Background Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently pe... more Background Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited. Aims To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. Methods/design A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises ...
Background The visually impaired have a higher risk of falling and are likely to avoid activity. ... more Background The visually impaired have a higher risk of falling and are likely to avoid activity. Objectives To adapt the existing Falls Management Exercise (FaME) programme, which is delivered in the community, for visually impaired older people (VIOP) and to investigate the feasibility of conducting a definitive randomised controlled trial of this adapted intervention. Design Phase I – consultation with stakeholders to adapt the existing programme. Two focus groups were conducted, each with 10 VIOP across the study sites. Phase II – two-centre randomised pilot trial and economic evaluation of the adapted programme for VIOP versus usual care. Phases III and IV – qualitative interviews with VIOP and Postural Stability Instructors regarding their views and experiences of the research process, undertaking the intervention and its acceptability. Intervention This was adapted from the group-based FaME programme. A 1-hour exercise programme ran weekly over 12 weeks at the study sites (New...
ObjectiveTo describe, using data from the Newcastle 85+ cohort study, the use of primary care and... more ObjectiveTo describe, using data from the Newcastle 85+ cohort study, the use of primary care and other healthcare services by 85-year-olds as they age.DesignLongitudinal population-based cohort study.SettingNewcastle on Tyne and North Tyneside, UK.ParticipantsCommunity dwelling and institutionalised men and women recruited through general practices (n=845, 319 men and 526 women).ResultsContact was established with 97% (n=1409/1459) of eligible 85-year-olds, consent obtained from 74% (n=1042/1409) and 851 agreed to undergo the multidimensional health assessment and a general practice medical records review. A total of 845 participants had complete data at baseline for this study (319 male, 526 female), with 344 (118 male, 226 female) reinterviewed at 60 months. After adjusting for confounders, all consultations significantly increased over the 5 years (incidence rate ratio, IRR=1.03, 95% CI 1.01 to 1.05, P=0.001) as did general practitioner (GP) consultations (IRR=1.03, 95% CI 1.01 ...
Critically ill patients with impaired neutrophil phagocytosis have significantly increased risk o... more Critically ill patients with impaired neutrophil phagocytosis have significantly increased risk of nosocomial infection. Granulocyte-macrophage colony-stimulating factor (GM-CSF) improves phagocytosis by neutrophils ex vivo. This study tested the hypothesis that GM-CSF improves neutrophil phagocytosis in critically ill patients in whom phagocytosis is known to be impaired. This was a multicentre, phase IIa randomised, placebo-controlled clinical trial. Using a personalised medicine approach, only critically ill patients with impaired neutrophil phagocytosis were included. Patients were randomised 1:1 to subcutaneous GM-CSF (3 μg/kg/day) or placebo, once daily for 4 days. The primary outcome measure was neutrophil phagocytosis 2 days after initiation of GM-CSF. Secondary outcomes included neutrophil phagocytosis over time, neutrophil functions other than phagocytosis, monocyte HLA-DR expression and safety. Thirty-eight patients were recruited from five intensive care units (17 random...
Looked after children (LAC) and care leavers are young people who have been placed under the lega... more Looked after children (LAC) and care leavers are young people who have been placed under the legal care of local authorities, in many instances due to a history of abuse and/or neglect. These young people have a significantly increased risk of substance use and mental disorder compared to their peers. The aim of the SOLID study is to assess the feasibility and acceptability of a definitive three-arm multi-centre randomised controlled trial (RCT) that compares the effectiveness of two interventions that aim to reduce risky drug and alcohol use and improve mental health among LAC aged 12 to 20 years with usual care. All LAC aged 12 to 20 years residing in four local authorities in North East England will be screened by their social worker for risky drug and alcohol use using the CRAFFT (Car, Relax, Alone, Forget, Friends and Trouble) screening tool. Those who score ≥2 will be invited to take part in the trial after further eligibility checks. Informed consent will be taken and baselin...
Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for... more Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for attendance at a secondary care throat or voice clinic. There is a growing trend to treat throat symptom patients with proton pump inhibitors (PPIs) to suppress stomach acid, but most controlled studies fail to demonstrate a significant benefit of PPI over placebo. In addition, patient views on PPI use vary widely. A UK multi-centre, randomised, controlled trial for adults with persistent throat symptoms to compare the effectiveness of treatment with the proton pump inhibitor (PPI) lansoprazole versus placebo. The trial includes a six-month internal pilot, during which three sites will recruit 30 participants in total, to assess the practicality of the trial and assess the study procedures and willingness of the patient population to participate. If the pilot is successful, three additional sites will be opened to recruitment, and a further 302 participants recruited across the six main ...
In 2002 feasibility certification studies were carried out on three different types of microbiolo... more In 2002 feasibility certification studies were carried out on three different types of microbiological reference materials for eight different ISO and EN standard methods, related to EU water legislation (Drinking-water Directive and Bathing-water Directive). These studies were performed as part of the European project 'Microbiological Certified Reference Materials in support of EU water legislation, performance testing and laboratory quality control' (MICROCRM 01/02/2001 - 01/11/2003). The aim of the project was to determine the conditions necessary to produce and certify key reference materials for water microbiology. The three different types of reference materials were capsules, lenticules and pastilles. For each type of reference material, eight batches - containing different strains - were prepared (for use for the eight different methods). Thirteen European laboratories participated in the studies. The results of the studies were statistically analysed by three statis...
The first estimates of Healthy Life Years at age 50 (HLY50) across the EU25 countries in 2005 sho... more The first estimates of Healthy Life Years at age 50 (HLY50) across the EU25 countries in 2005 showed substantial variation in healthy ageing. We investigate whether factors contributing to HLY50 inequalities have changed between 2005 and 2010. HLY50 for each country and year were calculated using Sullivan's method, applying the age-specific prevalence of activity limitation from the European Union Statistics on Income and Living Conditions (EU-SILC) survey to life tables. Inequalities in life expectancy at age 50 (LE50) and HLY50 between countries were defined as the difference between the maximum and minimum LE50 or HLY50. Relationships between HLY50 and macro-level socio-economic indicators were investigated using meta-regression. Men and women were analysed separately. Between 2005 and 2010 HLY50 inequalities for both men and women in Europe increased. In 2005 and 2010 HLY50 inequalities exceeded LE50 inequalities, particularly in the established EU15 countries in 2010 where ...
The Global Activity Limitation Indicator (GALI), the measure underlying the European indicator He... more The Global Activity Limitation Indicator (GALI), the measure underlying the European indicator Healthy Life Years (HLY), is widely used to compare population health across countries. However, the comparability of the item has been questioned. This study aims to further validate the GALI in the adult European population. Data from the European Health Interview Survey (EHIS), covering 14 European countries and 152,787 individuals, were used to explore how the GALI was associated with other measures of disability and whether the GALI was consistent or reflected different disability situations in different countries. When considering each country separately or all combined, we found that the GALI was significantly associated with measures of activities of daily living, instrumental activity of daily living, and functional limitations (P < 0.001 in all cases). Associations were largest for activity of daily living and lowest though still high for functional limitations. For each measu...
BackgroundHealth expectancies, taking into account both quality and quantity of life, have genera... more BackgroundHealth expectancies, taking into account both quality and quantity of life, have generally been based on disability and physical functioning.AimsTo compare mental health expectancies at age 25 and 55 based on common mental disorders both across countries and between males and females.MethodMental health expectancies were calculated by combining mortality data from population life tables and the age-specific prevalence of selected common mental disorders obtained from the European Study of the Epidemiology of Mental Disorders (ESEMeD).ResultsFor the male population aged 25 (all countries combined) life expectancy was 52 years and life expectancy spent with a common mental disorder was 1.8 years (95% CI 0.7-2.9),3.4% of overall life expectancy. In comparison, for the female population life expectancy at age 25 was higher (57.9 years) as was life expectancy spent with a common mental disorder (5.1 years, 95% CI 3.6-6.6) and as a proportion of overall life expectancy, 8.8%. By...
Estimating the life expectancy with and without cognitive impairment in an older adult population... more Estimating the life expectancy with and without cognitive impairment in an older adult population is critical for understanding the burden of illness on individuals and their families, the health care system, and society at large. This paper presents and compares estimates of life expectancy with and without cognitive impairment for the noninstitutionalized population ages 60 years and older in São Paulo, Brazil, for the years 2000 and 2010. Life expectancy with and without cognitive impairment was calculated using the Sullivan method and prevalence estimates from data collection at two points (2000 and 2010) of the Health, Well-Being, and Aging (SABE) Study. Results indicate that 60-year-old men in São Paulo in 2000 could expect to live 14.8 years and women 17.9 years without cognitive impairment. By 2010, life expectancy without cognitive impairment had increased to 17.1 years for men and 20.0 years for women. Length of life with cognitive impairment differed by gender (2.3 years for men and 3.7 years for women at age 60 in 2010). However, the absolute number of years with cognitive impairment remained relatively constant with age. The results indicate a trend for improvements in life expectancy without cognitive impairment over time in São Paulo. Adults in Brazil still face many years of cognitive impairment in their older years, particularly when compared with estimates from developed countries.
Background Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently pe... more Background Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited. Aims To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. Methods/design A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises ...
Background The visually impaired have a higher risk of falling and are likely to avoid activity. ... more Background The visually impaired have a higher risk of falling and are likely to avoid activity. Objectives To adapt the existing Falls Management Exercise (FaME) programme, which is delivered in the community, for visually impaired older people (VIOP) and to investigate the feasibility of conducting a definitive randomised controlled trial of this adapted intervention. Design Phase I – consultation with stakeholders to adapt the existing programme. Two focus groups were conducted, each with 10 VIOP across the study sites. Phase II – two-centre randomised pilot trial and economic evaluation of the adapted programme for VIOP versus usual care. Phases III and IV – qualitative interviews with VIOP and Postural Stability Instructors regarding their views and experiences of the research process, undertaking the intervention and its acceptability. Intervention This was adapted from the group-based FaME programme. A 1-hour exercise programme ran weekly over 12 weeks at the study sites (New...
ObjectiveTo describe, using data from the Newcastle 85+ cohort study, the use of primary care and... more ObjectiveTo describe, using data from the Newcastle 85+ cohort study, the use of primary care and other healthcare services by 85-year-olds as they age.DesignLongitudinal population-based cohort study.SettingNewcastle on Tyne and North Tyneside, UK.ParticipantsCommunity dwelling and institutionalised men and women recruited through general practices (n=845, 319 men and 526 women).ResultsContact was established with 97% (n=1409/1459) of eligible 85-year-olds, consent obtained from 74% (n=1042/1409) and 851 agreed to undergo the multidimensional health assessment and a general practice medical records review. A total of 845 participants had complete data at baseline for this study (319 male, 526 female), with 344 (118 male, 226 female) reinterviewed at 60 months. After adjusting for confounders, all consultations significantly increased over the 5 years (incidence rate ratio, IRR=1.03, 95% CI 1.01 to 1.05, P=0.001) as did general practitioner (GP) consultations (IRR=1.03, 95% CI 1.01 ...
Critically ill patients with impaired neutrophil phagocytosis have significantly increased risk o... more Critically ill patients with impaired neutrophil phagocytosis have significantly increased risk of nosocomial infection. Granulocyte-macrophage colony-stimulating factor (GM-CSF) improves phagocytosis by neutrophils ex vivo. This study tested the hypothesis that GM-CSF improves neutrophil phagocytosis in critically ill patients in whom phagocytosis is known to be impaired. This was a multicentre, phase IIa randomised, placebo-controlled clinical trial. Using a personalised medicine approach, only critically ill patients with impaired neutrophil phagocytosis were included. Patients were randomised 1:1 to subcutaneous GM-CSF (3 μg/kg/day) or placebo, once daily for 4 days. The primary outcome measure was neutrophil phagocytosis 2 days after initiation of GM-CSF. Secondary outcomes included neutrophil phagocytosis over time, neutrophil functions other than phagocytosis, monocyte HLA-DR expression and safety. Thirty-eight patients were recruited from five intensive care units (17 random...
Looked after children (LAC) and care leavers are young people who have been placed under the lega... more Looked after children (LAC) and care leavers are young people who have been placed under the legal care of local authorities, in many instances due to a history of abuse and/or neglect. These young people have a significantly increased risk of substance use and mental disorder compared to their peers. The aim of the SOLID study is to assess the feasibility and acceptability of a definitive three-arm multi-centre randomised controlled trial (RCT) that compares the effectiveness of two interventions that aim to reduce risky drug and alcohol use and improve mental health among LAC aged 12 to 20 years with usual care. All LAC aged 12 to 20 years residing in four local authorities in North East England will be screened by their social worker for risky drug and alcohol use using the CRAFFT (Car, Relax, Alone, Forget, Friends and Trouble) screening tool. Those who score ≥2 will be invited to take part in the trial after further eligibility checks. Informed consent will be taken and baselin...
Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for... more Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for attendance at a secondary care throat or voice clinic. There is a growing trend to treat throat symptom patients with proton pump inhibitors (PPIs) to suppress stomach acid, but most controlled studies fail to demonstrate a significant benefit of PPI over placebo. In addition, patient views on PPI use vary widely. A UK multi-centre, randomised, controlled trial for adults with persistent throat symptoms to compare the effectiveness of treatment with the proton pump inhibitor (PPI) lansoprazole versus placebo. The trial includes a six-month internal pilot, during which three sites will recruit 30 participants in total, to assess the practicality of the trial and assess the study procedures and willingness of the patient population to participate. If the pilot is successful, three additional sites will be opened to recruitment, and a further 302 participants recruited across the six main ...
In 2002 feasibility certification studies were carried out on three different types of microbiolo... more In 2002 feasibility certification studies were carried out on three different types of microbiological reference materials for eight different ISO and EN standard methods, related to EU water legislation (Drinking-water Directive and Bathing-water Directive). These studies were performed as part of the European project 'Microbiological Certified Reference Materials in support of EU water legislation, performance testing and laboratory quality control' (MICROCRM 01/02/2001 - 01/11/2003). The aim of the project was to determine the conditions necessary to produce and certify key reference materials for water microbiology. The three different types of reference materials were capsules, lenticules and pastilles. For each type of reference material, eight batches - containing different strains - were prepared (for use for the eight different methods). Thirteen European laboratories participated in the studies. The results of the studies were statistically analysed by three statis...
The first estimates of Healthy Life Years at age 50 (HLY50) across the EU25 countries in 2005 sho... more The first estimates of Healthy Life Years at age 50 (HLY50) across the EU25 countries in 2005 showed substantial variation in healthy ageing. We investigate whether factors contributing to HLY50 inequalities have changed between 2005 and 2010. HLY50 for each country and year were calculated using Sullivan's method, applying the age-specific prevalence of activity limitation from the European Union Statistics on Income and Living Conditions (EU-SILC) survey to life tables. Inequalities in life expectancy at age 50 (LE50) and HLY50 between countries were defined as the difference between the maximum and minimum LE50 or HLY50. Relationships between HLY50 and macro-level socio-economic indicators were investigated using meta-regression. Men and women were analysed separately. Between 2005 and 2010 HLY50 inequalities for both men and women in Europe increased. In 2005 and 2010 HLY50 inequalities exceeded LE50 inequalities, particularly in the established EU15 countries in 2010 where ...
The Global Activity Limitation Indicator (GALI), the measure underlying the European indicator He... more The Global Activity Limitation Indicator (GALI), the measure underlying the European indicator Healthy Life Years (HLY), is widely used to compare population health across countries. However, the comparability of the item has been questioned. This study aims to further validate the GALI in the adult European population. Data from the European Health Interview Survey (EHIS), covering 14 European countries and 152,787 individuals, were used to explore how the GALI was associated with other measures of disability and whether the GALI was consistent or reflected different disability situations in different countries. When considering each country separately or all combined, we found that the GALI was significantly associated with measures of activities of daily living, instrumental activity of daily living, and functional limitations (P < 0.001 in all cases). Associations were largest for activity of daily living and lowest though still high for functional limitations. For each measu...
BackgroundHealth expectancies, taking into account both quality and quantity of life, have genera... more BackgroundHealth expectancies, taking into account both quality and quantity of life, have generally been based on disability and physical functioning.AimsTo compare mental health expectancies at age 25 and 55 based on common mental disorders both across countries and between males and females.MethodMental health expectancies were calculated by combining mortality data from population life tables and the age-specific prevalence of selected common mental disorders obtained from the European Study of the Epidemiology of Mental Disorders (ESEMeD).ResultsFor the male population aged 25 (all countries combined) life expectancy was 52 years and life expectancy spent with a common mental disorder was 1.8 years (95% CI 0.7-2.9),3.4% of overall life expectancy. In comparison, for the female population life expectancy at age 25 was higher (57.9 years) as was life expectancy spent with a common mental disorder (5.1 years, 95% CI 3.6-6.6) and as a proportion of overall life expectancy, 8.8%. By...
Estimating the life expectancy with and without cognitive impairment in an older adult population... more Estimating the life expectancy with and without cognitive impairment in an older adult population is critical for understanding the burden of illness on individuals and their families, the health care system, and society at large. This paper presents and compares estimates of life expectancy with and without cognitive impairment for the noninstitutionalized population ages 60 years and older in São Paulo, Brazil, for the years 2000 and 2010. Life expectancy with and without cognitive impairment was calculated using the Sullivan method and prevalence estimates from data collection at two points (2000 and 2010) of the Health, Well-Being, and Aging (SABE) Study. Results indicate that 60-year-old men in São Paulo in 2000 could expect to live 14.8 years and women 17.9 years without cognitive impairment. By 2010, life expectancy without cognitive impairment had increased to 17.1 years for men and 20.0 years for women. Length of life with cognitive impairment differed by gender (2.3 years for men and 3.7 years for women at age 60 in 2010). However, the absolute number of years with cognitive impairment remained relatively constant with age. The results indicate a trend for improvements in life expectancy without cognitive impairment over time in São Paulo. Adults in Brazil still face many years of cognitive impairment in their older years, particularly when compared with estimates from developed countries.
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