Uranium processing workers are exposed to uranium and radium compounds from the ore dust and to γ-ray radiation, but less to radon decay products (RDP), typical of the uranium miners. We examined the risks of these exposures in a cohort of workers from Port Hope radium and uranium refinery and processing plant.
A retrospective cohort study with carefully documented exposures, which allowed separation of those with primary exposures to radium and uranium.
Port Hope, Ontario, Canada, uranium processors with no mining experience.
3000 male and female workers first employed (1932–1980) and followed for mortality (1950–1999) and cancer incidence (1969–1999).
Cohort mortality and incidence were compared with the general Canadian population. Poisson regression was used to evaluate the association between cumulative RDP exposures and γ-ray doses and causes of death and cancers potentially related to radium and uranium processing.
Overall, workers had lower mortality and cancer incidence compared with the general Canadian population. In analyses restricted to men (n=2645), the person-year weighted mean cumulative RDP exposure was 15.9 working level months (WLM) and the mean cumulative whole-body γ-ray dose was 134.4 millisieverts. We observed small, non-statistically significant increases in radiation risks of mortality and incidence of lung cancer due to RDP exposures (excess relative risks/100 WLM=0.21, 95% CI <−0.45 to 1.59 and 0.77, 95% CI <−0.19 to 3.39, respectively), with similar risks for those exposed to radium and uranium. All other causes of death and cancer incidence were not significantly associated with RDP exposures or γ-ray doses or a combination of both.
In one of the largest cohort studies of workers exposed to radium, uranium and γ-ray doses, no significant radiation-associated risks were observed for any cancer site or cause of death. Continued follow-up and pooling with other cohorts of workers exposed to by-products of radium and uranium processing could provide valuable insight into occupational risks and suspected differences in risk with uranium miners.
Epidemiology; Occupational & Industrial Medicine
To describe the hospitalisation patterns in children with intellectual disability (ID) and/or autism spectrum disorder (ASD) after the first year of life and compare with those unaffected.
Prospective cohort study using data linkage between health, ID and hospitalisation population-based datasets.
416 611 individuals born between 1983 and 1999 involving 1 027 962 hospital admission records. Five case categories were defined (mild/moderate ID, severe ID, biomedically caused ID, ASD with ID and ASD without ID) and compared with the remainder of children and young people.
Primary and secondary outcome measures
Time to event analysis was used to compare time hospitalisation and rate of hospitalisation between the different case-groups by estimating HR, accounting for birth year and preterm birth status.
ID and/or ASD were found to be associated with an increased risk of hospitalisation compared with the remainder of the population. The increase in risk was highest in those with severe ID and no ASD (HR=10.33, 95% CI 8.66 to 12.31). For those with ID of known biomedical cause or mild ID of unknown cause, the risk of hospitalisation was lower (HR=7.36, 95% CI 6.73 to 8.07 and HR=3.08, 95% CI 2.78 to 3.40, respectively). Those with ASDs had slightly increased risk (HR=2.82, 95% CI 2.26 to 3.50 for those with ID and HR=2.09, 95% CI 1.85 to 2.36 for those without ID).
Children with an ID or ASD experience an increased risk of hospitalisation after the first year of life which varied from 2 to 10 times that of the rest of the population. Findings can inform service planning or resource allocation for these children with special needs.
EPIDEMIOLOGY; PUBLIC HEALTH
To compare the rate of progression of diabetic chronic kidney disease in different ethnic groups.
Prospective longitudinal observational study.
All new patients attending a tertiary renal unit in east London with diabetic chronic kidney disease between 2000 and 2007 and followed up till 2009 were included. Patients presenting with acute end-stage kidney failure were excluded.
Main outcome measures
The primary outcome was annual decline in the estimated glomerular filtration rate (eGFR) in different ethnic groups. Secondary end points were the number of patients developing end-stage kidney failure and total mortality during the study period.
329 patients (age 60±11.9 years, 208 men) were studied comprising 149 south Asian, 105 White and 75 Black patients. Mean follow-up was 6.0±2.3, 5.0±2.7 and 5.6±2.4 years for White, Black and south Asian patients, respectively. South Asian patients were younger and had a higher baseline eGFR, but both systolic and diastolic blood pressures were higher in Black patients (p<0.05). Baseline proteinuria was highest for the south Asian group followed by the White and Black groups. Adjusted linear regression analysis showed that an annual decline in eGFR was not significantly different between the three groups. The numbers of patients developing end-stage kidney failure and total mortality were also not significantly different between the three groups. ACE or angiotensin receptor blockers use, and glycated haemoglobin were similar at baseline and throughout the study period.
We conclude that ethnicity is not an independent factor in the rate of progression renal failure in patients with diabetic chronic kidney disease.
The aims of this study were to: (1) determine the validity and reliability of the Nova Biomedical Lactate Plus portable analyzer, and quantify any fixed or proportional bias; (2) determine the effect of any bias on the determination of the lactate threshold and (3) determine the effect that blood sampling methods have on validity and reliability.
In this method comparison study we compared blood lactate concentration measured using the Lactate Plus portable analyzer to lactate concentration measured by a reference analyzer, the YSI 2300.
University campus in the USA.
Fifteen active men and women performed a discontinuous graded exercise test to volitional exhaustion on a motorised treadmill. Blood samples were taken via finger prick and collected in microcapillary tubes for analysis by the reference instrument at the end of each stage. Duplicate samples for the portable analyzer were either taken directly from the finger or from the micro capillary tubes.
Primary outcome measurements
Ordinary least products regressions were used to assess validity, reliability and bias in the portable analyzer. Lactate threshold was determined by visual inspection.
Though measurements from both instruments were correlated (r=0.91), the differences between instruments had large variability (SD=1.45 mM/l) when blood was sampled directly from finger. This variability was reduced by ∼95% when both instruments measured blood collected in the capillary tubes. As the proportional and fixed bias between instruments was small, there was no difference in estimates of the lactate threshold between instruments. Reliability for the portable instrument was strong (r=0.99, p<0.05) with no proportional bias (slope=1.02) and small fixed bias (−0.19 mM/l).
The Lactate Plus analyzer provides accurate and reproducible measurements of blood lactate concentration that can be used to estimate workloads corresponding to blood lactate transitions or any absolute lactate concentrations.
Accuracy; Lactate Threshold; Bias
To review the effects of school closures on pandemic and seasonal influenza outbreaks.
MEDLINE and EMBASE, reference lists of identified articles, hand searches of key journals and additional papers from the authors' collections.
Studies were included if they reported on a seasonal or pandemic influenza outbreak coinciding with a planned or unplanned school closure.
Of 2579 papers identified through MEDLINE and EMBASE, 65 were eligible for inclusion in the review along with 14 identified from other sources. Influenza incidence frequently declined after school closure. The effect was sometimes reversed when schools reopened, supporting a causal role for school closure in reducing incidence. Any benefits associated with school closure appeared to be greatest among school-aged children. However, as schools often closed late in the outbreak or other interventions were used concurrently, it was sometimes unclear how much school closure contributed to the reductions in incidence.
School closures appear to have the potential to reduce influenza transmission, but the heterogeneity in the data available means that the optimum strategy (eg, the ideal length and timing of closure) remains unclear.
Epidemiology; Public Health; Systematic Reviews
To establish an accurate and comprehensive injury incidence registry of all rugby union-related catastrophic events in South Africa between 2008 and 2011. An additional aim was to investigate correlates associated with these injuries.
The South African amateur and professional rugby-playing population.
An estimated 529 483 Junior and 121 663 Senior rugby union (‘rugby’) players (population at risk).
Annual average incidences of rugby-related catastrophic injuries by type (cardiac events, traumatic brain and acute spinal cord injuries (ASCIs)) and outcome (full recoveries—fatalities). Playing level (junior and senior levels), position and event (phase of play) were also assessed.
The average annual incidence of ASCIs and Traumatic Brain Injuries combined was 2.00 per 100 000 players (95% CI 0.91 to 3.08) from 2008 to 2011. The incidence of ASCIs with permanent outcomes was significantly higher at the Senior level (4.52 per 100 000 players, 95% CI 0.74 to 8.30) than the Junior level (0.24 per 100 000 players, 95% CI 0 to 0.65) during this period. The hooker position was associated with 46% (n=12 of 26) of all permanent ASCI outcomes, the majority of which (83%) occurred during the scrum phase of play.
The incidence of rugby-related catastrophic injuries in South Africa between 2008 and 2011 is comparable to that of other countries and to most other collision sports. The higher incidence rate of permanent ASCIs at the Senior level could be related to the different law variations or characteristics (eg, less regular training) compared with the Junior level. The hooker and scrum were associated with high proportions of permanent ASCIs. The BokSmart injury prevention programme should focus efforts on these areas (Senior level, hooker and scrum) and use this study as a reference point for the evaluation of the effectiveness of the programme.
PREVENTIVE MEDICINE; EPIDEMIOLOGY; SPORTS MEDICINE; AUDIT
To explore the structure and content of a non-random sample of clinical study reports (CSRs) to guide clinicians and systematic reviewers.
We searched public sources and lodged Freedom of Information requests for previously confidential CSRs primarily written by the industry for regulators.
CSRs reporting sufficient information for extraction (‘adequate’).
Primary outcome measures
Presence and length of essential elements of trial design and reporting and compression factor (ratio of page length for CSRs compared to its published counterpart in a scientific journal).
Data were extracted on standard forms and crosschecked for accuracy.
We assembled a population of 78 CSRs (covering 90 randomised controlled trials; 144 610 pages total) dated 1991–2011 of 14 pharmaceuticals. Report synopses had a median length of 5 pages, efficacy evaluation 13.5 pages, safety evaluation 17 pages, attached tables 337 pages, trial protocol 62 pages, statistical analysis plan 15 pages and individual efficacy and safety listings had a median length of 447 and 109.5 pages, respectively. While 16 (21%) of CSRs contained completed case report forms, these were accessible to us in only one case (765 pages representing 16 individuals). Compression factors ranged between 1 and 8805.
Clinical study reports represent a hitherto mostly hidden and untapped source of detailed and exhaustive data on each trial. They should be consulted by independent parties interested in a detailed record of a clinical trial, and should form the basic unit for evidence synthesis as their use is likely to minimise the problem of reporting bias. We cannot say whether our sample is representative and whether our conclusions are generalisable to an undefined and undefinable population of CSRs.
Medical Ethics; Medical Journalism; Internal Medicine
Main purpose To evaluate the feasibility of a measurement-based assessment of benzene exposure in case-control studies of paediatric cancer; Additional aims To identify the sources of exposure variability; to assess the performance of two benzene biomarkers; to verify the occurrence of participation bias; to check whether exposures to benzene and to 50 Hz magnetic fields were correlated, and might exert reciprocal confounding effects.
Pilot case-control study of childhood leukaemia and exposure to benzene assessed by repeated seasonal weekly measurements in breathing zone air samples and outside the children's dwellings, with concurrent determinations of cotinine, t-t-muconic acid (MA) and sulfo-phenylmercapturic acid (S-PMA) in urine.
108 cases and 194 controls were eligible for inclusion.
Full-participation was obtained from 46 cases and 60 controls, with low dropout rates before four repeats (11% and 17%); an additional 23 cases and 80 controls allowed the collection of outdoor air samples only. The average benzene concentration in personal and outdoor air samples was 3 μg/m3 (SD 1.45) and 2.7 μg/m3 (SD 1.41), respectively. Personal exposure was strongly influenced by outdoor benzene concentrations, higher in the cold seasons than in warm seasons, and not affected by gender, age, area of residence or caseness. Urinary excretion of S-PMA and personal benzene exposure were well correlated. Outdoor benzene levels were lower among participant controls compared with non-participants, but did not differ between participant and non-participant cases; the direction of the bias was found to depend on the cut-point chosen to distinguish exposed and unexposed. Exposures to benzene and extremely low-frequency magnetic fields were positively correlated.
Repeated individual measurements are needed to account for the seasonal variability in benzene exposure, and they have the additional advantage of increasing the study power. Measurement-based assessment of benzene exposure in studies of childhood leukaemia appears feasible, although it is financially and logistically demanding.
The aim of this study was to evaluate the impact of socioeconomic and clinical factors on the transitions between work, sickness absence and retirement in a cohort of Danish colorectal cancer survivors.
Register-based cohort study with up to 10 years of follow-up.
Population-based study with use of administrative health-related and socioeconomic registers.
All persons (N=4343) diagnosed with colorectal cancer in Denmark during the years 2001–2009 while they were in their working age (18–63 years) and who were part of the labour force 1 year postdiagnosis.
Primary and secondary outcome measures
By the use of multistate models in Cox proportional hazards models, we analysed the HR for re-employment, sickness absence and retirement in models including clinical as well as health-related variables.
1 year after diagnosis, 62% were working and 58% continued until the end of follow-up. Socioeconomic factors were found to be associated with retirement but not with sickness absence and return to work. The risk for transition from work to sickness absence increased if the disease was diagnosed at a later stage (stage III) 1.52 (95% CI 1.21 to 1.91), not operated curatively 1.35 (95% CI 1.11 to 1.63) and with occurrence of postoperative complications 1.25 (95% CI 1.11 to 1.41). The opposite was found for the transition from sickness absence back to work.
This nationwide study of colorectal cancer patients who have survived 1 year shows that the stage of disease, general health condition of the individual, postoperative complications and the history of sickness absence and unemployment have an impact on the transition between work, sickness absence and disability pension. This leads to an increased focus on the rehabilitation process for the more vulnerable persons who have a combination of severe disease and a history of work-related problems with episodes outside the working market.
Epidemiology; Social Medicine
To evaluate the reliability and agreement of digital tender point (TP) examination in chronic low back pain (LBP) patients.
Hospital-based validation study.
Among sick-listed LBP patients referred from general practitioners for low back examination and return-to-work intervention, 43 and 39 patients, respectively (18 women, 46%) entered and completed the study.
Main outcome measures
The reliability was estimated by the intraclass correlation coefficient (ICC), and agreement was calculated for up to ±3 TPs. Furthermore, the smallest detectable difference was calculated.
TP examination was performed twice by two consultants in rheumatology and rehabilitation at 20 min intervals and repeated 1 week later. Intrarater reliability in the more and less experienced rater was ICC 0.84 (95% CI 0.69 to 0.98) and 0.72 (95% CI 0.49 to 0.95), respectively. The figures for inter-rater reliability were intermediate between these figures. In more than 70% of the cases, the raters agreed within ±3 TPs in both men and women and between test days. The smallest detectable difference between raters was 5, and for the more and less experienced rater it was 4 and 6 TPs, respectively.
The reliability of digital TP examination ranged from acceptable to excellent, and agreement was good in both men and women. The smallest detectable differences varied from 4 to 6 TPs. Thus, TP examination in our hands was a reliable but not precise instrument. Digital TP examination may be useful in daily clinical practice, but regular use and training sessions are required to secure quality of testing.
Rheumatology; Statistics & Research Methods; Pain Management
HIV diagnoses acquired among Australian men working or travelling overseas including Southeast Asia are increasing. This change within transmission dynamics means traditional approaches to prevention need to be considered in new contexts. The significance and role of social networks in mediating sexual risk behaviours may be influential. Greater understanding of expatriate and traveller behaviour is required to understand how local relationships are formed, how individuals enter and are socialised into networks, and how these networks may affect sexual intentions and behaviours. This paper describes the development of a qualitative protocol to investigate how social networks of Australian expatriates and long-term travellers might support interventions to reduce transmission of HIV and sexually transmitted infections.
Methods and analysis
To explore the interactions of male expatriates and long-term travellers within and between their environments, symbolic interactionism will be the theoretical framework used. Grounded theory methods provide the ability to explain social processes through the development of explanatory theory. The primary data source will be interviews conducted in several rounds in both Australia and Southeast Asia. Purposive and theoretical sampling will be used to access participants whose data can provide depth and individual meaning.
Ethics and dissemination
The role of expatriate and long-term traveller networks and their potential to impact health are uncertain. This study seeks to gain a deeper understanding of the Australian expatriate culture, behavioural contexts and experiences within social networks in Southeast Asia. This research will provide tangible recommendations for policy and practice as the findings will be disseminated to health professionals and other stakeholders, academics and the community via local research and evaluation networks, conference presentations and online forums. The Curtin University Human Research Ethics Committee has granted approval for this research.
Public Health; Qualitative Research
To quantify geographical variation in the relative contribution of parasitic infections, socioeconomic factors and malnutrition in the aetiology of anaemia among schoolchildren across Kenya, thereby providing a rational basis for the targeting of an integrated school health package.
Nationally representative cross-sectional survey data were collected using standard protocols. For all included children, data were recorded on haemoglobin (Hb) concentration and common parasitic infections (Plasmodium falciparum, hookworm and schistosomes) and socioeconomic indicators. Ecological proxies of malnutrition and food security were generated using Demographic and Health Survey and UN Food and Agriculture Organization food security data, respectively. Spatially explicit, multilevel models were used to quantify impact upon child Hb concentration.
Randomly selected schools in ecologically diverse settings across Kenya.
Main outcome measures
Mean Hb concentration adjusted for infection, nutritional and socioeconomic risk factors; associated risk ratios and adjusted Population Attributable Fractions (PAFs) for anaemia, by region.
Data were available for 16 941 children in 167 schools; mean Hb was 122.1 g/l and 35.3% of children were anaemic. In multivariate analysis, mean Hb was significantly lower in boys and younger children. Severe malnutrition and interactions between P falciparum and hookworm infections were significantly associated with lower Hb, with greater impacts seen for coinfected children. The contribution of risk factors to anaemia risk varied by province: in 14-year-old girls, PAFs ranged between 0% and 27.6% for P falciparum, 0% and 29% for hookworm and 0% and 18.4% for severe malnutrition.
The observed geographical heterogeneity in the burden of anaemia attributable to different aetiological factors has important implications for the rational targeting of antianaemia interventions that can be included in an integrated school health programme.
Nutrition & Dietetics
To describe the design and baseline population characteristics of an adapted lifestyle intervention trial aimed at reducing weight and increasing physical activity in people of Indian and Pakistani origin at high risk of developing type 2 diabetes.
Cluster, randomised controlled trial.
Community-based in Edinburgh and Glasgow, Scotland, UK.
156 families, comprising 171 people with impaired glycaemia, and waist sizes ≥90 cm (men) and ≥80 cm (women), plus 124 family volunteers.
Families were randomised into either an intensive intervention of 15 dietitian visits providing lifestyle advice, or a light (control) intervention of four visits, over a period of 3 years.
The primary outcome is a change in mean weight between baseline and 3 years. Secondary outcomes are changes in waist, hip, body mass index, plasma blood glucose and physical activity. The cost of the intervention will be measured. Qualitative work will seek to understand factors that motivated participation and retention in the trial and families’ experience of adhering to the interventions.
Between July 2007 and October 2009, 171 people with impaired glycaemia, along with 124 family volunteers, were randomised. In total, 95% (171/196) of eligible participants agreed to proceed to the 3-year trial. Only 13 of the 156 families contained more than one recruit with impaired glycaemia. We have recruited sufficient participants to undertake an adequately powered trial to detect a mean difference in weight of 2.5 kg between the intensive and light intervention groups at the 5% significance level. Over half the families include family volunteers. The main participants have a mean age of 52 years and 64% are women.
Prevention of Diabetes & Obesity in South Asians (PODOSA) is one of the first community-based, randomised lifestyle intervention trials in a UK South Asian population. The main trial results will be submitted for publication during 2013.
Current controlled trials ISRCTN25729565 (http://www.controlled-trials.com/isrctn/).
randomised controlled trial; Prevention; diabetes mellitus, Type 2; ethnic groups
To provide a brief overview of the Needs and Provision Complexity Scale (NPCS) and report its first application to describe the level of ‘met’ and ‘unmet’ health/social care needs, and to estimate their costs in community-based patients with complex neurological disability.
A multicentre prospective cohort analysis.
Consecutive discharges to the community from the nine tertiary specialist inpatient neurorehabilitation units in London over 12 months (2010/2011).
Patients responding at follow-up (n=211). Mean age 50.2(SD14) years, males:females 127/84. Diagnosis 157(74%) brain injury, 27(13%) spinal cord injury/peripheral neuropathy; 27(13%) other.
Primary outcome measure
The NPCS is a brief, pragmatic, directly costable instrument for measuring both an individual's needs for rehabilitation and support (NPCS-Needs) and the levels of service provided (NPCS-Gets) within a given period.
The ‘NPCS-Needs’ was completed by the treating clinical team at discharge. Patients and/or their carers self-reported ‘NPCS-Gets’ after 6 months by a postal/online questionnaire supported by a follow-up telephone interview.
Needs for medical/nursing care and accommodation were generally well met. Significant shortfalls in provision were identified in the subscales of Rehabilitation (paired t test: t −9.7, p<0.001, effect size (ES)=−0.85), Social support (t −5.8, p<0.001, ES=−0.48) and Equipment (t −5.6, p<0.001, ES=−0.44). Item-level analysis demonstrated that the frequency of Personal care received exceeded predicted needs (Wilcoxon z=−3.3, p<0.001). In 80% of cases, this care was provided/paid for by families. Translated into mean costs/patient/year, the estimated underspends on Rehabilitation (−£2320) and Social support (−£1790) were exceeded >3.5-fold by excess costs of Personal care (£10 313) and Accommodation (£4296).
The results identify underprovision of community-based rehabilitation and support services compared with needs, which may contribute directly to excess care burden and costs to family carers. The NPCS requires further evaluation but has potential use as a simple, directly costable tool to inform both clinical decision-making and population-based service planning and delivery.
Rehabilitation; Health care; Social support; Measures; Cost Analysis; Needs and Provision Complexity Scale
To develop a predictive risk stratification model for the identification of preterm infants at risk of 2-year suboptimal neuromotor status.
Population-based observational study.
Regional preterm infant follow-up programme (Loire Infant Follow-up Team (LIFT) cohort) implemented in 2003.
4030 preterm infants were enrolled in the LIFT cohort, and examined by neonatologists using a modified version of the Amiel-Tison neurological assessment tool.
Main outcome criteria
2 year neuromotor status based on clinical examinations was conducted by trained paediatricians and parents’ responses to the Ages and Stages Questionnaire were reported.
At 2 years of corrected age, 3321 preterm infants were examined, and suboptimal neuromotor status was found in 355 (10.7%). The study population was divided into training and validation sets. In the training set, 13 neonatal neurological items were associated with a 2-year suboptimal neuromotor status. Having at least one abnormal item was defined as an abnormal neurological status at term. In the validation set, these data predicted a 2-year suboptimal neuromotor status with a sensitivity of 0.55 (95% CI 0.47 to 0.62) and a specificity of 0.65 (95% CI 0.62 to 0.67). Two predictive risk stratification trees were built using the training set, which were based on the neurological assessment at term along with either gestational age or severe cranial lesions or birth weight. Using the validation set, the first tree identified a subgroup with a relatively low risk of suboptimal neuromotor status (3%), representing 32% of infants, and the second tree identified a subgroup with a risk of 5%, representing 42% of infants.
A normal neurological assessment at term allows the identification of a subgroup of preterm infants with a lower risk of non-optimal neuromotor development at 2 years.
Largely, watchful waiting is the initial policy for patients with small-sized or medium-sized vestibular schwannoma, because of slow growth and relatively minor complaints, that do not improve by an intervention. If intervention (microsurgery, radiosurgery or fractionated radiotherapy) becomes necessary, the choice of intervention appears to be driven by the patient's or clinician's preference rather than by evidence based. This study addresses the existing evidence based on controlled studies of these interventions.
A systematic Boolean search was performed focused on controlled intervention studies. The quality of the retrieved studies was assessed based on the Sign-50 criteria on cohort studies.
Pubmed/Medline, Embase, Cochrane Central Register of Controlled Trials and reference lists.
Six eligibility criteria included a controlled intervention study on a newly diagnosed solitary, vestibular schwannoma reporting on clinical outcomes. Two prospective and four retrospective observational, controlled studies published before November 2011 were selected.
Two reviewers independently assessed the methodological quality of the studies and extracted the outcome data using predefined formats.
Neither randomised studies, nor controlled studies on fractionated radiotherapy were retrieved. Six studies compared radiosurgery and microsurgery in a controlled way. All but one were confined to solitary tumours less than 30 mm in diameter and had no earlier interventions. Four studies qualified for trustworthy conclusions. Among all four, radiosurgery showed the best outcomes: there were no direct mortality, no surgical or anaesthesiological complications, but better facial nerve outcome, better preservation of useful hearing and better quality of life.
The available evidence indicates radiosurgery to be the best practice for solitary vestibular schwannomas up to 30 mm in cisternal diameter.
Vestibular Schwannoma; Excision; Radiosurgery; RADIOTHERAPY; NEUROSURGERY
To evaluate the content of school textbooks as a tool to prevent tobacco use in developing countries.
Content analysis was used to evaluate if the textbooks incorporated the following five core components recommended by the WHO: (1) consequences of tobacco use; (2) social norms; (3) reasons to use tobacco; (4) social influences and (5) resistance and life skills.
Nine developing countries: Bangladesh, Cambodia, Laos, Nepal, Sri Lanka, Benin, Ghana, Niger and Zambia.
Of 474 textbooks for primary and junior secondary schools in nine developing countries, 41 were selected which contained descriptions about tobacco use prevention.
Of the 41 textbooks, the consequences of tobacco use component was covered in 30 textbooks (73.2%) and the social norms component was covered in 19 (46.3%). The other three components were described in less than 20% of the textbooks.
A rather limited number of school textbooks in developing countries contained descriptions of prevention of tobacco use, but they did not fully cover the core components for tobacco use prevention. The chance of tobacco prevention education should be seized by improving the content of school textbooks.
Prevention; Education & Training (see Medical Education & Training); Public Health
Magnesium (Mg) and calcium (Ca) antagonise each other in (re)absorption, inflammation and many other physiological activities. Based on mathematical estimation, the absorbed number of Ca or Mg depends on the dietary ratio of Ca to Mg intake. We hypothesise that the dietary Ca/Mg ratio modifies the effects of Ca and Mg on mortality due to gastrointestinal tract cancer and, perhaps, mortality due to diseases occurring in other organs or systems.
Population-based cohort studies (The Shanghai Women's Health Study and the Shanghai Men's Health Study) conducted in Shanghai, China.
74 942 Chinese women aged 40–70 years and 61 500 Chinese men aged 40–74 years participated in the study.
Primary outcome measures
All-cause mortality and disease-specific mortality.
In this Chinese population with a low Ca/Mg intake ratio (a median of 1.7 vs around 3.0 in US populations), intakes of Mg greater than US Recommended Daily Allowance (RDA) levels (320 mg/day among women and 420 mg/day among men) were related to increased risks of total mortality for both women and men. Consistent with our hypothesis, the Ca/Mg intake ratio significantly modified the associations of intakes of Ca and Mg with mortality risk, whereas no significant interactions between Ca and Mg in relation to outcome were found. The associations differed by gender. Among men with a Ca/Mg ratio >1.7, increased intakes of Ca and Mg were associated with reduced risks of total mortality, and mortality due to coronary heart diseases. In the same group, intake of Ca was associated with a reduced risk of mortality due to cancer. Among women with a Ca/Mg ratio ≤1.7, intake of Mg was associated with increased risks of total mortality, and mortality due to cardiovascular diseases and colorectal cancer.
These results, if confirmed, may help to understand the optimal balance between Ca and Mg in the aetiology and prevention of these common diseases and reduction in mortality.
EPIDEMIOLOGY; NUTRITION & DIETETICS
To evaluate the association between the long-term use of bisphosphonates and the risk of hip fracture compared to never use among women aged 65 years or older.
Case–control study nested in a cohort.
General practice research database operated by the Spanish Medicines Agency.
Cases of hip fracture were defined as women aged 65 years or older with a validated first diagnosis of hip fracture between 2005 and 2008. Five controls free of hip fracture were matched on age and calendar-year with each case.
Information on bisphosphonate use, hip fractures, comedication and comorbidities was collected.
Hip fracture risk comparing bisphosphonate users versus never users.
Hip fracture risk comparing bisphosphonate users versus never users by individual drugs.
The study included 2009 incident hip fractures and 10 045 matched controls. Hip-fracture risk did not differ between bisphosphonate users and never users, adjusted OR=1.09 (95% CI 0.94 to 1.27). No association was observed between hip fracture risk and cumulative duration of bisphosphonate treatment. However, when treatment duration is analysed as time since first prescription, hip fracture risks of the different subgroups compared to never users obtained were as follows: <1 year, OR 0.85 (95% CI 0.60 to 1.21); 1 to <3 years, OR 1.02 (95% CI 0.82 to 1.26); ≥3 years, OR 1.32 (95% CI 1.05 to 1.65) (p for trend=0.03).
Ever use of oral bisphosphonates was not associated with a decreased risk of hip fracture in women aged 65 or older as compared to never use. No association was observed between hip fracture risk and cumulative duration of bisphosphonate treatment. However, when treatment duration is analysed as time since first prescription, a statistically significant increased risk for hip fracture was observed in patients exposed to bisphosphonates over 3 years.
Spanish Ministry of Health. TRA-071
CLINICAL PHARMACOLOGY; EPIDEMIOLOGY; PRIMARY CARE
To explore the relational challenges for general practitioner (GP) leaders setting up new network-centric commissioning organisations in the recent health policy reform in England, we use innovation network theory to identify key network leadership practices that facilitate healthcare innovation.
Mixed-method, multisite and case study research.
Six clinical commissioning groups and local clusters in the East of England area, covering in total 208 GPs and 1 662 000 population.
Semistructured interviews with 56 lead GPs, practice managers and staff from the local health authorities (primary care trusts, PCT) as well as various healthcare professionals; 21 observations of clinical commissioning group (CCG) board and executive meetings; electronic survey of 58 CCG board members (these included GPs, practice managers, PCT employees, nurses and patient representatives) and subsequent social network analysis.
Main outcome measures
Collaborative relationships between CCG board members and stakeholders from their healthcare network; clarifying the role of GPs as network leaders; strengths and areas for development of CCGs.
Drawing upon innovation network theory provides unique insights of the CCG leaders’ activities in establishing best practices and introducing new clinical pathways. In this context we identified three network leadership roles: managing knowledge flows, managing network coherence and managing network stability. Knowledge sharing and effective collaboration among GPs enable network stability and the alignment of CCG objectives with those of the wider health system (network coherence). Even though activities varied between commissioning groups, collaborative initiatives were common. However, there was significant variation among CCGs around the level of engagement with providers, patients and local authorities. Locality (sub) groups played an important role because they linked commissioning decisions with patient needs and brought the leaders closer to frontline stakeholders.
With the new commissioning arrangements, the leaders should seek to move away from dyadic and transactional relationships to a network structure, thereby emphasising on the emerging relational focus of their roles. Managing knowledge mobility, healthcare network coherence and network stability are the three clinical leadership processes that CCG leaders need to consider in coordinating their network and facilitating the development of good clinical commissioning decisions, best practices and innovative services. To successfully manage these processes, CCG leaders need to leverage the relational capabilities of their network as well as their clinical expertise to establish appropriate collaborations that may improve the healthcare services in England. Lack of local GP engagement adds uncertainty to the system and increases the risk of commissioning decisions being irrelevant and inefficient from patient and provider perspectives.
Health Services Administration & Management; Qualitative Research
Neonatal care has been considered as one of the first priorities for improving quality of life in children. In 2010, 10% of babies were born prematurely influencing national healthcare policies, economic action plans and political decisions. The use of complementary medicine has been applied to the care of newborns. One previous study documented the positive effect of osteopathic manipulative treatment (OMT) in reducing newborns’ length of stay (LOS). Aim of this multicentre randomised controlled trial is to examine the association between OMT and LOS across three neonatal intensive care units (NICUs).
Methods and analysis
690 preterm infants will be recruited from three secondary and tertiary NICUs from north and central Italy and allocated into two groups, using permuted-block randomisation.
The two groups will receive standard medical care and OMT will be applied, twice a week, to the experimental group only. Outcome assessors will be blinded of study design and group allocation. The primary outcome is the mean difference in days between discharge and entry. Secondary outcomes are difference in daily weight gain, number of episodes of vomit, regurgitation, stooling, use of enema, time to full enteral feeding and NICU costs. Statistical analyses will take into account the intention-to-treat method. Missing data will be handled using last observation carried forward (LOCF) imputation technique.
Ethics and dissemination
Written informed consent will be obtained from parents or legal guardians at study enrolment. The trial has been approved by the ethical committee of Macerata hospital (n°22/int./CEI/27239) and it is under review by the other regional ethics committees.
Dissemination of results from this trial will be through scientific medical journals and conferences.
This trial has been registered at http://www.clinicaltrials.org (identifier NCT01645137).
Complementary Medicine; Paediatrics; Preventive Medicine
A growing body of evidence suggests that there is a relationship between impaired lung function and the risk of developing diabetes mellitus (DM). However, it is not known if this reflects a causal effect of lung function on glucose metabolism. To clarify the relationship between lung function and the development of DM, we examined the incidence of newly diagnosed prediabetes (a precursor of DM) among subjects with normal glucose tolerance (NGT) at baseline.
Primary analysis of an occupational cohort with both cross-sectional and longitudinal data (follow-up duration mean±SD: 28.4±6.1 months).
Setting and participants
Data were analysed from 1058 men in a cross-sectional study and from 560 men with NGT in a longitudinal study.
Outcomes and methods
Impaired lung function (per cent predicted value of forced vital capacity (%FVC) or per cent value of forced expiratory volume 1 s/FVC (FEV1/FVC ratio)) in relation to the ratio of prediabetes or DM in a cross-sectional study and development of new prediabetes in a longitudinal study. NGT, prediabetes including impaired glucose tolerance (IGT) and increased fasting glucose (IFG) and DM were diagnosed according to 75 g oral glucose tolerance tests.
Measurements and main results
%FVC at baseline, but not FEV1/FVC ratio at baseline, was significantly associated with the incidences of DM and prediabetes. Among prediabetes, IGT but not IFG was associated with %FVC. During follow-up, 102 subjects developed prediabetes among those with NGT. A low %FVC, but not FEV1/FVC ratio, was predictive of an increased risk for development of IGT, but not of IFG.
Low lung volume is associated with an increased risk for the development of prediabetes, especially IGT, in Japanese men. Although there is published evidence for an association between chronic obstructive pulmonary disease and DM, prediabetes is not associated with the early stage of COPD.
Chronic Obstructive Pulmonary Disease; Impaired Glucose Tolerance; Increased Fasting Glucose; Prediabetes; Pulmonary Function
Atrial fibrillation affects almost 2% of the population in the Western world. To preserve sinus rhythm, ablation is undertaken in symptomatic patients. Observational studies show that patients with atrial fibrillation often report a low quality of life and are less prone to be physically active due to fear of triggering fibrillation. Small trials indicate that exercise training has a positive effect on exercise capacity and mental health, and both patients with recurrent atrial fibrillation and in sinus rhythm may benefit from rehabilitation in managing life after ablation. No randomised trials have been published on cardiac rehabilitation for atrial fibrillation patients treated with ablation that includes exercise and psychoeducational components.
To test the effects of an integrated cardiac rehabilitation programme versus treatment as usual for patients with atrial fibrillation treated with ablation.
Methods and analysis design
The trial is a multicentre parallel arm design with 1:1 randomisation to the intervention and control group with blinded outcome assessment. 210 patients treated for atrial fibrillation with radiofrequency ablation will be included. The intervention consists of a rehabilitation programme including four psychoeducative consultations with a specially trained nurse and 12 weeks of individualised exercise training, plus the standard medical follow-up. Patients in the control group will receive the standard medical follow-up. The primary outcome measure is exercise capacity measured by the VO2 peak. The secondary outcome measure is self-rated mental health measured by the Short Form 36 questionnaire. Postintervention, qualitative interviews will be conducted in 10% of the intervention group.
Ethics and dissemination
The protocol is approved by the regional research ethics committee (number H-1-2011-135), the Danish Data Protection Agency (reg. nr. 2007-58-0015) and follows the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and may possibly impact on rehabilitation guidelines.
Clinicaltrials.gov identifier: NCT01523145.
Atrial Fibrillation ; QUALITATIVE RESEARCH
Low adherence to medicines is an important issue as up to 40% of patients with chronic diseases do not take their medications as prescribed. This leads to suboptimal clinical benefit. In the context of rheumatoid arthritis, there is a dearth of data on adherence to disease-modifying antirheumatic drugs among minority ethnic groups. This study aims to assess the relationship between adherence to medicines and biopsychosocial variables in patients with rheumatoid arthritis of South Asian and White British origin.
A mixed methods approach will be used, encompassing a cross-sectional survey of 176 patients collecting demographic and clinical data, including information on adherence behaviour collected using a series of questionnaires. This will be followed by indepth qualitative interviews.
Ethics and dissemination
This study has been approved by the South Birmingham (10/H1207/89) and Coventry and Warwickshire (12/WM/0041) Research Ethics Committees. The authors will disseminate the findings in peer-reviewed publications.
To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development.
Retrospective observational study.
Setting and data source
Database of new preparations added annually to the British National Formulary (BNF).
Main outcome measures
The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF.
There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11–12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period.
The purported ‘innovation dip’ is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective.
Innovation; Pharmaceutical; New drugs; Drug launches; United Kingdom