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Year of Publication
1.  Association of polypharmacy with fall-related fractures in older Taiwanese people: age- and gender-specific analyses 
BMJ Open  2014;4(3):e004428.
Objective
To elucidate the associations between polypharmacy and age- and gender-specific risks of admission for fall-related fractures.
Design
Nested case–control study.
Setting
This analysis was randomly selected from all elderly beneficiaries in 2007–2008, and represents some 30% of the whole older insurers using Taiwan's National Health Insurance Research Database.
Participants
We identified 5933 cases newly admitted for fall-related fractures during 2007–2008, and 29 665 random controls free from fracture.
Primary and secondary outcome measures
Polypharmacy was defined as the use of fall-related drugs of four or more categories of medications and prescribed related to fall within a 1-year period. Logistic regression models were employed to estimate the ORs and related 95% CIs. The interaction of polypharmacy with age and sex was assessed separately.
Results
Compared with those who consumed no category of medication, older people who consumed 1, 2, 3 and ≥4 categories of medications were all at significantly increased odds of developing fall-related fractures, with a significant dose–gradient pattern (β=0.7953; p for trend <0.0001). There were significant interactions between polypharmacy and age, but no significant interactions between polypharmacy and gender. The dose–gradient relationship between number of medications category and risk of fall-related fractures was more obvious in women than in men (β=0.1962 vs β=0.1873). Additionally, it was most evident in older people aged 75–84 years (β=0.2338).
Conclusions
This population-based study in Taiwan confirms the link between polypharmacy and increased risk of fall-related fractures in older people; and highlights that elderly women and older people aged 75–84 years will be the targeted participants for further prevention from fall-related fractures caused by polypharmacy.
doi:10.1136/bmjopen-2013-004428
PMCID: PMC3975737  PMID: 24682575
GENERAL MEDICINE (see Internal Medicine); GERIATRIC MEDICINE; PREVENTIVE MEDICINE
2.  Mental health admissions in paediatric populations in North Wales: two cohorts compared 1875–1924 and 1994–2008 
BMJ Open  2014;4(3):e004331.
Objectives
To investigate frequency of under-18s admitted to mental health services (MHS) in North West Wales (NWW) between 1875 and 2008. There are claims that 1 in 10 children have a mental illness, but there are little data on their inpatient MHS utilisation.
Setting
Looking at admissions at the secondary care level, three data samples were included; the first comprises historical asylum admissions, the second comprises contemporary admissions to acute psychiatric beds, and the third comprises admissions to district general hospital (DGH) beds that resulted in a mental health coding.
Participants
All were under 18. There were 65 historical patients, 41 contemporary mental illness admissions and 943 DGH admissions.
Primary and secondary outcome measures
The primary outcome measures were diagnoses based on case notes of the historical cohort between 1875 and 1924, as well as details of paediatric admissions to MHS from 1994 to 2008 and paediatric admissions with a mental health component to the DGH in NWW.
Results
The incidence of admission to a mental health bed was 1.55 per year in the historical cohort compared with 2.9 in the contemporary. The overall incidence of admission to any bed in the contemporary cohort was 129 patients per year. There has been a twofold increase in the incidence of admissions for schizophrenia and related psychosis, but this most likely stems from an earlier age of admission rather than a true increase.
Conclusions
There is a greater frequency of hospital admissions for youth under the age of 18 in NWW for mental health today than previously. The rates reported in the DGH sample are consistent with data from community surveys of patients meeting criteria for mental disorders and complement such data when it comes to planning for paediatric MHS. However, they also raise questions about the boundaries between disease and distress.
doi:10.1136/bmjopen-2013-004331
PMCID: PMC3975741  PMID: 24682574
Psychiatry
3.  Acute hospital-based services utilisation during the last year of life in New South Wales, Australia: methods for a population-based study 
BMJ Open  2014;4(3):e004455.
Objectives
The aim of this study is to describe healthcare utilisation in the last year of life for people in Australia, to help inform health services planning. The methods and datasets that are being used are described in this paper.
Design/Setting
Linked, routinely collected administrative health data are being analysed for all people who died in New South Wales (NSW), Australia's most populous state, in 2007. The data comprised linked death records (2007), hospital admissions and emergency department presentations (2006–2007) and cancer registrations (1994–2007).
Participants
There were 46 341 deaths in NSW in 2007. The initial analyses include 45 760 decedents aged 18 years and over.
Outcome measures
The primary measures address the utilisation of hospital-based services at the end of life, including number and length of hospital admissions, emergency department presentations, intensive care admissions, palliative-related admissions and place of death.
Results
The median age at death was 80 years. Cause of death was available for 95% of decedents and 85% were linked to a hospital admission record. In the greater metropolitan area, where data capture was complete, 83% of decedents were linked to an emergency department presentation. 38% of decedents were linked to a cancer diagnosis in 1994–2007. The most common causes of death were diseases of the circulatory system (34%) and neoplasms (29%).
Conclusions
This study is among the first in Australia to give an information-rich census of end-of-life hospital-based experiences. While the administrative datasets have some limitations, these population-wide data can provide a foundation to enable further exploration of needs and barriers in relation to care. They also serve to inform the development of a relatively inexpensive, timely and reliable approach to the ongoing monitoring of acute hospital-based care utilisation near the end of life and inform whether service access and care are optimised.
doi:10.1136/bmjopen-2013-004455
PMCID: PMC3975743  PMID: 24682576
STATISTICS & RESEARCH METHODS; EPIDEMIOLOGY
4.  The impact of funding deadlines on personal workloads, stress and family relationships: a qualitative study of Australian researchers 
BMJ Open  2014;4(3):e004462.
Objective
To examine the impact of applying for funding on personal workloads, stress and family relationships.
Design
Qualitative study of researchers preparing grant proposals.
Setting
Web-based survey on applying for the annual National Health and Medical Research Council (NHMRC) Project Grant scheme.
Participants
Australian researchers (n=215).
Results
Almost all agreed that preparing their proposals always took top priority over other work (97%) and personal (87%) commitments. Almost all researchers agreed that they became stressed by the workload (93%) and restricted their holidays during the grant writing season (88%). Most researchers agreed that they submitted proposals because chance is involved in being successful (75%), due to performance requirements at their institution (60%) and pressure from their colleagues to submit proposals (53%). Almost all researchers supported changes to the current processes to submit proposals (95%) and peer review (90%). Most researchers (59%) provided extensive comments on the impact of writing proposals on their work life and home life. Six major work life themes were: (1) top priority; (2) career development; (3) stress at work; (4) benefits at work; (5) time spent at work and (6) pressure from colleagues. Six major home life themes were: (1) restricting family holidays; (2) time spent on work at home; (3) impact on children; (4) stress at home; (5) impact on family and friends and (6) impact on partner. Additional impacts on the mental health and well-being of researchers were identified.
Conclusions
The process of preparing grant proposals for a single annual deadline is stressful, time consuming and conflicts with family responsibilities. The timing of the funding cycle could be shifted to minimise applicant burden, give Australian researchers more time to work on actual research and to be with their families.
doi:10.1136/bmjopen-2013-004462
PMCID: PMC3975760  PMID: 24682577
Public Health; Qualitative Research; Mental Health; Medical Education & Training
5.  Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality 
BMJ Open  2014;4(3):e003431.
Objectives
To investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies.
Design
Cross-sectional study of screened patients.
Setting
10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011.
Participants
The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications.
Primary outcome measures
Patients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality.
Results
Over a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; p<0.001). Combined with data from Ontario, Canada, a national proportion was calculated, which found that 45.4% (95% CI 43.8% to 47.0%) of Canadians who visit community pharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE.
Conclusions
A substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a greater risk of experiencing an AE. Active surveillance provides a means of detecting such AEs and collecting high-quality data on which causality assessment can be based.
doi:10.1136/bmjopen-2013-003431
PMCID: PMC3975764  PMID: 24682573
Complementary Medicine; Toxicology
6.  An observational study of giant cell interstitial pneumonia and lung fibrosis in hard metal lung disease 
BMJ Open  2014;4(3):e004407.
Background
Hard metal lung disease has various pathological patterns including giant cell interstitial pneumonia (GIP) and usual interstitial pneumonia (UIP). Although the UIP pattern is considered the prominent feature in advanced disease, it is unknown whether GIP finally progresses to the UIP pattern.
Objectives
To clarify clinical, pathological and elemental differences between the GIP and UIP patterns in hard metal lung disease.
Methods
A cross-sectional study of patients from 17 institutes participating in the 10th annual meeting of the Tokyo Research Group for Diffuse Parenchymal Lung Diseases, 2009. Nineteen patients (seven female) diagnosed with hard metal lung disease by the presence of tungsten in lung specimens were studied.
Results
Fourteen cases were pathologically diagnosed as GIP or centrilobular inflammation/fibrosing. The other five cases were the UIP pattern or upper lobe fibrosis. Elemental analyses of lung specimens of GIP showed tungsten throughout the centrilobular fibrotic areas. In the UIP pattern, tungsten was detected in the periarteriolar area with subpleural fibrosis, but no association with centrilobular fibrosis or inflammatory cell infiltration. The GIP group was younger (43.1 vs 58.6 years), with shorter exposure duration (73 vs 285 months; p<0.01), lower serum KL-6 (398 vs 710 U/mL) and higher lymphocyte percentage in bronchoalveolar lavage fluid (31.5% vs 3.22%; p<0.05) than the fibrosis group.
Conclusions
The UIP pattern or upper lobe fibrosis is remarkably different from GIP in distribution of hard metal elements, associated interstitial inflammation and fibrosis, and clinical features. In hard metal lung disease, the UIP pattern or upper lobe fibrosis may not be an advanced form of GIP.
doi:10.1136/bmjopen-2013-004407
PMCID: PMC3975739  PMID: 24674995
OCCUPATIONAL & INDUSTRIAL MEDICINE
7.  A new tool for converting food frequency questionnaire data into nutrient and food group values: FETA research methods and availability 
BMJ Open  2014;4(3):e004503.
Objectives
To describe the research methods for the development of a new open source, cross-platform tool which processes data from the European Prospective Investigation into Cancer and Nutrition Norfolk Food Frequency Questionnaire (EPIC-Norfolk FFQ). A further aim was to compare nutrient and food group values derived from the current tool (FETA, FFQ EPIC Tool for Analysis) with the previously validated but less accessible tool, CAFÉ (Compositional Analyses from Frequency Estimates). The effect of text matching on intake data was also investigated.
Design
Cross-sectional analysis of a prospective cohort study—EPIC-Norfolk.
Setting
East England population (city of Norwich and its surrounding small towns and rural areas).
Participants
Complete FFQ data from 11 250 men and 13 602 women (mean age 59 years; range 40–79 years).
Outcome measures
Nutrient and food group intakes derived from FETA and CAFÉ analyses of EPIC-Norfolk FFQ data.
Results
Nutrient outputs from FETA and CAFÉ were similar; mean (SD) energy intake from FETA was 9222 kJ (2633) in men, 8113 kJ (2296) in women, compared with CAFÉ intakes of 9175 kJ (2630) in men, 8091 kJ (2298) in women. The majority of differences resulted in one or less quintile change (98.7%). Only mean daily fruit and vegetable food group intakes were higher in women than in men (278 vs 212 and 284 vs 255 g, respectively). Quintile changes were evident for all nutrients, with the exception of alcohol, when text matching was not executed; however, only the cereals food group was affected.
Conclusions
FETA produces similar nutrient and food group values to the previously validated CAFÉ but has the advantages of being open source, cross-platform and complete with a data-entry form directly compatible with the software. The tool will facilitate research using the EPIC-Norfolk FFQ, and can be customised for different study populations.
doi:10.1136/bmjopen-2013-004503
PMCID: PMC3975761  PMID: 24674997
8.  Growth trajectories in the children of mothers with eating disorders: a longitudinal study 
BMJ Open  2014;4(3):e004453.
Objective
The aim of this study was to examine longitudinal patterns of growth trajectories in children of women with eating disorders (ED): anorexia nervosa (AN) and bulimia nervosa (BN).
Design
Prospective longitudinal birth cohort; Avon Longitudinal Study of Parents and Children (ALSPAC).
Setting
South West England, UK.
Participants
The sample consisted of women and their children (n=10 190) from ALSPAC. Patterns of growth among children of women reporting a history of AN (n=137), BN (n=165), both AN and BN (n=68) and other psychiatric disorders (n=920) were compared with an unexposed group of children (n=8900).
Main outcome measures
Height and weight data, from birth to 10 years, were extracted from health visitor records, parental report from questionnaires and clinic attendances. Growth trajectories were analysed using mixed-effects models and constructed separately for male and female children.
Results
Between birth and 10 years, male children of women with BN were taller than children in the unexposed group. Male children of women with a history of AN and BN, and female children of women with AN, were shorter throughout childhood. Between the ages of 2 and 5, higher body mass index (BMI) was observed in male children in all maternal ED groups. Conversely, female children of women with AN had a BMI of −0.35 kg/m2 lower at 2 years compared with the unexposed group, with catch-up by age 10.
Conclusions
Early childhood growth has been found to predict weight gain in adolescence and adulthood, and may be a risk factor for the development of an ED. These findings therefore have public health implications in relation to the prevention of weight-related and eating-related disorders later in life.
doi:10.1136/bmjopen-2013-004453
PMCID: PMC3975767  PMID: 24674996
Epidemiology; Psychiatry; Public Health
9.  Correction 
BMJ Open  2014;4(3):e003424corr1.
doi:10.1136/bmjopen-2013-003424corr1
PMCID: PMC3975768  PMID: 24674994
10.  Sexual minority population density and incidence of lung, colorectal and female breast cancer in California 
BMJ Open  2014;4(3):e004461.
Objective
Risk factors for breast, colorectal, and lung cancer are known to be more common among lesbian, gay, and bisexual (LGB) individuals, suggesting they may be more likely to develop these cancers. Our objective was to determine differences in cancer incidence by sexual orientation, using sexual orientation data aggregated at the county level.
Methods
Data on cancer incidence were obtained from the California Cancer Registry and data on sexual orientation were obtained from the California Health Interview Survey, from which a measure of age-specific LGB population density by county was calculated. Using multivariable Poisson regression models, the association between the age–race-stratified incident rate of breast, lung and colorectal cancer in each county and LGB population density was examined, with race, age group and poverty as covariates.
Results
Among men, bisexual population density was associated with lower incidence of lung cancer and with higher incidence of colorectal cancer. Among women, lesbian population density was associated with lower incidence of lung and colorectal cancer and with higher incidence of breast cancer; bisexual population density was associated with higher incidence of lung and colorectal cancer and with lower incidence of breast cancer.
Conclusions
These study findings clearly document links between county-level LGB population density and cancer incidence, illuminating an important public health disparity.
doi:10.1136/bmjopen-2013-004461
PMCID: PMC3975738  PMID: 24670430
11.  Individualisation of drug treatments for patients with long-term conditions: a review of concepts 
BMJ Open  2014;4(3):e004172.
Objectives
Patients and policy makers advocate that drug treatments should be individualised. However, the term is used in a variety of ways. We set out to identify the range of related terminology and concepts in the general field of individualisation, map out the relationships between these concepts and explore how patients’ perspectives are considered.
Design
We consulted members of an established patient and public involvement group about their experience of medicine taking for long-term conditions and their ideas about individualisation. We then conducted a scoping review of the literature to explore how terms surrounding individualisation of drug treatment are used and defined in the literature, and to explore the extent to which patients’ perspectives are represented, with a view to informing future recommendations as to how individualisation can be operationalised.
Methods
We identified relevant literature using a range of search strategies. Two researchers independently extracted definitions of terms using a template. Inductive and deductive methods were used to explore the data.
Results
Definitions were categorised according to the following themes: medical management; pharmacogenetics, the patient's perspective; interactions between the healthcare provider and patient and management of long-term conditions.
Conclusions
Within the literature reviewed, the involvement of patients in the ongoing management of drug treatment was largely absent. We propose the use of a new term ‘mutually agreed tailoring’ (MAT). This describes the ongoing pharmacological management of conditions that incorporates patients’ specific needs, experiences and existing strategies for using their medications, and the professionals’ clinical judgement. This usually includes patients monitoring their symptoms and, with the support of the professional, making appropriate product, dose or timing adjustments as necessary. Our previous work suggests that many patients and doctors are successfully practising MAT, so we suggest that a formal description may facilitate wider utilisation of strategies that will improve patient outcomes.
doi:10.1136/bmjopen-2013-004172
PMCID: PMC3975745  PMID: 24670429
HEALTH SERVICES ADMINISTRATION & MANAGEMENT
12.  Feasibility of aerosol drug delivery to sleeping infants: a prospective observational study 
BMJ Open  2014;4(3):e004124.
Objectives
Delivery of inhaled medications to infants is usually very demanding and is often associated with crying and mask rejection. It has been suggested that aerosol administration during sleep may be an attractive alternative. Previous studies in sleeping children were disappointing as most of the children awoke and rejected the treatment. The SootherMask (SM) is a new, gentle and innovative approach for delivering inhaled medication to infants and toddlers. The present pilot study describes the feasibility of administering inhaled medications during sleep using the SM.
Design
Prospective observational study.
Setting
Out patients.
Participants
13 sleeping infants with recurrent wheezing who regularly used pacifiers and were <12 months old.
Intervention
Participants inhaled technetium99mDTPA-labelled normal saline aerosol delivered via a Respimat Soft Mist Inhaler (SMI) (Boehringer-Ingelheim, Germany) and SM + InspiraChamber (IC; InspiRx Inc, New Jersey, USA).
Outcomes
The two major outcomes were the acceptability of the treatment and the lung deposition (per cent of emitted dose).
Results
All infants who fulfilled the inclusion criteria successfully received the SM treatment during sleep without difficulty. Mean lung deposition (±SD) averaged 1.6±0.5% in the right lung.
Conclusions
This study demonstrated that the combination of Respimat, IC and SM was able to administer aerosol therapy to all the sleeping infants who were regular pacifier users with good lung deposition. Administration of aerosols during sleep is advantageous since all the sleeping children accepted the mask and ensuing aerosol therapy under these conditions, in contrast to previous studies in which there was frequent mask rejection using currently available devices.
Clinical Trial Registry
NCT01120938.
doi:10.1136/bmjopen-2013-004124
PMCID: PMC3975762  PMID: 24670428
13.  Investments in respiratory infectious disease research 1997–2010: a systematic analysis of UK funding 
BMJ Open  2014;4(3):e004600.
Objectives
Respiratory infections are responsible for a large global burden of disease. We assessed the public and philanthropic investments awarded to UK institutions for respiratory infectious disease research to identify areas of underinvestment. We aimed to identify projects and categorise them by pathogen, disease and position along the research and development value chain.
Setting
The UK.
Participants
Institutions that host and carry out infectious disease research.
Primary and secondary outcome measures
The total amount spent and number of studies with a focus on several different respiratory pathogens or diseases, and to correlate these against the global burden of disease; also the total amount spent and number of studies relating to the type of science, the predominant funder in each category and the mean and median award size.
Results
We identified 6165 infectious disease studies with a total investment of £2·6 billion. Respiratory research received £419 million (16.1%) across 1192 (19.3%) studies. The Wellcome Trust provided greatest investment (£135.2 million; 32.3%). Tuberculosis received £155 million (37.1%), influenza £80 million (19.1%) and pneumonia £27.8 million (6.6%). Despite high burden, there was relatively little investment in vaccine-preventable diseases including diphtheria (£0.1 million, 0.03%), measles (£5.0 million, 1.2%) and drug-resistant tuberculosis. There were 802 preclinical studies (67.3%) receiving £273 million (65.2%), while implementation research received £81 million (19.3%) across 274 studies (23%). There were comparatively few phase I–IV trials or product development studies. Global health research received £68.3 million (16.3%). Relative investment was strongly correlated with 2010 disease burden.
Conclusions
The UK predominantly funds preclinical science. Tuberculosis is the most studied respiratory disease. The high global burden of pneumonia-related disease warrants greater investment than it has historically received. Other priority areas include antimicrobial resistance (particularly within tuberculosis), economics and proactive investments for emerging infectious threats.
doi:10.1136/bmjopen-2013-004600
PMCID: PMC3975787  PMID: 24670431
respiratory; investments; financing; policy
14.  Barriers to accurate diagnosis and effective management of heart failure have not changed in the past 10 years: a qualitative study and national survey 
BMJ Open  2014;4(3):e003866.
Objectives
To explore changes in healthcare professionals’ views about the diagnosis and management of heart failure since a study in 2003.
Design
Focus groups and a national online cross-sectional survey.
Setting and participants
Focus groups (n=8 with a total of 56 participants) were conducted in the North East of England using a phenomenological framework and purposive sampling, informing a UK online survey (n=514).
Results
4 categories were identified as contributing to variations in the diagnosis and management of heart failure. Three previously known categories included: uncertainty about clinical practice, the value of clinical guidelines and tensions between individual and organisational practice. A new category concerned uncertainty about end-of-life care. Survey responses found that confidence varied among professional groups in diagnosing left ventricular systolic dysfunction (LVSD): 95% of cardiologists, 93% of general physicians, 66% of general practitioners (GPs) and 32% of heart failure nurses. For heart failure with preserved ejection fraction (HFpEF), confidence levels were much lower: 58% of cardiologists, 43% of general physicians, 7% of GPs and 6% of heart failure nurses. Only 5–35% of respondents used natriuretic peptides for LVSD or HFpEF. Confidence in interpreting test findings was fundamental to the use of all diagnostic tests. Clinical guidelines were reported to be helpful when diagnosing LVSD by 33% of nurses and 50–56% of other groups, but fell to 5–28% for HFpEF. Some GPs did not routinely initiate diuretics (23%), ACE-inhibitors (22%) or β-blockers (38%) for LVSD for reasons including historical teaching, perceived side effects and burden of monitoring. For end-of-life care, there was no consensus about responsibility for heart failure management.
Conclusions
Reported differences in the way heart failure is diagnosed and managed have changed little in the past decade. Variable access to diagnostic tests, modes of care delivery and non-uniform management approaches persist. The current National Health Service (NHS) context may not be conducive to addressing these issues.
doi:10.1136/bmjopen-2013-003866
PMCID: PMC3975740  PMID: 24691215
15.  Does a GLP-1 receptor agonist change glucose tolerance in patients treated with antipsychotic medications? Design of a randomised, double-blinded, placebo-controlled clinical trial 
BMJ Open  2014;4(3):e004227.
Background
Metabolic disturbances, obesity and life-shortening cardiovascular morbidity are major clinical problems among patients with antipsychotic treatment. Especially two of the most efficacious antipsychotics, clozapine and olanzapine, cause weight gain and metabolic disturbances. Additionally, patients with schizophrenia-spectrum disorders not infrequently consume alcohol. Glucagon-like peptide-1 (GLP-1) has shown to improve glycaemic control and reduce alcohol intake among patients with type 2 diabetes.
Objectives
To investigate whether the beneficial effects of GLP-1 analogues on glycaemic control and alcohol intake, in patients with type 2 diabetes, can be extended to a population of pre-diabetic psychiatric patients receiving antipsychotic treatment.
Methods and analysis
Trial design, intervention and participants: The study is a 16-week, double-blinded, randomised, parallel-group, placebo-controlled clinical trial, designed to evaluate the effects of the GLP-1 analogue liraglutide on glycaemic control and alcohol intake compared to placebo in patients who are prediabetic, overweight (body mass index ≥27 kg/m2), diagnosed with a schizophrenia-spectrum disorder and on stable treatment with either clozapine or olanzapine. Outcomes: The primary endpoint is the change in glucose tolerance from baseline (measured by area under the curve for the plasma glucose excursion following a 4 h 75 g oral glucose tolerance test) to follow-up at week 16. The secondary endpoints include changes of dysglycaemia, body weight, waist circumference, blood pressure, secretion of incretin hormones, insulin sensitivity and β cell function, dual-energy X-ray absorption scan (body composition), lipid profile, liver function and measures of quality of life, daily functioning, severity of the psychiatric disease and alcohol consumption from baseline to follow-up at week 16. Status: Currently recruiting patients.
Ethics and dissemination
Ethical approval has been obtained. Before screening, all patients will be provided oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations.
Trial registration number
ClinicalTrials.gov: NCT01845259, EudraCT: 2013-000121-31.
doi:10.1136/bmjopen-2013-004227
PMCID: PMC3975765  PMID: 24667381
MENTAL HEALTH
16.  A national, cross-sectional survey of children's hospital-based safety resource centres 
BMJ Open  2014;4(3):e004398.
Objective
To describe the location, staffing, clientele, safety product disbursement patterns, education provided and sustainability of safety resource centres (SRCs) in US children's hospitals.
Methods
A cross-sectional survey was distributed to children's hospital-based SRC directors. Survey categories included: funding sources, customer base, items sold, items given free of charge, education provided and directors’ needs.
Results
32/38 (84.2%) SRC sites (affiliated with 30 hospitals) completed the survey. SRCs were in many hospital locations including lobby (28.1%), family resource centres (12.5%), gift shop/retail space (18.8%), mobile units (18.8%) and patient clinics (12.5%). 19% of respondents reported that their SRC was financially self-sustainable. Sales to patients predominated (mean of 44%); however, hospital employees made up a mean of 20% (range 0–60%) of sales. 78.1% of SRCs had products for children with special healthcare needs. Documentation kept at SRC sites included items purchased (96.9%), items given free of charge (65.6%) and customer demographics (50%). 56.3% of SRCs provided formal injury prevention education classes. The SRCs’ directors’ most important needs were finances (46.9%), staffing (50%) and space (46.9%). All of the directors were ‘somewhat interested’ or ‘very interested’ in each of the following: creation of a common SRC listserv, national SRC data bank and multisite SRC research platform.
Conclusions
SRCs are located in many US children's hospitals, and can be characterised as heterogeneous in location, products sold, data kept and ability to be financially sustained. Further research is needed to determine best practices for SRCs to maximise their impact on injury prevention.
doi:10.1136/bmjopen-2013-004398
PMCID: PMC3975766  PMID: 24667383
education; advocacy; safety center
17.  Is adequate pain relief and time to analgesia associated with emergency department length of stay? A retrospective study 
BMJ Open  2014;4(3):e004288.
Objectives
Evaluate the association of adequate analgesia and time to analgesia with emergency department (ED) length of stay (LOS).
Setting and Design
Post hoc analysis of real-time archived data.
Participants
We included all consecutive ED patients ≥18 years with pain intensity >6 (verbal numerical scale from 0 to 10), assigned to an ED bed, and whose pain was re-evaluated less than 1 h after receiving analgesic treatment.
Outcome measures
The main outcome was ED-LOS in patients who had adequate pain relief (AR=↓50% pain intensity) compared with those who did not have such relief (NR).
Results
A total of 2033 patients (mean age 49.5 years; 51% men) met our inclusion criteria; 58.3% were discharged, and 41.7% were admitted. Among patients discharged or admitted, there was no significant difference in ED-LOS between those with AR (median (25th–75th centile): 9.6 h (6.3–14.8) and 18.2 h (11.6–25.7), respectively) and NR (median (25th–75th centile): 9.6 h (6.6–16.0) and 17.4 h (11.3–26.5), respectively). After controlling for confounding factors, rapid time to analgesia (not AR) was associated with shorter ED-LOS of discharged and admitted patients (p<0.001 and <0.05, respectively). When adjusting for confounding variables, ED-LOS is shortened by 2 h (95% CI 1.1 to 2.8) when delay to receive analgesic is <90 min compared with >90 min for discharged and by 2.3 h (95% CI 0.17 to 4.4) for admitted patients.
Conclusions
In our study, AR was not linked with short ED-LOS. However, rapid administration of analgesia was associated with short ED-LOS.
doi:10.1136/bmjopen-2013-004288
PMCID: PMC3975786  PMID: 24667382
Accident & Emergency Medicine
18.  Cost-effectiveness of enhancing adherence with oral bisphosphonates treatment in osteoporotic women: an empirical approach based on healthcare utilisation databases 
BMJ Open  2014;4(3):e003758.
Objective
Adherence with bisphosphonates therapy is generally low. Enhancing adherence with bisphosphonates would be effective in achieving the full benefits of therapy albeit a growth in the expenditure for supporting incremented drug use is expected. The cost-effectiveness of enhancing adherence with oral bisphosphonates in a large population of osteoporotic women has been assessed in the current study.
Design
Retrospective cohort study.
Setting
Healthcare utilisation databases of Lombardy Region, Italy.
Participants
A cohort of 28 558 women aged 45 years or more, resident in the Italian Region of Lombardy, who were newly treated with oral bisphosphonates during 2003–2004, was followed for 6 years after index prescription.
Outcome measures
Fracture-free survival time, healthcare cost and incremental cost-effectiveness ratio (ICER) of enhancing adherence, that is, the additional cost that would be spent every year for gaining one fracture-free year as a consequence of enhancing adherence at a certain level.
Results
Enhanced adherence from 33% (baseline) to 80%, increased both fracture-free survivals from 970 to 973 years and healthcare costs from €118 000 to €265 000 every 1000 woman-years, with ICER value of €53 000 (95% CI €49 000 to €58 000). ICER values were lower for older women (€50 000; 95% CI €42 000 to €58 000) and for those suffering from at least a chronic comorbidity (€25000; 95% CI 95% CI €7000 to €47 000).
Conclusions
Enhancing adherence with oral bisphosphonates offers important benefits in reducing the risk of fracture, although at a substantial cost.
doi:10.1136/bmjopen-2013-003758
PMCID: PMC3975742  PMID: 24662445
Health Economics; Public Health; Epidemiology
19.  Clinical trial participants’ experiences of completing questionnaires: a qualitative study 
BMJ Open  2014;4(3):e004363.
Objectives
To improve clinical study developments for elderly populations, we aim to understand how they transfer their experiences into validated, standardised self-completed study measurement instruments. We analysed how women (mean 78±8 years of age) participating in a randomised controlled trial (RCT) cognised study instruments used to evaluate outcomes of the intervention.
Setting
The interview study was nested in an RCT on chronic neck pain using common measurement instruments situated in an elderly community in Berlin, Germany, which comprised of units for independent and assisted-living options.
Participants
The sample (n=20 women) was selected from the RCT sample (n=117, 95% women, mean age 76 (SD±8) years). Interview participants were selected using a purposive sampling list based on the RCT outcomes.
Outcomes
We asked participants about their experiences completing the RCT questionnaires. Interviews were analysed thematically, then compared with the questionnaires.
Results
Interviewees had difficulties in translating complex experiences into a single value on a scale and understanding the relationship of the questionnaires to study aims. Interviewees considered important for the trial that their actual experiences were understood by trial organisers. This information was not transferrable by means of the questionnaires. To rectify these difficulties, interviewees used strategies such as adding notes, adding response categories or skipping an item.
Conclusions
Elderly interview participants understood the importance of completing questionnaires for trial success. This led to strategies of completing the questionnaires that resulted in ‘missing’ or ambiguous data. To improve data collection in elderly populations, educational materials addressing the differential logics should be developed and tested. Pilot testing validated instruments using cognitive interviews may be particularly important in such populations. Finally, when the target of an intervention is a subjective experience, it seems important to create a method by which participants can convey their personal experiences. These could be nested qualitative studies.
Trial registration number
ISRCTN77108101807.
doi:10.1136/bmjopen-2013-004363
PMCID: PMC3975744  PMID: 24662446
QUALITATIVE RESEARCH; PAIN MANAGEMENT; GERIATRIC MEDICINE
20.  Diagnostic accuracy of copeptin sensitivity and specificity in patients with suspected non-ST-elevation myocardial infarction with troponin I below the 99th centile at presentation 
BMJ Open  2014;4(3):e004449.
Objective
To determine whether copeptin-us can rule out diagnosis of non-ST-segment elevation myocardial infarction (NSTEMI) without prolonged monitoring and serial blood sampling in patients with high-sensitive cardiac troponin I (hs-cTnT) below the 99th centile at presentation to the emergency department (ED).
Design
Prospective, non-randomised, individual blinded diagnostic accuracy study.
Setting
Two EDs of a rural region of France.
Participants
Patients with chest pain suspected of NSTEMI with onset within the last 12 h were considered for enrolment.
Interventions
Serial clinical, electrographical and biochemical investigations were performed at admission and after 2, 4, 6 and 12 h. Hs-cTnT was measured using an assay with Dimension VISTA, Siemens. Copeptin was measured by the BRAHMS copeptin-us assay on the KRYPTOR Compact Plus system. The follow-up period was 90 days.
Primary and secondary outcome measures
Copeptin, troponin, myoglobin and creatine kinase values. Clinical and paraclinical events. The final diagnosis was adjudicated blinded to copeptin result.
Results
During 12 months, 102 patients were analysed. Final diagnosis was NSTEMI for 7.8% (n=8), unstable angina for 3.9% (n=4), cardiac but non-coronary artery disease for 8.8% (n=9), non-cardiac chest pain for 52% (n=53) and unknown for 27.5% (n=28). There was no statistical difference for copeptin values between patients with NSTEMI and others (respectively 5.5 pmol/L IQR (3.1–7.9) and 6.5 pmol/L IQR (3.9–12.1), p=0.49). Only one patient with NSTEMI had a copeptin value above the cut-off of 95th centile at admission.
Conclusions
In this study, copeptin does not add a diagnostic value at admission to ED for patients with suspected acute coronary syndrome without ST-segment elevation and with hs-cTnT below the 99th centile.
Trial registration number
Clinicaltrials.gov identifier: NCT01334645.
doi:10.1136/bmjopen-2013-004449
PMCID: PMC3975746  PMID: 24662448
Accident & Emergency Medicine
21.  Association of digital vascular function with cardiovascular risk factors: a population study 
BMJ Open  2014;4(3):e004399.
Objectives
Vasodilation of the peripheral arteries during reactive hyperaemia depends in part on release of nitric oxide from endothelial cells. Previous studies mainly employed a fingertip tonometric device to derive pulse wave amplitude (PWA) and PWA hyperaemic changes. An alternative approach is based on photoplethysmography (PPG). We sought to evaluate the correlates of digital PPG PWA hyperaemic responses as a measure of peripheral vascular function.
Design
The Flemish Study on Environment, Genes and Health Outcomes (FLEMENGHO) is a population-based cohort study.
Setting
Respondents were examined at one centre in northern Belgium.
Participants
For this analysis, our sample consisted of 311 former participants (53.5% women; mean age 52.6 years; 43.1% hypertensive), who were examined from January 2010 until March 2012 (response rate 85.1%).
Primary outcome measures
Using a fingertip PPG device, we measured digital PWA at baseline and at 30 s intervals for 4 min during reactive hyperaemia induced by a 5 min forearm cuff occlusion. We performed stepwise regression to identify correlates of the hyperaemic response ratio for each 30 s interval after cuff deflation.
Results
The maximal hyperaemic response was detected in the 30–60 s interval. The explained variance for the PPG PWA ratio ranged from 9.7% at 0–30 s interval to 22.5% at 60–90 s time interval. The hyperaemic response at each 30 s interval was significantly higher in women compared with men (p≤0.001). The PPG PWA changes at 0–90 s intervals decreased with current smoking (p≤0.0007) and at 0–240 s intervals decreased with higher body mass index (p≤0.035). These associations with sex, current smoking and body mass index were mutually independent.
Conclusions
Our study is the first to implement the new PPG technique to measure digital PWA hyperaemic changes in a general population. Hyperaemic response, as measured by PPG, is inversely associated with traditional cardiovascular risk factors such as male sex, smoking and obesity.
doi:10.1136/bmjopen-2013-004399
PMCID: PMC3975759  PMID: 24662447
population; endothelial function; vasodilation; photoplethysmography
22.  Adapting data collection methods in the Australian Life Histories and Health Survey: a retrospective life course study 
BMJ Open  2014;4(3):e004476.
Objective
Ideally, life course data are collected prospectively through an ongoing longitudinal study. We report adaptive multimethod fieldwork procedures that gathered life history data by mail survey and telephone interview, comparable with the face-to-face methods employed in the English Longitudinal Study on Ageing (ELSA).
Design
The Australian Life Histories and Health (LHH) Survey was a substudy of the Australian 45 and Up Study, with data collection methods modified from the ELSA Study. A self-complete questionnaire and life history calendar were completed by the participants, followed by a computer-assisted telephone interview recording key life events.
Results
The LHH survey developed and tested procedures and instruments that gathered rich life history data within an ongoing Australian longitudinal survey on ageing. Data collection proved to be economical. The use of a self-complete questionnaire in conjunction with a life history calendar and coordinated computer-assisted telephone interview was successful in collecting retrospective life course information, in terms of being thorough, practical and efficient. This study has a diverse collection of data covering the life course, starting with early life experiences and continuing with socioeconomic and health exposures and outcomes during adult life.
Conclusions
Mail and telephone methodology can accurately and economically add a life history dimension to an ongoing longitudinal survey. The method is particularly valuable for surveying widely dispersed populations. The results will facilitate understanding of the social determinants of health by gathering data on earlier life exposures as well as comparative data across geographical and societal contexts.
doi:10.1136/bmjopen-2013-004476
PMCID: PMC3975763  PMID: 24662449
Epidemiology; Public Health; Statistics & Research Methods
23.  Risk marker associations with venous thrombotic events: a cross-sectional analysis 
BMJ Open  2014;4(3):e003208.
Objective
To examine the interrelations among, and risk marker associations for, superficial and deep venous events—superficial venous thrombosis (SVT), deep venous thrombosis (DVT) and pulmonary embolism (PE).
Design
Cross-sectional analysis.
Setting
San Diego, California, USA.
Participants
2404 men and women aged 40–79 years from four ethnic groups: non-Hispanic White, Hispanic, African-American and Asian. The study sample was drawn from current and former staff and employees of the University of California, San Diego and their spouses/significant others.
Outcome measures
Superficial and deep venous events, specifically SVT, DVT, PE and combined deep venous events (DVE) comprising DVT and PE.
Results
Significant correlates on multivariable analysis were, for SVT: female sex, ethnicity (African-American=protective), lower educational attainment, immobility and family history of varicose veins. For DVT and DVE, significant correlates included: heavy smoking, immobility and family history of DVEs (borderline for DVE). For PE, significant predictors included immobility and, in contrast to DVT, blood pressure (BP, systolic or diastolic). In women, oestrogen use duration for hormone replacement therapy, in all and among oestrogen users, predicted PE and DVE, respectively.
Conclusions
These findings fortify evidence for known risk correlates/predictors for venous disease, such as family history, hormone use and immobility. New risk associations are shown. Striking among these is an association of PE, but not DVT, to elevated BP: we conjecture PE may serve as cause rather than consequence. Future studies should evaluate the temporal direction of this association. Oxidative stress and cell energy compromise are proposed to explain and predict many risk factors, operating through cell-death mediated triggering of coagulation activation.
doi:10.1136/bmjopen-2013-003208
PMCID: PMC3963072  PMID: 24657882
24.  Effects of life satisfaction and psychache on risk for suicidal behaviour: a cross-sectional study based on data from Chinese undergraduates 
BMJ Open  2014;4(3):e004096.
Objectives
To examine predictive power of psychache and life satisfaction on risks for suicidal ideation and suicide attempt among young people.
Design
A cross-sectional study.
Setting
Data were collected from an online survey in Wuhan, China.
Participants
5988 university students from six universities were selected by a stratified cluster sampling method.
Primary and secondary outcome measures
Suicidal ideation and suicide attempt at some point of the students’ lifetime were the outcomes of interest.
Results
Students with suicidal ideation or attempted suicide reported a lower level of life satisfaction and high degree of psychache than counterparts without suicidal ideation or attempt. Regression analyses indicated that life satisfaction and psychache were significantly associated with the risk of suicidal ideation and the risk of suicidal attempt. Though psychache showed a relatively stronger predictive power than life satisfaction, the effect of the two factors remained significant when they were individually adjusted for personal demographic characteristics. However, when the two factors were included in the model simultaneously to adjust for each other, psychache could fully explain the association between life satisfaction and suicidal attempt. Life satisfaction remained to contribute unique variance in the statistical prediction of suicidal ideation.
Conclusions
Psychache and life satisfaction both have a significant predictive power on risk for suicidal behaviour, and life satisfaction could relieve the predictive power of psychache when suicidal behaviour is just starting. Shneidman's theory that psychache is the pre-eminent psychological cause of suicide is perhaps applicable only to a more serious form of suicidal behaviour.
doi:10.1136/bmjopen-2013-004096
PMCID: PMC3963073  PMID: 24657883
Suicide & self-harm < PSYCHIATRY; Public health < INFECTIOUS DISEASES; Health & safety < HEALTH SERVICES ADMINISTRATION & MANAGEMENT
25.  Rationale and cross-sectional study design of the Research on Obesity and type 2 Diabetes among African Migrants: the RODAM study 
BMJ Open  2014;4(3):e004877.
Introduction
Obesity and type 2 diabetes (T2D) are highly prevalent among African migrants compared with European descent populations. The underlying reasons still remain a puzzle. Gene–environmental interaction is now seen as a potential plausible factor contributing to the high prevalence of obesity and T2D, but has not yet been investigated. The overall aim of the Research on Obesity and Diabetes among African Migrants (RODAM) project is to understand the reasons for the high prevalence of obesity and T2D among sub-Saharan Africans in diaspora by (1) studying the complex interplay between environment (eg, lifestyle), healthcare, biochemical and (epi)genetic factors, and their relative contributions to the high prevalence of obesity and T2D; (2) to identify specific risk factors within these broad categories to guide intervention programmes and (3) to provide a basic knowledge for improving diagnosis and treatment.
Methods and analysis
RODAM is a multicentre cross-sectional study among homogenous sub-Saharan African participants (ie, Ghanaians) aged >25 years living in rural and urban Ghana, the Netherlands, Germany and the UK (http://rod-am.eu/). Standardised data on the main outcomes, genetic and non-genetic factors are collected in all locations. The aim is to recruit 6250 individuals comprising five subgroups of 1250 individuals from each site. In Ghana, Kumasi and Obuasi (urban stratum) and villages in the Ashanti region (rural stratum) are served as recruitment sites. In Europe, Ghanaian migrants are selected through the municipality or Ghanaian organisations registers.
Ethics and dissemination
Ethical approval has been obtained in all sites. This paper gives an overview of the rationale, conceptual framework and methods of the study. The differences across locations will allow us to gain insight into genetic and non-genetic factors contributing to the occurrence of obesity and T2D and will inform targeted intervention and prevention programmes, and provide the basis for improving diagnosis and treatment in these populations and beyond.
doi:10.1136/bmjopen-2014-004877
PMCID: PMC3963103  PMID: 24657884
Epidemiology

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