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Background: People post-hip fracture have reported experiences of fragmented care and poor discharge planning, therefore improvements in patient flow are required. This study reports the challenges people face during the discharge process and offers potential solutions for improving the transition from hospital to home from the perspectives of patients, carers, and health professionals., Methods: This was a qualitative study embedded within a multi-centre, feasibility randomised controlled trial (HIP HELPER). We undertook semi-structured interviews with 10 patient-carer dyads (10 people with hip fracture; 10 unpaid carers) and eight health professionals (four physiotherapists, two occupational therapists, one nurse and one physiotherapy researcher) between November 2021 and March 2022. Data were analysed using the principles of Framework Analysis., Results: Participants identified challenges in the transition from hospital to home post-hip fracture surgery: ineffective communication, disjointed systems, untimely services and 'it's more than just the hip'. Possible solutions and insights to facilitate this transition included the need for reassurance, collaborative planning, and individualisation., Conclusion: The transition from hospital to home following hip fracture surgery can be a challenging experience for patients, and for friends and family who support them as carers, making them feel vulnerable, frustrated and uncertain. Enabling a coordinated, collaborative approach to discharge planning and early recovery provision is considered a positive approach to improving NHS care., Trial Registration: ISRCTN13270387. Registered 29th October 2020., Competing Interests: Declarations Ethics approval and consent to participate North East—Newcastle & North Tyneside 1 Research Ethics Committee (20/NE/0213) Date: 14 October 2020. Written informed consent was obtained from all participants. Consent for publication Not required. Competing interests The authors declare no competing interests., (© 2024. The Author(s).)

Background: Globally, there are 42 million women and girls estimated to be forcibly displaced. Adolescent girls and young women in humanitarian settings have their sexual and reproductive health (SRH) neglected. This systematic review aimed to describe SRH obstacles that adolescent girls and young women (10-24 years old) face in humanitarian settings in line with the Sustainable Development Goals., Methods: We conducted a mixed-methods systematic review in six databases, focusing on migrant women ages 10 - 24and their SRH outcomes. The mixed-methods appraisal tool was used to evaluate the quality of the studies. This review follows PRISMA and the Systematic Review Guidelines from the Centre for Reviews and Dissemination recommendations., Results: Among the 1290 studies screened by abstracts, 32 met the eligibility criteria: 15 were qualitative, 10 were quantitative and seven were mixed-methods studies. Most studies were performed in the last four years, in African countries. They discussed the increased frequency of adolescent pregnancies (16-23%), lack of contraceptive use and access (8-32%), poor menstrual hygiene management (lack of water, shortage of menstrual hygiene supplies), ignorance and stigma about sexually transmitted infections and HIV, a higher number of child, early and forced marriage or partnership and sexual and gender-based violence, challenging to obtain SRH information/knowledge/access, and unmet SRH needs., Conclusion: Migration is a current issue. Although there is a growing number of studies on adolescent girls and young women's SRH in humanitarian settings, this population remains overlooked, and face several challenges in SRH. There is a need for targeting interventions on SRH., (© 2023. The Author(s).)

Background: Distal radius fractures are common fractures in older adults and associated with increased risk of future functional decline and hip fracture. Whether lower limb muscle strength and balance are impaired in this patient population is uncertain. To help inform rehabilitation requirements, this systematic review aimed to compare lower limb muscle strength and balance between older adults with a distal radius fracture with matched controls, and to synthesise lower limb muscle strength and balance outcomes in older adults with a distal radius fracture., Methods: We searched Embase, MEDLINE, and CINAHL (1990 to 25 May 2022) for randomised and non-randomised controlled clinical trials and observational studies that measured lower limb muscle strength and/or balance using instrumented measurements or validated tests, in adults aged ≥ 50 years enrolled within one year after distal radius fracture. We appraised included observational studies using a modified Newcastle-Ottawa Scale and included randomised controlled trials using the Cochrane risk-of-bias tool. Due to the clinical and methodological heterogeneity in included studies, we synthesised results narratively in tables and text., Results: Nineteen studies (10 case-control studies, five case series, and four randomised controlled trials) of variable methodological quality and including 1835 participants (96% women, mean age 55-73 years, median sample size 82) were included. Twelve included studies (63%) assessed strength using 10 different methods with knee extension strength most commonly assessed (6/12 (50%) studies). Five included case-control studies (50%) assessed lower limb strength. Cases demonstrated impaired strength during functional tests (two studies), but knee extension strength assessment findings were conflicting (three studies). Eighteen included studies (95%) assessed balance using 14 different methods. Single leg balance was most commonly assessed (6/18 (33%) studies). All case-control studies assessed balance with inconsistent findings., Conclusion: Compared to controls, there is some evidence that older adults with a distal radius fracture have impaired lower limb muscle strength and balance. A cautious interpretation is required due to inconsistent findings across studies and/or outcome measures. Heterogeneity in control participants' characteristics, study design, study quality, and assessment methods limited synthesis of results. Robust case-control and/or prospective observational studies are needed., Registration: International prospective register of systematic reviews (date of registration: 02 July 2020, registration identifier: CRD42020196274)., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Latin America has the highest Cesarean Section Rates (CSR) in the world. Robson's Ten Group Classification System (RTGCS) was developed to enable understanding the CSR in different groups of women, classified according to obstetric characteristics into one of ten groups. The size of each CS group may provide helpful data on quality of care in a determined region or setting. Data can potentially be used to compare the impact of conditions such as maternal morbidity on CSR. The objective of this study is to understand the impact of Severe Maternal Morbidity (SMM) on CSR in ten different groups of RTGCS., Methods: Secondary analysis of childbirth information from 2018 to 2021, including 8 health facilities from 5 Latin American and Caribbean countries (Bolivia, Guatemala, Honduras, Nicaragua, and the Dominican Republic), using a surveillance database (SIP-Perinatal Information System, in Spanish) implemented in different settings across Latin America. Women were classified into one of RTGCS. The frequency of each group and its respective CSR were described. Furthermore, the sample was divided into two groups, according to maternal outcomes: women without SMM and those who experienced SMM, considering Potentially Life-threatening Conditions, Maternal Near Miss and Maternal Death as the continuum of morbidity., Results: Available data were obtained from 92,688 deliveries using the Robson Classification. Overall CSR was around 38%. Group 5 was responsible for almost one-third of cesarean sections. SMM occurred in 6.7% of cases. Among these cases, the overall CSR was almost 70% in this group. Group 10 had a major role (preterm deliveries). Group 5 (previous Cesarean section) had a very high CSR within the group, regardless of the occurrence of maternal morbidity (over 80%)., Conclusion: Cesarean section rate was higher in women experiencing SMM than in those without SMM in Latin America. SMM was associated with higher Cesarean section rates, especially in groups 1 and 3. Nevertheless, group 5 was the major contributor to the overall CSR., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Patellar dislocations mainly affect adolescents and young adults. After this injury, patients are usually referred to physiotherapy for exercise-based rehabilitation. Currently, limited high-quality evidence exists to guide rehabilitation practice and treatment outcomes vary. A full-scale trial comparing different rehabilitation approaches would provide high-quality evidence to inform rehabilitation practice. Whether this full-scale trial is feasible is uncertain: the only previous trial that compared exercise-based programmes in this patient population had high loss to follow-up. This study aims to assess the feasibility of conducting a future full-scale trial comparing the clinical and cost-effectiveness of two different rehabilitation approaches for people with an acute patellar dislocation., Methods: Two-arm parallel external pilot randomised controlled trial and qualitative study. We aim to recruit at least 50 participants aged ≥ 14 years with an acute first-time or recurrent patellar dislocation from at least three English National Health Service hospitals. Participants will be randomised 1:1 to supervised rehabilitation (four to six, one-to-one, physiotherapy sessions of advice and prescription of tailored progressive home exercise over a maximum of 6 months) or self-managed rehabilitation (one physiotherapy session of self-management advice, exercise, and provision of self-management materials). Pilot objectives are (1) willingness to be randomised, (2) recruitment rate, (3) retention, (4) intervention adherence, and (5) intervention and follow-up method acceptability to participants assessed through one-to-one semi-structured interviews (maximum 20 participants). Follow-up data will be collected 3, 6, and 9 months after randomisation. Quantitative pilot and clinical outcomes will be numerically summarised, with 95% confidence intervals generated for the pilot outcomes using Wilson's and exact Poisson methods as appropriate., Discussion: This study will assess the feasibility of conducting a full-scale trial comparing supervised versus self-managed rehabilitation for people after acute first-time or recurrent patellar dislocation. This full-scale trial's results would provide high-quality evidence to guide rehabilitation provision for patients with this injury., Trial Registration: ISRCTN registry ISRCTN14235231 . Registered on 09 August 2022., (© 2023. The Author(s).)

Background: Resilience reflects coping with pregnancy-specific stress, including physiological adaptations of the maternal organism or factors arising from the socioeconomic context, such as low income, domestic violence, drug and alcohol use, lack of a support network and other vulnerability characteristics. Resilience is a dynamic characteristic that should be comparatively evaluated within a specific context; its association with perceived stress and social vulnerability during pregnancy is still not fully understood. This study aimed at exploring maternal resilience, perceived stress and social vulnerability during pregnancy and its associated factors and outcomes., Methods: Prospective multicenter cohort study of nulliparous women in Brazil determining resilience (Resilience Scale; RS) and stress (Perceived Stress Scale; PSS) at 28 weeks of gestation (± 1 week). Resilience and stress scores were compared according to sociodemographic characteristics related to maternal/perinatal outcomes and social vulnerability, defined as having low level of education, being adolescent, without a partner or ethnicity other than white., Results: We included 383 women who completed the RS and PSS instruments. Most women showed low resilience scores (median: 124.0; IQR 98-143). Women with a low resilience score (RS < 125) were more likely from the Northeast region, adolescents, other than whites, did not study or work, had a low level of education, low family income and received public antenatal care. Higher scores of perceived stress were shown in the Northeast, other than whites, at low levels of education, low annual family income and public antenatal care. Pregnant women with low resilience scores (n = 198) had higher perceived stress scores (median = 28) and at least one vulnerability criterion (n = 181; 91.4%)., Conclusion: Our results reinforce the role of resilience in protecting women from vulnerability and perceived stress. It may prevent complications and build a positive experience during pregnancy., (© 2023. The Author(s).)

Background: In 2019, WHO prioritized updating recommendations relating to three labour induction topics: labour induction at or beyond term, mechanical methods for labour induction, and outpatient labour induction. As part of this process, we aimed to review the evidence addressing factors beyond clinical effectiveness (values, human rights and sociocultural acceptability, health equity, and economic and feasibility considerations) to inform WHO Guideline Development Group decision-making using the WHO-INTEGRATE evidence-to-decision framework, and to reflect on how methods for identifying, synthesizing and integrating this evidence could be improved., Methods: We adapted the framework to consider the key criteria and sub-criteria relevant to our intervention. We searched for qualitative and other evidence across a variety of sources and mapped the eligible evidence to country income setting and perspective. Eligibility assessment and quality appraisal of qualitative evidence syntheses was undertaken using a two-step process informed by the ENTREQ statement. We adopted an iterative approach to interpret the evidence and provided both summary and detailed findings to the decision-makers. We also undertook a review to reflect on opportunities to improve the process of applying the framework and identifying the evidence., Results: Using the WHO-INTEGRATE framework allowed us to explore health rights and equity in a systematic and transparent way. We identified a lack of qualitative and other evidence from low- and middle-income settings and in populations that are most impacted by structural inequities or traditionally excluded from research. Our process review highlighted opportunities for future improvement, including adopting more systematic evidence mapping methods and working with social science researchers to strengthen theoretical understanding, methods and interpretation of the evidence., Conclusions: Using the WHO-INTEGRATE evidence-to-decision framework to inform decision-making in a global guideline for induction of labour, we identified both challenges and opportunities relating to the lack of evidence in populations and settings of need and interest; the theoretical approach informing the development and application of WHO-INTEGRATE; and interpretation of the evidence. We hope these insights will be useful for primary researchers as well as the evidence synthesis and health decision-making communities, and ultimately contribute to a reduction in health inequities., (© 2022. The Author(s).)

Background: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early., Methods: Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT., Results: The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up., Conclusions: The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly., (© 2022. The Author(s).)

Background: Childhood fractures can have a significant impact on the daily lives of families affecting children's normal activities and parent's work. Wrist fractures are the most common childhood fracture. The more serious wrist fractures, that can look visibly bent, are often treated with surgery to realign the bones; but this may not be necessary as bent bones straighten in growing children. The children's radius acute fracture fixation trial (CRAFFT) is a multicentre randomised trial of surgery versus a cast without surgery for displaced wrist fractures. Little is known about how families experience these wrist fractures and how they manage treatment uncertainty. This study aimed to understand families' experience of this injury and what it is like to be asked to include their child in a clinical trial., Methods: Nineteen families (13 mothers, 7 fathers, 2 children) from across the UK participated in telephone interviews. Interviews were audio recorded, transcribed and analysed using reflexive thematic analysis., Results: Our findings highlight parents' desire to be a good parent through the overarching theme "protecting my injured child". To protect their child after injury, parents endeavoured to make the right decisions about treatment and provide comfort to their child but they experienced ongoing worry about their child's recovery. Our findings show that parents felt responsible for the decision about their child's treatment and their child's recovery. They also reveal the extent to which parents worried about the look of their child's wrist and their need for reassurance that the wrist was healing., Conclusion: Our findings show that protecting their child after injury can be challenging for parents who need support to make decisions about treatment and confidently facilitate their child's recovery. They also highlight the importance of providing information about treatments, acknowledging parents' concerns and their desire to do the right thing for their child, reassuring parents that their child's wrist will heal and ensuring parents understand what to expect as their child recovers., (© 2022. The Author(s).)

Background: Distal radius fractures represent about 1 in 5 of all fractures treated in UK hospitals. Most distal radius fractures occur in women aged 50 years or over after a fall. Distal radius fractures are managed using splints or casting, some are also treated with surgical fixation. Patients often experience long-term muscle weakness of the hand and arm that may impact their ability to do daily activities such as personal hygiene, routine household chores and food preparation. We propose a structured and tailored flexibility and resistance exercise programme for the hand and arm supplemented with behaviour change strategies to help perform daily exercise. The main aim of our study is to assess the feasibility of conducting a definitive randomised controlled trial., Methods: This study is a multicentre, parallel-group individually randomised feasibility trial. We will recruit a minimum of 72 adults aged 50 years or over with distal radius fracture treated surgically or non-surgically from at least three UK National Health Service (NHS) hospitals. They will be randomised 1:1:1 to receive usual care, usual care and independent exercise with a single therapy session or usual care and supervised exercise with three therapy sessions over 12 weeks. Our primary feasibility objectives are (1) patient engagement assessed by recruitment, (2) acceptability of the interventions assessed by adherence and patient and clinician experience and (3) retention of participants in the trial. Outcome measures will be assessed at baseline, 3 months and at 6 months after randomisation. A qualitative sub-study will explore the experiences of the trial participants and therapists delivering the exercises., Discussion: A definitive trial will be considered feasible without major modifications if our progression criteria are met. If successful, the findings will inform the design of a future definitive RCT to evaluate the clinical and cost-effectiveness of the WISE exercise programme., Trial Registration: ISRCTN12290145 ., (© 2022. The Author(s).)

Background: Adolescent and young women (10-24 years old) are habitually a neglected group in humanitarian settings. Menstrual hygiene management (MHM) is an unmet aspect of sexual and reproductive health (SRH) and an additional challenge if lack of hygiene products, inadequate access to safe, clean, and private toilets identified as period poverty. Our objective was to provide an overview of the main MHM issues affecting Venezuelan migrant adolescents and young women in the north-western border of Venezuela-Brazil., Method: A cross-sectional study was conducted, early in 2021, with the use of a self-responded questionnaire, in Spanish, adapted from the Menstrual Practice Needs Scale (MPNS-36). All identified adolescents and young women aged between 12 and 24 years old were invited to participate (convenience sample-167 women). Women with complete questionnaires and who menstruate were included. Information on access to and quality of hygiene kits and toilets were retrieved, and a descriptive analysis performed, with an evaluation of frequencies for categorical variables (n, %) and mean (± SD-standard deviation) for continuous variables. In addition to the open-ended questions, we included one open question about their personal experience with menstruation., Results: According to official reports, at the moment of the interviews, there were 1.603 Venezuelans living on the streets in Boa Vista. A total of 167 young women were invited, and 142 further included, mean age was 17.7 years, almost half of the participants who menstruate (46.4%) did not receive any hygiene kits, 61% were not able to wash their hands whenever they wanted, and the majority (75.9%) did not feel safe to use the toilets. Further, menstruation was often described with negative words., Conclusions: Migrant Venezuelan adolescents and young women have their MHM needs overlooked, with evident period poverty, and require urgent attention. It is necessary to assure appropriate menstrual materials, education, and sanitation facilities, working in partnership among governmental and non-governmental organizations to guarantee menstrual dignity to these young women., (© 2021. The Author(s).)

Background: There are no accurate estimates of the prevalence of non-severe maternal morbidities. Given the lack of instruments to fully assess these morbidities, the World Health Organization (WHO) developed an instrument called WOICE. We aimed to evaluate the prevalence of non-severe maternal morbidities in puerperal women and factors associated to impaired clinical, social and mental health conditions., Method: A cross-sectional study with postpartum women at a high-risk outpatient clinic in southeast Brazil, from November 2017 to December 2018. The WOICE questionnaire included three sections: the first with maternal and obstetric history, sociodemographic data, risk and environment factors, violence and sexual health; the second considers functionality and disability, general symptoms and mental health; and the third includes data on physical and laboratory tests. Data collection was supported by Tablets with REDCAP software. Initially, a descriptive analysis was performed, with general prevalence of all variables contained in the WOICE, including scales on anxiety and depression (GAD-7 and PHQ-9- impaired if ≥10), functionality (WHODAS- high disability scores when ≥37.4) and data on violence and substance use. Subsequently, an evaluation of cases with positive findings was performed, with a Poisson regression to investigate factors associated to impaired non-clinical and clinical conditions., Results: Five hundred seventeen women were included, majority (54.3%) multiparous, between 20 and 34 years (65.4%) and with a partner (75,6%). Over a quarter had (26.2%) preterm birth. Around a third (30.2%) reported health problems informed by the physician, although more than 80% considered having good or very good health. About 10% reported any substance use and 5.9% reported exposure to violence. Anxiety was identified in 19.8% of cases, depression in 36.9% and impaired functioning in 4.4% of women. Poisson regression identified that poor overall health rating was associated to increased anxiety/depression and impaired functioning. Having a partner reduced perception of women on the presence of clinical morbidities., Conclusion: During postpartum care of a high-risk population, over one third of the considered women presented anxiety and depression; 10% reported substance use and around 6% exposure to violence. These aspects of women's health need further evaluation and specific interventions to improve quality of care.

Background: Segmental tibial fractures are fractures in two or more areas of the tibial diaphysis resulting in a separate intercalary segment of the bone. Surgical fixation is recommended for patients with segmental tibial fractures as non-operative treatment outcomes are poor. The most common surgical interventions are intramedullary nailing (IMN) and circular frame external fixation (CFEF), but evidence about which is better is of poor quality. An adequately powered randomised controlled trial (RCT) to determine optimum treatment is required. STIFF-F aimed to assess the feasibility of a multicentre RCT comparing IMN with CFEF for segmental tibial fracture., Methods: STIFF-F was a mixed-methods feasibility study comprising a pilot RCT conducted at six UK Major Trauma Centres, qualitative interviews drawing on Phenomenology and an online survey of rehabilitation. The primary outcome was recruitment rate. Patients, 16 years and over, with a segmental tibial fracture (open or closed) deemed suitable for IMN or CFEF were eligible to participate. Randomisation was stratified by site using random permuted blocks of varying sizes. Participant or assessor blinding was not possible. Interviews were undertaken with patients about their experience of injury, treatment, recovery and participation. Staff were interviewed to identify contextual factors affecting trial processes, their experience of recruitment and the treatment pathway. An online survey was developed to understand the rehabilitation context of the treatments., Results: Eleven patients were screened and three recruited to the pilot RCT. Nineteen staff and four patients participated in interviews, and 11 physiotherapists responded to the survey. This study found the following: (i) segmental tibial fractures were rarer than anticipated, (ii) the complexity of the injury, study setup times and surgeon treatment preferences impeded recruitment, (iii) recovery from a segmental tibial fracture is challenging, and rehabilitation protocols are inconsistent and (iv) despite the difficulty recruiting, staff valued this research question and strived to find a way forward., Conclusion: The proposed multicentre RCT comparing IMN with CFEF is not feasible. This study highlighted the difficulty of recruiting patients to an RCT of a complex rare injury over a short time period., Trial Registration: The study was registered with the International Standard Randomised Controlled Trials Number Registry: ISRCTN11229660.

Background: Coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 strain, was first identified in late 2019 in China. The outcomes of patients affected by the virus can worsen, developing acute respiratory failure and other serious complications, especially in older individuals and people with obesity and comorbidities. Thus, obese patients tend to have a more severe course of COVID-19. Thus, this review aims to synthesize the evidence in the literature that associates COVID-19 and the severity of clinical outcomes in infected obese patients., Methods: This protocol was designed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols Statement. Scientific and gray literature will be systematically selected from PubMed/MEDLINE, Latin American Literature in Health Sciences, Online Scientific Electronic Library, Scopus, ScienceDirect, Web of Science, Embase, and Cochrane. The selection of articles will be limited to studies published in English, Portuguese, and Spanish from December 2019 onwards. The main clinical outcomes will be clinical severity in obese patients with COVID-19 as tachypnea (respiratory rate, ≥ 30 breaths per minute), hypoxemia (oxygen saturation, ≤ 93%), the ratio of the partial pressure of arterial oxygen to fraction of inspired oxygen (< 300), lung infiltrate (> 50% of the lung field involved within 24-48 h), diagnosis of the severe acute respiratory syndrome, need of invasive mechanical ventilation, and mortality. Two reviewers will independently screen all citations, full-text articles, and abstract data. Selection bias will be minimized by excluding studies published before December 2019. Conflicts will be resolved through a third reviewer and consensus-building. Moreover, findings will be reported using narrative synthesis and tabulation of the summaries., Discussion: Given the need for early detection of the possible implications and treatment for patients with obesity diagnosed with COVID-19, the scoping review will be useful to capture the state of the current literature, identify the gaps, and make recommendations for future research for directing the conduct and optimization of therapies in these patients by the multiprofessional teams., Systematic Review Registration: Open Science Framework: https://osf.io/xrkec.

Background: Hip fracture is common, affecting 20% of women and 10% of men during their lifetime. The trajectory of patients' recovery as they transition from the acute hospital setting to their usual residence is poorly understood. Recently, the use of activity trackers to monitor physical activity during recovery has been investigated as a way to explore this trajectory., Methods: This prospective observational cohort study followed patients from hospital to home as they recovered from a hip fracture. Participants were recruited from a single centre and provided with a 3-axis logging accelerometer worn as a pendant, for 16 weeks from recruitment. Participants received monthly follow-up visits which included questions about wearing the monitor. Monthly activity monitor data were also downloaded. Participant activity was estimated from the monitor data using the calibrated "Euclidean Norm Minus One" (ENMO) metric. Polynomial mixed-effects modelling was used to evaluate the difference between the weekly activity trends of 2 groups of participants: those with and without independent mobility at 16 weeks (defined by whether aids or personal assistance were required to mobilise)., Results: Twenty-nine participants from 125 eligible patients were recruited. Of these, 19 (66%) reported being aware of wearing the monitor at least some of the time. Fourteen (48%) participants withdrew before study completion. Data for thirteen (45%) participants were of sufficient quantity to be included in the activity modelling procedure. Of these, 8 reported independent mobility at 16 weeks post-surgery, and 5 did not. By week 7, the weekly predicted mean ENMO ( ENMO ¯ W ) values were significantly different between the two participant groups, demonstrating feasibility of the model's ability to predict which patients will report independent mobility at 16 weeks., Conclusions: This is the first study to our knowledge to investigate acceptability and feasibility of a pendant-worn activity monitor in this patient cohort. Acceptability of wearing the monitor and feasibility of recruitment and retention of participants were limited. Future research into the use of activity monitors in this population should use minimally intrusive devices which are acceptable to this population., Study Registration: MoHIP is a sub-study of the World Hip Trauma Evaluation (WHiTE) Study (ISRCTN 63982700)., Competing Interests: Competing interestsNone to declare, (© The Author(s) 2020.)

Background: Prediction of preeclampsia is a challenge to overcome. The vast majority of prospective studies in large general obstetric populations have failed in the purpose of obtain a useful and effective model of prediction, sometimes based on complex tools unavaible in areas where the incidence of preeclampsia is the highest. The goal of this study was to assess mean arterial blood pressure (MAP) levels at 19-21, 27-29 and 37-39 weeks of gestation and performance of screening by MAP for the prediction of preeclampsia in a Brazilian cohort of healthy nulliparous pregnant women., Methods: This was a cohort approach to a secondary analysis of the Preterm SAMBA study. Mean arterial blood pressure was evaluated at three different time periods during pregnancy. Groups with early-onset preeclampsia, late-onset preeclampsia and normotension were compared. Increments in mean arterial blood pressure between 20 and 27 weeks and 20 and 37 weeks of gestation were also calculated for the three groups studied. The accuracy of mean arterial blood pressure in the prediction of preeclampsia was determined by ROC curves., Results: Of the 1373 participants enrolled, complete data were available for 1165. The incidence of preeclampsia was 7.5%. Women with early-onset preeclampsia had higher mean arterial blood pressure levels at 20 weeks of gestation, compared to the normotensive group. Women with late-onset preeclampsia had higher mean arterial blood pressure levels at 37 weeks of gestation, than the normotensive groups and higher increases in this marker between 20 and 37 weeks of gestation. Based on ROC curves, the predictive performance of mean arterial blood pressure was higher at 37 weeks of gestation, with an area under the curve of 0.771., Conclusion: As an isolated marker for the prediction of preeclampsia, the performance of mean arterial blood pressure was low in a healthy nulliparous pregnant women group. Considering that early-onset preeclampsia cases had higher mean arterial blood pressure levels at 20 weeks of gestation, future studies with larger cohorts that combine multiple markers are needed for the development of a preeclampsia prediction model.

Background: The incidence of Achilles tendon rupture in the UK is increasing and the best rehabilitation strategy for patients treated non-operatively remains unclear. We describe a statistical analysis plan (SAP) for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised trial., Methods/design: UK STAR is a 1:1, multi-centre, parallel, two-arm, superiority randomised controlled trial. This study aims to evaluate the use of functional bracing compared to plaster cast for the management of acute Achilles tendon rupture in adult patients treated non-operatively. The primary outcome is the Achilles Tendon Rupture Score measured at 9 months after injury and will be estimated based on a linear mixed effects regression model adjusted for the stratification factor (centre) and other key prognostic variables. Secondary outcomes include complications, quality of life and resource use evaluated at 8 weeks and at 3, 6 and 9 months after the injury. Missing data will be summarised and reported by treatment arm. Full details of the planned analysis methods are described in this paper. Further study design details are published in the UK STAR protocol., Discussion: The planned statistical analyses for UK STAR aim to reduce the risk of outcome reporting bias arising from prior data knowledge. Any changes or deviations from the current SAP will be described and justified in the final study report., Trial Registration: International Standard Randomised Controlled Trial Number Registry, ISRCTN62639639 . Registered on 22 June 2016.

Background: Displaced intracapsular hip fractures are typically treated with hemiarthroplasty (HA) or total hip arthroplasty (THA). A number of professional bodies recommend considering THA for patients that were independently mobile and cognitively intact before injury. The aim of this study was to compare the outcomes between HA and THA for independently mobile older adults with hip fractures., Methods: A systematic review and meta-analysis of RCTs was undertaken alongside analysis of a propensity score matched national cohort of older adults (aged > 60) with hip fractures. Participants were identified for the propensity score matched cohort from the National Hip Fracture Database (NHFD), which was linked to Hospital Episode Statistics (HES) and civil death registration data. The primary outcomes were 12-month dislocation, revision, and mortality. The secondary outcomes were length of stay, discharge home, unplanned re-admission, functional outcomes, and health-related quality of life., Results: Five RCTs reported higher THA dislocation but this was not statistically significant (THA risk ratio [RR] 2.77, 95% CI 0.81 to 9.48). However, THA dislocation was significantly higher in the national observational dataset (sub-distribution hazard ratio [SHR] 1.73, 95% CI 1.24 to 2.41). Meta-analysis of data from four RCTs did not identify a significant difference in terms of revision (RR 1.52, 95% CI 0.56 to 4.14). However, THA revision was significantly lower in the national dataset (SHR 0.66, 95% CI 0.48 to 0.90). Meta-analysis of data from 5 RCTs suggested higher mortality amongst patients undergoing HA (RR 0.63, 95% CI 0.38 to 1.04), which was also observed within the national registry dataset (hazard ratio 0.45, 95% CI 0.37 to 0.54)., Conclusions: National clinical registries can provide important context when interpreting RCT data, which may alone be inadequate for comparing the safety profile of surgical interventions. These data suggest that THA is at significantly higher risk of dislocation but lower risk of revision within 12 months. The finding from both RCT and clinical registry data that THA is associated with lower 12-month mortality amongst the fittest patients with hip fractures requires urgent further study to determine whether or not this can be replicated in other balanced populations.

Background: In the context of major trauma, the rate of wound infection in surgical incisions created during fracture fixation amongst patients with closed high-energy injuries is high. One of the factors which may reduce the risk of surgical site infection is the type of dressing applied over the closed incision. The WHIST trial evaluates the effects of negative-pressure wound therapy (NPWT) compared with standard dressings., Methods/design: The WHIST trial is a multicentre, parallel group, randomised controlled trial. The primary outcome is the rate of deep surgical site infection at 30 days after major trauma. Secondary outcomes are measured at 3 and 6 months post-randomisation and include the Disability Rating Index, the EuroQoL EQ-5D-5 L, the Doleur Neuropathique Questionnaire, a patient-reported scar assessment, and record of complications. The analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The full WHIST protocol has already been published., Discussion: This paper provides details of the planned statistical analyses for this trial and will reduce the risks of outcome reporting bias and data driven results., Trial Registration: International Standard Randomised Controlled Trials database, ISRCTN12702354 . Registered on 9 December 2015.

Background: Twin pregnancy was associated with significantly higher rates of adverse neonatal and perinatal outcomes, especially for the second twin. In addition, the maternal complications (potentially life-threatening conditions-PLTC, maternal near miss-MNM, and maternal mortality-MM) are directly related to twin pregnancy and independently associated with adverse perinatal outcome. The objective of the preset study is to evaluate perinatal outcomes associated with twin pregnancies, stratified by severe maternal morbidity and order of birth., Methods: Secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health (WHOMCS), a cross-sectional study implemented in 29 countries. Data from 8568 twin deliveries were compared with 308,127 singleton deliveries. The occurrence of adverse perinatal outcomes and maternal complications were assessed. Factors independently associated with adverse perinatal outcomes were reported with adjusted PR (Prevalence Ratio) and 95%CI., Results: The occurrence of severe maternal morbidity and maternal death was significantly higher among twin compared to singleton pregnancies in all regions. Twin deliveries were associated with higher rates of preterm delivery (37.1%), Apgar scores less than 7 at 5th minute (7.8 and 10.1% respectively for first and second twins), low birth weight (53.2% for the first and 61.1% for the second twin), stillbirth (3.6% for the first and 5.7% for the second twin), early neonatal death (3.5% for the first and 5.2% for the second twin), admission to NICU (23.6% for the first and 29.3% for the second twin) and any adverse perinatal outcomes (67% for the first twin and 72.3% for the second). Outcomes were consistently worse for the second twin across all outcomes. Poisson multiple regression analysis identified several factors independently associated with an adverse perinatal outcome, including both maternal complications and twin pregnancy., Conclusion: Twin pregnancy is significantly associated with severe maternal morbidity and with worse perinatal outcomes, especially for the second twin.

Background: Patients can struggle to make sense of trials in emergency situations. This study examines patient experience of participating in the United Kingdom, Wound management of Open Lower Limb Fractures (UK WOLLF) study, a trial of standard wound management versus Negative Pressure Wound Therapy (NPWT)., Methods: The aim of the study was to understand the patient's lived experience of taking part in a trial of wound dressings. Interviews drawing on Phenomenology were undertaken with a purposive sample of 20 patients, on average 12 days into their hospital stay from July 2012-July 2013., Results: The participants were vulnerable due to the emotional and physical impact of injury. They expressed their trial experience through the theme of being compromised identified in categories of being dependent, being trusting, being grateful and being without experience. Participants felt dependent on and trusted the team to make the right decisions for them and not cause them harm. Their hopes for future recovery were also invested within the expertise of the team. Despite often not being well enough to consent to the study prior to surgery, they wished to be involved as much as possible. In agreeing to take part they expressed gratitude for their care, wanted to be helpful to others and considered the trial interventions to be a small component in relation to the enormity of their injury and broader treatment. In making sense of the trial they felt they could not understand the interventions without experience of them but if they received NPWT they developed a strong technological preference for this intervention., Conclusions: Patients prefer to be involved in studies within the limits of their capacity, despite not being able to provide informed consent. A variety of sources of knowledge may enable participants to feel that they have a better understanding of the interventions. Professional staff need to be aware of the situated nature of decision making where participants invest their hopes for recovery in the team., Trial Registration: Current Controlled Trials, ID: ISRCTN33756652 . Registered on 24 February 2012.

Background: Distal femoral fractures are a source of considerable morbidity and best treatment is currently uncertain. The Trial of Acute Femoral Fracture Fixation (TrAFFix) is a randomised, parallel-group feasibility study designed to inform the design of a later, definitive clinical trial comparing intramedullary nails and locking plates for the treatment of distal femoral fractures., Methods/design: Patients aged 50 years and older with a femoral fracture within the distal two Müller squares are potentially eligible for inclusion. Participants are randomly allocated to receive fixation with either an intramedullary nail or a distal locking plate. Measurements (EuroQol 5 Dimensions, Dementia Quality of Life, Disability Rating Index) are collected at baseline, 6 weeks and 4 months. The recruitment rate will be assessed across seven participating centres over a total of 52 centre-months which is expected after 10 months of recruitment. Objectives are - feasibility phase, to assess recruitment rate and completion rate of the primary outcome measure; process evaluation, to assess the generalisability and likely success of a future trial; definitive trial, quantify and draw inferences on observed differences in health-related quality of life at 4 months between the study intervention groups (nail versus plate). A favourable opinion was granted by the Wales Research Ethics Committee (16/WA/0225), study-wide NHS approval was given by the Health Research Authority (IRAS 206745), and participating NHS trusts provided local approvals. This study was funded by the National Institute for Health Research Health Technology Assessment (HTA 15/59/22)., Discussion: This is the protocol for a feasibility study conducted prior to any future definitive trial. The estimates of participant recruitment rate and proportion of data completion will be coupled with outputs from the process evaluation to make a final decision regarding feasibility TRIAL REGISTRATIONS: The study is registered with the National Institute for Health Research Portfolio (CPMS ID: 32536) and the ISRCTN registry ( ISRCTN92089567 ) on 26 May 2016.

Background: Eclampsia is the main cause of maternal death in Brazil. Magnesium sulfate is the drug of choice for seizure prevention and control in the management of severe preeclampsia and eclampsia. Despite scientific evidence demonstrating its effectiveness and safety, there have been delays in managing hypertensive disorders, including timely access to magnesium sulfate. To conduct a general situational analysis on availability and use of magnesium sulfate for severe preeclampsia and eclampsia in the public health system., Method: A situational analysis was conducted with two components: a documental analysis on information available at the official websites on the policy, regulation and availability of the medication, plus a cross sectional study with field analysis and interviews with local managers of public obstetric health services in Campinas, in the southeast of Brazil. We used the fishbone cause and effect diagram to organize study components. Interviews with managers were held during field observations using specific questionnaires., Results: There was no access to magnesium sulfate in primary care facilities, obstetric care was excluded from urgency services and clinical protocols for professional guidance on the adequate use of magnesium sulfate were lacking in the emergency mobile care service. Magnesium sulfate is currently only administered in referral maternity hospitals., Conclusion: The lack of processes that promote the integration between urgency/emergency care and specialized obstetric care possibly favors the untimely use of magnesium sulfate and contributes to the high maternal morbidity/mortality rates.

Background: Spontaneous preterm birth is a complex syndrome with multiple pathways interactions determining its occurrence, including genetic, immunological, physiologic, biochemical and environmental factors. Despite great worldwide efforts in preterm birth prevention, there are no recent effective therapeutic strategies able to decrease spontaneous preterm birth rates or their consequent neonatal morbidity/mortality. The Preterm SAMBA study will associate metabolomics technologies to identify clinical and metabolite predictors for preterm birth. These innovative and unbiased techniques might be a strategic key to advance spontaneous preterm birth prediction., Methods/design: Preterm SAMBA study consists of a discovery phase to identify biophysical and untargeted metabolomics from blood and hair samples associated with preterm birth, plus a validation phase to evaluate the performance of the predictive modelling. The first phase, a case-control study, will randomly select 100 women who had a spontaneous preterm birth (before 37 weeks) and 100 women who had term birth in the Cork Ireland and Auckland New Zealand cohorts within the SCOPE study, an international consortium aimed to identify potential metabolomic predictors using biophysical data and blood samples collected at 20 weeks of gestation. The validation phase will recruit 1150 Brazilian pregnant women from five participant centres and will collect blood and hair samples at 20 weeks of gestation to evaluate the performance of the algorithm model (sensitivity, specificity, predictive values and likelihood ratios) in predicting spontaneous preterm birth (before 34 weeks, with a secondary analysis of delivery before 37 weeks)., Discussion: The Preterm SAMBA study intends to step forward on preterm birth prediction using metabolomics techniques, and accurate protocols for sample collection among multi-ethnic populations. The use of metabolomics in medical science research is innovative and promises to provide solutions for disorders with multiple complex underlying determinants such as spontaneous preterm birth.

Background: The aim of this study was to assess the burden of respiratory disease, considering the influenza A pandemic season (H1N1pdm09), within the Brazilian Network for Surveillance of Severe Maternal Morbidity, and factors associated with worse maternal outcome., Methods: A multicenter cross-sectional study, involving 27 referral maternity hospitals in five Brazilian regions. Cases were identified in a prospective surveillance by using the WHO standardized criteria for potentially life-threatening conditions (PLTC) and maternal near miss (MNM). Women with severe complications from respiratory disease identified as suspected or confirmed cases of H1N1 influenza or respiratory failure were compared to those with other causes of severe morbidity. A review of suspected H1N1 influenza cases classified women as non-tested, tested positive and tested negative, comparing their outcomes. Factors associated with severe maternal outcome (SMO = MNM + MD) were assessed in both groups, in comparison to PLTC, using PR and 95 % CI adjusted for design effect of cluster sampling., Results: Among 9555 cases of severe maternal morbidity, 485 (5 %) had respiratory disease. Respiratory disease occurred in one-quarter of MNM cases and two-thirds of MD. H1N1 virus was suspected in 206 cases with respiratory illness. Around 60 % of these women were tested, yielding 49 confirmed cases. Confirmed H1N1 influenza cases had worse adverse outcomes (MNM:MD ratio < 1 (0.9:1), compared to 12:1 in cases due to other causes), and a mortality index > 50 %, in comparison to 7.4 % in other causes of severe maternal morbidity. Delay in medical care was associated with SMO in all cases considered, with a two-fold increased risk among respiratory disease patients. Perinatal outcome was worse in cases complicated by respiratory disease, with increased prematurity, stillbirth, low birth weight and Apgar score < 7., Conclusions: Respiratory disease, especially considering the influenza season, is a very severe cause of maternal near miss and death. Increased awareness about this condition, preventive vaccination during pregnancy, early diagnosis and treatment are required to improve maternal health.

Background: Myoblasts undergo major changes in their plasma membrane during the initial steps of skeletal muscle differentiation, including major alterations in the distribution of cholesterol. Cholesterol is involved in crucial membrane functions, such as fluidity, and permeability, and in the organization of specialized membrane microdomains (or lipid rafts). We have previously shown that alterations in cholesterol levels in myoblasts induce changes in proliferation and differentiation, which involves activation of Wnt/beta-catenin signaling pathway. In this study we used methyl-β-cyclodextrin (MbCD) to extract cholesterol from the membrane of chick skeletal muscle cells grown in culture. Using Ion Torrent-based sequencing, we compared the transcriptome of untreated and MbCD treated cells. Our aim was to define the genes that are expressed in these two conditions and relate their expression to cellular functions., Results: Over 5.7 million sequences were obtained, representing 671.38 Mb of information. mRNA transcriptome profiling of myogenic cells after cholesterol depletion revealed alterations in transcripts involved in the regulation of apoptosis, focal adhesion, phagosome, tight junction, cell cycle, lysosome, adherens junctions, gap junctions, p53 signaling pathway, endocytosis, autophagy and actin cytoskeleton. Lim domain only protein 7 mRNA was found to be the highest up-regulated feature after cholesterol depletion., Conclusions: This is the first study on the effects of membrane cholesterol depletion in mRNA expression in myogenic cells. Our data shows that alterations in the availability of plasma membrane cholesterol lead to transcriptional changes in myogenic cells. The knowledge of the genes involved in the cellular response to cholesterol depletion could contribute to our understanding of skeletal muscle differentiation.

Background: The vast majority of maternal deaths in low-and middle-income countries are preventable. Delay in obtaining access to appropriate health care is a fairly common problem which can be improved. The objective of this study was to explore the association between delay in providing obstetric health care and severe maternal morbidity/death., Methods: This was a multicentre cross-sectional study, involving 27 referral obstetric facilities in all Brazilian regions between 2009 and 2010. All women admitted to the hospital with a pregnancy-related cause were screened, searching for potentially life-threatening conditions (PLTC), maternal death (MD) and maternal near-miss (MNM) cases, according to the WHO criteria. Data on delays were collected by medical chart review and interview with the medical staff. The prevalence of the three different types of delays was estimated according to the level of care and outcome of the complication. For factors associated with any delay, the PR and 95%CI controlled for cluster design were estimated., Results: A total of 82,144 live births were screened, with 9,555 PLTC, MNM or MD cases prospectively identified. Overall, any type of delay was observed in 53.8% of cases; delay related to user factors was observed in 10.2%, 34.6% of delays were related to health service accessibility and 25.7% were related to quality of medical care. The occurrence of any delay was associated with increasing severity of maternal outcome: 52% in PLTC, 68.4% in MNM and 84.1% in MD., Conclusions: Although this was not a population-based study and the results could not be generalized, there was a very clear and significant association between frequency of delay and severity of outcome, suggesting that timely and proper management are related to survival.

Background: The aim of this study was to assess severe maternal morbidity (SMM) and near miss (NM) cases among adolescent girls and women over 35 years of age in the Brazilian Network for Surveillance of Severe Maternal Morbidity, using a set of standard criteria, compared to pregnant women aged 20 to 34 years., Methods: A cross-sectional multicenter study conducted in 27 referral obstetric units in Brazil. All pregnant women admitted to these centers during a one-year period of prospective surveillance were screened to identify cases of maternal death (MD), NM and other SMM. Indicators of maternal morbidity and mortality were evaluated for the three age groups. Sociodemographic, clinical and obstetric characteristics, gestational and perinatal outcomes, main causes of morbidity and delays in care were also compared. Two multiple analysis models were performed, to estimate the adjusted prevalence ratio for identified factors that were independently associated with the occurrence of severe maternal outcome (SMO = MNM + MD)., Results: Among SMM and MD cases identified, the proportion of adolescent girls and older women were 17% each. The risk of MNM or death was 25% higher among older women. Maternal near miss ratio and maternal mortality ratios increased with age, but these ratios were also higher among adolescents aged 10 to 14, although the absolute numbers were low. On multivariate analysis, younger age was not identified as an independent risk factor for SMO, while this was true for older age (PR 1.25; 1.07-1.45)., Conclusions: SMO was high among women below 14 years of age and increased with age in Brazilian pregnant women.

Background: Hypertensive disorders represent the major cause of maternal morbidity in middle income countries. The main objective of this study was to identify the prevalence and factors associated with severe maternal outcomes in women with severe hypertensive disorders., Methods: This was a cross-sectional, multicenter study, including 6706 women with severe hypertensive disorder from 27 maternity hospitals in Brazil. A prospective surveillance of severe maternal morbidity with data collected from medical charts and entered into OpenClinica®, an online system, over a one-year period (2009 to 2010). Women with severe preeclampsia, severe hypertension, eclampsia and HELLP syndrome were included in the study. They were grouped according to outcome in near miss, maternal death and potentially life-threatening condition. Prevalence ratios and 95% confidence intervals adjusted for cluster effect for maternal and perinatal variables and delays in receiving obstetric care were calculated as risk estimates of maternal complications having a severe maternal outcome (near miss or death). Poisson multiple regression analysis was also performed., Results: Severe hypertensive disorders were the main cause of severe maternal morbidity (6706/9555); the prevalence of near miss was 4.2 cases per 1000 live births, there were 8.3 cases of Near Miss to 1 Maternal Death and the mortality index was 10.7% (case fatality). Early onset of the disease and postpartum hemorrhage were independent variables associated with severe maternal outcomes, in addition to acute pulmonary edema, previous heart disease and delays in receiving secondary and tertiary care., Conclusions: In women with severe hypertensive disorders, the current study identified situations independently associated with a severe maternal outcome, which could be modified by interventions in obstetric care and in the healthcare system. Furthermore, the study showed the feasibility of a hospital system for surveillance of severe maternal morbidity.

Background: The purpose of the study was to evaluate intraclass correlation coefficients (ICC) of variables concerning personal characteristics, structure, outcome and process in the Brazilian Network for Surveillance of Severe Maternal Morbidity study conducted to identify severe maternal morbidity/near miss cases using the World Health Organization criteria., Method: It was a cross-sectional, multicenter study involving 27 hospitals providing care for pregnant women in Brazil. Cluster size and the mean size of the primary sampling unit were described. Estimated prevalence rates, ICC, their respective 95% confidence intervals, the design effect and the mean cluster size were presented for each variable., Results: Overall, 9,555 cases of severe maternal morbidity (woman admitted with potentially life-threatening conditions, near miss events or death) were included in the study. ICC ranged from < 0.001 to 0.508, with a median of 0.035. ICC was < 0.1 for approximately 75% of the variables. For process-related variables, median ICC was 0.09, with 0.021 for those related to outcome. These findings confirm data from previous studies. Homogeneity may be considered minor, thus increasing reliability of these findings., Conclusions: These results may be used to design new cluster trials in maternal and perinatal health and to help calculate sample sizes.

Background: The Achilles tendon Total Rupture Score was developed by a research group in 2007 in response to the need for a patient reported outcome measure for this patient population. Beyond this original development paper, no further validation studies have been published.Consequently the purpose of this study was to evaluate internal consistency, convergent validity and responsiveness of this newly developed patient reported outcome measure within patients who have sustained an isolated acute Achilles tendon rupture., Methods: Sixty-four eligible patients with an acute rupture of their Achilles tendon completed the Achilles tendon Total Rupture Score alongside two further patient reported outcome measures (Disability Rating Index and EQ 5D). These were completed at baseline, six weeks, three months, six months and nine months post injury. The Achilles tendon Total Rupture Score was evaluated for internal consistency, using Cronbach's alpha, convergent validity, through correlation analysis and responsiveness, by analysing floor and ceiling effects and calculating its relative efficiency in comparison to the Disability Rating Index and EQ 5D scores., Results: The Achilles tendon Total Rupture Score demonstrated high internal consistency (Cronbachs alpha > 0.8) and correlated significantly (p < 0.001) with the Disability Rating Index at five time points (pre-injury, six weeks, three, six and nine months) with correlation coefficients between -0.5 and -0.9. However, the confidence intervals were wide. Furthermore, the ability of the new score to detect clinically important changes over time (responsiveness) was shown to be greater than the Disability Rating Index and EQ 5D., Conclusions: A universally accepted outcome measure is imperative to allow comparisons to be made across practice. This is the first study to evaluate aspects of validity of this newly developed outcome measure, outside of the developing centre. The ATRS demonstrated high internal consistency and responsiveness, with limited convergent validity. This research provides further support for the use of this outcome measure, however further research is required to advocate its universal use in patients with acute Achilles tendon ruptures. Such areas include inter-rater reliability and research to determine the minimally clinically important difference between scores.All authors have read and concur with the content of this manuscript. The material presented has not been and will not be submitted for publication elsewhere, except as an abstract. All authors have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content and (3) final approval of the submitted version. This research has been funded by Arthritis Research UK, no conflicts of interests have been declared by the authors.

Background: To build a reference curve for the area of Wharton's jelly (WJ) in low-risk pregnancies from 13 to 40 weeks and to assess its relationship with estimated fetal weight (EFW)., Methods: 2,189 low-risk pregnancies had the area of WJ estimated by ultrasound and the 10th, 50th and 90th percentiles calculated using a third-degree polynomial regression procedure. EFW by ultrasound was correlated with the measurement of the area of WJ., Results: The area of WJ increased according to gestational age (R² = 0.64), stabilizing from the 32nd week onwards. There was a significant linear correlation between area of WJ and EFW up to 26 weeks (R = 0.782) and after that 5t remained practically constant (R = 0.047)., Conclusion: The area of WJ increases according to gestational age, with a trend to stabilize at around 32 weeks of gestation. It is also linearly correlated with EFW only up to 26 weeks of gestation.

Background: Fractures of the distal radius are extremely common injuries in adults. However, the optimal management remains controversial. In general, fractures of the distal radius are treated non-operatively if the bone fragments can be held in anatomical alignment by a plaster cast or orthotic. However, if this is not possible, then operative fixation is required. There are several operative options but the two most common in the UK, are Kirschner-wire fixation (K-wires) and volar plate fixation using fixed-angle screws (locking-plates). The primary aim of this trial is to determine if there is a difference in the Patient-Reported Wrist Evaluation one year following K-wire fixation versus locking-plate fixation for adult patients with a dorsally-displaced fracture of the distal radius., Methods/design: All adult patients with an acute, dorsally-displaced fracture of the distal radius, requiring operative fixation are potentially eligible to take part in this study. A total of 390 consenting patients will be randomly allocated to either K-wire fixation or locking-plate fixation. The surgery will be performed in trauma units across the UK using the preferred technique of the treating surgeon. Data regarding wrist function, quality of life, complications and costs will be collected at six weeks and three, six and twelve months following the injury. The primary outcome measure will be wrist function with a parallel economic analysis., Discussion: This pragmatic, multi-centre trial is due to deliver results in December 2013., Trial Registration: Current Controlled Trials ISRCTN31379280 UKCRN portfolio ID 8956.

Objective: To identify perinatal outcomes associated with low birth weight (LBW)., Methods: A retrospective cohort study in a tertiary maternity hospital. Analysis of the database on 43,499 liveborn infants delivered between 1986 and 2004 with low (n = 6,477) and normal (n = 37,467) birth weight. Outcomes associated with LBW were identified through crude and adjusted risk ratio (RR) and 95%CI with bivariate and multivariate analysis. The main outcomes were: onset of labor, mode of delivery, indication for cesarean section; amniotic fluid, fetal heart rate pattern, Apgar score, somatic gestational age, gender and congenital malformation., Results: LBW infants showed more frequently signs of perinatal compromise such as abnormal amniotic fluid volume (especially olygohydramnios), nonreassuring patterns of fetal heart rate, malformation, lower Apgar scores and lower gestational age at birth. They were associated with a greater risk of labor induction and cesarean delivery, but lower risk of forceps., Conclusion: There was a clear association between LBW and unfavorable perinatal outcomes.

Background: Improving maternal health is one of the Millennium Development Goals for 2015. Recently some progress has been achieved in reducing mortality. On the other hand, in developed regions, maternal death is a relatively rare event compared to the number of cases of morbidity; hence studying maternal morbidity has become more relevant. Electronic surveillance systems may improve research by facilitating complete data reporting and reducing the time required for data collection and analysis. Therefore the purpose of this study was to describe the methods used in elaborating and implementing the National Network for the Surveillance of Severe Maternal Morbidity in Brazil., Methods: The project consisted of a multicenter, cross-sectional study for the surveillance of severe maternal morbidity including near-miss, in Brazil., Results: Following the development of a conceptual framework, centers were selected for inclusion in the network, consensus meetings were held among the centers, an electronic data collection system was identified, specific software and hardware tools were developed, research material was prepared, and the implementation process was initiated and analyzed., Conclusion: The conceptual framework developed for this network was based on the experience acquired in various studies carried out in the area over recent years and encompasses maternal and perinatal health. It is innovative especially in the context of a developing country. The implementation of the project represents the first step towards this planned management. The system online elaborated for this surveillance network may be used in further studies in reproductive and perinatal health.

Background: The association between overweight and gastrointestinal symptoms has been recently studied in the literature; however, few studies have evaluated the association between overweight and constipation in adolescents in a community-based sample. The aim of this study was to analyze the prevalence of constipation and its association with being overweight in a community-based survey with adolescents., Methods: This cross-sectional study included 1,077 adolescents who were enrolled in five schools in the city of Sao José dos Campos, Brazil. Constipation was defined according to modified and combined Rome III criteria for adolescents and adults. Being overweight was defined as a body mass index (BMI) that was equal to or greater than that of the 85th percentile for age and gender., Results: Constipation was diagnosed in 18.2% (196/1077) of the included adolescents. There was no significant difference in the prevalence of constipation in males and females who were both younger and older than 14 years. Fecal incontinence was observed in 25 adolescents, 22 (88.0%) of whom were diagnosed as being constipated. The prevalence of being overweight was found in 13.5% (145/1077) of the study population. The prevalence of constipation was observed to be similar in adolescents who were (19.4%; 28/144) and were not (18.0%; 168/933) overweight (p = 0.764; OR = 1.10). Fecal incontinence that was associated with constipation was more frequent in adolescents who were overweight (37.0%; 8/28) than in adolescents who were not overweight (8.5%; 14/168; p = 0.005; OR = 4.40)., Conclusions: The prevalence of constipation was high among the investigated adolescents. There was no association between being overweight and constipation; however, an association between being overweight and fecal incontinence in constipated adolescents was confirmed.

Background: The primary aim of this study was to provide an estimate of effect size for the functional outcome of operative versus non-operative treatment for patients with an acute rupture of the Achilles tendon using accelerated rehabilitation for both groups of patients. The secondary aim was to assess the use of a comprehensive cohort research design (i.e. a parallel patient-preference group alongside a randomised group) in improving the accuracy of this estimate within an orthopaedic trauma setting., Methods: Pragmatic randomised controlled trial and comprehensive cohort study within a level 1 trauma centre. Twenty randomised participants (10 operative and 10 non-operative) and 29 preference participants (3 operative and 26 non-operative). The ge range was 22-72 years and 37 of the 52 patients were men. All participants had an acute rupture of their Achilles tendon and no other injuries. All of the patients in the operative group had a simple end-to-end repair of the tendon with no augmentation. Both groups then followed the same eight-week immediate weight-bearing rehabilitation programme using an off-the-shelf orthotic. The disability rating index (DRI; primary outcome), EQ-5D, Achilles Total Rupture Score and complications were assessed ed at two weeks, six weeks, three months, six months and nine months after initial injury., Results: At nine months, there was no significant difference in DRI between patients randomised to operative or non-operative management. There was no difference in DRI between the randomised group and the parallel patient preference group. The use of a comprehensive cohort of patients did not provide useful additional information as to the treatment effect size because the majority of patients chose non-operative management., Conclusions: Recruitment to clinical trials that compare operative and non-operative interventions is notoriously difficult; especially within the trauma setting. Including a parallel patient preference group to create a comprehensive cohort of patients has been suggested as a way of increasing the power of such trials. In our study, the comprehensive cohort model doubled the number of patients involved in the study. However, a strong preference for non-operative treatment meant that the increased number of patients did not significantly increase the ability of the trial to detect a difference between the two interventions., Trial Registration: ISRCTN: ISRCTN29053307.

Background: Controversy exists regarding the optimal treatment for patients with displaced intracapsular fractures of the proximal femur. The recognised treatment alternatives are arthroplasty and internal fixation. The principal criticism of internal fixation is the high rate of non-union; up to 30% of patients will have a failure of the fixation leading to revision surgery. We believe that improved fracture healing may lead to a decreased rate of failure of fixation. We therefore propose to investigate strategies to both accelerate fracture healing and improve fixation that may significantly improve outcomes after internal fixation of intracapsular femoral fractures. We aim to test the clinical effectiveness of the osteoinductive agent platelet rich plasma and conduct a pilot study of a novel fixed-angle fixation system., Design: We have planned a three arm, single centre, standard-of-care controlled, double blinded, pragmatic, randomised clinical trial. The trial will include a standard two-way comparison between platelet-rich plasma and standard-of-care fixation versus standard-of-care fixation alone. In addition there will be a subsidiary pilot arm testing a fixed-angle screw and plate fixation system., Trial Registration: Current Controlled Trials ISRCTN49197425.

Objective: to compare the distribution of caesarean rates in the Robson's 10 groups classification in order to see if any change occurred after the implementation of an audit and feedback intervention., Design: cross sectional, before and after an audit and feedback study., Setting: a university hospital in Brazil., Methods: clinical records of all births during two three months-periods were evaluated. Each case of CS was classified into one of ten mutually exclusive categories according to obstetric characteristics. The proportion of CS in each group was compared in both periods., Results: total number of deliveries and the high rate of CS were similar in both periods. Group 3 (multiparous excluding previous CS, single, cephalic, >/= 37 weeks, spontaneous labour) accounted for the largest proportion of deliveries, 28.5 and 26.8% in both periods. Group 1 (nulliparous, single, cephalic, >/= 37 weeks, spontaneous labour) was the second largest one, while Group 5 (previous caesarean section, single, cephalic, and >/= 37 weeks) was the third but the largest contributor to CS, accounting for 16.6 and 14.9% among all deliveries in both periods. Groups 2 (nulliparous, single, cephalic, >/= 37 weeks, induction or CS before labour) and 4 (multiparous excluding previous CS, single, cephalic, >/= 37 weeks, induction or CS before labour) were less prevalent, however had higher rates of CS. Only in Group 10 (All single, cephalic,

Background: Hip replacement (arthroplasty) surgery is a highly successful treatment for patients with severe symptomatic arthritis of the hip joint. For older patients, several designs of Total Hip Arthroplasty have shown excellent results in terms of both function and value for money. However, in younger more active patients, there is approximately a 50% failure rate at 25 years for traditional implants. Hip resurfacing is a relatively new arthroplasty technique. In a recent review of the literature on resurfacing arthroplasty it was concluded that the short-term functional results appear promising but some potential early disadvantages were identified, including the risk of femoral neck fracture and collapse of the head of the femur. The aim of the current study is to assess whether there is a difference in functional hip scores at one year post-operation between Total Hip Arthroplasty and Resurfacing Arthroplasty. Secondary aims include assessment of complication rates for both procedures as well cost effectiveness., Methods/design: All patients medically fit for surgery and deemed suitable for a resurfacing arthroplasty are eligible to take part in this study. A randomisation sequence will be produced and administered independently. After consenting, all patients will be clinically reviewed and hip function, quality of life and physical activity level will be assessed through questionnaires. The allocated surgery will then be performed with the preferred technique of the surgeon. Six weeks post-operation hip function will be assessed and complications recorded. Three, six and 12 months post-operation hip function, quality of life and physical activity level will be assessed. Additional information about patients' out-of-pocket expenses will also be collected., Trial Registration: Current Controlled Trials ISRCTN33354155. UKCLRN portfolio ID 4093.

Background: It has been suggested that the study of women who survive life-threatening complications related to pregnancy (maternal near-miss cases) may represent a practical alternative to surveillance of maternal morbidity/mortality since the number of cases is higher and the woman herself is able to provide information on the difficulties she faced and the long-term repercussions of the event. These repercussions, which may include sexual dysfunction, postpartum depression and posttraumatic stress disorder, may persist for prolonged periods of time, affecting women's quality of life and resulting in adverse effects to them and their babies., Objective: The aims of the present study are to create a nationwide network of scientific cooperation to carry out surveillance and estimate the frequency of maternal near-miss cases, to perform a multicenter investigation into the quality of care for women with severe complications of pregnancy, and to carry out a multidimensional evaluation of these women up to six months., Methods/design: This project has two components: a multicenter, cross-sectional study to be implemented in 27 referral obstetric units in different geographical regions of Brazil, and a concurrent cohort study of multidimensional analysis. Over 12 months, investigators will perform prospective surveillance to identify all maternal complications. The population of the cross-sectional component will consist of all women surviving potentially life-threatening conditions (severe maternal complications) or life-threatening conditions (the maternal near miss criteria) and maternal deaths according to the new WHO definition and criteria. Data analysis will be performed in case subgroups according to the moment of occurrence and determining cause. Frequencies of near-miss and other severe maternal morbidity and the association between organ dysfunction and maternal death will be estimated. A proportion of cases identified in the cross-sectional study will comprise the cohort of women for the multidimensional analysis. Various aspects of the lives of women surviving severe maternal complications will be evaluated 3 and 6 months after the event and compared to a group of women who suffered no severe complications in pregnancy. Previously validated questionnaires will be used in the interviews to assess reproductive function, posttraumatic stress, functional capacity, quality of life, sexual function, postpartum depression and infant development.