomised timing-of-birth trial, WILL adapted its trial procedures in response to the COVID-19 pandemic. These are reviewed here to inform post-pandemic trial methodology. METHODS: The trial (internal pilot) paused in March 2020, re-opened in July 2020, and is currently recruiting in 37 UK NHS consultant-led maternity units. We evaluated pandemic adaptations made to WILL processes and surveyed sites for their views of these changes (20 sites, videoconference). RESULTS: Despite 88% of sites favouring an electronic investigator site file (ISF), information technology requirements and clinical trial unit (CTU) operating procedures mandated the ongoing use of paper ISFs; site start-up delays resulted from restricted access to the CTU. Site initiation visits (SIVs) were conducted remotely; 50% of sites preferred remote SIVs and 44% felt that it was trial-dependent, while few preferred SIVs in-person as standard procedure. The Central team felt remote SIVs provided scheduling and attendance flexibility (for sites and trial staff), the option of recording discussions for missing or future staff, improved efficiency by having multiple sites attend, and time and cost savings; the negative impact on rapport-building and interaction was partially mitigated over time with more familiarity with technology and new ways-of-working. Two methods of remote consent were developed and used by 30/37 sites and for 54/156 recruits. Most (86%) sites using remote consenting felt it improved recruitment. For remote data monitoring (5 sites), advantages were primarily for the monitor (e.g. flexibility, no time constraints, reduced cost), and disadvantages primarily for the sites (e.g. document and access preparation, attendance at a follow-up meeting), but 81% of sites desired having the option of remote monitoring post-pandemic. CONCLUSIONS: COVID adaptations to WILL trial processes improved the flexibility of trial delivery, for Central and site staff, and participants. Flexibility to use these strategies should be retained post-pandemic. TRIAL REGISTRATION: ISRCTN77258279. Registered on 05 December 2018

Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON) : a randomised controlled phase III trial

Acknowledgments This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research partnership (grant 12/206/52). Medical Research Council (MRC) Centre grants to the Centre for Reproductive Health (CRH) (G1002033 and MR/N022556/1) are also gratefully acknowledged. The views expressed in this publication are those of the authors and not necessarily those of the Medical Research Council, National Institute for Health Research, or Department of Health and Social Care. We thank our Collaborative Group (listed in the Supplementary Material) for their contribution to recruitment, randomisation and collection of data, and to our Trial Steering and Data Monitoring Committees (members listed in Supplementary Material).Peer reviewedPublisher PD

A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert

BACKGROUND: Induction of labor is a commonly performed obstetrical intervention. Vaginal prostaglandin E2 (dinoprostone) is a first-choice agent. Mechanical methods of induction are slower in achieving cervical ripening but have a lower risk of adverse effects. OBJECTIVE: This study aimed to compare the efficacy, maternal and neonatal safety, and maternal satisfaction of a synthetic osmotic cervical dilator (Dilapan-S) with those of dinoprostone. STUDY DESIGN: This was an open-label superiority randomized controlled trial in 4 English hospitals. Eligible participants were women ≥16 years of age undergoing induction of labor for a singleton pregnancy at ≥37 weeks’ gestation with vertex presentation and intact membranes. The women were randomly assigned to receive either Dilapan-S or dinoprostone using a telephone randomization system minimized by hospital, parity, body mass index, and maternal age. The induction agent was replaced as required until the cervix was assessed as favorable for labor by the Bishop score. The primary outcome was failure to achieve vaginal delivery (ieor a cesarean delivery being performed). The secondary outcome measures included maternal and neonatal adverse events. Analysis was by intention-to-treat, adjusting for design variables where possible. RESULTS: Between December 19, 2017 and January 26, 2021, 674 women were randomized (337 to Dilapan-S, and 337 to dinoprostone). The trial did not reach its planned sample size of 860 participants because of restrictions on research during the COVID-19 pandemic. The primary outcome was missing for 2 women in the dinoprostone group. Failure to achieve vaginal delivery (or a cesarean delivery being performed) occurred in 126 women (37.4%) allocated to Dilapan-S and in 115 (34.3%) women allocated to dinoprostone (adjusted risk difference, 0.02; 95% confidence interval, −0.05 to 0.10). There were similar maternal and neonatal adverse events between the groups. CONCLUSION: Women undergoing induction of labor with Dilapan-S have similar rates of cesarean delivery and maternal and neonatal adverse events compared with dinoprostone

A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert

Background: Induction of labor is a commonly performed obstetric intervention. Vaginal prostaglandin E2 (dinoprostone) is a first-choice agent. Mechanical methods of induction are slower to achieve cervical ripening but have a lower risk of adverse effects. Objective: To compare the efficacy, maternal and neonatal safety, and maternal satisfaction of a synthetic osmotic cervical dilator (Dilapan-S) with dinoprostone. Study Design: This was an open-label, superiority randomized controlled trial in four English hospitals. Eligible participants were women ≥ 16 years of age undergoing induction of labor for a singleton pregnancy, ≥ 37 weeks’ gestation with vertex presentation and intact membranes. Women were randomly assigned to receive Dilapan-S or dinoprostone using a telephone randomization system minimized by hospital, parity, BMI and maternal age. The induction agent was replaced as required until the cervix was assessed as favorable for labor by Bishop score. The primary outcome was failure to achieve vaginal delivery (i.e. Cesarean delivery). Secondary outcome measures included maternal and neonatal adverse events. Analysis was by intention-to-treat, adjusting for design variables where possible. Results: Between 19 December 2017 and 26 January 2021, 674 women were randomized (337 to Dilapan-S and 337 to dinoprostone). The trial did not reach its planned sample size of 860 due to restrictions on research during the Covid-19 pandemic. The primary outcome was missing for two women in the dinoprostone group. Failure to achieve vaginal delivery (Cesarean section) occurred in 126 women (37.4%) allocated to Dilapan-S, and 115 (34.3%) women allocated to dinoprostone (adjusted risk difference 0.02, 95% confidence interval -0.05 to 0.10). There were similar maternal and neonatal adverse events between the groups. Conclusion: Women undergoing induction of labor with Dilapan-S have similar rates of caesarean section and maternal and neonatal adverse events compared to dinoprostone

WILL (when to induce labour to limit risk in pregnancy hypertension): protocol for a multicentre randomised trial

Objectives: to address optimal timing of birth for women with chronic or gestational hypertension who reach term and remain well. Study design: Pragmatic, non-masked randomised trial. Inclusion: maternal age ≥16 years, chronic or gestational hypertension, singleton pregnancy, live fetus, 36+0–37+6 weeks’ gestation, and able to give documented informed consent. Exclusion: contraindication to either trial arm (e.g., pre-eclampsia or another indication for birth at term), blood pressure (BP) ≥ 160/110 mmHg until controlled, major fetal anomaly anticipated to require neonatal care unit admission, or participation in another timing of birth trial. Randomisation (1:1 ratio, minimised for key prognostic variables: site, hypertension type, and prior Caesarean) to ‘planned early term birth at 38+0-3 weeks’ or ‘usual care at term’ (revised from ‘expectant care until at least 40+0 weeks’, Aug 2022).Outcomes: maternal co-primary: composite of ‘poor maternal outcome’ (severe hypertension, maternal death, or maternal morbidity). Neonatal co-primary: neonatal care unit admission for ≥4 h. Each co-primary is measured until primary hospital discharge or 28 days post-birth (whichever is earlier). Key secondary: Caesarean birth.Analysis: sample of 1080 participants (540/arm) will detect an 8% reduction in the maternal co-primary (90% power, superiority hypothesis), and give 94% power for a between-group non-inferiority margin of difference of 9% in the neonatal co-primary. Analysis will be by intention-to-treat. Ethics approval has been obtained (NHS Health Research Authority London Fulham Research Ethics Committee, 18/LO/2033). Conclusions: The study will provide data for women to make informed choices about their care and allow health systems to plan services.</p