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Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial.
, , Farmer, AJ, Allen, J, Bartlett, YK, Bower, P, Chi, Y, French, DP, Gudgin, B, Holmes, E, Horne, R, et al
Pilot and feasibility studies. 2024;(1):15
Abstract
BACKGROUND The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. METHODS A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. RESULTS The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60-80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. CONCLUSION The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. TRIAL REGISTRATION ISCTRN ISRCTN13404264. Registered on 10 October 2018.
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A Double-Blind, Randomized, Placebo-Controlled Pilot Study examining an Oxygen Nanobubble Beverage for 16.1-km Time Trial and Repeated Sprint Cycling Performance.
King, DG, Stride, E, Mendis, J, Gurton, WH, Macrae, H, Jones, L, Hunt, J
Journal of dietary supplements. 2024;(2):167-181
Abstract
There is growing interest of ergogenic aids that deliver supplemental oxygen during exercise and recovery, however, breathing supplemental oxygen via specialist facemasks is often not feasible. Therefore, this study investigated the effect of an oxygen-nanobubble beverage during submaximal and repeated sprint cycling. In a double-blind, randomized, placebo-controlled study, 10 male cyclists (peak aerobic capacity, 56.9 ± 6.1 mL·kg-1·min-1; maximal aerobic power, 385 ± 25 W) completed submaximal or maximal exercise after consuming an oxygen-nanobubble (O2) or placebo (PLA) beverage. Submaximal trials comprised 30-min of steady-state cycling at 60% peak aerobic capacity and 16.1-km time-trial (TT). Maximal trials involved 4 × 30 s Wingate tests interspersed by 4-min recovery. Time-to-completion during the 16.1-km TT was 2.4% faster after O2 compared with PLA (95% CI = 0.7-4.0%, p = 0.010, d = 0.41). Average power for the 16.1-km TT was 4.1% higher for O2 vs. PLA (95% CI = 2.1-7.3%, p = 0.006, d = 0.28). Average peak power during the repeated Wingate tests increased by 7.1% for O2 compared with PLA (p = 0.002, d = 0.58). An oxygen-nanobubble beverage improves performance during submaximal and repeated sprint cycling, therefore may provide a practical and effective ergogenic aid for competitive cyclists.
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TFOS lifestyle: Impact of societal challenges on the ocular surface.
Stapleton, F, Abad, JC, Barabino, S, Burnett, A, Iyer, G, Lekhanont, K, Li, T, Liu, Y, Navas, A, Obinwanne, CJ, et al
The ocular surface. 2023;:165-199
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Abstract
Societal factors associated with ocular surface diseases were mapped using a framework to characterize the relationship between the individual, their health and environment. The impact of the COVID-19 pandemic and mitigating factors on ocular surface diseases were considered in a systematic review. Age and sex effects were generally well-characterized for inflammatory, infectious, autoimmune and trauma-related conditions. Sex and gender, through biological, socio-economic, and cultural factors impact the prevalence and severity of disease, access to, and use of, care. Genetic factors, race, smoking and co-morbidities are generally well characterized, with interdependencies with geographical, employment and socioeconomic factors. Living and working conditions include employment, education, water and sanitation, poverty and socioeconomic class. Employment type and hobbies are associated with eye trauma and burns. Regional, global socio-economic, cultural and environmental conditions, include remoteness, geography, seasonality, availability of and access to services. Violence associated with war, acid attacks and domestic violence are associated with traumatic injuries. The impacts of conflict, pandemic and climate are exacerbated by decreased food security, access to health services and workers. Digital technology can impact diseases through physical and mental health effects and access to health information and services. The COVID-19 pandemic and related mitigating strategies are mostly associated with an increased risk of developing new or worsening existing ocular surface diseases. Societal factors impact the type and severity of ocular surface diseases, although there is considerable interdependence between factors. The overlay of the digital environment, natural disasters, conflict and the pandemic have modified access to services in some regions.
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TFOS Lifestyle: Impact of contact lenses on the ocular surface.
Jones, L, Efron, N, Bandamwar, K, Barnett, M, Jacobs, DS, Jalbert, I, Pult, H, Rhee, MK, Sheardown, H, Shovlin, JP, et al
The ocular surface. 2023;:175-219
Abstract
Several lifestyle choices made by contact lens wearers can have adverse consequences on ocular health. These include being non-adherent to contact lens care, sleeping in lenses, ill-advised purchasing options, not seeing an eyecare professional for regular aftercare visits, wearing lenses when feeling unwell, wearing lenses too soon after various forms of ophthalmic surgery, and wearing lenses when engaged in risky behaviors (e.g., when using tobacco, alcohol or recreational drugs). Those with a pre-existing compromised ocular surface may find that contact lens wear exacerbates ocular disease morbidity. Conversely, contact lenses may have various therapeutic benefits. The coronavirus disease-2019 (COVID-19) pandemic impinged upon the lifestyle of contact lens wearers, introducing challenges such as mask-associated dry eye, contact lens discomfort with increased use of digital devices, inadvertent exposure to hand sanitizers, and reduced use of lenses. Wearing contact lenses in challenging environments, such as in the presence of dust and noxious chemicals, or where there is the possibility of ocular trauma (e.g., sport or working with tools) can be problematic, although in some instances lenses can be protective. Contact lenses can be worn for sport, theatre, at high altitude, driving at night, in the military and in space, and special considerations are required when prescribing in such situations to ensure successful outcomes. A systematic review and meta-analysis, incorporated within the review, identified that the influence of lifestyle factors on soft contact lens dropout remains poorly understood, and is an area in need of further research. Overall, this report investigated lifestyle-related choices made by clinicians and contact lens wearers and discovered that when appropriate lifestyle choices are made, contact lens wear can enhance the quality of life of wearers.
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Effect of 0.05% chlorhexidine gluconate in water on the hydrophilic inflatable penile prosthesis: biocompatibility, adherence, and dip time.
Griggs, R, Karpman, E, Jones, L, Twomey, C, Henry, G
The journal of sexual medicine. 2023;(1):113-117
Abstract
BACKGROUND Rates of infection after inflatable penile prosthesis range from 1% to 3%; however, a new surgical irrigation solution is Food and Drug Administration cleared as antimicrobial wound lavage and appears to be safe for patients and noncaustic during hydrophilic inflatable penile prosthesis (hIPP) dipping and irrigation. AIM: To evaluate if 0.05% chlorhexidine (CHG) lavage is caustic to the hIPP coating and if dip adherence is dependent on time. METHODS Preconnected hIPP devices were tested at a Coloplast research and development laboratory. The devices were soaked in the 0.05% CHG lavage solution or normal saline for 1, 15, 30, and 60 minutes. Subsequently, all parts were dried for 15 minutes in a 35 °C oven. A Congo red dye test was performed following a Coloplast-validated and Food and Drug Administration-cleared test method to ensure product reliability. Implants were then visually inspected for deleterious effects as well as dip coverage. In addition, we evaluated 0.05% CHG lavage solution vs previously published hIPP dipping solutions. OUTCOMES 0.05% CHG lavage does not appear to damage the hIPP coating, and adherence of this solution is not dependent on dip time. RESULTS All components of the preconnected hydrophilic IPPs were tested for coating adherence and defects. All tested IPPs achieved a "satisfactory" coating, meaning a uniform coat without flaking or clumping. Furthermore, there were no noticeable caustic effects or differences in coating adherence between the normal saline-soaked control and 0.05% CHG-coated arms with increasing dip time. A review of the literature for 0.05% CHG lavage solutions vs previously published hIPP dipping solutions revealed that it may have some advantages over previously reported antibiotic solutions. CLINICAL IMPLICATIONS This study serves as a foundation to introduce 0.05% CHG lavage to the urologic literature as a potentially new "magic bullet" irrigation. STRENGTHS AND LIMITATIONS Major strengths of the study are that it is the first study of its kind to address the question of what dip duration should be used and whether it is scientifically reproducible. A limitation is the in vitro model, thus needing validation in a clinical setting. CONCLUSION 0.05% CHG does not appear to negatively affect the hIPP coating or differ in adherence with increasing dip time; however, long-term device performance has not been verified.
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Gene editing to improve legume-rhizobia symbiosis in a changing climate.
Jain, D, Jones, L, Roy, S
Current opinion in plant biology. 2023;:102324
Abstract
In the last three years, several gene editing techniques have been developed for both model and crop legumes. CRISPR-Cas9-based tools, in particular, are outpacing other comparable gene editing technologies used in legume hosts and their microbial symbionts to understand the molecular basis of symbiotic nitrogen-fixation. Gene editing has helped identify new gene functions, validate genetic screens, resolve gene redundancy, examine the role of tandemly duplicated genes, and investigate symbiotic signaling networks in non-model plants. In this review, we discuss the advances made in understanding the legume-rhizobia symbiosis through the use of gene editing and highlight studies conducted under varying environmental conditions. We reason that future climate-hardy legumes must be able to better integrate environmental signals with nitrogen fixation by fine-tuning long distance signaling, continuing to select efficient rhizobial partners, and adjusting their molecular circuitry to function optimally under variable light and nutrient availability and rising atmospheric carbon dioxide.
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Adjuvant Therapy for Stage II Colon Cancer: ASCO Guideline Update.
Baxter, NN, Kennedy, EB, Bergsland, E, Berlin, J, George, TJ, Gill, S, Gold, PJ, Hantel, A, Jones, L, Lieu, C, et al
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2022;(8):892-910
Abstract
PURPOSE To develop recommendations for adjuvant therapy for patients with resected stage II colon cancer. METHODS ASCO convened an Expert Panel to conduct a systematic review of relevant studies and develop recommendations for clinical practice. RESULTS Twenty-one observational studies and six randomized controlled trials met the systematic review inclusion criteria. RECOMMENDATIONS Adjuvant chemotherapy (ACT) is not routinely recommended for patients with stage II colon cancer who are not in a high-risk subgroup. Patients with T4 tumors are at higher risk of recurrence and should be offered ACT, whereas patients with other high-risk factors, including sampling of fewer than 12 lymph nodes in the surgical specimen, perineural or lymphovascular invasion, poorly or undifferentiated tumor grade, intestinal obstruction, tumor perforation, or grade BD3 tumor budding, may be offered ACT. The addition of oxaliplatin to fluoropyrimidine-based ACT is not routinely recommended, but may be offered as a result of shared decision making. Patients with mismatch repair deficiency/microsatellite instability tumors should not be routinely offered ACT; if the combination of mismatch repair deficiency/microsatellite instability and high-risk factors results in a decision to offer ACT, oxaliplatin-containing chemotherapy is recommended. Duration of oxaliplatin-containing chemotherapy is also addressed, with recommendations for 3 or 6 months of treatment with capecitabine and oxaliplatin or fluorouracil, leucovorin, and oxaliplatin, with decision making informed by key evidence of 5-year disease-free survival in each treatment subgroup and the rate of adverse events, including peripheral neuropathy.Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.
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Impact of mothers' distress and emotional eating on calories served to themselves and their young children: An experimental study.
Warnick, J, Cardel, M, Jones, L, Gonzalez-Louis, R, Janicke, D
Pediatric obesity. 2022;(6):e12886
Abstract
BACKGROUND Parents play a significant role in children's eating behaviours and food environment. Emotional eating (i.e., eating due to/to cope with emotions regardless of hunger) can contribute to excess energy consumption and subsequent weight gain. Yet, there is a paucity of research examining mothers' feeding and eating behaviours in the presence of their young children during times of acute distress. OBJECTIVE The current study examined whether manipulated maternal mood impacted subsequent eating and parental-feeding in mothers with overweight or obesity with their preschool aged children in a laboratory-based experiment. METHODS Mothers (n = 47) with overweight or obesity and their preschool aged children were randomized to either an acute distress or control group. After completing a task which manipulated mothers' moods, respectively, dyads were offered a buffet of snack foods. Measures of mothers' reported emotional eating and distress were collected, and calories served and consumed were objectively measured. RESULTS There were no between-group differences regarding calories served or consumed. Mothers across both groups who reported higher emotional eating served themselves (p = 0.014) and their children (p = 0.007) less food, and mothers consumed less food (p = 0.045). Mothers who reported higher emotional eating and increased acute distress fed their children less food (p = 0.02) and both children and mothers ate less food (p < 0.05). CONCLUSIONS Results suggest that mothers who report emotional eating tendencies may feed their children less food during periods of acute distress.
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The Effect of Nitrate-Rich Beetroot Juice on Markers of Exercise-Induced Muscle Damage: A Systematic Review and Meta-Analysis of Human Intervention Trials.
Jones, L, Bailey, SJ, Rowland, SN, Alsharif, N, Shannon, OM, Clifford, T
Journal of dietary supplements. 2022;(6):749-771
Abstract
This systematic review and meta-analysis of randomized controlled trials examined whether dietary nitrate supplementation attenuates exercise-induced muscle damage (EIMD) and is reported according to the PRISMA guidelines. Medline and SPORTDiscus databases were searched from inception to June 2020. Inclusion criteria were studies in adult humans consuming inorganic nitrate before and after exercise and that measured markers implicated in the etiology of EIMD (muscle function, muscle soreness, inflammation, myocellular protein efflux, oxidative stress, range of motion) <168 h post. The Cochrane Collaboration risk of bias two tool was used to critically appraise the studies; forest plots were generated with random-effects models and standardized mean differences (SMD). Nine studies were included in the systematic review and six in the meta-analysis. All studies were rated to have some concerns for risk of bias. All trials in the meta-analysis provided nitrate as beetroot juice, which accelerated isometric strength recovery 72 h post-exercise (SMD: 0.54, p = 0.01) and countermovement jump performance 24-72 h post-exercise (SMD range: 0.75-1.32, p < 0.03). Pressure pain threshold was greater with beetroot juice 48 (SMD: 0.58, p = 0.03) and 72 h post-exercise (SMD: 0.61, p = 0.02). Beetroot juice had no effect on markers of oxidative stress and creatine kinase (p > 0.05), but c-reactive protein was higher vs. placebo at 48 h post-exercise (SMD: 0.55, p = 0.03). These findings suggest that nitrate-rich beetroot juice may attenuate some markers of EIMD, but more large-scale controlled trials in elite athletes are needed.
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Antiprogestins reduce epigenetic field cancerization in breast tissue of young healthy women.
Bartlett, TE, Evans, I, Jones, A, Barrett, JE, Haran, S, Reisel, D, Papaikonomou, K, Jones, L, Herzog, C, Pashayan, N, et al
Genome medicine. 2022;(1):64
Abstract
BACKGROUND Breast cancer is a leading cause of death in premenopausal women. Progesterone drives expansion of luminal progenitor cells, leading to the development of poor-prognostic breast cancers. However, it is not known if antagonising progesterone can prevent breast cancers in humans. We suggest that targeting progesterone signalling could be a means of reducing features which are known to promote breast cancer formation. METHODS In healthy premenopausal women with and without a BRCA mutation we studied (i) estrogen and progesterone levels in saliva over an entire menstrual cycle (n = 20); (ii) cancer-free normal breast-tissue from a control population who had no family or personal history of breast cancer and equivalently from BRCA1/2 mutation carriers (n = 28); triple negative breast cancer (TNBC) biopsies and healthy breast tissue taken from sites surrounding the TNBC in the same individuals (n = 14); and biopsies of ER+ve/PR+ve stage T1-T2 cancers and healthy breast tissue taken from sites surrounding the cancer in the same individuals (n = 31); and (iii) DNA methylation and DNA mutations in normal breast tissue (before and after treatment) from clinical trials that assessed the potential preventative effects of vitamins and antiprogestins (mifepristone and ulipristal acetate; n = 44). RESULTS Daily levels of progesterone were higher throughout the menstrual cycle of BRCA1/2 mutation carriers, raising the prospect of targeting progesterone signalling as a means of cancer risk reduction in this population. Furthermore, breast field cancerization DNA methylation signatures reflective of (i) the mitotic age of normal breast epithelium and (ii) the proportion of luminal progenitor cells were increased in breast cancers, indicating that luminal progenitor cells with elevated replicative age are more prone to malignant transformation. The progesterone receptor antagonist mifepristone reduced both the mitotic age and the proportion of luminal progenitor cells in normal breast tissue of all control women and in 64% of BRCA1/2 mutation carriers. These findings were validated by an alternate progesterone receptor antagonist, ulipristal acetate, which yielded similar results. Importantly, mifepristone reduced both the TP53 mutation frequency as well as the number of TP53 mutations in mitotic-age-responders. CONCLUSIONS These data support the potential usage of antiprogestins for primary prevention of poor-prognostic breast cancers. TRIAL REGISTRATION Clinical trial 1 Mifepristone treatment prior to insertion of a levonorgestrel releasing intrauterine system for improved bleeding control - a randomized controlled trial, clinicaltrialsregister.eu, 2009-009014-40 ; registered on 20 July 2009. Clinical trial 2 The effect of a progesterone receptor modulator on breast tissue in women with BRCA1 and 2 mutations, clinicaltrials.gov, NCT01898312 ; registered on 07 May 2013. Clinical trial 3 A pilot prevention study of the effects of the anti- progestin Ulipristal Acetate (UA) on surrogate markers of breast cancer risk, clinicaltrialsregister.eu, 2015-001587-19 ; registered on 15 July 2015.