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Barriers and Facilitators Associated with the Adoption of and Adherence to a Mediterranean Style Diet in Adults: A Systematic Review of Published Observational and Qualitative Studies.
Tsofliou, F, Vlachos, D, Hughes, C, Appleton, KM
Nutrients. 2022;(20)
Abstract
The Mediterranean diet (MedDiet) has been linked with physical and mental health benefits. Previous research, however, suggests that adoption and adherence to a Mediterranean diet might be difficult for people who live outside of the Mediterranean region. The aim of this systematic review was to investigate the factors that influence adoption and adherence to a Mediterranean style diet in adults aged 18 years old and over, as identified in published observational and qualitative studies. Following registration of our protocol on PROSPERO (ID: CRD42018116515), observational and qualitative studies of adults' perceptions and experiences relevant to following a Mediterranean style diet were identified using systematic searches of databases: MEDLINE, the Cochane Library, CINAHL, Web of Science and Scopus, over all years of records until February 2022. A narrative synthesis was then undertaken. Of 4559 retrieved articles, 18 studies fulfilled our inclusion criteria and were included. Factors influencing adoption and adherence to a MedDiet were identified and categorized as: financial, cognitive, socio-cultural, motivational, lifestyle, accessibility & availability, sensory & hedonic and demographic. Similar barriers and facilitators are often reported in relation to healthy eating or the consumption of specific healthy foods, with a few exceptions. These exceptions detailed concerns with specific components of the MedDiet; considerations due to culture and traditions, and concerns over a cooler climate. Suggestions for overcoming these barriers and facilitators specific to adoption and adherence to the Mediterranean diet are offered. These data will inform the development of future studies of robust methodology in eating behaviour change which offer pragmatic approaches for people to consume and maintain healthy diets.
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Treatment-induced mucositis in oncology.
Jasiewicz, F, Qurban, Z, Hughes, C
British journal of hospital medicine (London, England : 2005). 2022;(9):1-8
Abstract
Almost all cancer therapies lead to a wide array of side effects, owing to the disruption of normal physiological processes and alteration of immunological responses. Of these, mucositis is one of the most commonly encountered side effects, presenting in about 20-40% of all patients receiving chemotherapy and 80% of those being treated with radiotherapy for head and neck malignancies. This article provides a brief introduction and comprehensive overview of the various treatment modalities used in managing this complication. The key to management is a multidisciplinary approach, revolving around pain control, oral hygiene, nutritional support and management of superimposed infection. The scarcity of therapeutic options for prevention or treatment of mucositis has resulted in clinical difficulty in controlling it, which, in turn, seriously affects the patient's quality of life and cancer management, contributing to patient morbidity and mortality.
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A randomized clinical trial evaluating the effect of empagliflozin on triglycerides in obese adults: Role of visceral fat.
Lee, MH, Neeland, IJ, de Albuquerque Rocha, N, Hughes, C, Malloy, CR, Jin, ES
Metabolism open. 2022;:100161
Abstract
BACKGROUND Empagliflozin, a sodium glucose cotransporter 2 inhibitor, is a medication to treat type 2 diabetes. The effect of empagliflozin in persons without diabetes has received less attention. Here we conducted a randomized, double-blind placebo-controlled clinical trial to examine the effect of empagliflozin on plasma triglycerides in obese non-diabetic adults. METHODS Participants (n = 35; BMI ≥ 30 kg/m2) underwent body composition assessments using MRI, and were randomly assigned to either placebo or empagliflozin (10 mg/d) for three months. At the baseline and post-treatment visit, after an overnight fast, blood was drawn for biochemical analysis. Participants received [U-13C3]glycerol orally followed by multiple blood draws over 3 h to examine glycerol incorporation into triglycerides using NMR spectroscopy. RESULTS The changes in blood triglyceride concentration with empagliflozin therapy related to the mass of baseline visceral adipose tissue (VAT; r = 0.53, p = 0.04). Empagliflozin slightly lowered triglycerides in obese subjects with low VAT, but increased triglycerides in the subjects with high VAT. Consistently, empagliflozin effectively suppressed triglyceride synthesis following [U-13C3]glycerol administration in the subjects with low VAT (p < 0.05), but not in the subjects with high VAT. The subjects with high VAT lost body weight after three months of empagliflozin treatment. In all subjects, about 20% of the triglyceride backbone originated from mitochondrial metabolism of glycerol. CONCLUSIONS The effect of empagliflozin on triglycerides in obese adults differed depending on VAT. Empagliflozin suppressed triglyceride synthesis in the subjects with low VAT, but tended to increase triglycerides in those with high VAT.
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Considerations for multimodal prehabilitation in women with gynaecological cancers: a scoping review using realist principles.
Saggu, RK, Barlow, P, Butler, J, Ghaem-Maghami, S, Hughes, C, Lagergren, P, McGregor, AH, Shaw, C, Wells, M
BMC women's health. 2022;(1):300
Abstract
BACKGROUND There is increasing recognition that prehabilitation is important as a means of preparing patients physically and psychologically for cancer treatment. However, little is understood about the role and optimal nature of prehabilitation for gynaecological cancer patients, who usually face extensive and life-changing surgery in addition to other treatments that impact significantly on physiological and psychosexual wellbeing. REVIEW QUESTION This scoping review was conducted to collate the research evidence on multimodal prehabilitation in gynaecological cancers and the related barriers and facilitators to engagement and delivery that should be considered when designing a prehabilitation intervention for this group of women. METHODS Seven medical databases and four grey literature repositories were searched from database inception to September 2021. All articles, reporting on multimodal prehabilitation in gynaecological cancers were included in the final review, whether qualitative, quantitative or mixed-methods. Qualitative studies on unimodal interventions were also included, as these were thought to be more likely to include information about barriers and facilitators which could also be relevant to multimodal interventions. A realist framework of context, mechanism and outcome was used to assist interpretation of findings. RESULTS In total, 24 studies were included in the final review. The studies included the following tumour groups: ovarian only (n = 12), endometrial only (n = 1), mixed ovarian, endometrial, vulvar (n = 5) and non-specific gynaecological tumours (n = 6). There was considerable variation across studies in terms of screening for prehabilitation, delivery of prehabilitation and outcome measures. Key mechanisms and contexts influencing engagement with prehabilitation can be summarised as: (1) The role of healthcare professionals and organisations (2) Patients' perceptions of acceptability (3) Factors influencing patient motivation (4) Prehabilitation as a priority (5) Access to prehabilitation. IMPLICATIONS FOR PRACTICE A standardised and well evidenced prehabilitation programme for women with gynaecological cancer does not yet exist. Healthcare organisations and researchers should take into account the enablers and barriers to effective engagement by healthcare professionals and by patients, when designing and evaluating prehabilitation for gynaecological cancer patients.
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Effective and resource-efficient strategies for recruiting families in physical activity, sedentary behavior, nutrition, and obesity prevention research: A systematic review with expert opinion.
Guagliano, JM, Morton, KL, Hughes, C, van Sluijs, EMF
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2021;(4):e13161
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Abstract
We systematically identified effective and resource-efficient strategies for recruiting families into health promoting intervention research. Four databases were searched for reviews. Interventions were extracted from included reviews. Additionally, a Delphi study was conducted with 35 experts in family-based research. We assessed extracted data from our review and Delphi participants' opinions by collating responses into overarching themes based on recruitment setting then recruitment strategies to identify effective and resource-efficient strategies for recruiting families into intervention research. A total of 64 articles (n = 49 studies) were included. Data regarding recruitment duration (33%), target sample size (32%), reach (18%), expressions of interest (33%), and enrollment rate (22%) were scarcely reported. Recruitment settings (84%) and strategies (73%) used were available for most studies. However, the details were vague, particularly regarding who was responsible for recruitment or how recruitment strategies were implemented. The Delphi showed recruitment settings, and strategies fell under six themes: school-based, print/electronic media, community settings-based, primary care-based, employer-based, and referral-based strategies. Underrecruitment in family-based trials is a major issue. Reporting on recruitment can be improved by better adherence to existing guidelines. Our findings suggest a multifaceted recruitment approach targeting adults and children with multiple exposures to study information.
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Interventions for chronic palmoplantar pustulosis: abridged Cochrane systematic review and GRADE assessments.
Obeid, G, Do, G, Kirby, L, Hughes, C, Sbidian, E, Le Cleach, L
The British journal of dermatology. 2021;(6):1023-1032
Abstract
BACKGROUND Palmoplantar pustulosis (PPP) is a chronic inflammatory disease in which sterile and relapsing pustules appear on the palms and soles. OBJECTIVES To assess the effects of interventions for chronic PPP to induce and maintain complete remission. METHODS We searched for randomized controlled trials (RCTs), including people with PPP or chronic palmoplantar pustular psoriasis, in the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS and eight trials registers up to July 2020. Study selection, data extraction and risk-of-bias assessment were carried out independently by two review authors. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method. RESULTS We included 37 RCTs (1663 participants, 76% women, mean age 50 years). Mean treatment duration was 11 weeks. Topical vitamin D derivative may be more effective than placebo in achieving clearance [risk ratio (RR) 7·83, 95% confidence interval (CI) 1·85-33·12; low-certainty evidence from two trials]. Concerning biological therapies, there was little or no difference between etanercept and placebo in achieving clearance (low-certainty evidence from one trial), ustekinumab is less effective than placebo in reducing severity (low-certainty evidence from one trial), and guselkumab (RR 2·88, 95% CI 1·24-6·69) and secukinumab (RR 1·55, 95% CI 1·02-2·35) are probably better in reducing disease severity (moderate-certainty evidence from two and one trial(s), respectively) but may cause more serious adverse events than placebo. CONCLUSIONS Evidence is lacking for or against major chronic PPP treatments. Risk of bias and imprecision limit our confidence in the results.
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Vitamin D and Hospital Admission in Older Adults: A Prospective Association.
Beirne, A, McCarroll, K, Walsh, JB, Casey, M, Laird, E, McNulty, H, Ward, M, Hoey, L, Molloy, AM, Healy, M, et al
Nutrients. 2021;(2)
Abstract
The health effects of vitamin D are well documented, with increasing evidence of its roles beyond bone. There is, however, little evidence of the effects of vitamin D on hospitalisation among older adults. This study aimed to prospectively determine the relationship of vitamin D status in older adults with hospital admission and emergency department (ED) attendance. Trinity University of Ulster Department of Agriculture (TUDA) is a large cross-sectional study of older adults with a community population from three disease-defined cohorts (cognitive dysfunction, hypertension, and osteoporosis). Participants included in this analysis were recruited between 2008 and 2012. ED and hospital admission data were gathered from the date of TUDA participation until June 2013, with a mean follow up of 3.6 years. Of the 3093 participants, 1577 (50.9%) attended the ED during the period of follow-up. Attendees had lower mean serum 25(OH)D concentrations than non-attendees (59.1 vs. 70.6 nmol/L). Fully adjusted models showed an inverse association between vitamin D and ED attendance (Hazard Ratio (HR) 0.996; 95% Confidence Interval (CI) 0.995-0.998; p < 0.001). A total of 1269 participants (41%) were admitted to hospital during the follow-up. Those admitted had lower mean vitamin D concentrations (58.4 vs. 69.3 nmol/L, p < 0.001). In fully adjusted models, higher vitamin D was inversely associated with hospital admission (HR 0.996; 95% CI 0.994-0.998; p < 0.001) and length of stay (LOS) (β = -0.95, p = 0.006). This study showed independent prospective associations between vitamin D deficiency and increased hospitalisation by older adults. The need for further evaluation of current recommendations in relation to vitamin D supplementation, with consideration beyond bone health, is warranted and should focus on randomised controlled trials.
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Phase I clinical trial repurposing all-trans retinoic acid as a stromal targeting agent for pancreatic cancer.
Kocher, HM, Basu, B, Froeling, FEM, Sarker, D, Slater, S, Carlin, D, deSouza, NM, De Paepe, KN, Goulart, MR, Hughes, C, et al
Nature communications. 2020;(1):4841
Abstract
Pre-clinical models have shown that targeting pancreatic stellate cells with all-trans-retinoic-acid (ATRA) reprograms pancreatic stroma to suppress pancreatic ductal adenocarcinoma (PDAC) growth. Here, in a phase Ib, dose escalation and expansion, trial for patients with advanced, unresectable PDAC (n = 27), ATRA is re-purposed as a stromal-targeting agent in combination with gemcitabine-nab-paclitaxel chemotherapy using a two-step adaptive continual re-assessment method trial design. The maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D, primary outcome) is the FDA/EMEA approved dose of gemcitabine-nab-paclitaxel along-with ATRA (45 mg/m2 orally, days 1-15/cycle). Dose limiting toxicity (DLT) is grade 4 thrombocytopenia (n = 2). Secondary outcomes show no detriment to ATRA pharmacokinetics.. Median overall survival for RP2D treated evaluable population, is 11.7 months (95%CI 8.6-15.7 m, n = 15, locally advanced (2) and metastatic (13)). Exploratory pharmacodynamics studies including changes in diffusion-weighted (DW)-MRI measured apparent diffusion coefficient after one cycle, and, modulation of cycle-specific serum pentraxin 3 levels over various cycles indicate stromal modulation. Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable. This combination will be evaluated in a phase II randomized controlled trial for locally advanced PDAC. Clinical trial numbers: EudraCT: 2015-002662-23; NCT03307148. Trial acronym: STARPAC.
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9.
Interventions for chronic palmoplantar pustulosis.
Obeid, G, Do, G, Kirby, L, Hughes, C, Sbidian, E, Le Cleach, L
The Cochrane database of systematic reviews. 2020;(1):CD011628
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Abstract
BACKGROUND Palmoplantar pustulosis is a chronic inflammatory disease in which sterile, relapsing pustules appear on the palms and soles, possibly in conjunction with other symptoms. The previous Cochrane Review on this topic was published in 2006, before biological treatments were extensively used. OBJECTIVES To assess the effects of interventions for chronic palmoplantar pustulosis to induce and maintain complete remission. SEARCH METHODS We searched the following databases up to March 2019: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of the included studies for further references to relevant randomised controlled trials (RCTs). SELECTION CRITERIA We considered RCTs including people with palmoplantar pustulosis or chronic palmoplantar pustular psoriasis assessing topical therapy, systemic therapy, combinations of topical or systemic therapies, or non-pharmacological therapies compared with placebo, no intervention, or each other. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. Our outcomes included 'Proportion of participants cleared or almost cleared', 'Proportion of participants with adverse effects serious or severe enough to cause withdrawal', 'Proportion of participants with at least 50% improvement in disease severity', and 'Proportion of participants with adverse effects'. MAIN RESULTS We included 37 studies (1663 participants; mean age 50 years (range 34 to 63); 24% males). These studies reported condition severity differently. Around half of the included trials stated the setting (hospitals, community clinics, or both). More than half of the studies were at high risk of bias in at least one domain. Our included studies assessed mainly systemic treatments (retinoids, ciclosporin, biologics, etretinate + PUVA (combination of psoralens and long-wave ultraviolet radiation) therapy combined, and antibiotics), but also topical treatments (dermocorticoids, vitamin D) and phototherapy (PUVA, ultraviolet A1 (UVA1)). Other interventions were assessed by single studies. The most common comparator was placebo. All results presented in this abstract were assessed in the short term (mean treatment duration was 11 weeks (range 8 to 24 weeks)) and are based on participants with chronic palmoplantar pustulosis. All outcome time point measurements were taken from baseline and assessed at the end of treatment. Short-term and long-term outcomes were defined as measurement up to 24 weeks after randomisation and between 24 and 104 weeks after randomisation, respectively. One trial (188 participants) assessed the topical vitamin D derivative maxacalcitol versus placebo and found that maxacalcitol may be more effective than placebo in achieving clearance (risk ratio (RR) 7.83, 95% confidence interval (CI) 1.85 to 33.12; low-quality evidence), and the risk of adverse effects (such as mild local irritation, pruritus, and haematological or urinary test abnormalities) is probably similar in both groups (RR 0.87, 95% CI 0.64 to 1.19; moderate-quality evidence). Severity was not reported. Two trials (49 participants) assessed PUVA therapy versus placebo or no treatment, providing very low-quality evidence. Adverse effects were reported with oral PUVA (including nausea, ankle swelling, and non-purulent conjunctivitis) and with local PUVA (including blistering, erythema, and pruritus). With regard to the systemic retinoid alitretinoin, one trial (33 participants; moderate-quality evidence) showed that alitretinoin probably makes little or no difference in reducing severity when compared to placebo (RR 0.69, 95% CI 0.36 to 1.30). A similar number of adverse events were reported in both treatment groups, including headache, cheilitis, nausea, arthralgia, and nasopharyngitis (RR 0.84, 95% CI 0.61 to 1.17). Clearance was not reported. There may be little or no difference between etanercept and placebo in achieving clearance (RR 1.64, 95% CI 0.08 to 34.28; 1 study; 15 participants; low-quality evidence); however, the 95% CI was very wide, showing there may be a difference between groups. Severity was not measured. More patients treated with placebo may achieve reduced severity than those treated with ustekinumab, but the wide 95% CI indicates there might be little or no difference between groups and there might be greater effect with ustekinumab (RR 0.48, 95% CI 0.11 to 2.13; 1 study; 33 participants; low-quality evidence). Clearance was not reported. It is uncertain whether guselkumab increases clearance when compared to placebo (2 studies; 154 participants) because the quality of evidence is very low, but guselkumab probably better reduces disease severity (RR 2.88, 95% CI 1.24 to 6.69; 1 study; 49 participants; moderate-quality evidence). Secukinumab is probably superior to placebo in reducing severity (RR 1.55, 95% CI 1.02 to 2.35; 1 study; 157 participants; moderate-quality evidence), but our clearance outcome was not reported. None of these trials reported on occurrence of adverse effects. Only two of the studies discussed above reported adverse effects serious or severe enough to cause withdrawal. Guselkumab may cause more serious adverse events when compared to placebo, but there is uncertainty due to the very wide 95% CI showing there may be little or no difference and showing more events with placebo (RR 2.88, 95% CI 0.32 to 25.80; 1 study; 49 participants; low-quality evidence). Secukinumab probably causes more serious adverse events than placebo (RR 3.29, 95% CI 1.40 to 7.75; 1 study; 157 participants; moderate-quality evidence). AUTHORS' CONCLUSIONS Evidence is lacking for major chronic palmoplantar pustulosis treatments such as superpotent corticosteroids, phototherapy, acitretin, methotrexate, and ciclosporin. Risk of bias and imprecision limit our confidence. Maxacalcitol may be more effective than placebo in achieving clearance in the short term (low-quality evidence), and the risk of adverse effects is probably similar (moderate-quality evidence). Oral alitretinoin is probably no more effective than placebo in reducing severity, with a similar risk of adverse effects (moderate-quality evidence). Regarding biological treatments, we are uncertain of the effect of etanercept on clearance and the effect of ustekinumab on severity (low-quality evidence). Secukinumab and guselkumab are probably superior to placebo in reducing severity (moderate-quality evidence). Adverse events not requiring withdrawal were not reported for these treatments. Reporting of serious adverse effects was incomplete: compared to placebo, secukinumab probably caused more participant withdrawals (moderate-quality evidence), but we are uncertain of the effect of guselkumab (low-quality evidence). Future trials should assess commonly used treatments using validated severity and quality of life scales.
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Effects of Empagliflozin Treatment on Glycerol-Derived Hepatic Gluconeogenesis in Adults with Obesity: A Randomized Clinical Trial.
Neeland, IJ, de Albuquerque Rocha, N, Hughes, C, Ayers, CR, Malloy, CR, Jin, ES
Obesity (Silver Spring, Md.). 2020;(7):1254-1262
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Abstract
OBJECTIVE The aim of this study was to determine the effects of empagliflozin on glycerol-derived hepatic gluconeogenesis in adults with obesity without type 2 diabetes mellitus (T2DM) using oral carbon 13 (13 C)-labeled glycerol. METHODS A randomized, double-blind, placebo-controlled trial was performed in participants with magnetic resonance imaging assessment of body fat and measurement of glycerol-derived 13 C enrichment in plasma glucose by nuclear magnetic resonance spectroscopy following ingestion of [U-13 C3 ]glycerol. Participants were randomized to oral empagliflozin 10 mg once daily or placebo for 3 months. Glycerol-derived 13 C enrichment studies were repeated, and treatment differences in the mean percentage of 13 C glycerol enrichment in glucose were compared using mixed linear models. RESULTS Thirty-five participants completed the study. Empagliflozin increased glycerol-derived 13 C enrichment between baseline and follow-up by 6.5% (P = 0.005), consistent with less glycerol from visceral adipose tissue (VAT). No difference was found with placebo. Glycerol-derived 13 C enrichment was lower in participants with high VAT compared with low VAT by 12.6% (P = 0.04), but there was no heterogeneity of the treatment effect by baseline VAT. Glycerol-derived 13 C enrichment was inversely correlated with VAT but was not correlated with weight loss. CONCLUSIONS VAT is associated with endogenous glycerol-derived hepatic gluconeogenesis, and empagliflozin reduces endogenous glycerol gluconeogenesis in adults with obesity without T2DM. These findings suggest a mechanism by which sodium-glucose cotransporter 2 inhibitors may prevent T2DM in obesity.