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Year of Publication
1.  Clinical management issues vary by specialty in the Victorian Audit of Surgical Mortality: a retrospective observational study 
BMJ Open  2014;4(6):e005554.
Objective
Clinical management issues are contributory factors to mortality. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM), an educational peer-review process for surgeons, to discover differences in the incidence of these issues between surgical specialties in order to focus attention to areas of care that might be improved.
Design
This study used retrospectively analysed observational data from VASM. Clinical management issues between eight specialties were assessed using χ2 analysis.
Data sources
VASM data were reported by participating public and private health services, the Coroner and self-reporting surgeons across Victoria.
Results
A total of 2946 specific clinical issues as deficiencies of care were reported. 15% of cases had significant issues of care. The most common clinical management issue was the delay in delivery of treatment. Other clinical issues included the quality of communication and documentation, preoperative and postoperative care, adverse events and protocol issues. There were significant differences in issues between specialties.
Conclusions
The clinical management issues presented across surgical specialties were similar; however, five issues of clinical care differed significantly in frequency across surgical specialties. The three main issues varying among specialties were complications after operation, communication and postoperative care. Addressing these clinical management issues via the peer-review process may impact positively on patient care.
doi:10.1136/bmjopen-2014-005554
PMCID: PMC4078770  PMID: 24980043
Surgery
2.  Safety culture in a pharmacy setting using a pharmacy survey on patient safety culture: a cross-sectional study in China 
BMJ Open  2014;4(6):e004904.
Objective
To explore the attitudes and perceptions of patient safety culture for pharmacy workers in China by using a Pharmacy Survey on Patient Safety Culture (PSOPSC), and to assess the psychometric properties of the translated Chinese language version of the PSOPSC.
Design
Cross-sectional study.
Participants
Data were obtained from 20 hospital pharmacies in the southwest part of China.
Methods
We performed χ2 test to explore the differences on pharmacy staff in different hospital and qualification levels and countries towards patient safety culture. We also computed descriptive statistics, internal consistency coefficients and intersubscale correlation analysis, and then conducted an exploratory factor analysis. A test–retest was performed to assess reproducibility of the items.
Results
A total of 630 questionnaires were distributed of which 527 were responded to validly (response rate 84%). The positive response rate for each item ranged from 37% to 90%. The positive response rate on three dimensions (‘Teamwork’, ‘Staff Training and Skills’ and ‘Staffing, Work Pressure and Pace’) was higher than that of Agency for Healthcare Research and Quality (AHRQ) data (p<0.05). There was a statistical difference in the perception of patient safety culture at different hospital and qualification levels. The internal consistency of the total survey was comparatively satisfied (Cronbach's α=0.89).
Conclusions
The results demonstrated that among the pharmacy staffs surveyed in China, there was a positive attitude towards patient safety culture in their organisations. Identifying perspectives of patient safety culture from pharmacists in different hospital and qualification levels are important, since this can help support decisions about action to improve safety culture in pharmacy settings. The Chinese translation of the PSOPSC questionnaire (V.2012) applied in our study is acceptable.
doi:10.1136/bmjopen-2014-004904
PMCID: PMC4078772  PMID: 24980042
Health Services Administration & Management
3.  A systematic review of measures of self-reported adherence to unsupervised home-based rehabilitation exercise programmes, and their psychometric properties 
BMJ Open  2014;4(6):e005044.
Background
Adherence is an important factor contributing to the effectiveness of exercise-based rehabilitation. However, there appears to be a lack of reliable, validated measures to assess self-reported adherence to prescribed but unsupervised home-based rehabilitation exercises.
Objectives
A systematic review was conducted to establish what measures were available and to evaluate their psychometric properties.
Data sources
MEDLINE, EMBASE, PsycINFO CINAHL (June 2013) and the Cochrane library were searched (September 2013). Reference lists from articles meeting the inclusion criteria were checked to ensure all relevant papers were included.
Study selection
To be included articles had to be available in English; use a self-report measure of adherence in relation to a prescribed but unsupervised home-based exercise or physical rehabilitation programme; involve participants over the age of 18. All health conditions and clinical populations were included.
Data extraction
Descriptive data reported were collated on a data extraction sheet. The measures were evaluated in terms of eight psychometric quality criteria.
Results
58 studies were included, reporting 61 different measures including 29 questionnaires, 29 logs, two visual analogue scales and one tally counter. Only two measures scored positively for one psychometric property (content validity). The majority of measures had no reported validity or reliability testing.
Conclusions
The results expose a gap in the literature for well-developed measures that capture self-reported adherence to prescribed but unsupervised home-based rehabilitation exercises.
doi:10.1136/bmjopen-2014-005044
PMCID: PMC4078771  PMID: 24972606
Adherence; Self-Report; Exercise; Rehabilitation
4.  Multicentre observational cohort study of NSAIDs as risk factors for postoperative adverse events in gastrointestinal surgery 
BMJ Open  2014;4(6):e005164.
Introduction
Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as postoperative analgesia by the Enhanced Recovery After Surgery Society. Recent studies have raised concerns that NSAID administration following colorectal anastomosis may be associated with increased risk of anastomotic leak. This multicentre study aims to determine NSAIDs’ safety profile following gastrointestinal resection.
Methods and analysis
This prospective, multicentre cohort study will be performed over a 2-week period utilising a collaborative methodology. Consecutive adults undergoing open or laparoscopic, elective or emergency gastrointestinal resection will be included. The primary end point will be the 30-day morbidity, assessed using the Clavien-Dindo classification. This study will be disseminated through medical student networks, with an anticipated recruitment of at least 900 patients. The study will be powered to detect a 10% increase in complication rates with NSAID use.
Ethics and dissemination
Following the Research Ethics Committee Chairperson's review, a formal waiver was received. This study will be registered as a clinical audit or service evaluation at each participating hospital. Dissemination will take place through previously described novel research collaborative networks.
doi:10.1136/bmjopen-2014-005164
PMCID: PMC4078775  PMID: 24972607
Surgery
5.  Effect of hyperglycaemia in pregnancy on adiposity in their infants in India: a protocol of a multicentre cohort study 
BMJ Open  2014;4(6):e005417.
Introduction
The carbohydrate ‘fuel’ metabolism in a pregnant woman may have a long-term impact on the development of her offspring (‘fuel-mediated teratogenesis’ hypothesis) including in utero exposure to maternal hyperglycaemia leading to fetal hyperinsulinaemia, and the consequent increase in fetal fat cells. Therefore, a feed-forward loop can exist of rising adiposity and hyperinsulinaemia throughout childhood, perhaps leading to obesity and diabetes in later life. There is a need for prospective examination of body fat distribution in children born to mothers with different glycaemic levels to understand the plausible association between glucose metabolism and future risk of diabetes in offspring. The hypothesis is that maternal glucose levels in pregnant women are related to skinfold thickness in their infants.
Methods and analysis
Hyperglycaemia in pregnancy and adiposity in infants is a multicentre cohort study to evaluate the effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in predicting the risk of chronic diseases in infants. The study aims to recruit 1045 participants over a period of 1 year, who will be followed up irrespective of their glycaemia status for a period of 15 months, beginning in the 24th week of gestation. The glucose levels in pregnant women would be obtained through oral glucose tolerance testing. The primary outcome of our study was skinfold thickness in infants at the age of 6 weeks, 3rd and 9th month (as a proxy for fat distribution/adiposity).
Ethics and dissemination
The institutional review board at The Indian Institute of Public Health (IIPH)-Hyderabad, Public Health Foundation of India has approved the protocol. All participants are required to provide written informed consent.
doi:10.1136/bmjopen-2014-005417
PMCID: PMC4078779  PMID: 24972608
Epidemiology
6.  A cross-sectional comparison study on the iodine nutritional status between rural and urban residents in Zhejiang Province, China 
BMJ Open  2014;4(6):e005484.
Objectives
To evaluate the difference of iodine nutritional status between rural and urban residents under the universal salt iodisation policy.
Setting
A multistage cluster sampling technique was employed in the present cross-sectional study. In total, 3300 rural and 3300 urban households were selected where the investigation was conducted.
Participants
A total of 8553 rural and 8909 urban residents participated in this provincial survey.
Primary and secondary outcome measures
Spot urine samples were collected and the iodine concentration in urine was determined by the modified acid-digestion method.
Results
The median urinary iodine concentration of rural residents was 170.1 μg/L, which was higher than that of urban residents with 153.5 μg/L. For school-aged children, middle-aged people and older people, the median urinary iodine concentration of rural residents was 191.2, 160.2 and 154.0 μg/L, respectively, which was higher than that of urban residents with 166.2, 153.8 and 129.5 μg/L, respectively. Risk factors for urinary concentration of rural residents were age (OR=0.99), terrain (OR=0.83), usual intake of pickled products (OR=1.45) and non-iodised salt intake (OR=0.39), while those for urban residents were age (OR=0.99), terrain (OR=0.83), usual intake of aquatic products (OR=1.24) and non-iodised salt intake (OR=0.27) compared with iodised table salt intake.
Conclusions
The median urinary iodine concentration of rural residents was higher than that of urban residents although they were both falls in optimal iodine status as recommended by WHO/UNICEF/International Council for the Control of Iodine Deficiency Disorders. Iodised salt intake is the major factor which influences the iodine nutritional status mostly for rural and urban residents. The ongoing monitoring of population iodine status remains crucially important.
doi:10.1136/bmjopen-2014-005484
PMCID: PMC4078769  PMID: 24969785
NUTRITION & DIETETICS; PUBLIC HEALTH; EPIDEMIOLOGY
7.  Correction 
BMJ Open  2014;4(6):e004052corr1.
doi:10.1136/bmjopen-2013-004052corr1
PMCID: PMC4078773  PMID: 24969783
8.  Recruitment feasibility to a cohort study of endocrine and metabolic health among survivors of childhood brain tumours: a report from the Canadian study of Determinants of Endometabolic Health in ChIlDrEn (CanDECIDE) 
BMJ Open  2014;4(6):e005295.
Objectives
The aim of this study was to test the feasibility of recruitment and performance of study procedures of the Canadian Study of Determinants of Endometabolic Health in ChIlDrEn (CanDECIDE) study, which was designed to assess the determinants of endocrine and metabolic health in survivors of childhood brain tumours.
Setting
A single paediatric tertiary care centre in Hamilton, Ontario, Canada.
Participants
We included boys and girls, aged 5 years and older, who were lean (body mass index (BMI) below 85th centile for age and gender) or overweight/obese (BMI 85th centile or above for age and gender). We excluded children on steroids or immunosuppressant therapy, smokers and those who had an active infection for the 2 weeks prior to participation.
Outcomes
Feasibility targets included recruitment rate of at least 50%, the consenting of 80% of participants to provide biological samples, 90% questionnaire completion rate and the ability to process biological samples from at least 80% of participants.
Results
We approached 210 potential participants, and of the 112 (53%) who agreed to participate, 30 (26.8%) completed the study visit over 7 months. All participants agreed to fast, provide biological samples and complete the questionnaires. Sample collection was successful in 97% (29/30) of participants and laboratory procedures were feasible in 100% of collected samples. We also tested resources required for the conduct of the full study including personnel, space, laboratory equipment and procedures and determined that they are all feasible.
Conclusions
Recruitment and consenting of patients for the CanDECIDE study may be feasible. However, we are considering prolonging recruitment duration and collaboration with other centres to meet recruitment targets due to lower than expected recruitment rate. Completion of questionnaires and implementation of sample processing protocols are feasible.
doi:10.1136/bmjopen-2014-005295
PMCID: PMC4078774  PMID: 24969784
9.  Scaling up integrated prevention campaigns for global health: costs and cost-effectiveness in 70 countries 
BMJ Open  2014;4(6):e003987.
Objective
This study estimated the health impact, cost and cost-effectiveness of an integrated prevention campaign (IPC) focused on diarrhoea, malaria and HIV in 70 countries ranked by per capita disability-adjusted life-year (DALY) burden for the three diseases.
Methods
We constructed a deterministic cost-effectiveness model portraying an IPC combining counselling and testing, cotrimoxazole prophylaxis, referral to treatment and condom distribution for HIV prevention; bed nets for malaria prevention; and provision of household water filters for diarrhoea prevention. We developed a mix of empirical and modelled cost and health impact estimates applied to all 70 countries. One-way, multiway and scenario sensitivity analyses were conducted to document the strength of our findings. We used a healthcare payer's perspective, discounted costs and DALYs at 3% per year and denominated cost in 2012 US dollars.
Primary and secondary outcomes
The primary outcome was cost-effectiveness expressed as net cost per DALY averted. Other outcomes included cost of the IPC; net IPC costs adjusted for averted and additional medical costs and DALYs averted.
Results
Implementation of the IPC in the 10 most cost-effective countries at 15% population coverage would cost US$583 million over 3 years (adjusted costs of US$398 million), averting 8.0 million DALYs. Extending IPC programmes to all 70 of the identified high-burden countries at 15% coverage would cost an adjusted US$51.3 billion and avert 78.7 million DALYs. Incremental cost-effectiveness ranged from US$49 per DALY averted for the 10 countries with the most favourable cost-effectiveness to US$119, US$181, US$335, US$1692 and US$8340 per DALY averted as each successive group of 10 countries is added ordered by decreasing cost-effectiveness.
Conclusions
IPC appears cost-effective in many settings, and has the potential to substantially reduce the burden of disease in resource-poor countries. This study increases confidence that IPC can be an important new approach for enhancing global health.
doi:10.1136/bmjopen-2013-003987
PMCID: PMC4078786  PMID: 24969782
Health Economics
10.  Discussing prognosis and end-of-life care in the final year of life: a randomised controlled trial of a nurse-led communication support programme for patients and caregivers 
BMJ Open  2014;4(6):e005745.
Introduction
Timely communication about life expectancy and end-of-life care is crucial for ensuring good patient quality-of-life at the end of life and a good quality of death. This article describes the protocol for a multisite randomised controlled trial of a nurse-led communication support programme to facilitate patients’ and caregivers’ efforts to communicate about these issues with their healthcare team.
Methods and analysis
This NHMRC-sponsored trial is being conducted at medical oncology clinics located at/affiliated with major teaching hospitals in Sydney, Australia. Patients with advanced, incurable cancer and life expectancy of less than 12 months will participate together with their primary informal caregiver where possible. Guided by the self-determination theory of health-behaviour change, the communication support programme pairs a purpose-designed Question Prompt List (QPL—an evidence-based list of questions patients/caregivers can ask clinicians) with nurse-led exploration of QPL content, communication challenges, patient values and concerns and the value of early discussion of end-of-life issues. Oncologists are also cued to endorse patient and caregiver question asking and use of the QPL. Behavioural and self-report data will be collected from patients/caregivers approximately quarterly for up to 2.5 years or until patient death, after which patient medical records will be examined. Analyses will examine the impact of the intervention on patients’ and caregivers’ participation in medical consultations, their self-efficacy in medical encounters, quality-of-life, end-of-life care receipt and quality-of-death indicators.
Ethics and dissemination
Approvals have been granted by the human ethics review committee of Royal Prince Alfred Hospital and governance officers at each participating site. Results will be reported in peer-reviewed publications and conference presentations.
Trial registration number
Australian New Zealand Clinical Trials Registry ACTRN12610000724077.
doi:10.1136/bmjopen-2014-005745
PMCID: PMC4078787  PMID: 24969786
Communication; Cancer; End-of-life care; Advance care planning; Question prompt list; Caregivers
11.  Leadership and management in the undergraduate medical curriculum: a qualitative study of students’ attitudes and opinions at one UK medical school 
BMJ Open  2014;4(6):e005353.
Objective
To explore undergraduate medical students’ attitudes towards and opinions about leadership and management education.
Design
Between 2009 and 2012 we conducted a qualitative study comprising five focus group discussions, each devoted to one of the five domains in the Medical Leadership Competency Framework, (Personal Qualities, Working with Others, Managing Services, Improving Services and Setting Direction). Each discussion examined what should be learnt, when should learning occur, what methods should be used, how should learning be assessed, what are the barriers to such education.
Participants
28 students from all three clinical years (4–6) of whom 10 were women.
Results
2 inter-related themes emerged: understanding the broad perspective of patients and other stakeholders involved in healthcare provision and the need to make leadership and management education relevant in the clinical context. Topics suggested by students included structure of the National Health Service (NHS), team working skills, decision-making and negotiating skills. Patient safety was seen as particularly important. Students preferred experiential learning, with placements seen as providing teaching opportunities. Structured observation, reflection, critical appraisal and analysis of mistakes at all levels were mentioned as existing opportunities for integrating leadership and management education. Students’ views about assessment and timing of such education were mixed. Student feedback figured prominently as a method of delivery and a means of assessment, while attitudes of medical professionals, students and of society in general were seen as barriers.
Conclusions
Medical students may be more open to leadership and management education than thought hitherto. These findings offer insights into how students view possible developments in leadership and management education and stress the importance of developing broad perspectives and clinical relevance in this context.
doi:10.1136/bmjopen-2014-005353
PMCID: PMC4078777  PMID: 24965917
Medical Education & Training; Qualitative Research
12.  A health economic model for the development and evaluation of innovations in aged care: an application to consumer-directed care—study protocol 
BMJ Open  2014;4(6):e005788.
Introduction
Consumer-directed care is currently being embraced within Australia and internationally as a means of promoting autonomy and choice in the delivery of health and aged care services. Despite its wide proliferation little research has been conducted to date to assess the views and preferences of older people for consumer-directed care or to assess the costs and benefits of such an approach relative to existing models of service delivery.
Methods and analysis
A comprehensive health economic model will be developed and applied to the evolution, implementation and evaluation of consumer-directed care in an Australian community aged care setting. A mixed methods approach comprising qualitative interviews and a discrete choice experiment will determine the attitudes and preferences of older people and their informal carers for consumer-directed care. The results of the qualitative interviews and the discrete choice experiment will inform the introduction of a new consumer-directed care innovation in service delivery. The cost-effectiveness of consumer-directed care will be evaluated by comparing incremental changes in resource use, costs and health and quality of life outcomes relative to traditional services. The discrete choice experiment will be repeated at the end of the implementation period to determine the extent to which attitudes and preferences change as a consequence of experience of consumer-directed care. The proposed framework will have wide applicability in the future development and economic evaluation of new innovations across the health and aged care sectors.
Ethics and dissemination
The study is approved by Flinders University Social and Behavioural Research Ethics Committee (Project No. 6114/SBREC). Findings from the qualitative interviews, discrete choice experiments and the economic evaluation will be reported at a workshop of stakeholders to be held in 2015 and will be documented in reports and in peer reviewed journal articles.
doi:10.1136/bmjopen-2014-005788
PMCID: PMC4078785  PMID: 24965918
Health Economics; Public Health; Geriatric Medicine
13.  Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation 
BMJ Open  2014;4(6):e004817.
Objective
To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants.
Setting
We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants’ comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format.
Participants
The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages.
Outcome measure
The primary outcome measure was reliability and validity of the questionnaire.
Results
Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73–0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education.
Conclusions
We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants.
doi:10.1136/bmjopen-2014-004817
PMCID: PMC4078776  PMID: 24961716
Ethics (see Medical Ethics); Medical Ethics
14.  The safety and efficacy of daptomycin versus other antibiotics for skin and soft-tissue infections: a meta-analysis of randomised controlled trials 
BMJ Open  2014;4(6):e004744.
Objective
Daptomycin, a cyclic lipopeptide that exhibits rapid, concentration-dependent bactericidal activity in vitro against a broad spectrum of Gram-positive pathogens, has now, since 2003, been approved in more than 70 countries and regions to treat skin and soft-tissue infections (SSTIs). The purpose of this meta-analysis was to compare the safety and efficacy of daptomycin with other antibiotics, especially with vancomycin which has long been considered the standard therapy for complicated SSTIs.
Design
Meta-analysis of randomised controlled trials (RCTs).
Data sources
We thoroughly searched PubMed, EMBASE, Cochrane Central to identify relevant RCTs. Six RCTs with a total of 1710 patients were included in this meta-analysis.
Results
The results demonstrated that the efficacy of daptomycin was at par with or maybe better than other first-line antibiotics for treating SSTIs as shown by the OR for clinical success (OR=1.05, 95% CI 0.84 to 1.31, p=0.65, I2=0%); daptomycin versus vancomycin subgroup (OR=1.19, 95% CI 0.77 to 1.83, p=0.43, I2=0%); overall microbiological success (OR=1.05, 95% CI 0.61 to 1.79, p=0.86, I2=42%); microbiological success of daptomycin versus comparators for Staphylococcus aureus (SA, OR=1.05, 95% CI 0.61 to 2.60, p=0.53, I2=47%), for methicillin-resistant S. aureus (OR=0.90, 95% CI 0.77 to 1.06, p=0.20, I2=56%). However, daptomycin tended to have a similar treatment-related adverse events (AEs) incidence in comparison with other antibiotics (OR=1.06, 95% CI 0.71 to 1.59, p=0.76, I2=41%). The trend showed that daptomycin might cause less discontinuation due to AEs and death compared with other first-line antibiotics (OR=0.71, 95% CI 0.46 to 1.10, p=0.12, I2=11%). Significantly more patients in the daptomyicn group had creatine phosphokinase elevation than those in the control group; however, it could be reversed when the therapy ended (OR=1.95, 95% CI 1.04 to 3.65, p=0.04, I2=0).
Conclusions
This meta-analysis demonstrated that the safety and efficacy of daptomycin was not inferior to that of other first-line drugs, and daptomycin tended to exhibit superior efficacy when compared with vancomycin or with comparators for SA infections; nevertheless, more high-quality RCTs are needed to draw a more credible conclusion.
doi:10.1136/bmjopen-2013-004744
PMCID: PMC4078778  PMID: 24961714
Epidemiology
15.  Nutrient intake and brain biomarkers of Alzheimer's disease in at-risk cognitively normal individuals: a cross-sectional neuroimaging pilot study 
BMJ Open  2014;4(6):e004850.
Objective
There is increasing evidence to suggest that diet, one of the most important modifiable environmental factors, may play a role in preventing or delaying cognitive decline and Alzheimer's disease (AD). This study examines the relationship between dietary nutrients and brain biomarkers of AD in cognitively normal individuals (NL) with and without AD risk factors.
Design
As part of an ongoing brain imaging study, participants received clinical and laboratory examinations, a neurocognitive test battery, positron emission tomography (PET) with 11C-Pittsburgh Compound-B (PiB; a measure of amyloid-β (Aβ) load) and 18F-fluorodeoxyglucose (FDG; a proxy of neuronal activity), and completed semiquantitative food frequency questionnaires.
Setting
Research centre affiliated with the Alzheimer's disease Core Center at New York University School of Medicine.
Participants
49 NL individuals (age 25–72 years, 69% women) with dietary information, 11C-PiB and 18F-FDG PET scans were examined.
Results
Controlling for age and total caloric intake, higher intake of vitamin B12, vitamin D and ω-3 polyunsaturated fatty acid (PUFA) was associated with lower Aβ load in AD regions on PiB-PET, while higher intake of β-carotene and folate was associated with higher glucose metabolism on FDG-PET. β-carotene and folate were associated with reduced glucose metabolism for women, apolipoprotein E epsilon 4 (APOE4) carriers and participants with positive AD family history, but not for their risk-free counterparts. The associations of vitamin B12, vitamin D and ω-3 PUFA with PiB retention were independent of gender, APOE and family history. The identified nutrient combination was associated with higher intake of vegetables, fruit, whole grains, fish and legumes, and lower intake of high-fat dairies, meat and sweets.
Conclusions
Our data provide a potential pathophysiological mechanism for epidemiological findings showing that dietary interventions may play a role in the prevention of AD. Longitudinal studies are needed to determine whether there is a direct link between nutrient intake, brain biomarkers and risk of AD.
doi:10.1136/bmjopen-2014-004850
PMCID: PMC4078781  PMID: 24961717
Nuclear Medicine; Nutrition & Dietetics; Radiology & Imaging
16.  Effect of protective ventilation on postoperative pulmonary complications in patients undergoing general anaesthesia: a meta-analysis of randomised controlled trials 
BMJ Open  2014;4(6):e005208.
Objective
To determine whether anaesthetised patients undergoing surgery could benefit from intraoperative protective ventilation strategies.
Methods
MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) were searched up to February 2014. Eligible studies evaluated protective ventilation versus conventional ventilation in anaesthetised patients without lung injury at the onset of mechanical ventilation. The primary outcome was the incidence of postoperative pulmonary complications. Included studies must report at least one of the following end points: the incidence of atelectasis or acute lung injury or pulmonary infections.
Results
Four studies (594 patients) were included. Meta-analysis using a random effects model showed a significant decrease in the incidence of atelectasis (OR=0.36; 95% CI 0.22 to 0.60; p<0.0001; I2=0%) and pulmonary infections (OR=0.30; 95% CI 0.14 to 0.68; p=0.004; I2=20%) in patients receiving protective ventilation. Ventilation with protective strategies did not reduce the incidence of acute lung injury (OR=0.40; 95% CI 0.07 to 2.15; p=0.28; I2=12%), all-cause mortality (OR=0.77; 95% CI 0.33 to 1.79; p=0.54; I2=0%), length of hospital stay (weighted mean difference (WMD)=−0.52 day, 95% CI −4.53 to 3.48 day; p=0.80; I2=63%) or length of intensive care unit stay (WMD=−0.55 day, 95% CI −2.19 to 1.09 day; p=0.51; I2=39%).
Conclusions
Intraoperative use of protective ventilation strategies has the potential to reduce the incidence of postoperative pulmonary complications in patients undergoing general anaesthesia. Prospective, well-designed clinical trials are warranted to confirm the beneficial effects of protective ventilation strategies in surgical patients.
doi:10.1136/bmjopen-2014-005208
PMCID: PMC4078782  PMID: 24961718
17.  FluMum: a prospective cohort study of mother–infant pairs assessing the effectiveness of maternal influenza vaccination in prevention of influenza in early infancy 
BMJ Open  2014;4(6):e005676.
Introduction
Influenza vaccination in pregnancy is recommended for all women in Australia, particularly those who will be in their second or third trimester during the influenza season. However, there has been no systematic monitoring of influenza vaccine uptake among pregnant women in Australia. Evidence is emerging of benefit to the infant with respect to preventing influenza infection in the first 6 months of life. The FluMum study aims to systematically monitor influenza vaccine uptake during pregnancy in Australia and determine the effectiveness of maternal vaccination in preventing laboratory-confirmed influenza in their offspring up to 6 months of age.
Methods and analysis
A prospective cohort study of 10 106 mother–infant pairs recruited between 38 weeks gestation and 55 days postdelivery in six Australian capital cities. Detailed maternal and infant information is collected at enrolment, including influenza illness and vaccination history with a follow-up data collection time point at infant age 6 months. The primary outcome is laboratory-confirmed influenza in the infant. Case ascertainment occurs through searches of Australian notifiable diseases data sets once the infant turns 6 months of age (with parental consent). The primary analysis involves calculating vaccine effectiveness against laboratory-confirmed influenza by comparing the incidence of influenza in infants of vaccinated mothers to the incidence in infants of unvaccinated mothers. Secondary analyses include annual and pooled estimates of the proportion of mothers vaccinated during pregnancy, the effectiveness of maternal vaccination in preventing hospitalisation for acute respiratory illness and modelling to assess the determinants of vaccination.
Ethics and dissemination
The study was approved by all institutional Human Research Ethics Committees responsible for participating sites. Study findings will be published in peer review journals and presented at national and international conferences.
Trial registration number
The study is registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR) number: 12612000175875.
doi:10.1136/bmjopen-2014-005676
PMCID: PMC4078783  PMID: 24961719
18.  A systematic review of the influence of occupational organophosphate pesticides exposure on neurological impairment 
BMJ Open  2014;4(6):e004798.
Objective
The aim of this study was to conduct a systematic review of the published literature and to estimate whether or not there is a causal relationship between occupational exposure to organophosphate pesticides (OPs) and either neurological impairment or depressive symptoms.
Data sources
EMBASE, MEDLINE, Global Health and PsycINFO (1980 to April 2014).
Setting
Observational studies (cross-sectional, cohort and case–control studies) with exposed and unexposed groups.
Participants
People who occupationally use OPs for more than 1 month and their family.
Primary outcome
Results of neurological core test batteries or depressive symptoms such as headaches, anxiety and dizziness.
Study appraisal and synthesis methods
After an extensive search of various literature databases, one author screened titles and abstracts, searched the relevant publications manually and conducted data extraction. All extracted data from the selected articles were synthesised for analysis. Quality appraisal was conducted using the Newcastle Ottawa Scale.
Results
Of the 1024 articles retrieved by database search, 24 studies that met the inclusion and exclusion criteria were selected for analysis. Of the selected studies, 17 were cross-sectional and the remaining 7 were cohort and nested case–control studies. The geographical areas included in the studies were the USA (10 studies), the UK (4 studies), Africa (4 studies), Asia (3 studies), Europe (2 studies) and South America (1 study). Each of the included studies used different exposure and outcome assessments such as neurological scores and depressive symptoms, making it difficult to compare the results exactly. Most studies showed that exposed groups had poorer results than unexposed groups; however, owing to the inconsistent neurological test batteries, there was not enough pooling evidence to conduct a meta-analysis.
Conclusions
The findings of this literature review indicate that it is necessary to standardise the neurological or neuropsychological test battery and methods of measuring exposure to OPs.
doi:10.1136/bmjopen-2014-004798
PMCID: PMC4078784  PMID: 24961715
Environmental Health
19.  Addressing the evidence to practice gap for complex interventions in primary care: a systematic review of reviews protocol 
BMJ Open  2014;4(6):e005548.
Introduction
Getting the results of research implemented into routine healthcare is often a challenge. The disconnect between the development and implementation of evidence into practice is called the ‘second translational gap’ and is particularly apparent in primary care. To address this gap, we plan to identify, summarise and synthesise currently available evidence by undertaking a systematic review of reviews to: (1) explore barriers and facilitators of implementation of research evidence or complex interventions, and (2) assess the effectiveness of strategies in facilitating implementation of complex interventions in primary care.
Methods and analysis
This is a protocol for a systematic review of reviews. We will search MEDLINE, EMBASE, the Cochrane Library, CINAHL and PsycINFO up until December 2013. We will check reference lists of included studies for further studies. Two authors will independently screen the titles and abstracts identified from the search; any discrepancies will be resolved by discussion and consensus. Full-text papers will be obtained and relevant reviews will be selected against inclusion criteria. Eligible reviews have to be based on predominantly primary care in developed countries and examine either factors to implementation or, the effectiveness of strategies to optimise implementation. Data from eligible reviews will be extracted using standardised data abstraction forms. For barriers and facilitators, data will be synthesised using an interpretative meta-synthesis approach. For implementation strategies, findings will be summarised and described narratively and synthesised using a framework approach. All findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Ethics and dissemination
Ethical approval is not required. The review findings will inform the work of the design and implementation of future studies and will be of interest to a wide audience including health professionals, researchers, health service or commissioning managers and policymakers.
Trial registration number
Protocol registration number (PROSPERO CRD42014009410).
doi:10.1136/bmjopen-2014-005548
PMCID: PMC4067819  PMID: 24958212
Primary Care; Public Health
20.  Understanding how appraisal of doctors produces its effects: a realist review protocol 
BMJ Open  2014;4(6):e005466.
Introduction
UK doctors are now required to participate in revalidation to maintain their licence to practise. Appraisal is a fundamental component of revalidation. However, objective evidence of appraisal changing doctors’ behaviour and directly resulting in improved patient care is limited. In particular, it is not clear how the process of appraisal is supposed to change doctors’ behaviour and improve clinical performance. The aim of this research is to understand how and why appraisal of doctors is supposed to produce its effect.
Methods and analysis
Realist review is a theory-driven interpretive approach to evidence synthesis. It applies realist logic of inquiry to produce an explanatory analysis of an intervention that is, what works, for whom, in what circumstances, in what respects. Using a realist review approach, an initial programme theory of appraisal will be developed by consulting with key stakeholders in doctors’ appraisal in expert panels (ethical approval is not required), and by searching the literature to identify relevant existing theories. The search strategy will have a number of phases including a combination of: (1) electronic database searching, for example, EMBASE, MEDLINE, the Cochrane Library, ASSIA, (2) ‘cited by’ articles search, (3) citation searching, (4) contacting authors and (5) grey literature searching. The search for evidence will be iteratively extended and refocused as the review progresses. Studies will be included based on their ability to provide data that enable testing of the programme theory. Data extraction will be conducted, for example, by note taking and annotation at different review stages as is consistent with the realist approach. The evidence will be synthesised using realist logic to interrogate the final programme theory of the impact of appraisal on doctors’ performance. The synthesis results will be written up according to RAMESES guidelines and disseminated through peer-reviewed publication and presentations.
Trial registration number
The protocol is registered with PROSPERO 2014:CRD42014007092.
doi:10.1136/bmjopen-2014-005466
PMCID: PMC4067866  PMID: 24958211
EDUCATION & TRAINING (see Medical Education & Training); HEALTH SERVICES ADMINISTRATION & MANAGEMENT; MEDICAL EDUCATION & TRAINING
21.  Birth cohort study on the effects of desert dust exposure on children's health: protocol of an adjunct study of the Japan Environment & Children’s Study 
BMJ Open  2014;4(6):e004863.
Introduction
Desert dust is estimated to constitute about 35% of aerosol in the troposphere. Desertification, climatic variability and global warming all can contribute to increased dust formation. This study aims to examine possible health effects of desert dust exposure on pregnant women and their children. The purpose of this report was to present the study protocol.
Methods and analysis
This 4-year birth cohort study began in 2011 as an adjunct study of the Japan Environment & Children’s Study (JECS) involving three regions: Kyoto, Toyama and Tottori. The JECS participants of the three regions above who also agreed to participate in this adjunct study were enrolled prior to delivery. Light Detecting and Ranging (LIDAR) with a polarisation analyser, which can distinguish mineral dust particles from other particles, is used for exposure measurements. Outcomes are allergic symptoms for mothers and development of asthma and other allergic or respiratory diseases for their children. Data are acquired in a timely manner by connecting local LIDAR equipment to an online questionnaire system. Participants answer the online questionnaire using mobile phones or personal computers.
Ethics and dissemination
The study protocol was approved by the ethics committees of Kyoto University, University of Toyama and Tottori University. All participants provided written informed consent. The results of this study will be published in peer-reviewed journals and disseminated to the scientific community and general public.
Trial Registration number
UMIN000010826.
doi:10.1136/bmjopen-2014-004863
PMCID: PMC4067890  PMID: 24958210
Epidemiology; Immunology; Public Health
22.  Measures of vitamin K antagonist control reported in atrial fibrillation and venous thromboembolism studies: a systematic review 
BMJ Open  2014;4(6):e005379.
Objective
To aid trialists, systematic reviewers and others, we evaluated the degree of standardisation of control measure reporting that has occurred in atrial fibrillation (AF) and venous thromboembolism (VTE) studies since 2000; and attempted to determine whether the prior recommendation of reporting ≥2 measures per study has been employed.
Design
Systematic review.
Search strategy
We searched bibliographic databases (2000 to June 2013) to identify AF and VTE studies evaluating dose-adjusted vitamin K antagonists (VKAs) and reporting ≥1 control measure. The types of measures reported, proportion of studies reporting ≥2 measures and mean (±SD) number of measures per study were determined for all studies and compared between subgroups.
Data extraction
Through the use of a standardised data extraction tool, we independently extracted all data, with disagreements resolved by a separate investigator.
Results
148 studies were included, 57% of which reported ≥2 control measures (mean/study=2.13±1.36). The proportion of time spent in the target international normalised ratio range (TTR) was most commonly reported (79%), and was frequently accompanied by time above/below range (52%). AF studies more frequently reported ≥2 control measures compared with VTE studies (63% vs 37%; p=0.004), and reported a greater number of measures per study (mean=2.36 vs 1.53; p<0.001). Observational studies were more likely to provide ≥2 measures compared with randomised trials (76% vs 33%; p<0.001) and report a greater number of measures (mean=2.58 vs 1.63; p<0.001). More recent studies (2004–2013) reported ≥2 measures more often than older (2000–2003) studies (59% vs 35%; p=0.05) and reported more measures per study (mean=2.23 vs 1.48; p=0.02).
Conclusions
While TTR was often utilised, studies reported ≥2 measures of VKA control only about half of the time and lacked consistency in the types of measures reported. A trend towards studies reporting greater numbers of VKA control measures over time was observed over our review time horizon, particularly, with AF and observational studies.
doi:10.1136/bmjopen-2014-005379
PMCID: PMC4067815  PMID: 24951111
23.  Lifestyle risk factors for invasive pneumococcal disease: a systematic review 
BMJ Open  2014;4(6):e005224.
Objective
To systematically review the literature for evidence of smoking and alcohol intake as independent risk factors for invasive pneumococcal disease (IPD).
Design
Systematic review.
Methods
MEDLINE (1946—May 2012) and EMBASE (1947—May 2012) were searched for studies investigating alcohol or smoking as risk factors for acquiring IPD and which reported results as relative risk. Studies conducted exclusively in clinical risk groups, those assessing risk factors for outcomes other than acquisition of IPD and studies describing risk factors without quantifying a relative risk were excluded.
Results
Seven observational studies were identified and reviewed; owing to the heterogeneity of study design, meta-analysis was not attempted. Five of six studies investigating smoking reported an increased risk of IPD in the range 2.2–4.1. Four of the six studies investigating alcohol intake reported a significant increased risk for IPD ranging from 2.9 to 11.4, while one reported a significant protective effect.
Conclusions
Overall, these observational data suggest that smoking and alcohol misuse may increase the risk of IPD in adults, but the magnitude of this risk remains unclear and should be explored with further research. The findings of this review will contribute to the debate on whether pneumococcal vaccine should be offered to smokers and people who misuse alcohol in addition to other clinically defined risk groups.
doi:10.1136/bmjopen-2014-005224
PMCID: PMC4067833  PMID: 24951110
Infectious Diseases; Microbiology; Public Health
24.  Understanding experiences of participating in a weight loss lifestyle intervention trial: a qualitative evaluation of South Asians at high risk of diabetes 
BMJ Open  2014;4(6):e004736.
Objective
To explore the reasons for enrolling, experiences of participating and reasons for remaining in a family-based, cluster randomised controlled trial of a dietitian-delivered lifestyle modification intervention aiming to reduce obesity in South Asians at high risk of developing diabetes.
Design
Qualitative study using narrative interviews of a purposive sample of trial participants following completion of the intervention. Data were thematically analysed.
Setting
The intervention was conducted in Scotland and resulted in a modest decrease in weight, but did not statistically reduce the incidence of diabetes.
Participants
We conducted 21 narrative interviews with 24 participants (20 trial participants and four family volunteers).
Results
Many participants were motivated to participate because of: known family history of diabetes and the desire to better understand diabetes-related risks to their own and their family's health; ways to mitigate these risks and to benefit from personalised monitoring. Home-based interventions, communication in the participant's chosen language(s) and continuity in dietitians supported their continuing engagement with the trial. Adaptations in food choices were initially accommodated by participants, although social and faith-based responsibilities were reported as important barriers to persevering with agreed dietary goals. Many participants reported that increasing their level of physical activity was difficult given their long working hours, physically demanding employment and domestic commitments; this being compounded by Scotland's challenging climate and a related reluctance to exercise in the outdoors.
Conclusions
Although participants had strong personal interests in participation and found the information provided by dietitians useful, they nonetheless struggled to incorporate the dietary and exercise recommendations into their daily lives. In particular, increasing levels of physical exercise was described as an additional and in some cases unachievable burden. Consideration needs to be given to strengthening and supporting lifestyle interventions with community-based approaches in order to help overcome wider social and environmental factors.
doi:10.1136/bmjopen-2013-004736
PMCID: PMC4067864  PMID: 24951108
Diabetes & Endocrinology; Preventive Medicine; Public Health; Qualitative Research
25.  Association of lifestyle factors and suboptimal health status: a cross-sectional study of Chinese students 
BMJ Open  2014;4(6):e005156.
Objectives
Suboptimal health status (SHS) is considered to be an intermediate status between disease and health, and is characterised by a decline in vitality, in physiological function and in the capacity for adaptation. Although the incidence of SHS is high, the underlying causes remain unclear. Lifestyle is one of the most important factors affecting health status; however, the relationship between SHS and lifestyle has not been elucidated.
Design
Cross-sectional survey.
Setting
A questionnaire, based on ‘Health Promoting Lifestyle Profile-II (HPLP-II)’ and ‘Sub-Health Measurement Scale V1.0 (SHMS V1.0)’, was sent to four colleges in four districts (Guangzhou, Foshan, Zhanjiang and Shaoguan) of China between May and July 2013.
Participants
A total of 12 429 questionnaires were distributed during the study period, and 11 144 completed responses were received.
Results
The prevalence rates for the ‘healthy’, ‘SHS’ and ‘disease’ groups of respondents (students) were 22.81% (2542), 55.9% (6234) and 21.25% (2368), respectively. Most of the students reported a ‘moderate’ or ‘good’ lifestyle. There were significant differences in lifestyle and health status between the two genders. It was notable that health status was significantly positively correlated with lifestyle (r=0.563). For every dimension of the HPLP-II model, the mean values were lower for those participants who reported as ‘SHS’ or ‘disease’ than for those who reported that they were ‘healthy’. The individual dimensions of the HPLP-II model, including ‘spiritual growth’, ‘health responsibility’, ‘physical activity’, ‘interpersonal relations’ and ‘stress management’ were all related to SHS.
Conclusions
Health status is significantly positively correlated with lifestyle. Poor lifestyle is a risk factor for SHS. Conversely, adopting a healthier lifestyle can improve SHS.
Trial registration number
ChiCTR-OCH-12002317.
doi:10.1136/bmjopen-2014-005156
PMCID: PMC4067885  PMID: 24951109
PUBLIC HEALTH; EPIDEMIOLOGY; SOCIAL MEDICINE

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