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Introduction: Prep-4-RT is a co-designed stepped-care multimodal prehabilitation program for people scheduled to receive radiotherapy for head and neck cancer (HNC). Prehabilitation, which occurs between diagnosis and treatment commencement, aims to improve a patient's health to reduce the incidence and severity of current and future impairments. HNC treatment can be distressing and has detrimental impacts on function and quality of life. HNC patients have increased social vulnerabilities including higher rates of socio-economic disadvantage and engagement in lifestyle habits which increase cancer risk. High levels of physical and psychological impacts of HNC treatment and increased social vulnerabilities of this population warrant investigation of optimal pathways of care, such as prehabilitation. This paper describes a research protocol to evaluate the feasibility of Prep-4-RT, which was designed to prepare HNC patients for the physical and psychological impacts of radiotherapy. Methods and analysis: At least sixty adult HNC patients, scheduled to receive radiotherapy (with or without chemotherapy), will be recruited over a five-month period. All participants will receive access to Prep-4-RT self-management resources. Participants identified through screening as high-risk will also be offered individualised interventions with relevant allied health professionals prior to the commencement of radiotherapy (psychologists, dietitians, speech pathologists and physiotherapists). Participants will complete evaluation surveys assessing their experiences with Prep-4-RT resources and interventions. Clinicians will also complete program evaluation surveys. Primary feasibility outcomes include adoption (uptake and intention to try) and fidelity (adherence to the specialist prehabilitation pathway). Secondary feasibility outcomes include acceptability (patient and clinician) of and satisfaction (patient) with Prep-4-RT as well as operational costs. Feasibility outcome data will be analysed using exact binomial and one-sample t tests, as appropriate. Ethics and dissemination: Ethics approval has been obtained at the Peter MacCallum Cancer Centre in Melbourne, Australia. Results will be presented at national conferences and published in peer-reviewed journal(s) so that it can be accessed by clinicians involved in the care of HNC patients receiving radiotherapy. If the model of care is found to be feasible and acceptable, the transferability and scalability to other cancer centres, or for other cancer types, may be investigated. Registration details: ANZCTA (Australian New Zealand Clinical Trials Registry) ACTRN12623000770662. [ABSTRACT FROM AUTHOR]

Background: Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group.Methods: This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity.Results: A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures.Discussion: If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners.Trial Registration: This trial has been registered with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health on April 19, 2014. The registration ID is NCT02290808 . [ABSTRACT FROM AUTHOR]

Background: Cigarette smoking remains the leading cause of preventable disease and death in the United States. Primary care offers an ideal setting to reach adults who smoke cigarettes and improve uptake of evidence-based cessation treatment. Although U.S. Preventive Services Task Force Guidelines recommend the 5As model (Ask, Advise, Assess, Assist, Arrange) in primary care, there are many barriers to its implementation. Automated, comprehensive, and proactive tools are needed to overcome barriers. Our team developed and preliminarily evaluated a proactive electronic visit (e-visit) delivered via the Electronic Health Record patient portal to facilitate evidence-based smoking cessation treatment uptake in primary care, with promising initial feasibility and efficacy. This paper describes the rationale, design, and protocol for an ongoing Hybrid Type I effectiveness-implementation trial that will simultaneously assess effectiveness of the e-visit intervention for smoking cessation as well as implementation potential across diverse primary care settings. Methods: The primary aim of this remote five-year study is to examine the effectiveness of the e-visit intervention vs. treatment as usual (TAU) for smoking cessation via a clinic-randomized clinical trial. Adults who smoke cigarettes are recruited across 18 primary care clinics. Clinics are stratified based on their number of primary care providers and randomized 2:1 to either e-visit or TAU. An initial baseline e-visit gathers information about patient smoking history and motivation to quit, and a clinical decision support algorithm determines the best evidence-based cessation treatment to prescribe. E-visit recommendations are evaluated by a patient's own provider, and a one-month follow-up e-visit assesses cessation progress. Main outcomes include: (1) cessation treatment utilization (medication, psychosocial cessation counseling), (2) reduction in cigarettes per day, and (3) biochemically verified 7-day point prevalence abstinence (PPA) at six-months. We hypothesize that patients randomized to the e-visit condition will have better cessation outcomes (vs. TAU). A secondary aim evaluates e-visit implementation potential at patient, provider, and organizational levels using a mixed-methods approach. Implementation outcomes include acceptability, adoption, fidelity, implementation cost, penetration, and sustainability. Discussion: This asynchronous, proactive e-visit intervention could provide substantial benefits for patients, providers, and primary care practices and has potential to widely improve reach of evidence-based cessation treatment. Trial registration: NCT05493254. [ABSTRACT FROM AUTHOR]

Background: This paper presents insight into the scale of mental health concerns for families who have a child or young person with a diagnosis of Juvenile Idiopathic Arthritis (JIA) living in any of the four nations of the United Kingdom (UK). The study's objective is to share the current experiences of those that responded to a charity survey and consider future work to improve mental health support. Methods: This work was initiated and led by five UK charity partner organisations working with families affected by JIA. Parents/carers of a child or young person with JIA, and young people with JIA, submitted self-completion online questionnaires. The questionnaire asked 19 core questions, with a focus on the mental health impact of having and living with a JIA diagnosis. Questionnaires were delivered via charity partner UK-wide mailing lists and social media. Results: Questionnaire were completed by 291 participants over a 3-week period in February 2022. The majority of respondents were parents (229, 79%), 103 children had been diagnosed for over six years (35%), and 131 (45%) received shared care between paediatric rheumatology centres. In total, 168 (59%) children and young people with JIA had received, were currently receiving or were waiting for mental health support. Parents reported that their child's diagnosis impacted their own mental health (218, 82%). Children and young people reported never being offered mental health support during appointments for JIA (157, 54%), and 71 (50%) of these had never received support. Conclusion: Children and young people with JIA have significant mental health sequelae from their diagnosis. Our findings found that nearly 60% of our respondents have had or are requiring mental health support, with significant numbers of parents/carers reporting difficulties in accessing care for their child's mental health or their own mental health, due to their child's diagnosis. This unique collaborative charity-led study, illustrates the importance of timely and accessible mental health support. Further work is needed to understand why best practice guidance for mental health support is not being met consistently and to identify how to embed it into standard rheumatology care. [ABSTRACT FROM AUTHOR]

Phenylketonuria (PKU) is an inherited metabolic disease characterized by a defective conversion of phenylalanine (Phe) to tyrosine, potentially leading to Phe accumulation in the brain. Dietary restriction since birth has led to normal cognitive development. However, PKU patients can still develop cognitive or behavioral abnormalities and subtle neurological deficits. Despite the increasing evidence in the field, the assessment of neurocognitive, psychopathological, and neurological follow-up of PKU patients at different ages is still debated. The high interindividual variability in the cognitive outcome of PKU patients makes the specificity of the neurocognitive and behavioral assessment extremely challenging. In the present paper, a multidisciplinary panel of Italian PKU experts discussed different tools available for cognitive, psychopathological, and neurological assessment at different ages based on the existing literature and daily clinical practice. This study aims to provide evidence and a real-life-based framework for a specific clinical assessment of pediatric, adolescent, and adult patients affected by PKU. [ABSTRACT FROM AUTHOR]

Background: Health-related quality of life (HRQoL) is determined by multiple factors that include components such as spirituality and religiousness (S/R). Even though various systematic reviews have investigated the association between S/R and improved health outcomes in the most different groups, healthy young individuals are seldom addressed.Objective: To assess the association between S/R and HRQoL among young, healthy individuals.Methods: Systematic review of papers published in the last ten years and indexed in four academic research databases (PubMed, Web of Science, Cochrane Library, and Scopus) and two gray literature databases. Inclusion criteria were studies assessing S/R and HRQoL using validated instruments and assessing healthy adults (i.e., non-clinical patients, not belonging to any specific group of chronic diseases), aged between 18 and 64 years old.Results: Ten out of 1,952 studies met the inclusion criteria: nine cross-sectional and one longitudinal cohort study, in which 89% of the participants were college students. Nine studies report a positive association between S/R and HRQoL, while one study did not report any significant association. The main HRQoL domains associated with S/R were the psychological, social relationships, and environment domains, while the S/R most influent facets/components were optimism, inner strength, peace, high control, hope, and happiness.Conclusions: Higher S/R levels among healthy adult individuals were associated with higher HRQoL levels, suggesting the S/R can be an important strategy to deal with adverse environmental situations even among those without chronic diseases, enhancing the wellbeing of individuals. Registration of systematic review: PROSPERO-CRD42018104047. [ABSTRACT FROM AUTHOR]

Background: Impaired physical function due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms may lead to diminished quality of life. However, even with the knowledge of the effects of CIPN on physical function, clinicians infrequently assess and manage CIPN. Interventions that prioritize the early identification of CIPN to provide prompt treatment may reduce the impact of CIPN on physical function. The purpose of this paper is to compare self-reported physical function in individuals receiving neurotoxic chemotherapy between Electronic Symptom Assessment-Cancer (ESRA-C) intervention group (e.g., opportunity for symptom screening, self-care recommendations, communication coaching, and symptom tracking) and control group participants (i.e., electronic assessment alone). Secondary outcomes include pain intensity, sensory/motor CIPN, depression, fatigue, and insomnia.Methods: The data used in this paper are a subset of a randomized controlled trial that examined the impact of the ESRA-C intervention on symptom distress in individuals receiving cancer treatment. Since the interest in this analysis is on the effects of neurotoxic chemotherapy on physical function, subjects were included if they received platinum and/or taxane-based chemotherapy and completed the baseline and end-of-treatment measures. Participants completed standardized questionnaires of physical function, CIPN, fatigue, depression, pain intensity, and insomnia prior to treatment, 3-6 weeks after treatment initiation, and after the completion of treatment. Changes in mean scores are compared between groups using linear mixed models adjusting for age.Results: Intervention group participants reported significantly less reduction in physical functioning (baseline: 87.4/100; end-of-treatment: 84.5/100) relative to the control (baseline: 90.2/100; end-of-treatment: 81.8/100) (p = 0.011). For secondary measures, significantly less depression (p = 0.005) was observed in the intervention group as compared to the control, but otherwise, there were no between-group differences. Among participants who received high cumulative doses of neurotoxic chemotherapy, the intervention group reported significantly less severe sensory (p = 0.007) and motor CIPN (p = 0.039) relative to the control.Conclusion: Use of the ESRA-C intervention led to less reduction in physical function in comparison to the control in individuals receiving neurotoxic chemotherapy. Further research is needed to confirm our findings and to identify how electronic symptom assessment technology may mediate physical function preservation.Trial Registration: ClinicalTrials.Gov NCT00852852 . Registered 27 February 2009. [ABSTRACT FROM AUTHOR]

Background: Mandrake (Mandragora spp.) is one of the most famous medicinal plant in western cultures since Biblical times and throughout written history. In many cultures, mandrake is related to magic and witchcraft, which is said to have a psychosomatic effect (especially when mandrake contains narcotic compounds) in addition to the pharmacological influence, as occurs with other narcotic magical plants. Due to its unique properties and related myths, it is not surprising that this plant has many names in many languages. Methods: This paper presents an attempt to reconstruct the historical, ethnobotanical, and folkloristic roots of 292 vernacular names of Mandragora spp. in forty-one languages. We used the plant's morphological data, philology, myths and legends, medicinal properties and uses, as well as historical evidence and folkloric data, to explain meaning, origin, migration, and history of the plant's names. Results: The names were classified into the following main categories: Derivatives of mandragora (19 languages), alraun (7) and of yabroukh (5). The salient groups of the plant's vernacular names are related to: Anthropomorphism (33 names in 13 languages); Similarity to other plants (28/9); Supernatural agents (28/9); Narcotic effects (21/8); Leaves, fruits, and seeds (21/8); Aphrodisiac properties (17/10); Use of a dog (15/9); Gallows (14/5); Black magic, sorcery, witchcraft (13/8), and Medicinal use (11/7). Conclusions: This frequency distribution of the mandrake's vernacular names reflects its widespread reputation as related to the doctrine of signatures, beliefs in its supernatural, natural, and mythic powers, and to a lesser extent, its uses in magic and medicine. A spatiotemporal analysis of the mandrake's names supports the old idea that the pulling ceremonies for this plant originated in the Near East and that various other myths related to this plant may have originated in different places and periods. [ABSTRACT FROM AUTHOR]

Background: The most popular tool used for measuring personality traits is the Five-Factor Model (FFM). It includes neuroticism, extraversion, openness, agreeableness and conscientiousness. Many studies indicated the association of genes encoding neurotransmitter receptors/transporters with personality traits. The relationship connecting polymorphic DNA sequences and FFM features has been described in the case of genes encoding receptors of cannabinoid and dopaminergic systems. Moreover, dopaminergic system receives inputs from other neurotransmitters, like GABAergic or serotoninergic systems. Methods: We searched PubMed Central (PMC), Science Direct, Scopus, Cochrane Library, Web of Science and EBSCO databases from their inception to November 19, 2020, to identify original studies, as well as peer-reviewed studies examining the FFM and its association with gene polymorphisms affecting the neurotransmitter functions in central nervous system. Results: Serotonin neurons modulate dopamine function. In gene encoding serotonin transporter protein, SLC6A4, was found polymorphism, which was correlated with openness to experience (in Sweden population), and high scores of neuroticism and low levels of agreeableness (in Caucasian population). The genome-wide association studies (GWASs) found an association of 5q34-q35, 3p24, 3q13 regions with higher scores of neuroticism, extraversion and agreeableness. However, the results for chromosome 3 regions are inconsistent, which was shown in our review paper. Conclusions: GWASs on polymorphisms are being continued in order to determine and further understand the relationship between the changes in DNA and personality traits. [ABSTRACT FROM AUTHOR]

Background: Collaboration between humans and computers has become pervasive and ubiquitous, however current computer systems are limited in that they fail to address the emotional component. An accurate understanding of human emotions is necessary for these computers to trigger proper feedback. Among multiple emotional channels, physiological signals are synchronous with emotional responses; therefore, analyzing physiological changes is a recognized way to estimate human emotions. In this paper, a three-stage decision method is proposed to recognize four emotions based on physiological signals in the multi-subject context. Emotion detection is achieved by using a stage-divided strategy in which each stage deals with a fine-grained goal.Methods: The decision method consists of three stages. During the training process, the initial stage transforms mixed training subjects to separate groups, thus eliminating the effect of individual differences. The second stage categorizes four emotions into two emotion pools in order to reduce recognition complexity. The third stage trains a classifier based on emotions in each emotion pool. During the testing process, a test case or test trial will be initially classified to a group followed by classification into an emotion pool in the second stage. An emotion will be assigned to the test trial in the final stage. In this paper we consider two different ways of allocating four emotions into two emotion pools. A comparative analysis is also carried out between the proposal and other methods.Results: An average recognition accuracy of 77.57% was achieved on the recognition of four emotions with the best accuracy of 86.67% to recognize the positive and excited emotion. Using differing ways of allocating four emotions into two emotion pools, we found there is a difference in the effectiveness of a classifier on learning each emotion. When compared to other methods, the proposed method demonstrates a significant improvement in recognizing four emotions in the multi-subject context.Conclusions: The proposed three-stage decision method solves a crucial issue which is 'individual differences' in multi-subject emotion recognition and overcomes the suboptimal performance with respect to direct classification of multiple emotions. Our study supports the observation that the proposed method represents a promising methodology for recognizing multiple emotions in the multi-subject context. [ABSTRACT FROM AUTHOR]

Background: Recent World Health Organization recommendations recognize the important role Traditional Birth Attendants (TBAs) can play in supporting the health of women and newborns. This paper provides an analysis of key factors that affect the implementation of interventions to develop partnerships with TBAs to promote improved access to skilled care at birth.Methods: We conducted a secondary analysis of 20 papers identified through two systematic reviews that examined the effectiveness of interventions to find new roles for TBAs on maternal and newborn health outcomes, as well as papers identified through a systematic mapping of the maternal health literature. The Supporting the Use of Research Evidence framework (SURE) guided the thematic analysis to explore the perceptions of various stakeholders and implementation barriers and facilitators, as well as other contextual issues.Results: This analysis identified countries that have implemented interventions to support the transition from birth with a TBA to birth with a skilled birth attendant. Drawing on the experiences of these countries, the analysis highlights factors that are important to consider when designing and implementing such interventions. Barriers to implementation included resistance to change in more traditional communities, negative attitudes between TBAs and skilled attendants and TBAs concerns about the financial implications of assuming new roles. Facilitating factors included stakeholder involvement in devising and implementing interventions, knowledge sharing between TBAs and skilled birth attendants, and formalised roles and responsibilities and remuneration for TBAs.Conclusions: The implementation barriers identified in this analysis could, if not addressed, prevent or discourage TBAs from carrying out newly defined roles supporting women in pregnancy and childbirth and linking them to the formal health system. This paper also identifies the factors that seem critical to success, which new programmes could consider adopting from the outset. In most cases a multi-faceted approach is needed to prepare TBAs and others for new roles, including the training of TBAs to strengthen their knowledge and skills to enable them to be able to assume new roles, alongside the sensitization of healthcare providers, communities, women and their families. Further research is required to map the transition process and stakeholder experiences in more detailed ways and to provide longer-term monitoring of existing interventions. [ABSTRACT FROM AUTHOR]

Background: Rasch analysis with a focus on Differential Item Functioning (DIF) is increasingly used for examination of psychometric properties of health outcome measures. To take account of DIF in order to retain precision of measurement, split of DIF-items into separate sample specific items has become a frequently used technique. The purpose of the paper is to present and summarise recent advances of analysis of DIF in a unified methodology. In particular, the paper focuses on the use of analysis of variance (ANOVA) as a method to simultaneously detect uniform and non-uniform DIF, the need to distinguish between real and artificial DIF and the trade-off between reliability and validity. An illustrative example from health research is used to demonstrate how DIF, in this case between genders, can be identified, quantified and under specific circumstances accounted for using the Rasch model.Methods: Rasch analyses of DIF were conducted of a composite measure of psychosomatic problems using Swedish data from the Health Behaviour in School-aged Children study for grade 9 students collected during the 1985-2014 time periods.Results: The procedures demonstrate how DIF can be identified efficiently by ANOVA of residuals, and how the magnitude of DIF can be quantified and potentially accounted for by resolving items according to identifiable groups and using principles of test equating on the resolved items. The results of the analysis also show that the real DIF in some items does affect person measurement estimates.Conclusions: Firstly, in order to distinguish between real and artificial DIF, the items showing DIF initially should not be resolved simultaneously but sequentially. Secondly, while resolving instead of deleting a DIF item may retain reliability, both options may affect the content validity negatively. Resolving items with DIF is not justified if the source of the DIF is relevant for the content of the variable; then resolving DIF may deteriorate the validity of the instrument. Generally, decisions on resolving items to deal with DIF should also rely on external information. [ABSTRACT FROM AUTHOR]

Background: A large mental health treatment gap exists among conflict-affected populations, and Syrian refugees specifically. Promising brief psychological interventions for conflict-affected populations exist such as the World Health Organization's Problem Management Plus (PM+) and the Early Adolescent Skills for Emotions (EASE) intervention, however, there is limited practical guidance for countries of how these interventions can be taken to scale. The aim of this study was to unpack pathways for scaling up PM+ and EASE for Syrian refugees.Methods: We conducted three separate Theory of Change (ToC) workshops in Turkey, the Netherlands, and Lebanon in which PM+ and EASE are implemented for Syrian refugees. ToC is a participatory planning process involving key stakeholders, and aims to understand a process of change by mapping out intermediate and long-term outcomes on a causal pathway. 15-24 stakeholders were invited per country, and they participated in a one-day interactive ToC workshop on scaling up.Results: A cross-country ToC map for scale up brief psychological interventions was developed which was based on three country-specific ToC maps. Two distinct causal pathways for scale up were identified (a policy and financing pathway, and a health services pathway) which are interdependent on each other. A list of key assumptions and interventions which may hamper or facilitate the scaling up process were established.Conclusion: ToC is a useful tool to help unpack the complexity of scaling up. Our approach highlights that scaling up brief psychological interventions for refugees builds on structural changes and reforms in policy and in health systems. Both horizontal and vertical scale up approaches are required to achieve sustainability. This paper provides the first theory-driven map of causal pathways to help support the scaling-up of evidence-based brief psychological interventions for refugees and populations in global mental health more broadly. [ABSTRACT FROM AUTHOR]

Background: Women's childbirth experience can have immediate as well as long-term positive or negative effects on their life, well-being and health. When evaluating and drawing conclusions from research results, women's experiences of childbirth should be one aspect to consider. Researchers and clinicians need help in finding and selecting the most suitable instrument for their purpose. The aim of this study was therefore to systematically identify and present validated instruments measuring women's childbirth experience.Methods: A systematic review was conducted in January 2016 with a comprehensive search in the bibliographic databases PubMed, CINAHL, Scopus, The Cochrane Library and PsycINFO. Included instruments measured women's childbirth experiences. Papers were assessed independently by two reviewers for inclusion, and quality assessment of included instruments was made by two reviewers independently and in pairs using Terwee et al's criteria for evaluation of psychometric properties.Results: In total 5189 citations were screened, of which 5106 were excluded by title and abstract. Eighty-three full-text papers were reviewed, and 37 papers were excluded, resulting in 46 included papers representing 36 instruments. These instruments demonstrated a wide range in purpose and content as well as in the quality of psychometric properties.Conclusions: This systematic review provides an overview of existing instruments measuring women's childbirth experiences and can support researchers to identify appropriate instruments to be used, and maybe adapted, in their specific contexts and research purpose. [ABSTRACT FROM AUTHOR]

Background: Obstetricians are often reluctant to grant requests for an elective cesarean section (ECS) due to childbirth fear. To date, it is unknown if an ECS on request improves mental well-being in the mother in the peripartum period and if possible beneficial effects on anxiety and depression could outweigh the increased risk of complications associated with a surgical delivery. A systematic review was conducted to explore the effect of ECS on request on peripartum anxiety and depression.Methods: We searched on PubMed, PsychoInfo and Embase. Studies were included with primary data on anxiety and/or depression postpartum in women with childbirth fear who had requested an ECS. After full-text evaluation of 65 papers and quality analysis of four papers, three papers were included. Of one paper additional and yet unpublished data were provided. Studies varied in outcome measures, hence no meta-analysis was performed.Results: Women who requested an ECS had higher antepartum depression and anxiety levels but no different postpartum depression levels than women who delivered vaginally. One study of good quality examined the effect of vaginal delivery in women preferring ECS: These women had significantly higher symptom levels of post-traumatic stress disorder (PTSD) and depression than women with normal vaginal delivery.Conclusions: The prospect of an ECS does not lower antepartum anxiety and/or depression levels in women requesting an ECS. If women resolutely persist in wishing an ECS despite adequate counselling and/or psychiatric treatment, the risk of developing depressive and PTSD symptoms in case of vaginal delivery should be taken into account, and an ECS may be considered as a valid alternative. [ABSTRACT FROM AUTHOR]

Background: Dissociative seizures (DSs), also called psychogenic non-epileptic seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims of reducing seizure frequency and severity and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES trial, as agreed by the trial steering committee.Methods: The CODES trial is a multicentre, pragmatic, parallel group, randomised controlled trial performed to evaluate the clinical effectiveness and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) compared with SMC alone for adult outpatients with DS.Discussion: The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as are the descriptive statistics that will be reported. This paper provides transparency to the planned inferential analyses for the CODES trial prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials.Trial Registration: ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014). [ABSTRACT FROM AUTHOR]

Background: Asthma and pregnancy are both sources of anxiety for women. Although there has been a focus on physiological management of asthma and pregnancy, there has been little research on the impact that personalised support can have on asthma care during pregnancy. This systematic review and narrative synthesis of the literature set out to answer the question 'What are women's experiences of asthma care, its management and education, during pregnancy?'Methods: This systematic review was carried out using accepted methodology from the York Centre for Reviews and Dissemination. Electronic database searches were conducted using PsycInfo, CINAHL, MedLine, Google Scholar and the Cochrane Library, using the combination search terms: 'Asthma' AND 'Pregnancy' AND 'Care' AND ('Education OR Information OR Experience'). Hand searching of journals and searches for grey literature were also undertaken. Independent quality appraisal by the three authors took place using the criteria detailed by Kmet et al. (Standard Quality Assessment Criteria for Evaluating Primary Research Papers from a Variety of Fields, 2004).Results: All papers scoring in excess of 60% were deemed to be of adequate quality for inclusion, of which there were five: two qualitative designs and three quantitative designs. The designs were too methodologically heterogeneous to permit statistical meta-analysis so narrative review and synthesis was undertaken. Despite an embryonic evidence bases, it is reasonable to conclude that personalised care has beneficial outcomes for pregnant asthmatic women.Conclusions: Larger randomised controlled trials investigating personalised care are required to build an evidence base which can establish the efficacy of such interventions. [ABSTRACT FROM AUTHOR]

Background: Postpartum Haemorrhage (PPH) is a leading cause of maternal mortality with approximately 225 women dying as a result of it each day especially in low income countries. However, much less is known about morbidity after a PPH. This systematic review aimed to determine the overall prevalence of emotional and physical health problems experienced by women following a postpartum haemorrhage.Methods: Eight databases were searched for published non-randomised, observational, including cohort, primary research studies that reported on the prevalence of emotional and/or physical health problems following a PPH. Intervention studies were included and data, if available, were abstracted on the control group. All authors independently screened the papers for inclusion. Of the 2210 papers retrieved, six met the inclusion criteria. Data were extracted independently by two authors. The methodological quality of the included studies was assessed using a modified Newcastle Ottawa Scale (NOS). The primary outcome measure reported was emotional and physical health problems up to 12 months postpartum following a postpartum haemorrhage.Results: Two thousand two hundred ten citations were identified and screened with 2089 excluded by title and abstract. Following full-text review of 121 papers, 115 were excluded. The remaining 6 studies were included. All included studies were judged as having strong or moderate methodological quality. Five studies had the sequelae of PPH as their primary focus, and one study focused on morbidity postnatally, from which we could extract data on PPH. Persistent morbidities following PPH (at ≥ 3 and < 6 months postpartum) included postnatal depression (13 %), post-traumatic stress disorder (3 %), and health status 'much worse than one year ago' (6 %). Due to the different types of health outcomes reported in the individual studies, it was possible to pool results from only four studies, and only then by accepting the slightly differing definitions of PPH. Those that could be pooled reported rates of acute renal failure (0.33 %), coagulopathy (1.74 %) and re-admission to hospital following a PPH between 1 and 3 months postpartum (3.6 %), an appreciable indication of underlying physical problems.Conclusion: This systematic review demonstrates that the existence and type of physical and emotional health problems post PPH, regardless of the volume of blood lost, are largely unknown. Further large cohort or case control studies are necessary to obtain better knowledge of the sequelae of this debilitating morbidity. [ABSTRACT FROM AUTHOR]

Background: Health personnel are susceptible to high levels of work stress and burnout due to the psychological and emotional demands of their work, as well as to other aspects related to the organisation of that work. This paper describes the rationale and design of the MINDUUDD study, the aim of which is to evaluate the effectiveness of a mindfulness and self-compassion 4-session programme versus the standard 8-session programme to reduce work stress and burnout in Family and Community Medicine and Nursing tutors and residents. Methods: The MINDUDD study is a multicentre cluster randomised controlled trial with three parallel arms. Six Teaching Units will be randomised to one of the three study groups: 1) Experimental Group-8 (EG8); 2) Experimental Group-4 (EG4) Control group (CG). At least 132 subjects will participate (66 tutors/66 residents), 44 in the EG8, 44 in the EG4, and 44 in the CG. Interventions will be based on the Mindfulness-Based Stress Reduction (MBSR) program, including some self-compassion practices of the Mindful Self-Compassion (MSC) programme. The EG8 intervention will be implemented during 8 weekly face-to-face sessions of 2.5 h each, while the EG4 intervention will consist of 4 sessions of 2.5 h each. The participants will have to practice at home for 30 min/day in the EG8 and 15 min/day in the EG4. The Five Facet Mindfulness Questionnaire (FFMQ), Self-Compassion Scale (SCS), Perceived Stress Questionnaire (PSQ), Maslach Burnout Inventory (MBI), Jefferson Scale of Physician Empathy (JSPE), and Goldberg Anxiety-Depression Scale (GADS) will be administered. Measurements will be taken at baseline, at the end of the programs, and at three months after completion. The effect of the interventions will be evaluated by bivariate and multivariate analyses (Multiple Linear Regression). Discussion: If the abbreviated mindfulness programme is at least as effective as the standard program, its incorporation into the curriculum and training plans will be easier and more appropriate. It will also be more easily applied and accepted by primary care professionals because of the reduced resources and means required for its implementation, and it may also extend beyond care settings to academic and teaching environments as well. Trial registration: The study has been registered at ClinicalTrials.gov (NCT03629457; date of registration: 13.08.2018). [ABSTRACT FROM AUTHOR]

Background: National and international guidelines for the management of hypertensive disorders of pregnancy (HDP) are available in developing countries. However, more detailed clinical pathways for primary care settings are limited. This study focuses on Indonesia, where 72% of women who died from HDP and its complications had received less appropriate treatment according to international guidelines. There is an urgent need to develop primary care focused pathways that enable general practitioners (GPs), midwives and other relevant providers to manage HDP better. Objectives: This paper describes a study protocol for the development of HDP management pathways for Indonesian primary care settings. Methods: This study design is informed by Implementation Science theories and consists of three phases. The exploratory phase will involve conducting semi-structured interviews with key Indonesian primary care stakeholders to explore their experiences and views on HDP management. The development phase will apply evidence from the literature review and results of the exploratory phase to develop HDP management pathways contextualised to Indonesian primary care settings. Consensus will be sought from approximately 50 experts, consist of general practitioners (GPs), midwives, obstetricians, nurses and policy makers using Delphi technique survey. The evaluation phase will involve a pilot study to evaluate the pathways' acceptability and feasibility in a sample of Indonesian primary care practices using mixed methods. Discussion: The implementation science frameworks inform and guide the phases in this study. Qualitative interviews in the exploratory phase are conducive to eliciting opinions from key stakeholders. Using Delphi technique at the development phase is suitable to seek participants' consensus on HDP management in primary care. Observations, focus group discussions, interviews as well as analysis of patients' medical records at the evaluation phase are expected to provide a comprehensive investigation of the implementation of the pathways in practice settings. [ABSTRACT FROM AUTHOR]

Background: Since the emergence of social media in 2004, a growing percentage of patients use this technology for health related reasons. To reflect on the alleged beneficial and potentially harmful effects of social media use by patients, the aim of this paper is to provide an overview of the extant literature on the effects of social media use for health related reasons on patients and their relationship with healthcare professionals.Methods: We conducted a systematic literature review on empirical research regarding the effects of social media use by patients for health related reasons. The papers we included met the following selection criteria: (1) published in a peer-reviewed journal, (2) written in English, (3) full text available to the researcher, (4) contain primary empirical data, (5) the users of social media are patients, (6) the effects of patients using social media are clearly stated, (7) satisfy established quality criteria.Results: Initially, a total of 1,743 articles were identified from which 22 were included in the study. From these articles six categories of patients' use of social media were identified, namely: emotional, information, esteem, network support, social comparison and emotional expression. The types of use were found to lead to seven identified types of effects on patients, namely improved self-management and control, enhanced psychological well-being, and enhanced subjective well-being, diminished subjective well-being, addiction to social media, loss of privacy, and being targeted for promotion. Social media use by patients was found to affect the healthcare professional and patient relationship, by leading to more equal communication between the patient and healthcare professional, increased switching of doctors, harmonious relationships, and suboptimal interaction between the patient and healthcare professional.Conclusions: Our review provides insights into the emerging utilization of social media in healthcare. In particular, it identifies types of use by patients as well as the effects of such use, which may differ between patients and doctors. Accordingly, our results framework and propositions can serve to guide future research, and they also have practical implications for healthcare providers and policy makers. [ABSTRACT FROM AUTHOR]

Background: First generation migrants are reportedly at higher risk of mental ill-health compared to the settled population. This paper systematically reviews and synthesizes all reviews on the mental health of first generation migrants in order to appraise the risk factors for, and explain differences in, the mental health of this population.Methods: Scientific databases were searched for systematic reviews (inception-November 2015) which provided quantitative data on the mental ill-health of first generation migrants and associated risk factors. Two reviewers screened titles, abstracts and full text papers for their suitability against pre-specified criteria, methodological quality was assessed.Results: One thousand eight hundred twenty articles were identified, eight met inclusion criteria, which were all moderate or low quality. Depression was mostly higher in first generation migrants in general, and in refugees/asylum seekers when analysed separately. However, for both groups there was wide variation in prevalence rates, from 5 to 44 % compared with prevalence rates of 8-12 % in the general population. Post-Traumatic Stress Disorder prevalence was higher for both first generation migrants in general and for refugees/asylum seekers compared with the settled majority. Post-Traumatic Stress Disorder prevalence in first generation migrants in general and refugees/ asylum seekers ranged from 9 to 36 % compared with reported prevalence rates of 1-2 % in the general population. Few studies presented anxiety prevalence rates in first generation migrants and there was wide variation in those that did. Prevalence ranged from 4 to 40 % compared with reported prevalence of 5 % in the general population. Two reviews assessed the psychotic disorder risk, reporting this was two to three times more likely in adult first generation migrants. However, one review on the risk of schizophrenia in refugees reported similar prevalence rates (2 %) to estimates of prevalence among the settled majority (3 %). Risk factors for mental ill-health included low Gross National Product in the host country, downward social mobility, country of origin, and host country.Conclusion: First generation migrants may be at increased risk of mental illness and public health policy must account for this and influencing factors. High quality research in the area is urgently needed as is the use of culturally specific validated measurement tools for assessing migrant mental health. [ABSTRACT FROM AUTHOR]

Background: HIV-related mHealth interventions have demonstrable efficacy in supporting treatment adherence, although the evidence base for promoting HIV testing is inconclusive. Progress is constrained by a limited understanding of processes used to develop interventions and weak theoretical underpinnings. This paper describes a research project that informed the development of a theory-based mHealth intervention to promote HIV testing amongst city-dwelling African communities in the conditions.Methods: A community-based participatory social marketing design was adopted. Six focus groups (48 participants in total) were undertaken and analysed using a thematic framework approach, guided by constructs from the Health Belief Model. Key themes were incorporated into a set of text messages, which were pre-tested and refined.Results: The focus groups identified a relatively low perception of HIV risk, especially amongst men, and a range of social and structural barriers to HIV testing. In terms of self-efficacy around HIV testing, respondents highlighted a need for communities and professionals to work together to build a context of trust through co-location in, and co-involvement of, local communities which would in turn enhance confidence in, and support for, HIV testing activities of health professionals. Findings suggested that messages should: avoid an exclusive focus on HIV, be tailored and personalised, come from a trusted source, allay fears and focus on support and health benefits.Conclusions: HIV remains a stigmatized and de-prioritized issue within African migrant communities in the UK, posing barriers to HIV testing initiatives. A community-based participatory social marketing design can be successfully used to develop a culturally appropriate text messaging HIV intervention. Key challenges involved turning community research recommendations into brief text messages of only 160 characters. The intervention needs to be evaluated in a randomized control trial. Future research should explore the application of the processes and methodologies described in this paper within other communities. [ABSTRACT FROM AUTHOR]

Background: Recommendations in clinical practice guidelines for non-specific low back pain (NSLBP) are not necessarily translated into practice. Multiple studies have investigated different interventions to implement best evidence into clinical practice yet no synthesis of these studies has been carried out to date. The aim of this study was to systematically review available studies to determine whether implementation interventions in this field have been effective and to identify which strategies have been most successful in changing healthcare practitioner behaviours and improving patient outcomes.Methods: A systematic review was undertaken, searching electronic databases until end of December 2012 plus hand searching, writing to key authors and using prior knowledge of the field to identify papers. Included studies evaluated an implementation intervention to improve the management of NSLBP in clinical practice, measured key outcomes regarding change in practitioner behaviour and/or patient outcomes and subjected their data to statistical analysis. The Cochrane Effective Practice and Organisation of Care (EPOC) recommendations about systematic review conduct were followed. Study inclusion, data extraction and study risk of bias assessments were conducted independently by two review authors.Results: Of 7654 potentially eligible citations, 17 papers reporting on 14 studies were included. Risk of bias of included studies was highly variable with 7 of 17 papers rated at high risk. Single intervention or one-off implementation efforts were consistently ineffective in changing clinical practice. Increasing the frequency and duration of implementation interventions led to greater success with those continuously ongoing over time the most successful in improving clinical practice in line with best evidence recommendations.Conclusions: Single intervention or one-off implementation interventions may seem attractive but are largely unsuccessful in effecting meaningful change in clinical practice for NSLBP. Increasing frequency and duration of implementation interventions seems to lead to greater success and the most successful implementation interventions used consistently sustained strategies. [ABSTRACT FROM AUTHOR]

Background: The present research paper aims to bring deeper understanding and insight to perceptions and experiences of occupational stress from relationships at work in the cultural context of Vietnam. The paper also examines differences in perceptions, experiences of occupational stress from this problem and makes a comparison with perspectives in other cultures. Methods: Grounded theory approach is used to study occupational stress by collecting data from in-depth interviews with 42 academic women employed at Vietnamese higher education institutions to understand the meaning, the nature and source of the occupational stress from relationships at work they experience and the impact of occupational stress on their lives. Results: Cultural factors play an important role in occupational stress. Cultural factors such as power distance and hierarchy influence perception, experiences of occupational stress and the ways occupational stress is responded to. The Vietnamese context differs from other cultural contexts in the range of factors perceived as stressors for Vietnamese women. Conclusion: This paper is the first grounded theory study of occupational stress among women academics in Vietnam that determines that the natural of the relationship at work play an important role in how women understand and respond to occupational stress and supports the growing evidence that occupational stress is common, global but different in other cultures. [ABSTRACT FROM AUTHOR]

Background: Collection and storage of an infant's cord blood at birth is an option available to many new parents. Antenatal health care providers have an important role in providing non-biased and evidence based information to expectant parents about cord blood and tissue banking options. The aim of this paper was to identify and review studies of health care professionals' knowledge, attitudes and practices concerning cord blood banking and the sources by which healthcare professionals obtained their information on this topic.Methods: An integrative review was conducted using several electronic databases to identify papers on health care professionals' knowledge, attitudes and practices pertaining to cord blood banking. The CASP tool was used to determine validity and quality of the studies included in the review.Results: The search of the international literature identified nine papers which met review inclusion criteria. The literature review identified that there was little focus placed on antenatal health care professionals' knowledge of cord blood banking options despite these health care professionals being identified by expectant parents as their preferred, key source of information.Conclusion: Limited high quality studies have investigated what health care professionals know and communicate to expectant parents regarding cord blood banking. Further research should focus on understanding the knowledge, attitudes and practices of healthcare professionals and how they communicate with expectant parents about this issue. In addition, how this knowledge influences professional practice around birth is also important, as this may positively or negatively impact the information that is provided to expectant parents. [ABSTRACT FROM AUTHOR]

Background: Electronic formats of patient-reported outcome (PRO) measures are now routinely used in clinical research studies. When changing from a validated paper and pen to electronic administration it is necessary to establish their equivalence. This study reports on the value of Rasch analysis in this process.Methods: Three groups of US pulmonary hypertension (PH) patients participated. The first completed an electronic version of the CAMPHOR Activity Limitation scale (e-sample) and this was compared with two pen and paper administrated samples (pp1 and pp2). The three databases were combined and analysed for fit to the Rasch model. Equivalence was evaluated by differential item functioning (DIF) analyses.Results: The three datasets were matched randomly in terms of sample size (n = 147). Mean age (years) and percentage of male respondents were as follows: e-sample (51.7, 16.0 %); pp1 (50.0, 14.0 %); pp2 (55.5, 40.4 %). The combined dataset achieved fit to the Rasch model. Two items showed evidence of borderline DIF. Further analyses showed the inclusion of these items had little impact on Rasch estimates indicating the DIF identified was unimportant.Conclusions: Differences between the performance of the electronic and pen and paper administrations of the CAMPHOR Activity Limitation scale were minor. The results were successful in showing how the Rasch model can be used to determine the equivalence of alternative formats of PRO measures. [ABSTRACT FROM AUTHOR]

Background: Over the past few decades Egypt has attempted to limit and control female genital mutilation (FGM). However, these efforts have not succeeded in curbing the practice, which maintains wide popular support and is firmly embedded in local traditions and structures. An attitudinal change is therefore a prerequisite for any successful campaign against FGM. This paper charts the evolution of beliefs that the practice of FGM in Egypt should be stopped. Method: This paper examines trends in opposition to FGM among ever-married women in Egypt between 1995 and 2014, using six waves of the Egypt Demographic and Health Surveys. Results: The results show that the percentage of ever-married women who think the practice of FGM should be stopped rose from 13.9 % in 1995 to 31.3 % in 2014. The central question here is whether this trend exists because new cohorts of young married women are more modern and more opposed to the practice, or because opposition to FGM has spread through multiple segments of society. Our results show that back in 1995 opposition to FGM was concentrated in two groups: non-circumcised women, and wealthy, highly educated urban women. Between 1995 and 2014 opposition to FGM increased considerably among other groups of women. Conclusion: Our results show that the observed increases in opposition to FGM are not caused by younger cohorts of married women who oppose FGM, nor by the expansion of the groups most likely to oppose FGM. Rather, the results imply that the belief that FGM should be stopped spread to all walks of life, although poorly educated rural women remain least likely to oppose FGM. [ABSTRACT FROM AUTHOR]

Background: Physical activity has been associated with many benefits throughout the life course. As levels of physical activity appear to be insufficient in large populations, the development of effective interventions to promote or maintain activity levels in young people are therefore of key public health concern. Physical activity intervention research in young people is challenging, but this should not be a reason to continue conducting inferior quality evaluations. This paper highlights some of the key issues that require more careful and consistent consideration to enable future research to achieve meaningful impact. Discussion: This paper critically evaluates, amongst others, current research practice regarding intervention development, targeting, active involvement of the target population, challenge of recruitment and retention, measurement and evaluation protocols, long-term follow-up, economic evaluation, process evaluation, and publication. It argues that funders and researchers should collaborate to ensure high quality long-term evaluations are prioritised and that a trial's success should be defined by its quality, not its achieved effect. Summary: The conduct and publication of well-designed evaluations of well-defined interventions is crucial to advance the field of youth physical activity promotion and make us better understand which intervention strategies may or may not work, why, and for whom. [ABSTRACT FROM AUTHOR]

Background: A major challenge to outbreak control lies in early detection of viral haemorrhagic fevers (VHFs) in local community contexts during the critical initial stages of an epidemic, when risk of spreading is its highest ("the first mile"). In this paper we document how a major Ebola outbreak control effort in central Uganda in 2012 was experienced from the perspective of the community. We ask to what extent the community became a resource for early detection, and identify problems encountered with community health worker and social mobilization strategies.Methods: Analysis is based on first-hand ethnographic data from the center of a small Ebola outbreak in Luwero Country, Uganda, in 2012. Three of this paper's authors were engaged in an 18 month period of fieldwork on community health resources when the outbreak occurred. In total, 13 respondents from the outbreak site were interviewed, along with 21 key informants and 61 focus group respondents from nearby Kaguugo Parish. All informants were chosen through non-probability sampling sampling.Results: Our data illustrate the lack of credibility, from an emic perspective, of biomedical explanations which ignore local understandings. These explanations were undermined by an insensitivity to local culture, a mismatch between information circulated and the local interpretative framework, and the inability of the emergency response team to take the time needed to listen and empathize with community needs. Stigmatization of the local community--in particular its belief in amayembe spirits--fuelled historical distrust of the external health system and engendered community-level resistance to early detection.Conclusions: Given the available anthropological knowledge of a previous outbreak in Northern Uganda, it is surprising that so little serious effort was made this time round to take local sensibilities and culture into account. The "first mile" problem is not only a question of using local resources for early detection, but also of making use of the contextual cultural knowledge that has already been collected and is readily available. Despite remarkable technological innovations, outbreak control remains contingent upon human interaction and openness to cultural difference. [ABSTRACT FROM AUTHOR]

Background: Continuity of care by a primary midwife during the antenatal, intrapartum and postpartum periods has been recommended in Australia and many hospitals have introduced a caseload midwifery model of care. The aim of this paper is to evaluate the effect of caseload midwifery on women's satisfaction with care across the maternity continuum.Methods: Pregnant women at low risk of complications, booking for care at a tertiary hospital in Melbourne, Australia, were recruited to a randomised controlled trial between September 2007 and June 2010. Women were randomised to caseload midwifery or standard care. The caseload model included antenatal, intrapartum and postpartum care from a primary midwife with back-up provided by another known midwife when necessary. Women allocated to standard care received midwife-led care with varying levels of continuity, junior obstetric care, or community-based general practitioner care. Data for this paper were collected by background questionnaire prior to randomisation and a follow-up questionnaire sent at two months postpartum. The primary analysis was by intention to treat. A secondary analysis explored the effect of intrapartum continuity of carer on overall satisfaction rating.Results: Two thousand, three hundred fourteen women were randomised: 1,156 to caseload care and 1,158 to standard care. The response rate to the two month survey was 88% in the caseload group and 74% in the standard care group. Compared with standard care, caseload care was associated with higher overall ratings of satisfaction with antenatal care (OR 3.35; 95% CI 2.79, 4.03), intrapartum care (OR 2.14; 95% CI 1.78, 2.57), hospital postpartum care (OR 1.56, 95% CI 1.32, 1.85) and home-based postpartum care (OR 3.19; 95% CI 2.64, 3.85).Conclusion: For women at low risk of medical complications, caseload midwifery increases women's satisfaction with antenatal, intrapartum and postpartum care.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN012607000073404 (registration complete 23rd January 2007). [ABSTRACT FROM AUTHOR]

Background: E-mental health is a promising medium to keep mental health affordable and accessible. For consumers with severe mental illness the evidence of the effectiveness of e-health is limited. A number of difficulties and barriers have to be addressed concerning e-health for consumers with severe mental illness. One possible solution might be to blend e-health with face-to-face delivery of a recovery-oriented treatment, like the Illness Management & Recovery (IMR) programme. This paper describes the development of an e-health application for the IMR programme and the design of an early clustered randomized controlled trial.Method/design: We developed the e-IMR intervention according to the six-step protocol of Intervention Mapping. Consumers joined the development group to address important and relevant issues for the target group. Decisions during the six-step development process were based on qualitative evaluations of the Illness Management & Recovery programme, structured interviews, discussion in the development group, and literature reviews on qualitative papers concerning consumers with severe mental illness, theoretical models, behavioural change techniques, and telemedicine for consumers with severe mental illness. The aim of the e-IMR intervention is to help consumers with severe mental illness to involve others, manage achieving goals, and prevent relapse. The e-IMR intervention consists of face-to-face delivery of the Illness Management & Recovery programme and an e-health application containing peer-testimonials on videos, follow up on goals and coping strategies, monitoring symptoms, solving problems, and communication opportunities. We designed an early cluster randomized controlled trial that will evaluate the e-IMR intervention. In the control condition the Illness Management & Recovery programme is provided. The main effect-study parameters are: illness management, recovery, psychiatric symptoms severity, self-management, quality of life, and general health. The process of the IMR program will be evaluated on fidelity and feasibility in semi-structured interviews with participants and trainers.Discussion: Intervention Mapping provided a systematic procedure for the development of this e-health intervention for consumers with severe mental illness and the preparation of an early randomized controlled trial.Trial Registration: The trial is registered in the Dutch Trial Register: NTR4772 . [ABSTRACT FROM AUTHOR]

Background: There is worldwide debate regarding the appropriateness and safety of different birthplaces for well women. The Evaluating Maternity Units (EMU) study's primary objective was to compare clinical outcomes for well women intending to give birth in either a tertiary level maternity hospital or a freestanding primary level maternity unit. Little is known about how women experience having to change their birthplace plans during the antenatal period or before admission to a primary unit, or transfer following admission. This paper describes and explores women's experience of these changes-a secondary aim of the EMU study.Methods: This paper utilised the six week postpartum survey data, from the 174 women from the primary unit cohort affected by birthplace plan change or transfer (response rate 73%). Data were analysed using descriptive statistics and thematic analysis. The study was undertaken in Christchurch, New Zealand, which has an obstetric-led tertiary maternity hospital and four freestanding midwife-led primary maternity units (2010-2012). The 702 study participants were well, pregnant women booked to give birth in one of these facilities, all of whom received continuity of midwifery care, regardless of their intended or actual birthplace.Results: Of the women who had to change their planned place of birth or transfer the greatest proportion of women rated themselves on a Likert scale as unbothered by the move (38.6%); 8.8% were 'very unhappy' and 7.6% 'very happy' (quantitative analysis). Four themes were identified, using thematic analysis, from the open ended survey responses of those who experienced transfer: 'not to plan', control, communication and 'my midwife'. An interplay between the themes created a cumulatively positive or negative effect on their experience. Women's experience of transfer in labour was generally positive, and none expressed stress or trauma with transfer.Conclusions: The women knew of the potential for change or transfer, although it was not wanted or planned. When they maintained a sense control, experienced effective communication with caregivers, and support and information from their midwife, the transfer did not appear to be experienced negatively. The model of continuity of midwifery care in New Zealand appeared to mitigate the negative aspects of women's experience of transfer and facilitate positive birth experiences. [ABSTRACT FROM AUTHOR]

Background: Women considering female genital cosmetic surgery (FGCS) are likely to use the internet as a key source of information during the decision-making process. The aim of this systematic review was to determine what is known about the role of the internet in the promotion and normalisation of female genital cosmetic surgery and to identify areas for future research.Methods: Eight social science, medical, and communication databases and Google Scholar were searched for peer-reviewed papers published in English. Results from all papers were analysed to identify recurring and unique themes.Results: Five papers met inclusion criteria. Three of the papers reported investigations of website content of FGCS providers, a fourth compared motivations for labiaplasty publicised on provider websites with those disclosed by women in online communities, and the fifth analysed visual depictions of female genitalia in online pornography. Analysis yielded five significant and interrelated patterns of representation, each functioning to promote and normalise the practice of FGCS: pathologisation of genital diversity; female genital appearance as important to wellbeing; characteristics of women's genitals are important for sex life; female body as degenerative and improvable through surgery; and FGCS as safe, easy, and effective. A significant gap was identified in the literature: the ways in which user-generated content might function to perpetuate, challenge, or subvert the normative discourses prevalent in online pornography and surgical websites.Conclusions: Further research is needed to contribute to knowledge of the role played by the internet in the promotion and normalisation of female genital cosmetic surgery. [ABSTRACT FROM AUTHOR]

Introduction: The aim of the paper is to examine the role of income inequality and redistribution for income-related health inequalities in Europe. This paper contributes in two ways to the literature on macro determinants of socio-economic inequalities in health. First, it widens the distinctive focus of the research field on welfare state regimes to quantifiable measures such as social policy indicators. Second, looking at income differences completes studies on socio-economic health inequalities, which often analyse health inequalities based on educational differences. Methods: Using data from the European Values Study (2008/2009), 42 European countries are available for analysis. Country characteristics are derived from SWIID, Eurostat, and ILO and include indicators for income inequality, social policies, and economic performance. The data is analysed by using a two-step hierarchical estimation approach: At the first step--the individual level--the effect of household income on self-assessed health is extracted and introduced as an indicator measuring income-related health inequalities at the second step, the country-level. Results: Individual-level analyses reveal that income-related health inequalities exist all across Europe. Results from country-level analyses show that higher income inequality is significantly positively related to higher health inequalities while social policies do not show significant relations. Nevertheless, the results show the expected negative association between social policies and health inequalities. Economic performance also has a reducing influence on health inequalities. In all models, income inequality was the dominating explanatory effect for health inequalities. Conclusions: The analyses indicate that income inequality has more impact on health inequalities than social policies. On the contrary, social policies seemed to matter to all individuals regardless of socio-economic position since it is significantly positively linked to overall population health. Even though social policies are not significantly related to health inequalities, the power of public redistribution to impact health inequalities should not be downplayed. Social policies as a way of public redistribution are a possible instrument to reduce income inequalities which would in turn lead to a reduction in health inequalities. [ABSTRACT FROM AUTHOR]

Background: There is a lack of research reporting on the physical and emotional experiences of women who sustain severe perineal trauma (third and fourth degree tears). When the researcher identifies with the group being researched, autoethnography can allow an insight into the experiences of the marginalised group through the telling of a personal story. The aim of this paper is to share the journey travelled by an autoethnographer who on examining the issue of severe perineal trauma came to understand the challenges and rewards she experienced through this reflective and analytic process.Methods: A transformative emancipatory approach guided the design, data collection and analysis of findings from this study. For this paper, a multivocal narrative approach was taken in presenting the findings, which incorporated the words of both the autoethnographer and the twelve women who were interviewed as a component of the study, all of whom had sustained severe perineal trauma.Results: As an autoethnographer, being a member of the group being researched, can be confronting as the necessary reflection upon one's personal journey may lead to feelings of vulnerability, sadness, and emotional pain. The transformation from disembodied to embodied self, resulted in a physical and emotional breakdown that occurred for this autoethnographer.Conclusion: Autoethnographers may experience unexpected emotional and physical challenges as they reflect upon their experiences and research the experiences of others. When incorporating a transformative emancipatory framework, the hardships are somewhat balanced by the rewards of witnessing 'self-transformation' as a result of the research. [ABSTRACT FROM AUTHOR]

Background: Compared to other pregnancy-related events, the full cost of stillbirth remains poorly described. In the UK one in every 200 births ends in stillbirth. As a follow-up to a recent study which explored the direct costs of stillbirth, this study aimed to explore the intangible costs of stillbirth in terms of their duration and economic implication. Methods: Systematic searches identified relevant papers on the psychological consequences of stillbirth. A narrative review of the quantitative studies was undertaken. This was followed by a qualitative synthesis using metaethnography to identify over-arching themes common to the papers. Finally, the themes were used to generate questions proposed for use in a questionnaire to capture the intangible costs of stillbirth. Results: The narrative review revealed a higher level of anxiety and depression in couples with stillbirth compared to those without stillbirth. The qualitative synthesis identified a range of psychological effects common to families that have experienced stillbirth. Both methods revealed the persistent nature of these effects and the subsequent economic burden. Conclusions: The psychological effects of stillbirth adversely impacts on the daily functioning, relationships and employment of those affected with far-reaching economic implications. Knowledge of the intangible costs of stillbirth is therefore important to accurately estimate the size of the impact on families and health services and to inform policy and decision making. [ABSTRACT FROM AUTHOR]

Background: Considerable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient/consumer perspectives of generic medicines. Methods: Literature published between January 2003 and November 2014, which is indexed in PubMed and Scopus, on the topic of opinions of physicians, pharmacists and patients with respect to generic medicines was searched, and articles within the scope of this review were appraised. Search keywords used included perception, opinion, attitude and view, along with keywords specific to each cohort. Results: Following review of titles and abstracts to identify publications relevant to the scope, 16 papers on physician opinions, 11 papers on pharmacist opinions and 31 papers on patient/consumer opinions were included in this review. Quantitative studies (n = 37) were the most common approach adopted by researchers, generally in the form of self-administered questionnaires/surveys. Qualitative methodologies (n = 15) were also reported, albeit in fewer cases. In all three cohorts, opinions of generic medicines have improved but some mistrust remains, most particularly in the patient group where there appears to be a strongly held belief that less expensive equals lower quality. Acceptance of generics appears to be higher in consumers with higher levels of education while patients from lower socioeconomic demographic groups, hence generally having lower levels of education, tend to have greater mistrust of generics. Conclusions: A key factor in improving confidence in generic products is the provision of information and education, particularly in the areas of equivalency, regulation and dispelling myths about generic medicines (such as the belief that they are counterfeits). Further, as patient trust in their physician often overrules their personal mistrust of generic medicines, enhancing the opinions of physicians regarding generics may have particular importance in strategies to promote usage and acceptance of generic medicines in the future. [ABSTRACT FROM AUTHOR]

Context: It is common practice worldwide for health professionals to study abroad. However, the outcome of such experience has not been rigorously evaluated in China. Our current study aimed to quantify the impact on research of studying abroad among Chinese health professionals. Methods: A self-administered structured questionnaire was developed among health professionals in Harbin Medical University and its affiliated hospitals who had studied abroad ('returning' professionals) and health professionals who did not have experience abroad ('resident' professionals). 166 'returning' professionals (Group A) and 166 age-, sex- and specialty-matched 'resident' professionals (Group B) were included in the study. SPSS software was used for data entry and analysis. Results: The total IF of papers published by Group A and Group B was, respectively, 1933.52 and 629.23 (P < 0.01) and the number of NSFC was 154 and 34 (P < 0.01), respectively. The total IF of papers published abroad was associated with the duration abroad (P < 0.01) and not with the age of going abroad (P > 0.05). The total IF of papers published at home, and the number of NSFC had no relationship with the duration abroad (both P > 0.05) nor the age of going abroad (both P > 0.05). The total IF of papers published at home and the number of NSFC were positively correlated with the total IF of papers published abroad (both P < 0.01). Conclusions: This study reflects the beneficial experience of working overseas. The opportunity for overseas experience should not be limited by age. Overseas study should be prolonged. [ABSTRACT FROM AUTHOR]

Background: Exposure to sunlight can have both positive and negative health impacts. Excessive exposure to ultra-violet (UV) radiation from the sun can cause skin cancer, however insufficient exposure to sunlight has a detrimental effect on production of Vitamin D. In the construction industry there are onsite proactive behaviours for safety, but sun-safety remains a low priority. There is limited research on understanding the barriers to adopting sun-safe behaviours and the association this may have with Vitamin D production. This paper reports a protocol for an intervention study, using text messaging in combination with a supportive smartphone App. The intervention aims to both reduce UV exposure during months with higher UV levels and promote appropriate dietary changes to boost Vitamin D levels during months with low UV levels.Method/design: Approximately 60 construction workers will be recruited across the United Kingdom. A randomised control crossover trial (RCCT) will be used to test the intervention, with randomisation at site level - i.e. participants will receive both the control (no text messages or supportive App support) and intervention (daily text messages and supportive App). Using the Theory of Planned Behaviour (TPB) the intervention focuses on supporting sun-safety and healthy dietary decisions in relation to Vitamin D intake. The intervention emphasises cultivating the perception of normative support in the workplace, increasing awareness of control and self-efficacy in taking sun-protective behaviours, making healthier eating choices to boost Vitamin D, and tackling stigmas attached to image and group norms. Each study epoch will last 21 days with intervention text messages delivered on workdays only. The supportive App will provide supplementary information about sun protective behaviours and healthy dietary choices. The primary outcome measure is 25-hydroxy-Vitamin D [25(OH)D] level (obtained using blood spot sampling), which will be taken pre and post control and intervention periods. Secondary outcome measures are two-fold, (1) using the TPB to detect changes in behaviour, and (2) quantifying UV exposure during the UK peak radiation season (April-September) using body-mounted UV sensors.Discussion: This study will provide important information about the effectiveness of a technology-based intervention to promote sun-safety and healthy behaviours in outdoor construction workers.Trial Registration: ISRCTN15888934 retrospectively registered 15.01.2018. [ABSTRACT FROM AUTHOR]

Background: Fear of Childbirth (FOC) is a common problem affecting women's health and wellbeing, and a common reason for requesting caesarean section. The aims of this review were to summarise published research on prevalence of FOC in childbearing women and how it is defined and measured during pregnancy and postpartum, and to search for useful measures of FOC, for research as well as for clinical settings.Methods: Five bibliographic databases in March 2015 were searched for published research on FOC, using a protocol agreed a priori. The quality of selected studies was assessed independently by pairs of authors. Prevalence data, definitions and methods of measurement were extracted independently from each included study by pairs of authors. Finally, some of the country rates were combined and compared.Results: In total, 12,188 citations were identified and screened by title and abstract; 11,698 were excluded and full-text of 490 assessed for analysis. Of these, 466 were excluded leaving 24 papers included in the review, presenting prevalence of FOC from nine countries in Europe, Australia, Canada and the United States. Various definitions and measurements of FOC were used. The most frequently-used scale was the W-DEQ with various cut-off points describing moderate, severe/intense and extreme/phobic fear. Different 3-, 4-, and 5/6 point scales and visual analogue scales were also used. Country rates (as measured by seven studies using W-DEQ with ≥85 cut-off point) varied from 6.3 to 14.8%, a significant difference (chi-square = 104.44, d.f. = 6, p < 0.0001).Conclusions: Rates of severe FOC, measured in the same way, varied in different countries. Reasons why FOC might differ are unknown, and further research is necessary. Future studies on FOC should use the W-DEQ tool with a cut-off point of ≥85, or a more thoroughly tested version of the FOBS scale, or a three-point scale measurement of FOC using a single question as 'Are you afraid about the birth?' In this way, valid comparisons in research can be made. Moreover, validation of a clinical tool that is more focussed on FOC alone, and easier than the longer W-DEQ, for women to fill in and clinicians to administer, is required. [ABSTRACT FROM AUTHOR]

Background: Interactive web-based physical activity interventions using Web 2.0 features (e.g., social networking) have the potential to improve engagement and effectiveness compared to static Web 1.0 interventions. However, older adults may engage with Web 2.0 interventions differently than younger adults. The aims of this study were to determine whether an interaction between intervention (Web 2.0 and Web 1.0) and age group (<55y and ≥55y) exists for website usage and to determine whether an interaction between intervention (Web 2.0, Web 1.0 and logbook) and age group (<55y and ≥55y) exists for intervention effectiveness (changes in physical activity). Methods: As part of the WALK 2.0 trial, 504 Australian adults were randomly assigned to receive either a paper logbook (n = 171), a Web 1.0 (n = 165) or a Web 2.0 (n = 168) physical activity intervention. Moderate to vigorous physical activity was measured using ActiGraph monitors at baseline 3, 12 and 18 months. Website usage statistics including time on site, number of log-ins and number of step entries were also recorded. Generalised linear and intention-to-treat linear mixed models were used to test interactions between intervention and age groups (<55y and ≥55y) for website usage and moderate to vigorous physical activity changes. Results: Time on site was higher for the Web 2.0 compared to the Web 1.0 intervention from baseline to 3 months, and this difference was significantly greater in the older group (OR = 1.47, 95%CI = 1.01-2.14, p = .047). Participants in the Web 2.0 group increased their activity more than the logbook group at 3 months, and this difference was significantly greater in the older group (moderate to vigorous physical activity adjusted mean difference = 13.74, 95%CI = 1.08-26.40 min per day, p = .03). No intervention by age interactions were observed for Web 1.0 and logbook groups. Conclusions: Results partially support the use of Web 2.0 features to improve adults over 55 s' engagement in and behaviour changes from web-based physical activity interventions. [ABSTRACT FROM AUTHOR]

Background: No validated disease-specific questionnaires exist to capture health-related quality of life (HRQoL) in patients with Merkel cell carcinoma (MCC). The Functional Assessment of Cancer Therapy - Melanoma (FACT-M) is validated in patients with melanoma, which shares many similarities with MCC. This paper reports the psychometric properties of the FACT-M in the metastatic MCC population.Methods: Data were collected as part of a single-arm, open-label, multicenter trial involving patients with metastatic MCC who had failed at least one previous line of chemotherapy. FACT-M and EQ-5D were administered at baseline, Week 7, Week 13, and Week 25. An optional interview was administered at the same time points. MCC-specific FACT-M scores were derived following a combined quantitative and qualitative approach. Reliability and construct validity of original and additional MCC-specific FACT-M scores were assessed at baseline. Capacity to detect change in tumor size was assessed from baseline to Week 7. Minimally important differences (MIDs) were computed using distribution and anchor-based methods.Results: Baseline assessments were available in 70 patients (mean age: 70 years; 74.3% male); 19 patients were interviewed at baseline. Additional MCC-specific scores were as follows: Physical Function score (six items), Psychological Impact score (six items), and MCC summary score (12 items). FACT-M original and additional MCC-specific scores both demonstrated acceptable psychometric properties: high reliability (Cronbach's alpha: 0.81-0.96), good convergent validity (correlations above 0.4 observed for 88% of items of the Melanoma surgery scale, 75% of items of the Melanoma scale, and 100% of items of the other FACT-M domains). Some evidence of floor/ceiling effects and poor discriminant ability was found. Higher scores (better HRQoL) on all FACT-M domains were observed in patients with better functioning (assessed by ECOG performance score), supporting clinical validity. Despite the small sample for responsiveness analysis (n = 37), the majority of FACT-M scores showed sensitivity to changes in tumor size at Week 7 with small to moderate effect sizes. MIDs were consistent with previously reported values in the literature for FACT-M domains.Conclusions: FACT-M is suitable to capture HRQoL in patients with metastatic MCC, thus making it a potential candidate for assessing HRQoL in MCC trials.Trial Registration: This study is a post-hoc analysis conducted on data collected in Part A of the JAVELIN Merkel 200 trial. This trial was registered on 2 June 2014 with ClinicalTrials.gov as NCT02155647 . [ABSTRACT FROM AUTHOR]

Background: Despite recent guidelines suggesting that patients with chronic non-malignant pain might not benefit, there has been a significant rise in opioid prescription for chronic non-malignant pain. This topic is important because an increasing number of HCPs are prescribing opioids despite very limited evidence for long-term opioid therapy for chronic non-malignant pain outside of end-of-life care. To better understand the challenges of providing effective treatment, we conducted the first qualitative evidence synthesis to explore healthcare professionals' experience of treating people with chronic non-malignant pain. We report findings that explore healthcare professionals' experience of prescribing opioids to this group of patients. Methods: We searched five electronic bibliographic databases (Medline, Embase, CINAHL, PsychINFO, AMED) from inception to November 2015 and screened titles, abstracts and full texts of potential studies. We included studies in English that explored healthcare professionals' experience of treating adults with chronic non-malignant pain. Two reviewers quality appraised each paper. We used the methods of meta-ethnography developed and refined for large reviews, and the GRADE-CERQual framework to rate confidence in review findings. Results: We screened 954 abstracts and 184 full texts, and included 77 studies in the full review. 17 of these 77 studies included concepts that explored the experience of prescribing opioids. We abstracted these concepts into 6 overarching themes: (1) Should I, shouldn't I? (2) Pain is Pain; (3) Walking a fine line; (4) Social guardianship; (5) Moral boundary work; (6) Regulations and guidelines. We used the GRADE-CERQual framework to evaluate confidence in findings. A new overarching concept of 'ambiguity' explains the balancing required around the factors taken into account when prescribing opioids. Managing this ambiguity is challenging and these findings can inform healthcare professionals dealing with these decisions. Conclusions: This conceptual model demonstrates the complexity of making a decision to prescribe opioids to someone with chronic non-malignant pain. Although opioid prescription is underpinned by the therapeutic aim of alleviating pain, this aim may be misplaced. This has implications for education in light of the new regulations for opioid prescription. Findings also demonstrate that the decision is influenced by intra- and interpersonal factors and broader external concerns. [ABSTRACT FROM AUTHOR]

Background: Knowledge of HIV status can be important in reducing the risk of HIV exposure. In a European sample of men-who-have-sex-with-men (MSM), we aimed to identify factors associated with HIV serostatus disclosure to the most recent anal intercourse (AI) partner. We also aimed to describe the impact of HIV serostatus disclosure on HIV exposure risks.Methods: During 2013 and 2014, 4901 participants were recruited for the bio-behavioural Sialon-II study in 13 European cities. Behavioural data were collected with a self-administered paper questionnaire. Biological specimens were tested for HIV antibodies. Factors associated with HIV serostatus disclosure with the most recent AI partner were examined using bivariate and multilevel multivariate logistic regression analysis. We also describe the role of serostatus disclosure for HIV exposure of the most recent AI partner.Results: Thirty-five percent (n = 1450) of the study participants reported mutual serostatus disclosure with their most recent AI partner or disclosed having HIV to their partner. Most of these disclosures occurred between steady partners (74%, n = 1077). In addition to the type of partner and HIV diagnosis status, other factors positively associated with HIV serostatus disclosure in the multilevel multivariate logistic regression model were recent testing, no condom use, and outness regarding sexual orientation. Disclosure rates were lowest in three south-eastern European cities. Following condom use (51%, n = 2099), HIV serostatus disclosure (20%, n = 807) was the second most common prevention approach with the most recent AI partner, usually resulting in serosorting. A potential HIV exposure risk for the partner was reported by 26% (111/432) of HIV antibody positive study participants. In 18% (20/111) of exposure episodes, an incorrect HIV serostatus was unknowingly communicated. Partner exposures were equally distributed between steady and non-steady partners.Conclusions: The probability of HIV exposure through condomless AI is substantially lower after serostatus disclosure compared to non-disclosure. Incorrect knowledge of one's HIV status contributes to a large proportion of HIV exposures amongst European MSM. Maintaining or improving condom use for anal intercourse with non-steady partners, frequent testing to update HIV serostatus awareness, and increased serostatus disclosure particularly between steady partners are confirmed as key aspects for reducing HIV exposures amongst European MSM. [ABSTRACT FROM AUTHOR]

Background: Interventions to reduce malaria burden are effective if communities use them appropriately and consistently. Several tools have been suggested to promote uptake and use of malaria control interventions. Community workshops on malaria, using the 'Health Animator' approach, are a potential behaviour change strategy for malaria control. The strategy aims to influence a change in mind-set of vulnerable populations to encourage self-reliance, using community volunteers known as Health Animators. The aim of the paper is to describe the process of implementing community workshops on malaria by Health Animators to improve uptake and use of malaria control interventions in rural Malawi.Methods: This is a descriptive study reporting feasibility, acceptability, appropriateness and fidelity of using Health Animator-led community workshops for malaria control. Quantitative data were collected from self-reporting and researcher evaluation forms. Qualitative assessments were done with Health Animators, using three focus groups (October-December 2015) and seven in-depth interviews (October 2016-February 2017).Results: Seventy seven health Animators were trained from 62 villages. A total of 2704 workshops were conducted, with consistent attendance from January 2015 to June 2017, representing 10-17% of the population. Attendance was affected by social responsibilities and activities, relationship of the village leaders and their community and involvement of Community Health Workers. Active discussion and participation were reported as main strengths of the workshops. Health Animators personally benefited from the mind-set change and were proactive peer influencers in the community. Although the information was comprehended and accepted, availability of adequate health services was a challenge for maintenance of behaviour change.Conclusion: Community workshops on malaria are a potential tool for influencing a positive change in behaviour towards malaria, and applicable for other health problems in rural African communities. Social structures of influence and power dynamics affect community response. There is need for systematic monitoring of community workshops to ensure implementation fidelity and strengthening health systems to ensure sustainability of health behaviour change. [ABSTRACT FROM AUTHOR]

Background: Globally, prematurity is the leading cause of death in children under the age of 5. Many efforts have focused on clinical approaches to improve the survival of premature babies. There is a need, however, to explore psychosocial, sociocultural, economic, and other factors as potential mechanisms to reduce the burden of prematurity. Women's empowerment may be a catalyst for moving the needle in this direction. The goal of this paper is to examine links between women's empowerment and prematurity in developing settings. We propose a conceptual model that shows pathways by which women's empowerment can affect prematurity and review and summarize the literature supporting the relationships we posit. We also suggest future directions for research on women's empowerment and prematurity.Methods: The key words we used for empowerment in the search were "empowerment," "women's status," "autonomy," and "decision-making," and for prematurity we used "preterm," "premature," and "prematurity." We did not use date, language, and regional restrictions. The search was done in PubMed, Population Information Online (POPLINE), and Web of Science. We selected intervening factors-factors that could potentially mediate the relationship between empowerment and prematurity-based on reviews of the risk factors and interventions to address prematurity and the determinants of those factors.Results: There is limited evidence supporting a direct link between women's empowerment and prematurity. However, there is evidence linking several dimensions of empowerment to factors known to be associated with prematurity and outcomes for premature babies. Our review of the literature shows that women's empowerment may reduce prematurity by (1) preventing early marriage and promoting family planning, which will delay age at first pregnancy and increase interpregnancy intervals; (2) improving women's nutritional status; (3) reducing domestic violence and other stressors to improve psychological health; and (4) improving access to and receipt of recommended health services during pregnancy and delivery to help prevent prematurity and improve survival of premature babies.Conclusions: Women's empowerment is an important distal factor that affects prematurity through several intervening factors. Improving women's empowerment will help prevent prematurity and improve survival of preterm babies. Research to empirically show the links between women's empowerment and prematurity is however needed. [ABSTRACT FROM AUTHOR]

Background: Recruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely.Methods: Eligible children were identified by participating general practitioners (GPs) and referred to a study research nurse, who then visited them at home. This allowed the consent and recruitment processes to take place outside the general practice setting. Information was recorded about patients who were referred and recruited, or if not, the reasons for non-recruitment. Data on recruitment challenges were collected through semi-structured interviews and questionnaires with a sample of participating GPs. Data were thematically analysed to identify key themes.Results: Of the children referred to the study 34% (58/171) were not recruited - 48% (28/58) because of difficulties arranging a baseline visit within the defined time frame, 31% (18/58) did not meet the study inclusion criteria at the time of nurse assessment, and 21% (12/58) declined participation. GPs had positive views about the recruitment process, reporting that parents valued and benefitted from additional contact with a nurse. GPs felt that the deferred recruitment model did not negatively impact on the study.Conclusions: GPs and parents recognised the benefits of deferred recruitment, but these did not translate into enhanced recruitment of participants. The model resulted in the loss of a third of children who were identified by the GP as eligible, but not subsequently recruited to the study. If the potential for improving outcomes in primary care through complex studies is to be realised, new approaches to recruitment into primary care trials need to be developed and evaluated.Trial Registration: International Standard Randomised Controlled Trials, ISRCTN96705420 . Registered on 27 June 2012. [ABSTRACT FROM AUTHOR]

Background: Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases.Methods: This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice.Discussion: This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases.Trial Registration: ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016. [ABSTRACT FROM AUTHOR]

Background: Diarrhoea is a leading cause of child death in Zambia. As elsewhere, the disease burden could be greatly reduced through caregiver uptake of existing prevention and treatment strategies. We recently reported the results of the Komboni Housewives intervention which tested a novel strategy employing motives including affiliation and disgust to improve caregiver practice of four diarrhoea control behaviours: exclusive breastfeeding; handwashing with soap; and correct preparation and use of oral rehydration salts (ORS) and zinc. The intervention was delivered via community events (women's forums and road shows), at health clinics (group session) and via radio. A cluster randomised trial revealed that the intervention resulted in a small improvement in exclusive breastfeeding practices, but was only associated with small changes in the other behaviours in areas with greater intervention exposure. This paper reports the findings of the process evaluation that was conducted alongside the trial to investigate how factors associated with intervention delivery and receipt influenced caregiver uptake of the target behaviours.Methods: Process data were collected from the eight peri-urban and rural intervention areas throughout the six-month implementation period and in all 16 clusters 4-6 weeks afterwards. Intervention implementation (fidelity, reach, dose delivered and recruitment strategies) and receipt (participant engagement and responses, and mediators) were explored through review of intervention activity logs, unannounced observation of intervention events, semi-structured interviews, focus groups with implementers and intervention recipients, and household surveys. Evaluation methods and analyses were guided by the intervention's theory of change and the evaluation framework of Linnan and Steckler.Results: Intervention reach was lower than intended: 39% of the surveyed population reported attending one or more face-to-face intervention event, of whom only 11% attended two or more intervention events. The intervention was not equally feasible to deliver in all settings: fewer events took place in remote rural areas, and the intervention did not adequately penetrate communities in several peri-urban sites where the population density was high, the population was slightly higher socio-economic status, recruitment was challenging, and numerous alternative sources of entertainment existed. Adaptations made by the implementers affected the fidelity of implementation of messages for all target behaviours. Incorrect messages were consequently recalled by intervention recipients. Participants were most receptive to the novel disgust and skills-based interactive demonstrations targeting exclusive breastfeeding and ORS preparation respectively. However, initial disgust elicitation was not followed by a change in associated psychological mediators, and social norms were not measurably changed.Conclusions: The lack of measured behaviour change was likely due to issues with both the intervention's content and its delivery. Achieving high reach and intensity in community interventions delivered in diverse settings is challenging. Achieving high fidelity is also challenging when multiple behaviours are targeted for change. Further work using improved tools is needed to explore the use of subconscious motives in behaviour change interventions. To better uncover how and why interventions achieve their measured effects, process evaluations of complex interventions should develop and employ frameworks for investigation and interpretation that are structured around the intervention's theory of change and the local context.Trial Registration: The study was registered as part of the larger trial on 5 March 2014 with ClinicalTrials.gov: NCT02081521 . [ABSTRACT FROM AUTHOR]