Publications by authors named "Caroline Smith"

318 Publications

Barriers and Facilitators to Integrative Oncology Services in Australia: A Changed Mind Set Required.

J Altern Complement Med 2021 Mar;27(S1):S89-S98

NICM Health Research Institute, Western Sydney University, Penrith, Australia.

This study aimed to explore barriers and facilitators to integrative oncology (IO) service provision and access in Australia. The study design was mixed method with two substudies: a cross-sectional national cancer service survey of public and private sectors; and focus group interviews and an online survey of cancer survivors. Triangulation analysis of qualitative and quantitative data was used to identify and interrogate meta-themes. The cancer service response rate was 93.2% ( = 275/295); 71/275 (25.8%) provided IO. Thirty-three cancer survivors from Anglo-European, Arabic, Vietnamese, and Chinese backgrounds were interviewed, and 121 survivors answered the online survey. IO gaps were substantial, with no services in many regions and cities; a lack of diversity and availability of therapeutic options, including culturally appropriate services; and a mismatch between the high use of natural health products by survivors and types of IO services provided. Two overlapping meta-themes were identified: "barriers and facilitators" and "peoples and institutions"; each with four subthemes, respectively, "access/provision, affordability/funding, information/evidence, and culture/values" and "cancer survivors, healthcare professionals, organizations, and policies." While affordability/funding was the greatest barrier to survivors and providers, solutions varied (e.g., building a stronger evidence-base, business model advice) and often conflicted (e.g., public verses private sector funding). The most insidious barrier was professional/corporate cultures and values that influenced hospital policies (or lack thereof), conceptions of evidence and the therapeutic alliance. Survivors called for a change of mindset in the culture of medicine and value-based health care. The barriers and facilitators to IO services were more complex than building the evidence-base and demonstrating value to justify funding. To achieve a better alignment of patients' preferences with service provision, providers require more guidance on clinical governance, business models, local service gaps, and interprofessional collaboration. National strategies and funding models are needed to ensure appropriate, equitable IO service provision.
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http://dx.doi.org/10.1089/acm.2020.0299DOI Listing
March 2021

Perceptions and experiences of lifestyle interventions in women with polycystic ovary syndrome (PCOS), as a management strategy for symptoms of PCOS.

BMC Womens Health 2021 Mar 17;21(1):107. Epub 2021 Mar 17.

NICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.

Background: The international clinical practice guidelines for PCOS emphasize diet and exercise as first-line management of clinical signs and symptoms. This study aimed to describe the patterns, perceptions and experiences of lifestyle interventions for women in the community with PCOS.

Method: An electronic survey of 493 members of two PCOS consumer support groups, collected by cloud-based Survey Monkey, described women's types and patterns of diet and exercise, experiences and perceptions of effectiveness. Women were recruited from the Polycystic Ovary Association of Australia (POSAA) and from the Facebook group, PCOS University Research Group. Associations between participants perceptions of effectiveness, and diet types and exercise patterns were assessed using logistic regression. Response bias for the POSAA group was assessed with a continuum of resistance model.

Results: 91% of POSAA members and 311 Facebook group members aged 16-50 years responded to the survey. Nearly all women reported adjusting their dietary and exercise practices with the aim to improve their health and/or PCOS (82% and 73% respectively), however less than 13% reported achievement of health goals (12.2% and 8.1% respectively). Low carbohydrate, high protein diets, and vigorous activity were associated with self-perceived effectiveness (r.0.16, p < 0.01; r.0.15 p < 0.01 and r.0.2 p < 0.01 respectively). Barriers for lifestyle interventions included psychosocial factors. Response bias was not assessed for the Facebook group, however self-reported PCOS aligned with prevalence of clinical phenotypes and suggests results are generalizable to clinical populations of women with PCOS, who are responsible for self-directing and administering lifestyle interventions to manage their PCOS.

Conclusions: Perceptions of effectiveness for lifestyle interventions by women with PCOS may be complicated by a lack of rigorous evidence. The strength of recommendations in clinical practice guidelines may be enhanced by clinical trials investigating flexible and feasible lifestyle interventions for women in the community with PCOS.
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http://dx.doi.org/10.1186/s12905-021-01252-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7968330PMC
March 2021

Adult Onset Xanthogranuloma With Frontal Nerve and Intracranial Involvement.

Ophthalmic Plast Reconstr Surg 2021 Mar 8. Epub 2021 Mar 8.

Discipline of Ophthalmology and Visual Science, University of Adelaide, Adelaide, South Australia, Australia Department of Ophthalmology, Royal Adelaide Hospital and South Australian Institute of Ophthalmology, Adelaide, South Australia, Australia SA Pathology, Adelaide, South Australia, Australia.

Adult-onset xanthogranuloma (AOX) typically affects the preseptal and anterior orbital regions. The authors report a 49-year-old man with a 6-month history of unilateral AOX, demonstrating diffuse extraconal and intraconal orbital involvement, including the lacrimal gland and extraocular muscles. There was frontal nerve enlargement, intracranial and pterygopalatine fossa involvement. Investigations excluded IgG4 disease and Erdheim-Chester disease. This case illustrates that AOX may be added to the causes of orbital nerve enlargement and may demonstrate intracranial extension.
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http://dx.doi.org/10.1097/IOP.0000000000001964DOI Listing
March 2021

Sickness and the Social Brain: Love in the Time of COVID.

Front Psychiatry 2021 22;12:633664. Epub 2021 Feb 22.

Department of Psychology and Neuroscience, Duke University, Durham, NC, United States.

As a highly social species, inclusion in social networks and the presence of strong social bonds are critical to our health and well-being. Indeed, impaired social functioning is a component of numerous neuropsychiatric disorders including depression, anxiety, and substance use disorder. During the current COVID-19 pandemic, our social networks are at risk of fracture and many are vulnerable to the negative consequences of social isolation. Importantly, infection itself leads to changes in social behavior as a component of "sickness behavior." Furthermore, as in the case of COVID-19, males and females often differ in their immunological response to infection, and, therefore, in their susceptibility to negative outcomes. In this review, we discuss the many ways in which infection changes social behavior-sometimes to the benefit of the host, and in some instances for the sake of the pathogen-in species ranging from eusocial insects to humans. We also explore the neuroimmune mechanisms by which these changes in social behavior occur. Finally, we touch upon the ways in which the social environment (group living, social isolation, etc.) shapes the immune system and its ability to respond to challenge. Throughout we emphasize how males and females differ in their response to immune activation, both behaviorally and physiologically.
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http://dx.doi.org/10.3389/fpsyt.2021.633664DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937950PMC
February 2021

Adolescent Menstrual Health Literacy in Low, Middle and High-Income Countries: A Narrative Review.

Int J Environ Res Public Health 2021 Feb 25;18(5). Epub 2021 Feb 25.

NICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, NSW 2751, Australia.

Background: Poor menstrual health literacy impacts adolescents' quality of life and health outcomes across the world. The aim of this systematic review was to identify concerns about menstrual health literacy in low/middle-income countries (LMICs) and high-income countries (HICs).

Methods: Relevant social science and medical databases were searched for peer-reviewed papers published from January 2008 to January 2020, leading to the identification of 61 relevant studies.

Results: A thematic analysis of the data revealed that LMICs report detrimental impacts on adolescents in relation to menstrual hygiene and cultural issues, while in HICs, issues related to pain management and long-term health outcomes were reported more frequently.

Conclusions: In order to improve overall menstrual health literacy in LMICs and HICs, appropriate policies need to be developed, drawing on input from multiple stakeholders to ensure evidence-based and cost-effective practical interventions.
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http://dx.doi.org/10.3390/ijerph18052260DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7956698PMC
February 2021

Tolerance to alcohol: A critical yet understudied factor in alcohol addiction.

Pharmacol Biochem Behav 2021 May 23;204:173155. Epub 2021 Feb 23.

Integrative Neuroscience Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA. Electronic address:

Alcohol tolerance refers to a lower effect of alcohol with repeated exposure. Although alcohol tolerance has been historically included in diagnostic manuals as one of the key criteria for a diagnosis of alcohol use disorder (AUD), understanding its neurobiological mechanisms has been neglected in preclinical studies. In this mini-review, we provide a theoretical framework for alcohol tolerance. We then briefly describe chronic tolerance, followed by a longer discussion of behavioral and neurobiological aspects that underlie rapid tolerance in rodent models. Glutamate/nitric oxide, γ-aminobutyric acid, opioids, serotonin, dopamine, adenosine, cannabinoids, norepinephrine, vasopressin, neuropeptide Y, neurosteroids, and protein kinase C all modulate rapid tolerance. Most studies have evaluated the ability of pharmacological manipulations to block the development of rapid tolerance, but only a few studies have assessed their ability to reverse already established tolerance. Notably, only a few studies analyzed sex differences. Neglected areas of study include the incorporation of a key element of tolerance that involves opponent process-like neuroadaptations. Compared with alcohol drinking models, models of rapid tolerance are relatively shorter in duration and are temporally defined, which make them suitable for combining with a wide range of classic and modern research tools, such as pharmacology, optogenetics, calcium imaging, in vivo electrophysiology, and DREADDs, for in-depth studies of tolerance. We conclude that studies of the neurobiology of alcohol tolerance should be revisited with modern conceptualizations of addiction and modern neurobiological tools. This may contribute to our understanding of AUD and uncover potential targets that can attenuate hazardous alcohol drinking.
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http://dx.doi.org/10.1016/j.pbb.2021.173155DOI Listing
May 2021

The Role of Research in Guiding Treatment for Women's Health: A Qualitative Study of Traditional Chinese Medicine Acupuncturists.

Int J Environ Res Public Health 2021 01 19;18(2). Epub 2021 Jan 19.

NICM Health Research Institute, Western Sydney University, Sydney 2517, Australia.

Background: Surveys of acupuncture practitioners worldwide have shown an increase in the use of acupuncture to treat women's health conditions over the last ten years. Published studies have explored the effectiveness of acupuncture for various conditions such as period pain, fertility, and labor induction. However, it is unclear what role, if any, peer-reviewed research plays in guiding practice.

Methods: Acupuncturists with a significant women's health caseload were interviewed online in three small groups to explore factors that contribute to acupuncturists' clinical decision made around treatment approaches and research.

Results: Eleven practitioners participated in the focus groups. The overarching theme that emerged was one of 'Not mainstream but a stream.' This captured two themes relating to acupuncture as a distinct practice: 'working with what you've got' as well as 'finding the right lens', illustrating practitioners' perception of research needing to be more relevant to clinical practice.

Conclusions: Acupuncture practitioners treating women's health conditions reported a disconnect between their clinical practice and the design of clinical trials, predominantly due to what they perceived as a lack of individualization of treatment. Case histories were popular as a learning tool and could be used to support increasing research literacy.
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http://dx.doi.org/10.3390/ijerph18020834DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835913PMC
January 2021

Chronic active Epstein-Barr virus: a multidisciplinary approach.

BMJ Case Rep 2020 Dec 21;13(12). Epub 2020 Dec 21.

ENT Department, Royal Victoria Hospital, Belfast, UK.

A 17-year-old Caucasian male presented to ENT with angular stomatitis, oral ulceration and cervical lymphadenopathy. Over the subsequent 18 months he developed recurrent upper respiratory tract infections, pyrexia of unknown origin, oral ulceration and maxillary sinus osteomyelitis. Extensive investigation ensued from various specialties. Positive investigations included a mild but persistently elevated serum Epstein-Barr virus PCR; however, no unifying diagnosis was elicited. It is noteworthy that a significant factor contributing to a delay in his diagnosis was poor compliance with invasive investigations. Ultimately, deteriorating liver function prompted liver biopsy which confirmed a diagnosis of chronic active Epstein-Barr virus infection (CAEBV). This enabled referral for curative treatment in the form of a stem cell transplant. CAEBV is extremely rare in Western countries. Due to fatal complications early diagnosis is critical for successful treatment. Our case highlights the need for regular clinical re-evaluation and a comprehensive multispecialty approach in such cases.
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http://dx.doi.org/10.1136/bcr-2020-236287DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7754638PMC
December 2020

IVF, acupuncture and mental health: a qualitative study of perceptions and experiences of women participating in a randomized controlled trial of acupuncture during IVF treatment.

Reprod Biomed Soc Online 2021 Mar 1;12:22-31. Epub 2020 Oct 1.

National Institute of Complementary Medicine, Western Sydney University, Sydney, NSW, Australia.

Infertility treatments such as in-vitro fertilization (IVF) are stressful and challenging to mental health and well-being. The use of alternative therapies adjunct to IVF treatment, such as acupuncture, is common and women hope to improve their chance of pregnancy and live birth. While many women engage in acupuncture adjunct to IVF in Australia, few qualitative studies of women's motivations and experiences have been conducted in this field. A qualitative study was nested within a randomized controlled trial of acupuncture during IVF treatment in order to explore women's perceptions of acupuncture, its effects in the context of IVF treatment, and how acupuncture is perceived in relation to the outcome of IVF. Fifty women randomized into both acupuncture and sham acupuncture groups were interviewed using a semi-structured format. In-depth interviews were transcribed, coded and categorized in a theoretical thematic analysis. Two primary themes emerged: 'psychological benefit' and 'perceived influence of acupuncture on fertility/medical outcome'. Regardless of randomization, women in both groups described similar psychological effects suggesting that a placebo effect was present. They were not convinced that acupuncture could enhance their treatment outcome through biomedical pathways. Rather, they perceived that acupuncture or sham acupuncture gave them a psychological advantage through increased relaxation, reduced psychological stress, and enhanced well-being and self-efficacy. In conclusion, there are significant features associated with a placebo effect in acupuncture that might be exploited to provide psychological benefit for women undertaking IVF.
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http://dx.doi.org/10.1016/j.rbms.2020.08.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7653009PMC
March 2021

Paraneoplastic acute fibrinous and organizing pneumonia from lymphoma completely responding to bendamustine-rituximab.

Respirol Case Rep 2020 Dec 5;8(9):e00681. Epub 2020 Nov 5.

Department of Thoracic Medicine Royal Adelaide Hospital Adelaide SA Australia.

Acute fibrinous and organizing pneumonia (AFOP) is a rare histopathological pattern of lung injury characterized by prominent fibrin deposition in alveolar spaces. It may be idiopathic or associated with medications, connective tissue disease, infection, environmental exposures, transplantation, and malignancy. There is no proven treatment but multiple reports describe response to corticosteroids. We report the case of a 65-year-old male never-smoker with a 15-month history of dry cough, dyspnoea, anorexia, and night sweats only partially responsive to doxycycline and oral prednisolone. Computed tomography chest demonstrated adenopathy on both sides of the diaphragm and patchy consolidation in a peribronchovascular and subpleural distribution with lower zone predominance. Axillary node biopsy revealed low-grade non-Hodgkin's lymphoma. Lung biopsy showed AFOP but no lymphoma. Complete pulmonary and neoplastic responses were achieved with bendamustine-rituximab. We report a compelling instance of paraneoplastic AFOP responding to chemotherapy for lymphoma with very limited use of corticosteroids.
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http://dx.doi.org/10.1002/rcr2.681DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7644388PMC
December 2020

Menstrual Health Literacy and Management Strategies in Young Women in Australia: A National Online Survey of Young Women Aged 13-25 Years.

J Pediatr Adolesc Gynecol 2021 Apr 12;34(2):135-143. Epub 2020 Nov 12.

Centre for Educational Research, Western Sydney University, Penrith, NSW, Australia.

Study Objective: To explore key aspects of menstrual health literacy and menstrual management in young women at school or in tertiary education.

Design: Cross-sectional online survey.

Setting: Australia-wide.

Participants: A total of 4202 adolescent and young women (13-25 years of age; median age 17 years), having reached menarche, living in Australia and currently attending school (n = 2421) or tertiary education (n = 1781).

Interventions: Online survey hosted by Qualtrics between November 2017 and January 2018. Data were collected on contraceptive use, management strategies, sources of information, and knowledge of menstruation.

Main Outcome Measures: Information on prevalence and effectiveness of different management strategies, health-seeking behavior, knowledge about menstruation, and common menstrual disorders such as endometriosis.

Results: The majority of young women did not seek medical advice for their menstrual symptoms, but used information from the Internet (50%) and engaged in self-management, most commonly with over-the-counter medications such as paracetamol (51%) or ibuprofen (52%). Oral contraceptive use was relatively common (35%), and mostly for reduction of menstrual pain (58%). Despite having significant dysmenorrhea, approximately one-half of the participants (51%) thought that their period was normal. Women with higher pain scores were more likely to rate their period as "abnormal" (P < .0001) but not more likely to consult a doctor (P = .13). Only 53% of those at school had heard of endometriosis.

Conclusion: Self-management of menstrual symptoms is common, but a significant minority of women are underdosing or choosing ineffective methods. Most women do not seek medical advice even when symptoms are severe, and cannot identify symptoms suggestive of secondary dysmenorrhea. Improved education on menstruation is vital.
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http://dx.doi.org/10.1016/j.jpag.2020.11.007DOI Listing
April 2021

Variation in the expression of a transmembrane protein influences cell growth in Arabidopsis thaliana petals by altering auxin responses.

BMC Plant Biol 2020 Oct 22;20(1):482. Epub 2020 Oct 22.

Cell and Developmental Biology Department John Innes Centre, Norwich Research Park, Norwich, NR4 7UH, UK.

Background: The same species of plant can exhibit very diverse sizes and shapes of organs that are genetically determined. Characterising genetic variation underlying this morphological diversity is an important objective in evolutionary studies and it also helps identify the functions of genes influencing plant growth and development. Extensive screens of mutagenised Arabidopsis populations have identified multiple genes and mechanisms affecting organ size and shape, but relatively few studies have exploited the rich diversity of natural populations to identify genes involved in growth control.

Results: We screened a relatively well characterised collection of Arabidopsis thaliana accessions for variation in petal size. Association analyses identified sequence and gene expression variation on chromosome 4 that made a substantial contribution to differences in petal area. Variation in the expression of a previously uncharacterised gene At4g16850 (named as KSK) had a substantial role on variation in organ size by influencing cell size. Over-expression of KSK led to larger petals with larger cells and promoted the formation of stamenoid features. The expression of auxin-responsive genes known to limit cell growth was reduced in response to KSK over-expression. ANT expression was also reduced in KSK over-expression lines, consistent with altered floral identities. Auxin responses were reduced in KSK over-expressing cells, consistent with changes in auxin-responsive gene expression. KSK may therefore influence auxin responses during petal development.

Conclusions: Understanding how genetic variation influences plant growth is important for both evolutionary and mechanistic studies. We used natural populations of Arabidopsis thaliana to identify sequence variation in a promoter region of Arabidopsis accessions that mediated differences in the expression of a previously uncharacterised membrane protein. This variation contributed to altered auxin responses and cell size during petal growth.
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http://dx.doi.org/10.1186/s12870-020-02698-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7584087PMC
October 2020

"The whole package deal": experiences of overweight/obese women living with polycystic ovary syndrome.

BMC Womens Health 2020 10 2;20(1):221. Epub 2020 Oct 2.

Monash Centre for Health Research and Implementation - MCHRI, School of Public Health and Preventive Medicine, Monash University, Level 1, 43-51 Kanooka Grove, Clayton, Vic, 3168, Australia.

Background: Polycystic Ovary Syndrome (PCOS) is a common female reproductive disorder with multiple manifestations. There are relatively few qualitative studies exploring the nature of living with PCOS despite its high prevalence. Qualitative research can enhance clinical practice via the provision of patient insights into the experience of living with their condition.

Methods: We conducted two focus groups and three semi-structured interviews of Australian overweight/obese women with PCOS aged 18-46 years between March and April 2017 who were recruited through social media advertising. Interviews and focus groups were audio recorded and transcribed verbatim. Thematic analysis was applied to the data, using the method of constant comparison.

Results: Ten women contributed data from two focus groups and two semi-structured interviews. Five themes emerged from the data: complexity of the condition with its multiple manifestations, difficulties with delayed diagnosis and lack of information provided after diagnosis, negative experiences on social media and online forums and the need for support, frustration over lack of a "cure"; and the impact of symptoms and concern about long-term sequelae.

Conclusions: Living with PCOS appears to generate a significant degree of anxiety about the future, dissatisfaction with current treatment models, and loss of feminine identity. Gaps in timely diagnosis, information and support provision need to be addressed. This includes supporting weight management as a fundamental concern for women with PCOS.
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http://dx.doi.org/10.1186/s12905-020-01090-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532653PMC
October 2020

Endometriosis and chronic pelvic pain have similar impact on women, but time to diagnosis is decreasing: an Australian survey.

Sci Rep 2020 10 1;10(1):16253. Epub 2020 Oct 1.

School of Women's and Children's Health, University of New South Wales, Sydney, NSW, Australia.

Chronic pelvic pain (CPP) affects a significant number of women worldwide. Internationally, people with endometriosis report significant negative impact across many areas of their life. We aimed to use an online survey using the EndoCost tool to determine if there was any difference in the impact of CPP in those with vs. those without a confirmed diagnosis of endometriosis, and if there was any change in diagnostic delay since the introduction of clinical guidelines in 2005. 409 responses were received; 340 with a diagnosis of endometriosis and 69 with no diagnosis. People with CPP, regardless of diagnosis, reported moderate to severe dysmenorrhea and non-cyclical pelvic pain. Dyspareunia was also common. Significant negative impact was reported for social, academic, and sexual/romantic relationships in both cohorts. In the endometriosis cohort there was a mean diagnostic delay of eight years, however there was a reduction in both the diagnostic delay (p < 0.001) and number of doctors seen before diagnosis (p < 0.001) in those presenting more recently. Both endometriosis and CPP have significant negative impact. Whilst there is a decrease in the time to diagnosis, there is an urgent need for improved treatment options and support for women with the disease once the diagnosis is made.
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http://dx.doi.org/10.1038/s41598-020-73389-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529759PMC
October 2020

Impact of population tobacco control interventions on socioeconomic inequalities in smoking: a systematic review and appraisal of future research directions.

Tob Control 2020 Sep 29. Epub 2020 Sep 29.

Usher Institute, University of Edinburgh, Edinburgh, UK.

Background: While price increases and targeted cessation support have been found to reduce inequalities in smoking by socioeconomic status (SES), evidence on other measures is mixed. We aimed to update the most recent (2014) previous review by identifying and appraising evidence published since 2013 on the equity impact of population tobacco control measures.

Methods: Systematic searching of 10 electronic databases and hand-searching of four key journals identified 68 primary research articles published since 2013 that sought to examine the equity impact of population tobacco control measures in high-income countries with a negative socioeconomic gradient in smoking. Reported equity impacts were categorised as positive (greater impact among lower SES), neutral (no difference by SES), negative (greater impact among higher SES) or mixed/unclear.

Results: There was substantial growth in research seeking to evaluate the equity impact of tobacco control interventions, but the majority of new studies showed mixed/unclear results. Findings for price increases and targeted cessation support continue to suggest an equity-positive impact, but limitations in the available evidence make further assessment difficult. Substantial differences in the context, scale and implementation of tobacco control policies make straightforward comparison of findings from the previous 2014 and current reviews problematic.

Conclusion: Researchers need to adopt more sophisticated, multidisciplinary approaches in evaluating the equity impact of tobacco control measures-developing robust measures of equity effect and using frameworks that take account of context, existing systems/processes and the likely mechanisms of action. Socioeconomic differences in intervention impact within low-income and middle-income countries require evaluation.
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http://dx.doi.org/10.1136/tobaccocontrol-2020-055874DOI Listing
September 2020

The AEDUCATE Collaboration. Comprehensive antenatal education birth preparation programmes to reduce the rates of caesarean section in nulliparous women. Protocol for an individual participant data prospective meta-analysis.

BMJ Open 2020 09 23;10(9):e037175. Epub 2020 Sep 23.

NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia.

Introduction: Rates of medical interventions in normal labour and birth are increasing. This prospective meta-analysis (PMA) proposes to assess whether the addition of a comprehensive multicomponent birth preparation programme reduces caesarean section (CS) in nulliparous women compared with standard hospital care. Additionally, do participant characteristics, intervention components or hospital characteristics modify the effectiveness of the programme? METHODS AND ANALYSIS: : women with singleton vertex pregnancies, no planned caesarean section (CS) or epidural.: in addition to hospital-based standard care, a comprehensive antenatal education programme that includes multiple components for birth preparation, addressing the three objectives: preparing women and their birth partner/support person for childbirth through education on physiological/hormonal birth (knowledge and understanding); building women's confidence through psychological preparation (positive mindset) and support their ability to birth without pain relief using evidence-based tools (tools and techniques). The intervention could occur in a hospital-based or community setting.: standard care alone in hospital-based maternity units.

Outcomes: : CS.: epidural analgesia, mode of birth, perineal trauma, postpartum haemorrhage, newborn resuscitation, psychosocial well-being.: parity, model of care, maternal risk status, maternal education, maternal socio-economic status, intervention components.

Study Design: An individual participant data (IPD) prospective meta-analysis (PMA) of randomised controlled trials, including cluster design. Each trial is conducted independently but share core protocol elements to contribute data to the PMA. Participating trials are deemed eligible for the PMA if their results are not yet known outside their Data Monitoring Committees.

Ethics And Dissemination: Participants in the individual trials will consent to participation, with respective trials receiving ethical approval by their local Human Research Ethics Committees. Individual datasets remain the property of trialists, and can be published prior to the publication of final PMA results. The overall data for meta-analysis will be held, analysed and published by the collaborative group, led by the Cochrane PMA group.

Trial Registration Number: CRD42020103857.
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http://dx.doi.org/10.1136/bmjopen-2020-037175DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7513601PMC
September 2020

Fecal Short-Chain Fatty Acid Concentrations Increase in Newly Paired Male Marmosets (Callithrix jacchus).

mSphere 2020 09 16;5(5). Epub 2020 Sep 16.

Department of Biology, University of Nebraska at Omaha, Omaha, Nebraska, USA.

The role by which the gut microbiome influences host health (e.g., energy equilibrium and immune system) may be partly mediated by short-chain fatty acids, which are bacterial fermentation products from the dietary fibers. However, little is known about longitudinal changes in gut microbiome metabolites during cohabitation alongside social contact. In common marmosets (), the gut microbiome community is influenced by social contact, as newly paired males and females develop convergent microbial profiles. Here, we monitored the dynamics of short-chain fatty acid concentrations in common marmoset feces from the prepairing (PRE) to postpairing (POST) stages. In males, we observed that the concentrations of acetate, propionate, isobutyrate, and isovalerate significantly increased in the POST stage compared to the PRE stage. However, no significant changes were found in females. We further found that the propionate concentration was significantly positively correlated with the abundance of in the male feces. Thus, the sex difference in the changes in the concentrations of short-chain fatty acids might be related to sex-biased gut microbiome transmission after pairing. We suggest that the significant changes in the gut microbiomes and some short-chain fatty acids of the common marmoset during cohabitation may contribute to physiological homeostasis during pairing. This study addressed a knowledge gap about longitudinal changes in the gut microbiome metabolites during animal pairing. This research in the laboratory common marmoset can control for the confounding factors such as diet and other environmental conditions. showed the highest contribution to the sex-biased transmission of the female to the male after pairing. Here, we observed the sex difference in the increase in short-chain fatty acid concentration in the feces of newly paired marmosets, which may be caused by the sex-biased gut microbiome transmission after pairing.
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http://dx.doi.org/10.1128/mSphere.00794-20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7494834PMC
September 2020

A de-waxing methodology for scanning probe microscopy.

Anal Methods 2020 07;12(26):3397-3403

Department of Physics, University of Liverpool, L69 7ZE, UK.

A de-waxing protocol that successfully removes paraffin from tissue microarray (TMA) cores of fixed tissue obtained from oral cancer is described. The success of the protocol is demonstrated by the comparison of Fourier transform infrared (FTIR) results obtained on paraffin-embedded and de-waxed tissue and the absence of any significant correlations between infrared scanning near-field optical microscopy (SNOM) images of de-waxed tissue obtained at the three main paraffin IR peaks. The success of the protocol in removing paraffin from tissue is also demonstrated by images obtained with scanning electron microscopy (SEM) and by energy dispersive spectra (EDS) of a de-waxed CaF2 disc which shows no significant contribution from carbon. The FTIR spectra of the de-waxed TMA core overlaps that obtained from OE19 oesophageal cancer cells which had never been exposed to paraffin.
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http://dx.doi.org/10.1039/d0ay00965bDOI Listing
July 2020

Quantification of anthracene after dermal absorption test APCI-tandem mass spectrometry.

Anal Methods 2020 06;12(22):2820-2826

Department of Textile Engineering, Chemistry and Science, College of Textiles, North Carolina State University, Raleigh, NC 27695, USA.

An analytical method for the detection and quantification of anthracene from interstitial fluid samples was developed by using Atmospheric Pressure Chemical Ionization-Tandem Mass Spectrometry (APCI-MS/MS). The anthracene samples were obtained using intradermal microdialysis to assess dermal absorption of this polycyclic aromatic hydrocarbon (PAH). The experimental considerations were evaluated based on the chemical properties of this PAH and the detection limits of the instrumentation. The addition of an isotopically labeled internal standard allows the reduction of ionization suppression due to instrumental fluctuation and run-to-run deviation. The dermal extraction samples were prepared considering the proceeding conditions for measurement enhancement. Several variables for method validation including coefficient of determination (R2 = 0.993 ± 0.003), percent error (% error = 0 ± 2%), coefficient of variation (% CV = 5 ± 1%), lowest limit of detection (LOD = 39 ± 3 ng mL-1), and lowest limit of quantification (LLOQ = 129 ± 10 ng mL-1) were obtained from the inter- and intra-day measurements for the calibration and the quality control samples. Posterior to this, actual dermal interstitial fluid samples were measured, and it was observed they fitted into the ranges defined from the method development with good accuracy and precision. It was observed that the introduction of an internal standard while performing APCI-MS/MS allows an accurate and precise measurement of the concentration of anthracene to be obtained from dermal extraction samples. This method could be further used for complex mixtures to enhance our understanding of hazardous exposure of PAH on firefighter gear.
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http://dx.doi.org/10.1039/d0ay00486cDOI Listing
June 2020

Neonatal immune challenge induces female-specific changes in social behavior and somatostatin cell number.

Brain Behav Immun 2020 11 26;90:332-345. Epub 2020 Aug 26.

Duke University, Department of Psychology and Neuroscience, Durham, NC, USA. Electronic address:

Decreases in social behavior are a hallmark aspect of acute "sickness behavior" in response to infection. However, immune insults that occur during the perinatal period may have long-lasting consequences for adult social behavior by impacting the developmental organization of underlying neural circuits. Microglia, the resident immune cells of the central nervous system, are sensitive to immune stimulation and play a critical role in the developmental sculpting of neural circuits, making them likely mediators of this process. Here, we investigated the impact of a postnatal day (PND) 4 lipopolysaccharide (LPS) challenge on social behavior in adult mice. Somewhat surprisingly, neonatal LPS treatment decreased sociability in adult female, but not male mice. LPS-treated females also displayed reduced social interaction and social memory in a social discrimination task as compared to saline-treated females. Somatostatin (SST) interneurons within the anterior cingulate cortex (ACC) have recently been suggested to modulate a variety of social behaviors. Interestingly, the female-specific changes in social behavior observed here were accompanied by an increase in SST interneuron number in the ACC. Finally, these changes in social behavior and SST cell number do not appear to depend on microglial inflammatory signaling, because microglia-specific genetic knock-down of myeloid differentiation response protein 88 (MyD88; the removal of which prevents LPS from increasing proinflammatory cytokines such as TNFα and IL-1β) did not prevent these LPS-induced changes. This study provides novel evidence for enduring effects of neonatal immune activation on social behavior and SST interneurons in females, largely independent of microglial inflammatory signaling.
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http://dx.doi.org/10.1016/j.bbi.2020.08.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7556772PMC
November 2020

Processing Has Differential Effects on Microbiota-Accessible Carbohydrates in Whole Grains during Fermentation.

Appl Environ Microbiol 2020 10 15;86(21). Epub 2020 Oct 15.

Department of Food Science and Technology, University of Nebraska-Lincoln, Lincoln, Nebraska, USA

Whole grains are generally low in nondigestible carbohydrates that are available for fermentation by the gut microbiota, or microbiota-accessible carbohydrates (MAC). However, there is potential to increase MAC in whole grains through food processing. Five processing methods: boiling, extrusion, sourdough bread, unleavened bread, and yeast bread, were applied to whole wheat flour and then subjected to digestion followed by fermentation using fecal microbiomes from 10 subjects. The microbiomes separated into 2 groups: those that showed high carbohydrate utilization (CU) and those that exhibited low CU. The former exhibited not only enhanced CU but also increased butyrate production (MAC, 31.1 ± 1.1% versus 19.3 ± 1.2%,  < 0.001; butyrate, 5.26 ± 0.26 mM versus 3.17 ± 0.27 mM,  < 0.001). Only the microbiomes in the high-CU group showed significant differences among processing methods: extrusion and sourdough bread led to dichotomous results for MAC and short-chain fatty acid production, where extrusion resulted in high MAC but low butyrate production while sourdough bread resulted in low MAC but high butyrate production. Extrusion led to a noticeable decrease in α-diversity and some members of the families and , with increases in , , and This study demonstrated that only microbiomes that exhibited high CU responded to the effects of processing by showing significant differences among processing methods. In these microbiomes, extrusion was able to increase accessibility of the cell wall polysaccharides but did not increase butyrate production. In contrast, sourdough bread led to high butyrate production by supporting important butyrate-producers in the families and Dietary nondigestible carbohydrates, or dietary fiber, have long been recognized for their beneficial health effects. However, recent studies have revealed that fermentation of nondigestible carbohydrates by gut bacteria is critical in mediating many of the health-promoting properties of dietary fibers. Whole grains are excellent candidates to supply the microbiome with a plentiful source of nondigestible carbohydrates, although unfortunately a majority of these carbohydrates in whole grains are not available to gut bacteria for fermentation. Processing is known to alter the structural characteristics of nondigestible carbohydrates in whole grains, yet the relationship between these effects and gut microbial fermentation is unknown. This research aimed to address this important research gap by identifying interactions between whole-grain processing and gut bacteria, with the ultimate goal of increasing the availability of nondigestible carbohydrates for fermentation to enhance host health.
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http://dx.doi.org/10.1128/AEM.01705-20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7580540PMC
October 2020

Hospital policies on complementary medicine: a cross-sectional survey of Australian cancer services.

Med J Aust 2020 11 12;213(10):474-475. Epub 2020 Aug 12.

Translational Health Research Institute, Western Sydney University, Campbelltown, NSW.

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http://dx.doi.org/10.5694/mja2.50731DOI Listing
November 2020

Isolation of Microglia from Mouse or Human Tissue.

STAR Protoc 2020 Jun 3;1(1). Epub 2020 Jun 3.

Department of Pediatrics, Lurie Center for Autism, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

Microglia are the innate immune cells of the central nervous system. Although numerous methods have been developed to isolate microglia from the brain, the method of dissociation and isolation can have a profound effect on the function of these highly dynamic cells. Here, we present an optimized protocol to isolate CD11b+ cells (microglia) from mouse or human brain tissue using magnetic bead columns. Isolated microglia can be used to model diseases with neuroinflammatory components for potential therapeutic discoveries. For complete details on the use and execution of this protocol, please refer to Hanamsagar et al. (2017), Rivera et al. (2019), and Edlow et al. (2019).
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http://dx.doi.org/10.1016/j.xpro.2020.100035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7416840PMC
June 2020

Emerging roles of melanocortin receptor accessory proteins (MRAP and MRAP2) in physiology and pathophysiology.

Gene 2020 Oct 15;757:144949. Epub 2020 Jul 15.

School of Life Sciences, University of Westminster, 115 New Cavendish Street, London W1W 6UW, UK. Electronic address:

Melanocortin-2 receptor accessory protein (MRAP) has an unusual dual topology and influences the expression, localisation, signalling and internalisation of the melanocortin receptor 2 (MC); the adrenocorticotropic hormone (ACTH) receptor. Mutations in MRAP are associated with familial glucocorticoid deficiency type-2 and evidence is emerging of the importance of MRAP in adrenal development and ACTH signalling. Human MRAP has two functional splice variants: MRAP-α and MRAP-β, unlike MRAP-β, MRAP-α has little expression in brain but is highly expressed in ovary. MRAP2, identified through whole human genome sequence analysis, has approximately 40% sequence homology to MRAP. MRAP2 facilitates MC2 localisation to the cell surface but not ACTH signalling. MRAP and MRAP2 have been found to regulate the surface expression and signalling of all melanocortin receptors (MC). Additionally, MRAP2 moderates the signalling of the G-protein coupled receptors (GCPRs): orexin, prokineticin and GHSR1a; the ghrelin receptor. Whilst MRAP appears to be mainly involved in glucocorticoid synthesis, an important role is emerging for MRAP2 in regulating appetite and energy homeostasis. Transgenic models indicate the importance of MRAP in adrenal gland formation. Like MC3R and MC4R knockout mice, MRAP2 knockout mice have an obese phenotype. In vitro studies indicate that MRAP2 enhances the MC3 and MC4 response to the agonist αMSH, which, like ACTH, is produced through precursor polypeptide proopiomelanocortin (POMC) cleavage. Analysis of cohorts of individuals with obesity have revealed several MRAP2 genetic variants with loss of function mutations which are causative of monogenic hyperphagic obesity with hyperglycaemia and hypertension. MRAP2 may also be associated with female infertility. This review summarises current knowledge of MRAP and MRAP2, their influence on GPCR signalling, and focusses on pathophysiology, particularly familial glucocorticoid deficiency type-2 and obesity.
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http://dx.doi.org/10.1016/j.gene.2020.144949DOI Listing
October 2020

The feasibility of acupuncture as an adjunct intervention for antenatal depression: a pragmatic randomised controlled trial.

J Affect Disord 2020 10 24;275:82-93. Epub 2020 May 24.

Professor of Mental Health, Translational Health Research Institute, School of Medicine Western Sydney University and Camden and Campbelltown Hospitals SWSLHD, Locked Bag 1797, Penrith, NSW 2751, Australia. Electronic address:

Background: Antenatal depression is common and associated with adverse consequences for mothers, babies, and future generations. Limitations with conventional approaches has resulted in additional therapies being considered. This study examined the feasibility and effectiveness of acupuncture for improving mental health.

Methods: Fifty-seven pregnant women with depressive symptomologies were randomised to acupuncture (n=19) plus treatment as usual (TAU), progressive muscle relaxation (PMR, n=19) plus TAU or TAU (n=19). Treatments were conducted from 24 to 31 weeks gestation. Clinical assessments were performed throughout the intervention, as well as at a six-week postnatal follow-up. The primary outcome measure was depression. Secondary outcome measurements were stress, anxiety, psychological distress, quality of life and adjustment to mothering. Intention to treat (ITT), Linear Mixed Model (LMM) repeated measures and per protocol (PP) analyses were conducted.

Results: At end-of-intervention there were significantly lower depression scores in the acupuncture group versus TAU and PMR respectively [ITT p<0.001, mean difference (MD) -5.84 (95% CI -9.10 to -2.58); MD -3.42 (95% CI -6.64 to -0.20)]. LMM repeated measures analysis (including postnatal follow-up) also demonstrated significantly lowered acupuncture group scores for stress (p=0.006) and psychological distress (p<0.001) when compared to PMR and TAU. Between group differences were not significant at six-weeks postnatal. No adverse events were reported.

Limitations: Main limitations are small sample size and the use of self-reported outcome measures.

Conclusion: Prenatal acupuncture reduced depression, stress and distress, whilst also being well-tolerated and free from adverse events. Further research is warranted.
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http://dx.doi.org/10.1016/j.jad.2020.05.089DOI Listing
October 2020

The Prevalence and Educational Impact of Pelvic and Menstrual Pain in Australia: A National Online Survey of 4202 Young Women Aged 13-25 Years.

J Pediatr Adolesc Gynecol 2020 Oct 13;33(5):511-518. Epub 2020 Jun 13.

Centre for Educational Research, Western Sydney University, Penrith, NSW, Australia.

Study Objective: To explore the prevalence and impact of dysmenorrhea, pelvic pain and menstrual symptoms on young women at school or in tertiary education.

Design And Setting: Cross-sectional online survey in Australia.

Participants: A total of 4202 adolescent and young women (13-25 years of age; median age 17 years), having reached menarche, living in Australia and currently attending school (n = 2421) or tertiary education (n = 1781).

Interventions: Online survey hosted by Qualtrics between November 2017 to January 2018. Data were collected on sociodemographic data, menstrual cycle characteristics, dysmenorrhea, pelvic pain, and educational and social impact.

Main Outcome Measures: Information on menstrual and pelvic pain impact, academic absenteeism and presenteeism, impact on non-academic activities and interactions with teaching staff.

Results And Conclusions: Dysmenorrhea was reported by 92% of respondents. Dysmenorrhea was moderate (median 6.0 on a 0-10 numeric rating scale) and pain severity stayed relatively constant with age [r(3804) = 0.012, P = .477]. Noncyclical pelvic pain at least once a month was reported by 55%. Both absenteeism and presenteeism related to menstruation were common. Just under half of women reported missing at least one class/lecture in the previous three menstrual cycles. The majority of young women at school (77%) and in tertiary education (70%) reported problems with classroom concentration during menstruation. Higher menstrual pain scores were strongly correlated with increased absenteeism and reduced classroom performance at both school and in tertiary education. Despite the negative impact on academic performance the majority of young women at school (60%) or tertiary education (83%) would not speak to teaching staff about menstruation.
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http://dx.doi.org/10.1016/j.jpag.2020.06.007DOI Listing
October 2020

The effect of antenatal pelvic floor muscle exercises on labour and birth outcomes: a systematic review and meta-analysis.

Int Urogynecol J 2020 Nov 6;31(11):2189-2203. Epub 2020 Jun 6.

School of Nursing and Midwifery (SONM), Western Sydney University (WSU), Locked Bag 1797, Penrith, NSW, 2751, Australia.

Introduction And Hypothesis: The current data on the effectiveness of antenatal pelvic floor muscle exercises (PFME) on childbirth outcomes are limited. Therefore, in this study the effect of antenatal PFMEs on labour and birth outcomes was assessed by undertaking a meta-analysis.

Methods: Databases were systematically searched from 1988 until June 2019. Randomised controlled trials (RCTs) and quasi-experimental studies were included. The methodological quality of studies was assessed using Cochrane Collaboration tools. The outcomes of interest were: duration of first and second stage of labour, episiotomy and perineal outcomes, mode of birth (spontaneous vaginal birth, instrumental birth and caesarean section) and fetal presentation. The mean difference (MD) and risk ratio RR) with the corresponding 95% confidence intervals (CIs) were calculated to assess the association between PFME and the childbirth outcomes.

Results: A total of 16 articles were included (n = 2,829 women). PFME shortened the duration of the second stage of labour (MD: -20.90, 95%, CI: -31.82 to -9.97, I: 0%, p = 0.0002) and for primigravid women (MD: -21.02, 95% CI: -32.10 to -9.94, I: 0%, p = 0.0002). PFME also reduced severe perineal lacerations (RR 0.57, 95% CI: 0.38 to 0.84, I: 30%, p = 0.005). No significant difference was seen in normal vaginal birth, caesarean section, instrumental birth and episiotomy rate. Most of the studies carried a moderate to high risk of bias.

Conclusion: Antenatal PFME may be effective at shortening the second stage of labour and reducing severe perineal trauma. These findings need to be interpreted considering the included studies' risk of bias. More high-quality RCTs are needed.
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http://dx.doi.org/10.1007/s00192-020-04298-1DOI Listing
November 2020

Acupuncture or auricular electro-acupuncture as adjuncts to lifestyle interventions for weight management in PCOS: protocol for a randomised controlled feasibility study.

Pilot Feasibility Stud 2020 25;6:53. Epub 2020 Apr 25.

4Monash Centre for Health Research and Implementation, Locked Bag, Clayton, VIC 29 Australia.

Background: Polycystic ovary syndrome (PCOS) is a prevalent women's health condition with reproductive, metabolic, and psychological manifestations. Weight loss can improve these symptoms and is a key goal; however, many women find this difficult to achieve. Acupuncture is a Chinese medical treatment that involves insertion of very fine metal needles into specific areas of the body and has been shown to be efficacious for weight loss in non-PCOS populations. However, few studies have been conducted in women with PCOS. A variant of acupuncture, auricular electro-acupuncture (AEA), may have beneficial effects on sympathetic tone, which is associated with insulin resistance, obesity and PCOS.

Methods: This prospective three-arm open label parallel randomised controlled trial will assess feasibility and acceptability of acupuncture and/or AEA for weight loss in women with PCOS. We will enrol 39 women from the community aged between 18 and 45 years, with physician diagnosis of PCOS according to the Rotterdam criteria: body mass index (BMI) between 25 and 40 kg/m. Women will be randomly allocated to receive one of three treatments for 12 weeks duration: body electro-acupuncture + lifestyle interventions, AEA + lifestyle interventions, or lifestyle interventions alone. The lifestyle intervention in this study is telephone-based health coaching (between 4 and 13 phone calls, depending on individual need), provided by the Get Healthy Service. Primary outcomes of the study are feasibility and acceptability of trial methods as determined by recruitment and retention rates, adherence, acceptability, credibility, and safety. Secondary outcomes include anthropometric (body weight, BMI, waist and hip circumference), metabolic (glucose tolerance and insulin sensitivity obtained from a 2-h 75 g oral glucose tolerance test with area under the curve insulin calculated using the trapezoid rule), reproductive (androgen levels, menstrual cyclicity, clinical hyperandrogenism using the Ferriman-Gallwey scoring system), autonomic (heart rate variability, blood pressure), lifestyle (physical activity levels, diet quality, weight self-efficacy), quality of life, and psychological (depression and anxiety symptoms, internal health locus of control).

Discussion: This study addresses the feasibility and acceptability of novel interventions to treat overweight/obesity in PCOS. Study findings have the potential to generate a new understanding of the role of acupuncture and auricular acupuncture in weight management.

Trial Registration: Australian New Zealand Clinical Trial Registry, 8/6/18 ACTRN12618000975291.
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http://dx.doi.org/10.1186/s40814-020-00591-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7183107PMC
April 2020

Health literacy needs in weight management of women with Polycystic Ovary Syndrome.

Health Promot J Austr 2021 Feb 26;32 Suppl 1:41-48. Epub 2020 May 26.

NICM Health Research Institute, Western Sydney University, Sydney, NSW, Australia.

Issue Addressed: Lifestyle modification plays a key role in weight management and chronic disease prevention in polycystic ovary syndrome (PCOS). Women with PCOS experience challenges in adopting and maintaining healthy lifestyle behaviours, which may be related to health literacy. The aims of this study were to explore the health literacy needs of women with PCOS in lifestyle and weight management to inform research and practice.

Methods: Ten women with PCOS participated in focus groups and semi-structured telephone interviews on lifestyle and weight management in PCOS.

Results: For functional health literacy, women with PCOS are highly motivated for lifestyle and weight management due to the long-term consequences of PCOS. For interactive health literacy, barriers included delayed diagnosis and poor communication. Women with PCOS were resourceful in accessing a wide range of weight management services but some experience barriers such as costs or the feelings of embarrassment associated with accessing relevant services. For critical health literacy, no facilitators and barriers could be identified for the domain of participation in making decisions for health.

Conclusions: Women with PCOS experience facilitators and barriers in functional and interactive health literacy in lifestyle and weight management. SO WHAT?: Future interventions should seek to further understand and address these gaps in health literacy by increasing weight management skills through behaviour change techniques, improving health professional-patient communication through tools such as question prompt lists, enhancing peer support by increasing distributed health literacy in PCOS support groups and by providing opportunities for co-design of interventions.
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http://dx.doi.org/10.1002/hpja.349DOI Listing
February 2021

The effects of sildenafil on ciliary beat frequency in patients with pulmonary non-tuberculous mycobacteria disease: phase I/II trial.

BMJ Open Respir Res 2020 03;7(1)

Immunopathogenesis Section, Laboratory of Clinical Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.

Rationale: Pulmonary non-tuberculous mycobacterial (PNTM) disease has increased over the past several decades, especially in older women. Abnormal mucociliary clearance and abnormal nasal nitric oxide (nNO) have been associated with PNTM disease in other patient cohorts. Mucociliary clearance can be affected by NO-cyclic guanosine monophosphate signalling and, therefore, modulation of the pathway may be possible with phosphodiesterase inhibitors such as sildenafil as a novel therapeutic approach.

Objective: To define ex vivo characteristics of PNTM disease affected by sildenafil.

Methods: Subjects with PNTM infections were recruited into an open-label dose-escalation trial of sildenafil. Laboratory measurements and mucociliary measurements-ciliary beat frequency, nNO and 24-hour sputum production-were collected throughout the study period. Patients received sildenafil daily during the study period, with escalation from 20 to 40 mg three times per day.

Measurements And Main Results: Increased ciliary beat frequency occurred after a single dose of 40 mg sildenafil and after extended dosing of 40 mg sildenafil. The increase ciliary beat frequency was not seen with 20 mg sildenafil dosing. There were no changes in sputum production, nNO production, Quality of Life-Bronchiectasis-NTM module (QOL-B-NTM) questionnaire or the St George's Respiratory Questionnaire during the study period.

Conclusion: Sildenafil, 40 mg, increased ciliary beat frequency acutely as well as with extended administration.
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http://dx.doi.org/10.1136/bmjresp-2020-000574DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069259PMC
March 2020