29 results on '"Bouliotis, G."'
Search Results
2. P420 A pilot study looking at gamification to improve the experience of airway clearance for children with cystic fibrosis
- Author
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Walsh, A., primary, Davies, S., additional, Jackson, W., additional, Bouliotis, G., additional, and Thursfield, R., additional
- Published
- 2023
- Full Text
- View/download PDF
3. Left ventricular hypertrophy and incident cognitive decline in older adults with hypertension
- Author
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Xu, Y. (Ying), Bouliotis, G. (George), Beckett, N. S. (Nigel S.), Antikainen, R. L. (Riitta L.), Anderson, C. S. (Craig S.), Bulpitt, C. J. (Christopher J.), Peters, R. (Ruth), Xu, Y. (Ying), Bouliotis, G. (George), Beckett, N. S. (Nigel S.), Antikainen, R. L. (Riitta L.), Anderson, C. S. (Craig S.), Bulpitt, C. J. (Christopher J.), and Peters, R. (Ruth)
- Abstract
The association between raised blood pressure and increased risk of subsequent cognitive decline is well known. Left ventricular hypertrophy (LVH), as a marker of hypertensive target organ damage, may help identify those at risk of cognitive decline. We assessed whether LVH was associated with subsequent cognitive decline or dementia in hypertensive participants aged ≥80 years in the randomized, placebo-controlled Hypertension in the Very Elderly Trial. LVH was assessed using 12-lead electrocardiography (ECG) based on the Cornell Product (CP-LVH), Sokolow-Lyon (SL-LVH), and Cornell Voltage (CV-LVH) criteria. The Mini-Mental State Examination (MMSE) was used to assess cognitive function at baseline and annually. A fall in MMSE to <24 or an annual fall of >3 points were defined as cognitive decline and triggered dementia screening (Diagnostic Statistical Manual IV). Death was defined as a competing event. Fine-Gray regression models were used to examine the relationship between baseline LVH and cognitive outcomes. There were 2645 in the analytical sample, including 201 (7.6%) with CP-LVH, 225 (8.5%) SL-LVH and 251 (9.5%) CV-LVH. CP-LVH was associated with increased risk of cognitive decline, subdistribution hazard ratio (sHR)1.3 (95% confidence interval (CI) 1.01–1.67) in multivariate analyses. SL-LVH and CV-LVH were not associated with cognitive decline (sHR1.06 (95% CI 0.82–1.37) and sHR1.13 (95% CI 0.89–1.43), respectively). LVH was not associated with dementia. LVH may be related to subsequent cognitive decline, but evidence was inconsistent depending on ECG criterion and there were no associations with incident dementia. Additional work is needed to understand the relationships between blood pressure, LVH assessment and cognition.
- Published
- 2023
4. Effect of managed transition on mental health outcomes for young people at the child-adult mental health service boundary:A randomised clinical trial
- Author
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Singh, S. P., Tuomainen, H., Bouliotis, G., Canaway, A., De Girolamo, G., Dieleman, G. C., Franić, T., Madan, J., Maras, A., McNicholas, F., Paul, M., Purper-Ouakil, D., Santosh, P., Schulze, U. M.E., Street, C., Tremmery, S., Verhulst, F. C., Wells, P., Wolke, D., Warwick, J., Tah, Priya, Griffin, James, Appleton, Rebecca, Heaney, Natalie, Lievesley, Kate, Mastroianni, Mathilde, Singh, Jatinder, Adams, Laura, Signorini, Giulia, Ferrari, Alessandro, Gheza, Elisa, Ferrari, Cecilia, Rivolta, Laura, Levi, Flavia, Cataldo, Maria, Manenti, Lidia, Morini, Giorgia, Pastore, Adriana, Stagni, Pamela, Toselli, Cecilia, Varvara, Pamela, Russet, Frédérick, Maurice, Virginie, Humbertclaude, Véronique, Bodegom, Larissa S.Van, Overbeek, Mathilde M., Gerritsen, Suzanne E., Saam, Melanie, Breuninger, Ulrike, Hendrickx, Gaëlle, Singh, S. P., Tuomainen, H., Bouliotis, G., Canaway, A., De Girolamo, G., Dieleman, G. C., Franić, T., Madan, J., Maras, A., McNicholas, F., Paul, M., Purper-Ouakil, D., Santosh, P., Schulze, U. M.E., Street, C., Tremmery, S., Verhulst, F. C., Wells, P., Wolke, D., Warwick, J., Tah, Priya, Griffin, James, Appleton, Rebecca, Heaney, Natalie, Lievesley, Kate, Mastroianni, Mathilde, Singh, Jatinder, Adams, Laura, Signorini, Giulia, Ferrari, Alessandro, Gheza, Elisa, Ferrari, Cecilia, Rivolta, Laura, Levi, Flavia, Cataldo, Maria, Manenti, Lidia, Morini, Giorgia, Pastore, Adriana, Stagni, Pamela, Toselli, Cecilia, Varvara, Pamela, Russet, Frédérick, Maurice, Virginie, Humbertclaude, Véronique, Bodegom, Larissa S.Van, Overbeek, Mathilde M., Gerritsen, Suzanne E., Saam, Melanie, Breuninger, Ulrike, and Hendrickx, Gaëlle
- Abstract
Background Poor transition planning contributes to discontinuity of care at the child-adult mental health service boundary (SB), adversely affecting mental health outcomes in young people (YP). The aim of the study was to determine whether managed transition (MT) improves mental health outcomes of YP reaching the child/adolescent mental health service (CAMHS) boundary compared with usual care (UC). Methods A two-arm cluster-randomised trial (ISRCTN83240263 and NCT03013595) with clusters allocated 1:2 between MT and UC. Recruitment took place in 40 CAMHS (eight European countries) between October 2015 and December 2016.
- Published
- 2023
5. Effect of managed transition on mental health outcomes for young people at the child–adult mental health service boundary : a randomised clinical trial
- Author
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Singh, S. P., Tuomainen, H., Bouliotis, G., Canaway, A., De Girolamo, G., Dieleman, G. C., Franić, T., Madan, J., Maras, A., McNicholas, F., Paul, M., Purper-Ouakil, D., Santosh, P., Schulze, U. M.E., Street, C., Tremmery, S., Verhulst, F. C., Wells, P., Wolke, D., Warwick, J., Tah, Priya, Griffin, James, Appleton, Rebecca, Heaney, Natalie, Lievesley, Kate, Mastroianni, Mathilde, Singh, Jatinder, Adams, Laura, Signorini, Giulia, Ferrari, Alessandro, Gheza, Elisa, Ferrari, Cecilia, Rivolta, Laura, Levi, Flavia, Cataldo, Maria, Manenti, Lidia, Morini, Giorgia, Pastore, Adriana, Stagni, Pamela, Toselli, Cecilia, Varvara, Pamela, Russet, Frédérick, Maurice, Virginie, Humbertclaude, Véronique, Bodegom, Larissa S.Van, Overbeek, Mathilde M., Gerritsen, Suzanne E., Saam, Melanie, Breuninger, Ulrike, Hendrickx, Gaëlle, The MILESTONE Consortium, and Child and Adolescent Psychiatry / Psychology
- Subjects
Clinical trial ,Psychiatry and Mental health ,medicine.medical_specialty ,SDG 3 - Good Health and Well-being ,RJ ,medicine ,Psychiatry ,Psychology ,Mental health ,Applied Psychology ,Boundary (real estate) ,Mental health service - Abstract
BackgroundPoor transition planning contributes to discontinuity of care at the child–adult mental health service boundary (SB), adversely affecting mental health outcomes in young people (YP). The aim of the study was to determine whether managed transition (MT) improves mental health outcomes of YP reaching the child/adolescent mental health service (CAMHS) boundary compared with usual care (UC).MethodsA two-arm cluster-randomised trial (ISRCTN83240263 and NCT03013595) with clusters allocated 1:2 between MT and UC. Recruitment took place in 40 CAMHS (eight European countries) between October 2015 and December 2016. Eligible participants were CAMHS service users who were receiving treatment or had a diagnosed mental disorder, had an IQ ⩾ 70 and were within 1 year of reaching the SB. MT was a multi-component intervention that included CAMHS training, systematic identification of YP approaching SB, a structured assessment (Transition Readiness and Appropriateness Measure) and sharing of information between CAMHS and adult mental health services. The primary outcome was HoNOSCA (Health of the Nation Outcome Scale for Children and Adolescents) score 15-months post-entry to the trial.ResultsThe mean difference in HoNOSCA scores between the MT and UC arms at 15 months was −1.11 points (95% confidence interval −2.07 to −0.14, p = 0.03). The cost of delivering the intervention was relatively modest (€17–€65 per service user).ConclusionsMT led to improved mental health of YP after the SB but the magnitude of the effect was small. The intervention can be implemented at low cost and form part of planned and purposeful transitional care.
- Published
- 2021
6. OC-097 An externally validated nomogram to predict the risk of bowel dysfunction following an anterior resection
- Author
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Battersby, N, Bouliotis, G, Emmertsen, K, Laurberg, S, and Moran, B
- Published
- 2015
- Full Text
- View/download PDF
7. A COHORT STUDY: Epidemiology and outcome of fracture of the hip in women aged 65 years and under
- Author
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Karantana, A., Boulton, C., Bouliotis, G., Shu, Shan K., Scammell, B. E., and Moran, C. G.
- Published
- 2011
- Full Text
- View/download PDF
8. Prospective randomized trial using cost–utility analysis of early versus delayed laparoscopic cholecystectomy for acute gallbladder disease
- Author
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Macafee, D. A. L., Humes, D. J., Bouliotis, G., Beckingham, I. J., Whynes, D. K., and Lobo, D. N.
- Published
- 2009
- Full Text
- View/download PDF
9. A first-in-human study of the novel HIV-fusion inhibitor C34-PEG4-Chol
- Author
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Quinn, K, Traboni, C, Dily Penchala, S, Bouliotis, G, Doyle, N, Libri, V, Khoo, S, Ashby, D, Weber, J, Nicosia, A, Cortese, R, Pessi, A, Winston, A, Quinn, K, Traboni, C, Penchala, Sd, Bouliotis, G, Doyle, N, Libri, V, Khoo, S, Ashby, D, Weber, J, Nicosia, A, Cortese, R, Pessi, Annalisa, Winston, A., and Medical Research Council (MRC)
- Subjects
lcsh:R ,lcsh:Medicine ,lcsh:Q ,lcsh:Science - Abstract
Long-acting injectable antiretroviral (LA-ARV) drugs with low toxicity profiles and propensity for drug-drug interactions are a goal for future ARV regimens. C34-PEG4-Chol is a novel cholesterol tagged LA HIV-fusion-inhibitor (FI). We assessed pre-clinical toxicology and first-in-human administration of C34-PEG4-Chol. Pre-clinical toxicology was conducted in 2 species. HIV-positive men were randomised to a single subcutaneous dose of C34-PEG4-Chol at incrementing doses or placebo. Detailed clinical (including injection site reaction (ISR) grading), plasma pharmacokinetic (time-to-minimum-effective-concentration (MEC, 25 ng/mL) and pharmacodynamic (plasma HIV RNA) parameters were assessed. In both mice and dogs, no-observed-adverse effect level (NOAEL) was observed at a 12 mg/kg/dose after two weeks. Of 5 men enrolled, 3 received active drug (10 mg, 10 mg and 20 mg). In 2 individuals grade 3 ISR occurred and the study was halted. Both ISR emerged within 12 hours of active drug dosing. No systemic toxicities were observed. The time-to-MEC was >72 and >96 hours after 10 and 20 mg dose, respectively, and mean change in HIV RNA was −0.9 log10 copies/mL. These human pharmacodynamic and pharmacokinetic data, although limited to 3 subjects, of C34-PEG-4-Chol suggest continuing evaluation of this agent as a LA-ARV. However, alternative administration routes must be explored.
- Published
- 2017
10. Changes in cerebral function parameters with maraviroc intensified antiretroviral therapy in treatment naïve HIV-Positive individuals; A randomised controlled study
- Author
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Mora-Peris, B, Bouliotis, G, Kulasegaram, R, Clarke, A, Post, FA, Nelson, M, Burgess, L, Tiraboschi, J, Khoo, S, Taylor, S, Ashby, D, and Winston, A
- Subjects
17 Psychology And Cognitive Sciences ,Virology ,11 Medical And Health Sciences ,06 Biological Sciences - Abstract
Background: Maraviroc-intensified antiretroviral therapy (ART) may be associated with cognitive benefits. Methods: Therapy-naive, cognitively asymptomatic, HIV-positive individuals were randomly allocated on a 1 : 1 basis to standard ART (Arm1: tenofovir-emtricitabine and atazanavir/ritonavir) or maraviroc intensified ART (Arm2: abacavir-lamivudine and darunavir/ritonavir/maraviroc). Over 48 weeks, detailed assessments of cognitive function tests were undertaken and cerebral metabolites measured using proton magnetic resonance spectroscopy. Our primary endpoint was mean change in cognitive function across treatment arms with factors associated with cognitive function changes also assessed. Results: Of 60 individuals randomized (30 Arm1 and 30 Arm2), 58 were men and 44 of white ethnicity. Treatment groups had similar disease characteristics including overall mean (SD) baseline CD4+ cell count 428 (209) and 414 (229) cells/μl, Arms1 and 2, respectively. At week 48, plasma HIV RNA was less than 50 copies/ml in 55 of 56 of those completing study procedures. Cognitive function improved over 48 weeks [mean change z-score (SD) 0.16 (0.09) Arm1 and 0.25 (0.08) Arm2, P = 0.96 for differences between study arms]. A greater increase in frontal grey matter N-acetyl aspartate/creatine ratio was observed in Arm1 [ratio change of 0.071 (SD 0.16)] versus Arm2 [change −0.097 (SD 0.18), P = 0.009], although this was not associated with changes in cognitive function (P = 0.17). Conclusion: Maraviroc-intensified ART had no demonstrable benefit on cognitive function in individuals initiating ART. Greater improvement in neuronal metabolites (N-acetyl aspartate/creatine) was observed with standard ART. Future work should focus on maraviroc-intensified ART in individuals with cognitive impairment.
- Published
- 2018
11. Combined skin and muscle vaccination differentially impact the quality of effector T cell functions: the CUTHIVAC-001 randomized trial
- Author
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Haidari, G., primary, Cope, A., additional, Miller, A., additional, Venables, S., additional, Yan, C., additional, Ridgers, H., additional, Reijonen, K., additional, Hannaman, D., additional, Spentzou, A., additional, Hayes, P., additional, Bouliotis, G., additional, Vogt, A., additional, Joseph, S., additional, Combadiere, B., additional, McCormack, S., additional, and Shattock, R. J., additional
- Published
- 2017
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- View/download PDF
12. Receptionist recognition and referral of patients with stroke: a study using simulated patient telephone calls in the West Midlands in 2013
- Author
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Mellor, R, primary, Sheppard, J, additional, Bates, E, additional, Bouliotis, G, additional, Jones, J, additional, Singh, S, additional, Skelton, J, additional, Wiskin, C, additional, and McManus, R, additional
- Published
- 2014
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13. Visual impairment registration: evaluation of agreement among ophthalmologists
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Guerin, E, primary, Bouliotis, G, additional, and King, A, additional
- Published
- 2014
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14. Long-term survival after treatment for Hodgkin’s disease (1973–2002): improved survival with successive 10-year cohorts
- Author
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Bessell, E M, primary, Bouliotis, G, additional, Armstrong, S, additional, Baddeley, J, additional, Haynes, A P, additional, O'Connor, S, additional, Nicholls-Elliott, H, additional, and Bradley, M, additional
- Published
- 2012
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- View/download PDF
15. Epidemiology and outcome of fracture of the hip in women aged 65 years and under
- Author
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Karantana, A., primary, Boulton, C., additional, Bouliotis, G., additional, Shu, K. Shan Shan, additional, Scammell, B. E., additional, and Moran, C. G., additional
- Published
- 2011
- Full Text
- View/download PDF
16. Chemo-Radiotherapy for Cervix Cancer Utilizing a Two-fraction High Dose Rate Brachytherapy Scheme
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Panades, M., primary, Bouliotis, G., additional, Flynn, J., additional, and Murray, E.C., additional
- Published
- 2009
- Full Text
- View/download PDF
17. Predicting the time to get back to work using statistical models and machine learning approaches.
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Bouliotis G, Underwood M, and Froud R
- Subjects
- Humans, Proportional Hazards Models, Male, Female, Adult, Time Factors, Support Vector Machine, Survival Analysis, Middle Aged, Machine Learning, Models, Statistical, Algorithms, Return to Work statistics & numerical data
- Abstract
Background: Whether machine learning approaches are superior to classical statistical models for survival analyses, especially in the case of lack of proportionality, is unknown., Objectives: To compare model performance and predictive accuracy of classic regressions and machine learning approaches using data from the Inspiring Families programme., Methods: The Inspiring Families programme aims to support members of families with complex issues to return to work. We explored predictors of time to return to work with proportional hazards (Semi-Parametric Cox in Stata) and (Flexible Parametric Parmar-Royston in Stata) against the Survival penalised regression with Elastic Net penalty (scikit-survival), (conditional) Survival Forest algorithm (pySurvival), and (kernel) Survival Support Vector Machine (pySurvival)., Results: At baseline we obtained data on 61 binary variables from all 3161 participants. No model appeared superior, with a low predictive power (concordance index between 0.51 and 0.61). The median time for finding the first job was about 254 days. The top five contributing variables were 'family issues and additional barriers', 'restriction of hours', 'available CV', 'self-employment considered' and 'education'. The Harrell's Concordance index was range from 0.60 (Cox model) to 0.71 (Random Survival Forest) suggesting a better fit for the machine learning approaches. However, the comparison for predicting median time on a selected scenario based showed only minor differences., Conclusion: Implementing a series of survival models with and without proportional hazards background provides a useful insight as well as better interpretation of the coefficients affected by non-linearities. However, that better fit does not translate to substantially higher predictive power and accuracy from using machine learning approaches. Further tuning of the machine learning algorithms may provide improved results., Competing Interests: Declarations. Ethics approval and consent to participate: Ethical approval was given by University of Warwick Biomedical and Scientific Research ethics Sub-committee for the study Predicting RTW class membership using Machine Learning (PRIMAL) REGO-2018-2186. Informed consent was obtained, from participants in the Inspiring Families, at the point of entry onto the programme for the University of Warwick to use depersonalised data obtained from participants. Consent for publication: N/A. Competing interests: MU is chief investigator or co-investigator on multiple previous and current research grants from the UK National Institute for Health Research, Arthritis Research UK and is a co-investigator on grants funded by the Australian NHMRC and Norwegian MRC. He was an NIHR Senior Investigator until March 2021. He receives some salary support from University Hospitals Coventry and Warwickshire. He is a co-investigator on two current and one completed NIHR funded studies that are, of have had, additional support from Stryker Ltd. Until March 2020 he was an editor of the NIHR journal series, and a member of the NIHR Journal Editors Group, for which he received a fee. RF is Chief Investigator on a research grant from Norwegian Medical Research Council on return-to-work initiatives. RF & MU are shareholders and directors of a University of Warwick spinout company that provide data collection services for health services research. These services were not use in this study. GB declares no competing interests., (© 2024. The Author(s).)
- Published
- 2024
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- View/download PDF
18. Preconceptual administration of doxycycline in women with recurrent miscarriage and chronic endometritis: protocol for the Chronic Endometritis and Recurrent Miscarriage (CERM) trial, a multicentre, double-blind, placebo-controlled, adaptive randomised trial with an embedded translational substudy.
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Odendaal J, Black N, Bouliotis G, Guck J, Underwood M, Fisher J, and Quenby S
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- Pregnancy, Female, Humans, Doxycycline therapeutic use, State Medicine, Chronic Disease, Double-Blind Method, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Endometritis drug therapy, Endometritis complications, Abortion, Habitual drug therapy, Abortion, Habitual etiology, Abortion, Habitual prevention & control
- Abstract
Introduction: Recurrent miscarriage is a common condition with a substantial associated morbidity. A hypothesised cause of recurrent miscarriage is chronic endometritis (CE). The aetiology of CE remains uncertain. An association between CE and recurrent miscarriage has been shown. This study will aim to determine if preconceptual administration of doxycycline, in women with recurrent miscarriages, and CE, reduces first trimester miscarriages, increasing live births., Methods and Analysis: Chronic Endometritis and Recurrent Miscarriage is a multicentre, double-blind adaptive trial with an embedded translational substudy. Women with a history of two or more consecutive first trimester losses with evidence of CE on endometrial biopsy (defined as ≥5 CD138 positive cells per 10 mm
2 ) will be randomised to oral doxycycline or placebo for 14 days. A subset will be recruited to a mechanistic substudy in which microbial swabs and preintervention/postintervention endometrial samples will be collected. Up to 3062 women recruited from 29 National Health Service (NHS) hospital sites across the UK are expected to be screened with up to 1500 women randomised in a 1:1 ratio. Women with a negative endometrial biopsy (defined as <5 CD138 positive cells per 10 mm2 ) will also be followed up to test validity of the tool. The primary outcome is live births plus pregnancies ≥24 + 0 weeks gestation at the end of the trial, in the first or subsequent pregnancy. Secondary clinical outcomes will also be assessed. Exploratory outcomes will assess the effect of doxycycline treatment on the endometrial microbiota, the differentiation capacity of the endometrium and the senescent profile of the endometrium with CE., Ethics and Dissemination: Ethical approval has been obtained from the NHS Research Ethics Committee Northwest-Haydock (19/NW/0462). Written informed consent will be gained from all participants. The results will be published in an open-access peer-reviewed journal and reported in the National Institute for Health and Care Research journals library., Trial Registration Number: ISRCTN23947730., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)- Published
- 2023
- Full Text
- View/download PDF
19. Left ventricular hypertrophy and incident cognitive decline in older adults with hypertension.
- Author
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Xu Y, Bouliotis G, Beckett NS, Antikainen RL, Anderson CS, Bulpitt CJ, and Peters R
- Subjects
- Aged, Humans, Blood Pressure, Electrocardiography, Hypertrophy, Left Ventricular diagnosis, Hypertrophy, Left Ventricular epidemiology, Hypertrophy, Left Ventricular complications, Cognitive Dysfunction diagnosis, Cognitive Dysfunction epidemiology, Dementia, Hypertension complications, Hypertension diagnosis, Hypertension epidemiology
- Abstract
The association between raised blood pressure and increased risk of subsequent cognitive decline is well known. Left ventricular hypertrophy (LVH), as a marker of hypertensive target organ damage, may help identify those at risk of cognitive decline. We assessed whether LVH was associated with subsequent cognitive decline or dementia in hypertensive participants aged ≥80 years in the randomized, placebo-controlled Hypertension in the Very Elderly Trial. LVH was assessed using 12-lead electrocardiography (ECG) based on the Cornell Product (CP-LVH), Sokolow-Lyon (SL-LVH), and Cornell Voltage (CV-LVH) criteria. The Mini-Mental State Examination (MMSE) was used to assess cognitive function at baseline and annually. A fall in MMSE to <24 or an annual fall of >3 points were defined as cognitive decline and triggered dementia screening (Diagnostic Statistical Manual IV). Death was defined as a competing event. Fine-Gray regression models were used to examine the relationship between baseline LVH and cognitive outcomes. There were 2645 in the analytical sample, including 201 (7.6%) with CP-LVH, 225 (8.5%) SL-LVH and 251 (9.5%) CV-LVH. CP-LVH was associated with increased risk of cognitive decline, subdistribution hazard ratio (sHR)1.3 (95% confidence interval (CI) 1.01-1.67) in multivariate analyses. SL-LVH and CV-LVH were not associated with cognitive decline (sHR1.06 (95% CI 0.82-1.37) and sHR1.13 (95% CI 0.89-1.43), respectively). LVH was not associated with dementia. LVH may be related to subsequent cognitive decline, but evidence was inconsistent depending on ECG criterion and there were no associations with incident dementia. Additional work is needed to understand the relationships between blood pressure, LVH assessment and cognition., (© 2022. The Author(s).)
- Published
- 2023
- Full Text
- View/download PDF
20. Effect of managed transition on mental health outcomes for young people at the child-adult mental health service boundary: a randomised clinical trial.
- Author
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Singh SP, Tuomainen H, Bouliotis G, Canaway A, De Girolamo G, Dieleman GC, Franić T, Madan J, Maras A, McNicholas F, Paul M, Purper-Ouakil D, Santosh P, Schulze UME, Street C, Tremmery S, Verhulst FC, Wells P, Wolke D, and Warwick J
- Subjects
- Adolescent, Humans, Adult, Mental Health, Europe, Outcome Assessment, Health Care, Mental Health Services, Psychotic Disorders
- Abstract
Background: Poor transition planning contributes to discontinuity of care at the child-adult mental health service boundary (SB), adversely affecting mental health outcomes in young people (YP). The aim of the study was to determine whether managed transition (MT) improves mental health outcomes of YP reaching the child/adolescent mental health service (CAMHS) boundary compared with usual care (UC)., Methods: A two-arm cluster-randomised trial (ISRCTN83240263 and NCT03013595) with clusters allocated 1:2 between MT and UC. Recruitment took place in 40 CAMHS (eight European countries) between October 2015 and December 2016. Eligible participants were CAMHS service users who were receiving treatment or had a diagnosed mental disorder, had an IQ ⩾ 70 and were within 1 year of reaching the SB. MT was a multi-component intervention that included CAMHS training, systematic identification of YP approaching SB, a structured assessment (Transition Readiness and Appropriateness Measure) and sharing of information between CAMHS and adult mental health services. The primary outcome was HoNOSCA (Health of the Nation Outcome Scale for Children and Adolescents) score 15-months post-entry to the trial., Results: The mean difference in HoNOSCA scores between the MT and UC arms at 15 months was -1.11 points (95% confidence interval -2.07 to -0.14, p = 0.03). The cost of delivering the intervention was relatively modest (€17-€65 per service user)., Conclusions: MT led to improved mental health of YP after the SB but the magnitude of the effect was small. The intervention can be implemented at low cost and form part of planned and purposeful transitional care.
- Published
- 2023
- Full Text
- View/download PDF
21. Transforming access to care for serious mental disorders in slums (the TRANSFORM Project): rationale, design and protocol.
- Author
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Singh SP, Jilka S, Abdulmalik J, Bouliotis G, Chadda R, Egbokhare O, Huque R, Hundt GL, Iyer S, Jegede O, Khera N, Lilford R, Madan J, Omigbodun A, Omigbodun O, Raja T, Read UM, Siddiqi BA, Sood M, Soron TR, and Ahmed HU
- Abstract
This paper introduces the TRANSFORM project, which aims to improve access to mental health services for people with serious and enduring mental disorders (SMDs - psychotic disorders and severe mood disorders, often with co-occurring substance misuse) living in urban slums in Dhaka (Bangladesh) and Ibadan (Nigeria). People living in slum communities have high rates of SMDs, limited access to mental health services and conditions of chronic hardship. Help is commonly sought from faith-based and traditional healers, but people with SMDs require medical treatment, support and follow-up. This multicentre, international mental health mixed-methods research project will (a) conduct community-based ethnographic assessment using participatory methods to explore community understandings of SMDs and help-seeking; (b) explore the role of traditional and faith-based healing for SMDs, from the perspectives of people with SMDs, caregivers, community members, healers, community health workers (CHWs) and health professionals; (c) co-design, with CHWs and healers, training packages for screening, early detection and referral to mental health services; and (d) implement and evaluate the training packages for clinical and cost-effectiveness in improving access to treatment for those with SMDs. TRANSFORM will develop and test a sustainable intervention that can be integrated into existing clinical care and inform priorities for healthcare providers and policy makers.
- Published
- 2022
- Full Text
- View/download PDF
22. Changes in cerebral function parameters with maraviroc-intensified antiretroviral therapy in treatment naive HIV-positive individuals.
- Author
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Mora-Peris B, Bouliotis G, Ranjababu K, Clarke A, Post FA, Nelson M, Burgess L, Tiraboschi J, Khoo S, Taylor S, Ashby D, and Winston A
- Subjects
- AIDS Dementia Complex pathology, Adult, Antiretroviral Therapy, Highly Active methods, Brain Chemistry, Female, HIV Infections complications, Humans, Magnetic Resonance Imaging, Male, Treatment Outcome, AIDS Dementia Complex prevention & control, Anti-HIV Agents administration & dosage, Anti-Retroviral Agents administration & dosage, HIV Infections drug therapy, Maraviroc administration & dosage
- Abstract
Background: Maraviroc-intensified antiretroviral therapy (ART) may be associated with cognitive benefits., Methods: Therapy-naive, cognitively asymptomatic, HIV-positive individuals were randomly allocated on a 1 : 1 basis to standard ART (Arm1: tenofovir-emtricitabine and atazanavir/ritonavir) or maraviroc intensified ART (Arm2: abacavir-lamivudine and darunavir/ritonavir/maraviroc). Over 48 weeks, detailed assessments of cognitive function tests were undertaken and cerebral metabolites measured using proton magnetic resonance spectroscopy. Our primary endpoint was mean change in cognitive function across treatment arms with factors associated with cognitive function changes also assessed., Results: Of 60 individuals randomized (30 Arm1 and 30 Arm2), 58 were men and 44 of white ethnicity. Treatment groups had similar disease characteristics including overall mean (SD) baseline CD4 cell count 428 (209) and 414 (229) cells/μl, Arms1 and 2, respectively. At week 48, plasma HIV RNA was less than 50 copies/ml in 55 of 56 of those completing study procedures. Cognitive function improved over 48 weeks [mean change z-score (SD) 0.16 (0.09) Arm1 and 0.25 (0.08) Arm2, P = 0.96 for differences between study arms]. A greater increase in frontal grey matter N-acetyl aspartate/creatine ratio was observed in Arm1 [ratio change of 0.071 (SD 0.16)] versus Arm2 [change -0.097 (SD 0.18), P = 0.009], although this was not associated with changes in cognitive function (P = 0.17)., Conclusion: Maraviroc-intensified ART had no demonstrable benefit on cognitive function in individuals initiating ART. Greater improvement in neuronal metabolites (N-acetyl aspartate/creatine) was observed with standard ART. Future work should focus on maraviroc-intensified ART in individuals with cognitive impairment.
- Published
- 2018
- Full Text
- View/download PDF
23. Development and external validation of a nomogram and online tool to predict bowel dysfunction following restorative rectal cancer resection: the POLARS score.
- Author
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Battersby NJ, Bouliotis G, Emmertsen KJ, Juul T, Glynne-Jones R, Branagan G, Christensen P, Laurberg S, and Moran BJ
- Subjects
- Adult, Aged, Aged, 80 and over, Defecation, Denmark, Female, Humans, Male, Middle Aged, Recovery of Function, Rectal Neoplasms pathology, Reproducibility of Results, Retrospective Studies, Surveys and Questionnaires, Treatment Outcome, United Kingdom, Colectomy methods, Nomograms, Online Systems, Quality of Life, Rectal Neoplasms surgery
- Abstract
Objective: Bowel dysfunction is common following a restorative rectal cancer resection, but symptom severity and the degree of quality of life impairment is highly variable. An internationally validated patient-reported outcome measure, Low Anterior Resection Syndrome (LARS) score, now enables these symptoms to be measured. The study purpose was: (1) to develop a model that predicts postoperative bowel function; (2) externally validate the model and (3) incorporate these findings into a nomogram and online tool in order to individualise patient counselling and aid preoperative consent., Design: Patients more than 1 year after curative restorative anterior resection (UK, median 54 months; Denmark (DK), 56 months since surgery) were invited to complete The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version3 (EORTC QLQ-C30 v3), LARS and Wexner incontinence scores. Demographics, tumour characteristics, preoperative/postoperative treatment and surgical procedures were recorded. Using transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) guidelines, risk factors for bowel dysfunction were independently assessed by advanced linear regression shrinkage techniques for each dataset (UK:DK)., Results: Patients in the development (UK, n=463) and validation (DK, n=938) datasets reported mean (SD) LARS scores of 26 (11) and 24 (11), respectively. Key predictive factors for LARS were: age (at surgery); tumour height, total versus partial mesorectal excision, stoma and preoperative radiotherapy, with satisfactory model calibration and a Mallow's Cp of 7.5 and 5.5, respectively., Conclusions: The Pre-Operative LARS score (POLARS) is the first nomogram and online tool to predict bowel dysfunction severity prior to anterior resection. Colorectal surgeons, gastroenterologist and nurse specialists may use POLARS to help patients understand their risk of bowel dysfunction and to preoperatively highlight patients who may require additional postoperative support., Competing Interests: Competing interests: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)
- Published
- 2018
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24. A first-in-human study of the novel HIV-fusion inhibitor C34-PEG 4 -Chol.
- Author
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Quinn K, Traboni C, Penchala SD, Bouliotis G, Doyle N, Libri V, Khoo S, Ashby D, Weber J, Nicosia A, Cortese R, Pessi A, and Winston A
- Subjects
- Adolescent, Adult, Animals, Cells, Cultured, Cholesterol chemistry, Cohort Studies, Dogs, Double-Blind Method, Drug Evaluation, Preclinical, Drug Resistance, Viral genetics, HIV Envelope Protein gp41 chemistry, HIV Envelope Protein gp41 genetics, HIV Fusion Inhibitors chemistry, Humans, Male, Mice, Middle Aged, Mutagenesis, Site-Directed, Peptide Fragments chemistry, Placebo Effect, Polyethylene Glycols chemistry, Recombinant Fusion Proteins chemistry, T-Lymphocytes immunology, T-Lymphocytes virology, Viral Load, Young Adult, HIV Envelope Protein gp41 therapeutic use, HIV Fusion Inhibitors therapeutic use, HIV Infections drug therapy, HIV-1 physiology, Peptide Fragments therapeutic use, Recombinant Fusion Proteins therapeutic use, T-Lymphocytes drug effects
- Abstract
Long-acting injectable antiretroviral (LA-ARV) drugs with low toxicity profiles and propensity for drug-drug interactions are a goal for future ARV regimens. C34-PEG
4 -Chol is a novel cholesterol tagged LA HIV-fusion-inhibitor (FI). We assessed pre-clinical toxicology and first-in-human administration of C34-PEG4 -Chol. Pre-clinical toxicology was conducted in 2 species. HIV-positive men were randomised to a single subcutaneous dose of C34-PEG4 -Chol at incrementing doses or placebo. Detailed clinical (including injection site reaction (ISR) grading), plasma pharmacokinetic (time-to-minimum-effective-concentration (MEC, 25 ng/mL) and pharmacodynamic (plasma HIV RNA) parameters were assessed. In both mice and dogs, no-observed-adverse effect level (NOAEL) was observed at a 12 mg/kg/dose after two weeks. Of 5 men enrolled, 3 received active drug (10 mg, 10 mg and 20 mg). In 2 individuals grade 3 ISR occurred and the study was halted. Both ISR emerged within 12 hours of active drug dosing. No systemic toxicities were observed. The time-to-MEC was >72 and >96 hours after 10 and 20 mg dose, respectively, and mean change in HIV RNA was -0.9 log10 copies/mL. These human pharmacodynamic and pharmacokinetic data, although limited to 3 subjects, of C34-PEG-4-Chol suggest continuing evaluation of this agent as a LA-ARV. However, alternative administration routes must be explored.- Published
- 2017
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25. A Comparative Phase I Study of Combination, Homologous Subtype-C DNA, MVA, and Env gp140 Protein/Adjuvant HIV Vaccines in Two Immunization Regimes.
- Author
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Joseph S, Quinn K, Greenwood A, Cope AV, McKay PF, Hayes PJ, Kopycinski JT, Gilmour J, Miller AN, Geldmacher C, Nadai Y, Ahmed MI, Montefiori DC, Dally L, Bouliotis G, Lewis DJ, Tatoud R, Wagner R, Esteban M, Shattock RJ, McCormack S, and Weber J
- Abstract
There remains an urgent need for a prophylactic HIV vaccine. We compared combined MVA and adjuvanted gp140 to sequential MVA/gp140 after DNA priming. We expected Env-specific CD4+ T-cells after DNA and MVA priming, and Env-binding antibodies in 100% individuals after boosting with gp140 and that combined vaccines would not compromise safety and might augment immunogenicity. Forty volunteers were primed three times with DNA plasmids encoding (CN54) env and (ZM96) gag-pol-nef at 0, 4 and 8 weeks then boosted with MVA-C (CN54 env and gag-pol-nef) and glucopyranosyl lipid adjuvant-aqueous formulation (GLA-AF) adjuvanted CN54gp140. They were randomised to receive them in combination at the same visit at 16 and 20 weeks (accelerated) or sequentially with MVA-C at 16, 20, and GLA-AF/gp140 at 24 and 28 weeks (standard). All vaccinations were intramuscular. Primary outcomes included ≥grade 3 safety events and the titer of CN54gp140-specific binding IgG. Other outcomes included neutralization, binding antibody specificity and T-cell responses. Two participants experienced asymptomatic ≥grade 3 transaminitis leading to discontinuation of vaccinations, and three had grade 3 solicited local or systemic reactions. A total of 100% made anti-CN54gp140 IgG and combining vaccines did not significantly alter the response; geometric mean titer 6424 (accelerated) and 6578 (standard); neutralization of MW965.2 Tier 1 pseudovirus was superior in the standard group (82 versus 45% responders, p = 0.04). T-cell ELISpot responses were CD4+ and Env-dominant; 85 and 82% responding in the accelerated and standard groups, respectively. Vaccine-induced IgG responses targeted multiple regions within gp120 with the V3 region most immunodominant and no differences between groups detected. Combining MVA and gp140 vaccines did not result in increased adverse events and did not significantly impact upon the titer of Env-specific binding antibodies, which were seen in 100% individuals. The approach did however affect other immune responses; neutralizing antibody responses, seen only to Tier 1 pseudoviruses, were poorer when the vaccines were combined and while T-cell responses were seen in >80% individuals in both groups and similarly CD4 and Env dominant, their breadth/polyfunctionality tended to be lower when the vaccines were combined, suggesting attenuation of immunogenicity and cautioning against this accelerated regimen.
- Published
- 2017
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26. Receptionist rECognition and rEferral of Patients with Stroke (RECEPTS): unannounced simulated patient telephone call study in primary care.
- Author
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Mellor RM, Sheppard JP, Bates E, Bouliotis G, Jones J, Singh S, Skelton J, Wiskin C, and McManus RJ
- Subjects
- Cross-Sectional Studies, Humans, Morbidity trends, Prospective Studies, Stroke epidemiology, Surveys and Questionnaires, Telephone, United Kingdom epidemiology, Medical Receptionists organization & administration, Patient Simulation, Primary Health Care organization & administration, Referral and Consultation organization & administration, Stroke diagnosis
- Abstract
Background: Stroke is a leading cause of morbidity and mortality. Timely recognition and referral are essential for treatment., Aim: To examine the ability of receptionists in general practices to recognise symptoms of stroke and direct patients to emergency care., Design and Setting: Unannounced simulated patient telephone calls and prospective cross-sectional survey study in general practices in the Birmingham and Solihull area., Method: A total of 52 general practices participated in a total of 520 simulated telephone calls, with 183 receptionists completing questionnaires. Logistic regression analyses were used to examine likelihood of referral for immediate care by ease of vignette recognition and number of common stroke symptoms present., Results: General practice receptionists correctly referred 69% of simulated calls for immediate care. Calls classed as 'difficult' to recognise were less likely to be immediately referred. Compared with 'easy' calls: 'difficult' calls odds ratio (OR) 0.15, 95% confidence interval (CI) = 0.08 to 0.26; 'moderate' calls OR 0.55, 95% CI = 0.32 to 0.92. Similarly, calls including one or two 'FAST' symptoms were less likely to be referred immediately (compared with three FAST symptoms: one symptom OR 0.30, 95% CI = 0.13 to 0.72; two symptoms OR 0.35, 95% CI = 0.15 to 0.83)., Conclusion: General practice receptionists refer patients with stroke for immediate care when they present with several symptoms; however, they are less likely to refer patients presenting with only one symptom or less common symptoms of stroke. Optimum management of acute stroke in primary care requires interventions that improve receptionists' knowledge of lesser-known stroke symptoms., (© British Journal of General Practice 2015.)
- Published
- 2015
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27. Hodgkin disease (1973-2002): long-term survival and cure fractions.
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Bouliotis G and Bessell EM
- Subjects
- Adult, Aged, Aged, 80 and over, Female, History, 20th Century, History, 21st Century, Hodgkin Disease diagnosis, Hodgkin Disease history, Hodgkin Disease therapy, Humans, Male, Middle Aged, Neoplasm Staging, Outcome Assessment, Health Care, Registries, Survival Analysis, Young Adult, Hodgkin Disease epidemiology
- Abstract
The Nottinghamshire Lymphoma Registry contains the details of all patients diagnosed with lymphoma (since 1 January 1973) within a defined geographical area with a stable population of 1.1 million. The aim of this study was to investigate the relative survival and estimate the cure fraction for patients with Hodgkin disease (HD) using various cure fraction models. Five- and 10-year survival was estimated in comparison to the general population of the same age, gender and year of diagnosis. Relative survival probabilities at 10 years were 52.3% for the 1973-1982 cohort, 67.8% (1983-1992) and 75.7% (1993-2002). The estimated cured fraction (π) was 45%, 65% and 75%, respectively, for the same cohorts. There was very little excess mortality after 4 years from treatment. The prognosis of patients with HD has improved progressively within a defined unselected population over this 30-year period. In the 1993-2002 cohort the prognosis after 4 years of treatment is almost the same as for a normal population.
- Published
- 2015
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28. Metachronous colorectal cancer: a competing risks analysis with consideration for a stratified approach to surveillance colonoscopy.
- Author
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Battersby NJ, Coupland A, Bouliotis G, Mirza N, and Williams JG
- Subjects
- Actuarial Analysis, Adult, Aged, Aged, 80 and over, Colorectal Neoplasms pathology, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Neoplasms, Second Primary mortality, Prospective Studies, Risk Assessment, Risk Factors, United Kingdom epidemiology, Colectomy methods, Colonoscopy, Colorectal Neoplasms diagnosis, Colorectal Neoplasms surgery, Neoplasms, Second Primary diagnosis, Neoplasms, Second Primary epidemiology, Population Surveillance methods
- Abstract
Background: The incidence of metachronous cancer will become an important clinical consideration as the life expectancy of the population increases and as rates of curative resection improve., Objective: To assess the pattern of metachronous cancer development following curative resection of colorectal cancer in an unselected patient population offered postoperative colonoscopic surveillance., Method: Prospective clinical follow-up after curative colorectal cancer resection and surveillance colonoscopy with or without polypectomy in accordance with the national guidelines. Actuarial analysis and competing risk analysis were performed to account for death and recurrence and to stratify for age, gender, stage, and tumor site., Results: Five hundred thirty-eight patients with median follow-up 4 years 2 month (0-16) years. Fifteen patients (3%) developed metachronous cancer, at a median time interval of 90 months from primary resection. Thirteen metachronous cancer patients (87%, 13/15) underwent one to five surveillance colonoscopies: nine patients were asymptomatic at time of diagnosis of metachronous cancer. Competing risks analysis suggests that the adjusted cumulative incidence in males aged 55 is 4% at 10 years compared with 1% in females aged 85 years old., Conclusions: A patient aged under 65 at the time of the primary curative resection carries a 2% 5-year risk of metachronous cancer, implying that 3 year surveillance colonoscopy is justified. Whereas patients aged over 75 carry less than a 2% 10-year risk, implying that it is seldom warranted to repeat the colonoscopy more frequently than every 5 years. A stratified approach to the frequency of surveillance colonoscopy requires further consideration., (© 2013 Wiley Periodicals, Inc.)
- Published
- 2014
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29. Exploratory cross-sectional study of factors associated with pre-hospital management of pain.
- Author
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Siriwardena AN, Shaw D, and Bouliotis G
- Subjects
- Adult, Aged, Aged, 80 and over, Analgesics therapeutic use, Cross-Sectional Studies, England, Female, Fractures, Bone physiopathology, Humans, Male, Middle Aged, Myocardial Infarction physiopathology, Young Adult, Emergency Medical Services, Pain drug therapy
- Abstract
Rationale, Aims and Objectives: Improving pain management is important in pre-hospital settings. We aimed to investigate how pain was managed in pre-hospital suspected acute myocardial infarction (AMI) or fracture and how this could be improved., Method: We conducted a cross-sectional study in Lincolnshire using recorded suspected AMI and fracture between April 2005 and March 2006. Outcomes included pain assessment, improvement in pain scores and administration of Entonox, opiates or GTN (in AMI)., Results: We accessed 3654 patients with suspected AMI or fracture. Pain was assessed in over three quarters of patients but analgesics administered in under two-fifths. Assessment was more likely in patients with suspected AMI (OR 2.05, 95% CI [1.70, 2.47]), and who were alert (OR 3.55, 95% CI [2.32, 5.43]). Entonox was less likely to be administered for suspected AMI (OR 0.11, 95% CI [0.087, 0.15]) or by paramedic crews (OR 0.56, 95% CI [0.45, 0.68]) but more likely to be given when pain had been assessed (OR 3.54, 95% CI [2.77, 4.52]). Opiates were more likely to be prescribed for suspected AMI (OR 1.30, 95% CI [1.07, 1.57]), in alert patients (OR 1.35, 95% CI [0.71, 2.56]) assessed for pain (OR 2.20, 95% CI [1.73, 2.80]) by paramedic crews., Conclusions: This exploratory study showed shortfalls in assessment and treatment of pain, but also demonstrated that assessment of pain was associated with more effective treatment. Further research is needed to understand barriers to pre-hospital pain management and investigate mechanisms to overcome these., (© 2010 Blackwell Publishing Ltd.)
- Published
- 2010
- Full Text
- View/download PDF
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