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Year of Publication
1.  Association of birth of girls with postnatal depression and exclusive breastfeeding: an observational study 
BMJ Open  2014;4(6):e003545.
Objectives and hypothesis
To examine the influence of gender of the baby on exclusive breastfeeding and incidence of postnatal depression (PND). We hypothesise that in a society with a male gender bias there may be more PND and less exclusive breastfeeding of the girl child.
Design
Prospective study.
Setting
The study was conducted in an urban, tertiary hospital in Delhi.
Participants
Mothers delivering normally with their babies roomed-in.1537 eligible women participated in the study.
Primary and secondary outcome measures
Exclusive breastfeeding within the first 48 h of life and score on the Edinburgh Postnatal Depression Scale (EPDS) were recorded.
Results
3466 babies were born in the hospital. There were 792 girls for every 1000 boys. Among primiparous women, the sex ratio was 901 girls per 1000 boys. For second babies, the sex ratio was 737:1000. If the first child was a girl the birth ratio fell to 632. 1026 mothers were exclusively breastfeeding. Exclusive breastfeeding of boys was significantly higher (70.8% vs 61.5%, p<0.001). The EPDS score was significantly higher with the birth of girls (EPDS 6.0±3.39 vs 5.4±2.87, p<0.01). Women with an EPDS score >11 were less likely to exclusively breastfeed (p<0.01).
Conclusions
The results point to a pro-male gender bias evidenced by a low sex ratio at birth, higher EPDS score in mothers of girls and less breastfeeding of female children.
doi:10.1136/bmjopen-2013-003545
PMCID: PMC4054658  PMID: 24913326
2.  Marital status and survival after oesophageal cancer surgery: a population-based nationwide cohort study in Sweden 
BMJ Open  2014;4(6):e005418.
Objectives
A beneficial effect of being married on survival has been shown for several cancer types, but is unclear for oesophageal cancer. The objective of this study was to clarify the potential influence of the marital status on the overall and disease-specific survival after curatively intended treatment of oesophageal cancer using a nationwide population-based design, taking into account the known major prognostic variables.
Design
Prospective, population-based cohort.
Setting
All Swedish hospitals performing surgery for oesophageal cancer during 2001–2005.
Participants
This study included 90% of all patients with oesophageal or junctional cancer who underwent surgical resection in Sweden in 2001–2005, with follow-up until death or the end of the study period (2012).
Primary and secondary outcome measures
Cox regression was used to estimate associations between the marital status and the 5-year overall and disease-specific mortality, expressed as HRs with 95% CIs, with adjustment for sex, age, tumour stage, histological type, complications, comorbidities and annual surgeon volume.
Results
Of all 606 included patients (80.4% men), 55.1% were married, 9.2% were remarried, 22.6% were previously married and 13% were never married. Compared with the married patients, the never married (HR 1.02, 95% CI 0.77 to 1.35), previously married (HR 0.90, 95% CI 0.71 to 1.15) and remarried patients (HR 0.79, 95% CI 0.55 to 1.13) had no increased overall 5-year mortality. The corresponding HRs for disease-specific survival, and after excluding the initial 90 days of surgery, were similar to the HRs for the overall survival.
Conclusions
This study showed no evidence of a better 5-year survival in married patients compared with non-married patients undergoing surgery for oesophageal cancer.
doi:10.1136/bmjopen-2014-005418
PMCID: PMC4054621  PMID: 24907248
Oesophageal Cancer; Marital Status; Survival
3.  Psychiatric disorders following fetal death: a population-based cohort study 
BMJ Open  2014;4(6):e005187.
Objectives
Women have increased risks of severe mental disorders after childbirth and death of a child, but it remains unclear whether this association also applies to fetal loss and, if so, to which extent. We studied the risk of any inpatient or outpatient psychiatric treatment during the time period from 12 months before to 12 months after fetal death.
Design
Cohort study using Danish population-based registers.
Setting
Denmark.
Participants
A total of 1 112 831 women born in Denmark from 1960 to 1995 were included. In total, 87 687cases of fetal death (International Classification of Disease-10 codes for spontaneous abortion or stillbirth) were recorded between 1996 and 2010.
Primary and secondary outcome measures
The main outcome measures were incidence rate ratios (risk of first psychiatric inpatient or outpatient treatment).
Results
A total of 1379 women had at least one psychiatric episode during follow-up from the year before fetal death to the year after. Within the first few months after the loss, women had an increased risk of psychiatric contact, IRR: 1.51 (95% CI 1.15 to 1.99). In comparison, no increased risk of psychiatric contact was found for the period before fetal death. The risk of experiencing a psychiatric episode was highest for women with a loss occurring after 20 weeks of gestation (12 month probability: 1.95%, 95% CI 1.50 to 2.39).
Conclusions
Fetal death was associated with a transient increased risk of experiencing a first-time episode of a psychiatric disorder, primarily adjustment disorders. The risk of psychiatric episodes tended to increase with increasing gestational age at the time of the loss.
doi:10.1136/bmjopen-2014-005187
PMCID: PMC4054628  PMID: 24907247
Epidemiology; Obstetrics; Psychiatry
4.  An instrument for the assessment of diarrhoeal severity based on a longitudinal community-based study 
BMJ Open  2014;4(6):e004816.
Objective
Diarrhoea is a significant contributer to morbidity and is among the leading causes of death of children living in poverty. As such, the incidence, duration and severity of diarrhoeal episodes in the household are often key variables of interest in a variety of community-based studies. However, there currently exists no means of defining diarrhoeal severity that are (A) specifically designed and adapted for community-based studies, (B) associated with poorer child outcomes and (C) agreed on by the majority of researchers. Clinical severity scores do exist and are used in healthcare settings, but these tend to focus on relatively moderate-to-severe dehydrating and dysenteric disease, require trained observation of the child and, given the variability of access and utilisation of healthcare, fail to sufficiently describe the spectrum of disease in the community setting.
Design
Longitudinal cohort study.
Setting
Santa Clara de Nanay, a rural community in the Northern Peruvian Amazon.
Participants
442 infants and children 0–72 months of age.
Main outcome measures
Change in weight over 1-month intervals and change in length/height over 9-month intervals.
Results
Diarrhoeal episodes with symptoms of fever, anorexia, vomiting, greater number of liquid stools per day and greater number of total stools per day were associated with poorer weight gain compared with episodes without these symptoms. An instrument to measure the severity was constructed based on the duration of these symptoms over the course of a diarrhoeal episode.
Conclusions
In order to address limitations of existing diarrhoeal severity scores in the context of community-based studies, we propose an instrument comprised of diarrhoea-associated symptoms easily measured by community health workers and based on the association of these symptoms with poorer child growth. This instrument can be used to test the impact of interventions on the burden of diarrhoeal disease.
doi:10.1136/bmjopen-2014-004816
PMCID: PMC4054634  PMID: 24907244
5.  Association of lifestyle-related factors with circadian onset patterns of acute myocardial infarction: a prospective observational study in Japan 
BMJ Open  2014;4(6):e005067.
Objective
The onset of acute myocardial infarction (AMI) shows characteristic circadian variations involving a definite morning peak and a less-defined night-time peak. However, the factors influencing the circadian patterns of AMI onset and their influence on morning and night-time peaks have not been fully elucidated.
Design, setting and participants
An analysis of patients registered between 1998 and 2008 in the Osaka Acute Coronary Insufficiency Study, which is a prospective, multicentre observational study of patients with AMI in the Osaka region of Japan. The present study included 7755 consecutive patients with a known time of AMI onset.
Main outcomes and measures
A mixture of two von Mises distributions was used to examine whether a circadian pattern of AMI had uniform, unimodal or bimodal distribution, and the likelihood ratio test was then used to select the best circadian pattern among them. The hierarchical likelihood ratio test was used to identify factors affecting the circadian patterns of AMI onset. The Kaplan-Meier method was used to estimate survival curves of 1-year mortality according to AMI onset time.
Results
The overall population had a bimodal circadian pattern of AMI onset characterised by a high and sharp morning peak and a lower and less-defined night-time peak (bimodal p<0.001). Although several lifestyle-related factors had a statistically significant association with the circadian patterns of AMI onset, serum triglyceride levels had the most prominent association with the circadian patterns of AMI onset. Patients with triglyceride ≥150 mg/dL on admission had only one morning peak in the circadian pattern of AMI onset during weekdays, with no peaks detected on weekends, whereas all other subgroups had two peaks throughout the week.
Conclusions
The circadian pattern of AMI onset was characterised by bimodality. Notably, several lifestyle-related factors, particularly serum triglyceride levels, had a strong relation with the circadian pattern of AMI onset.
Trial registration number
UMIN000004575.
doi:10.1136/bmjopen-2014-005067
PMCID: PMC4054644  PMID: 24907246
6.  Study protocol for the nutritional route in oesophageal resection trial: a single-arm feasibility trial (NUTRIENT trial) 
BMJ Open  2014;4(6):e004557.
Introduction
The best route of feeding for patients undergoing an oesophagectomy is unclear. Concerns exist that early oral intake would increase the incidence and severity of pneumonia and anastomotic leakage. However, in studies including patients after many other types of gastrointestinal surgery and in animal experiments, early oral intake has been shown to be beneficial and enhance recovery. Therefore, we aim to determine the feasibility of early oral intake after oesophagectomy.
Methods and analysis
This study is a feasibility trial in which 50 consecutive patients will start oral intake directly following oesophagectomy. Primary outcomes will be the frequency and severity of anastomotic leakage and (aspiration) pneumonia. Clinical parameters will be registered prospectively and nutritional requirements and intake will be assessed by a dietician. Surgical complications will be registered.
Ethics and dissemination
Approval for this study has been obtained from the Medical Ethical Committee of the Catharina Hospital Eindhoven and the study has been registered at the Dutch Trial Register, NTR4136. Results will be published and presented at international congresses.
Discussion
We hypothesise that the oral route of feeding is safe and feasible following oesophagectomy, as has been shown previously for other types of gastrointestinal surgery. It is expected that early oral nutrition will result in enhanced recovery. Furthermore, complications related to artificial feeding, such as jejunostomy tube feeding, are believed to be reduced. However, (aspiration) pneumonia and anastomotic leakage are potential risks that are carefully monitored.
Trial registration number
NTR4136.
doi:10.1136/bmjopen-2013-004557
PMCID: PMC4054648  PMID: 24907243
Nutrition & Dietetics
7.  How weight change is modelled in population studies can affect research findings: empirical results from a large-scale cohort study 
BMJ Open  2014;4(6):e004860.
Objectives
To investigate how results of the association between education and weight change vary when weight change is defined and modelled in different ways.
Design
Longitudinal cohort study.
Participants
60 404 men and women participating in the Social, Environmental and Economic Factors (SEEF) subcomponent of the 45 and Up Study—a population-based cohort study of people aged 45 years or older, residing in New South Wales, Australia.
Outcome measures
The main exposure was self-reported education, categorised into four groups. The outcome was annual weight change, based on change in self-reported weight between the 45 and Up Study baseline questionnaire and SEEF questionnaire (completed an average of 3.3 years later). Weight change was modelled in four different ways: absolute change (kg) modelled as (1) a continuous variable and (2) a categorical variable (loss, maintenance and gain), and relative (%) change modelled as (3) a continuous variable and (4) a categorical variable. Different cut-points for defining weight-change categories were also tested.
Results
When weight change was measured categorically, people with higher levels of education (compared with no school certificate) were less likely to lose or to gain weight. When weight change was measured as the average of a continuous measure, a null relationship between education and annual weight change was observed. No material differences in the education and weight-change relationship were found when comparing weight change defined as an absolute (kg) versus a relative (%) measure. Results of the logistic regression were sensitive to different cut-points for defining weight-change categories.
Conclusions
Using average weight change can obscure important directional relationship information and, where possible, categorical outcome measurements should be included in analyses.
doi:10.1136/bmjopen-2014-004860
PMCID: PMC4054657  PMID: 24907245
education; cohort studies
8.  Coproduction in commissioning decisions: is there an association with decision satisfaction for commissioners working in the NHS? A cross-sectional survey 2010/2011 
BMJ Open  2014;4(6):e004810.
Objectives
To undertake an assessment of the association between coproduction and satisfaction with decisions made for local healthcare communities.
Design
A coproduction scale was developed and tested to measure individual National Health Service (NHS) commissioners’ satisfaction with commissioning decisions.
Setting
11 English Primary Care Trusts in 2010–2011.
Participants
Staff employed at NHS band 7 or above involved in commissioning decisions in the NHS. 345/440 (78%) of participants completed part of all of the survey.
Main outcome measure
Reliability and validity of a coproduction scale were assessed using a correlation-based principal component analysis model with direct oblimin rotation. Multilevel modelling was used to predict decision satisfaction.
Results
The analysis revealed that coproduction consisted of three principal components: productive discussion, information and dealing with uncertainty. Higher decision satisfaction was associated with smaller decisions, more productive discussion, decisions where information was readily available to use and those where decision-making tools were more often used.
Conclusions
The research indicated that coproduction may be an important factor for satisfaction with decision-making in the commissioning of healthcare services.
doi:10.1136/bmjopen-2014-004810
PMCID: PMC4054620  PMID: 24902728
Health Services Administration & Management; Health Services Commissioning; Healthcare Decision Making; Health Services Management ; Health Policy
9.  Use of corticosteroids during pregnancy and risk of asthma in offspring: a nationwide Danish cohort study 
BMJ Open  2014;4(6):e005053.
Objective
To examine whether in utero exposure to local and systemic corticosteroids is associated with asthma development in offspring.
Design
Cohort study.
Setting
Denmark.
Participants
We included all singletons born alive in Denmark between 1996 and 2009. Data on maternal corticosteroid use, asthma in offspring and covariates were obtained from medical registries.
Main outcome measures
We compared asthma risks of children prenatally exposed to corticosteroids and of children of former corticosteroid users with that of unexposed children. We computed absolute risks and used proportional-hazards regression to compute adjusted HRs (aHRs). Using logistic regression we compared exposed children with unexposed siblings in a ‘within-mother-between-pregnancy’ analysis. Adjustment addressed varying length of follow-up.
Results
We identified 877 778 children, 3.6% of whom were prenatally exposed to systemic (n=5327) or local (n=24 436) corticosteroids. A total of 105 677 children developed asthma during follow-up with a 10-year risk of 18.4% among the exposed and 13.5% among the unexposed. The aHR was 1.54 (95% CI 1.45 to 1.65) for systemic use, 1.45 (95% CI 1.40 to 1.50) for local use and 1.32 (95% CI 1.30 to 1.34) for former use. The adjusted OR of the ‘within-mother-between-pregnancy’ analysis was 1.11 (95% CI 0.98 to 1.25).
Conclusions
These population-based data do not support a strong causal association between maternal corticosteroid use during pregnancy and increased asthma risk in offspring.
doi:10.1136/bmjopen-2014-005053
PMCID: PMC4054622  PMID: 24902733
CLINICAL PHARMACOLOGY; EPIDEMIOLOGY; PERINATOLOGY; RESPIRATORY MEDICINE (see Thoracic Medicine)
10.  Comparison of the aetiology of stillbirth over five decades in a single centre: a retrospective study 
BMJ Open  2014;4(6):e004635.
Objective
To compare the rates and aetiologies of stillbirth over the past 50 years.
Study design
We reviewed all autopsy reports for stillbirths occurring between 1989 and 2009 at the McGill University Health Centre to determine the pathological aetiology of stillbirths. We also reviewed maternal characteristics. We compared our results with a previous study published in 1992 on aetiologies of stillbirth from 1961 to 1988 at the same institution.
Results
From among the 79 410 births between 1989 and 2009, 217 stillbirths were included in our study. The mean maternal age was 31.05 (±5.8) years. In 28.1% of cases, there was a history of subfertility. The mean gestational age at diagnosis was 32.69 (±5.58) weeks, with a birthweight of 1888 (±1084) g. The main causes of stillbirth were unknown (26.7%), placental factors (19.8%) and abruptio placentae (12.9%). Other causes included haematogenous or ascending infection (10.6%), fetal malformations (8.3%), maternal hypertension (3.2%), intrauterine growth restriction (2.8%), diabetes (1.8%) and intrapartum asphyxia (1.4%). Other fetal causes were found in 12.4% of cases.
Conclusions
Owing to detailed pathological examination of most stillbirth cases over the past five decades at our tertiary obstetrical centre, we could study the trends in the aetiology of stillbirths in a cohort of more than 150 000 births. In 50 years, the rate of stillbirth has decreased from 115 to 32 cases/10 000 births from the 1960s to 2000s, which represents a reduction of 72%. Stillbirth from unknown cause remains the most common contributor, with 40% of these cases occurring in late pregnancy.
doi:10.1136/bmjopen-2013-004635
PMCID: PMC4054626  PMID: 24902725
11.  Unexpectedly long hospital stays as an indicator of risk of unsafe care: an exploratory study 
BMJ Open  2014;4(6):e004773.
Objectives
We developed an outcome indicator based on the finding that complications often prolong the patient's hospital stay. A higher percentage of patients with an unexpectedly long length of stay (UL-LOS) compared to the national average may indicate shortcomings in patient safety. We explored the utility of the UL-LOS indicator.
Setting
We used data of 61 Dutch hospitals. In total these hospitals had 1 400 000 clinical discharges in 2011.
Participants
The indicator is based on the percentage of patients with a prolonged length of stay of more than 50% of the expected length of stay and calculated among survivors.
Interventions
No interventions were made.
Outcome measures
The outcome measures were the variability of the indicator across hospitals, the stability over time, the correlation between the UL-LOS and standardised mortality and the influence on the indicator of hospitals that did have problems discharging their patients to other health services such as nursing homes.
Results
In order to compare hospitals properly the expected length of stay was computed based on comparison with benchmark populations. The standardisation was based on patients’ age, primary diagnosis and main procedure. The UL-LOS indicator showed considerable variability between the Dutch hospitals: from 8.6% to 20.1% in 2011. The outcomes had relatively small CIs since they were based on large numbers of patients. The stability of the indicator over time was quite high. The indicator had a significant positive correlation with the standardised mortality (r=0.44 (p<0.001)), and no significant correlation with the percentage of patients that was discharged to other facilities than other hospitals and home (r=−0.15 (p>0.05)).
Conclusions
The UL-LOS indicator is a useful addition to other patient safety indicators by revealing variation between hospitals and areas of possible patient safety improvement.
doi:10.1136/bmjopen-2013-004773
PMCID: PMC4054630  PMID: 24902727
12.  Physical activity, diet and BMI in children aged 6–8 years: a cross-sectional analysis 
BMJ Open  2014;4(6):e005001.
Objective
To assess relationships between current physical activity (PA), dietary intake and body mass index (BMI) in English children.
Design and setting
Longitudinal birth cohort study in northeast England, cross-sectional analysis.
Participants
425 children (41% of the original cohort) aged 6–8 years (49% boys).
Main outcome measures
PA over 7 days was measured objectively by an accelerometer; three categories of PA were created: ‘active’ ≥60 min/day moderate-to-vigorous-intensity PA (MVPA); ‘moderately active’ 30–59 min/day MVPA; ‘inactive’ <30 min/day MVPA. Dietary intake over 4 days was measured using a prospective dietary assessment tool which incorporated elements of the food diary and food frequency methods. Three diet categories were created: ‘healthy’, ‘unhealthy’ and ‘mixed’, according to the number of portions of different foods consumed. Adherence to the ‘5-a-day’ recommendations for portions of fruit and vegetables was also assessed. Children were classified as ‘healthy weight’ or ‘overweight or obese’ (OW/OB) according to International Obesity Taskforce cutpoints for BMI. Associations between weight status and PA/diet categories were analysed using logistic regression.
Results
Few children met the UK-recommended guidelines for either MVPA or fruit and vegetable intake, with just 7% meeting the recommended amount of MVPA of 60 min/day, and 3% meeting the 5-a-day fruit and vegetable recommendation. Higher PA was associated with a lower OR for OW/OB in boys only (0.20, 95% CI 0.04 to 0.88). There was no association detected between dietary intake and OW/OB in either sex.
Conclusions
Increasing MVPA may help to reduce OW/OB in boys; however, more research is required to examine this relationship in girls. Children are not meeting the UK guidelines for diet and PA, and more needs to be done to improve this situation.
doi:10.1136/bmjopen-2014-005001
PMCID: PMC4054632  PMID: 24902732
Public Health; Epidemiology
13.  Validation of risk assessment scales and predictors of intentions to quit smoking in Australian Aboriginal and Torres Strait Islander peoples: a cross-sectional survey protocol 
BMJ Open  2014;4(6):e004887.
Introduction
Tobacco smoking is a very significant behavioural risk factor for the health of Australian Aboriginal and Torres Strait Islanders, and is embedded as a social norm. With a focus on women of childbearing age, and men of similar age, this project aims to determine how Aboriginal and Torres Strait Islander smokers assess smoking risks and how these assessments contribute to their intentions to quit. The findings from this pragmatic study should contribute to developing culturally targeted interventions.
Methods and analysis
A cross-sectional study using quantitative and qualitative data. A total of 120 Aboriginal and Torres Strait Islander community members aged 18–45 years will be recruited at community events and through an Aboriginal Community Controlled Health Service (ACCHS). Participants will be interviewed using a tablet computer or paper survey. The survey instrument uses modified risk behaviour scales, that is, the Risk Behaviour Diagnosis (RBD) scale and the Smoking Risk Assessment Target (SRAT) (adapted from the Risk Acceptance Ladder) to determine whether attitudes of Aboriginal and Torres Strait Islander smokers to health risk messages are predictors of intentions to quit smoking.
The questionnaire will be assessed for face and content validity with a panel of Indigenous community members. The internal consistency of the RBD subscales and their patterns of correlation will be explored. Multivariate analyses will examine predictors of intentions to quit. This will include demographics such as age, gender, nicotine dependence, household smoking rules and perceived threat from smoking and efficacy for quitting. The two risk-assessment scales will be examined to see whether participant responses are correlated.
Ethics and dissemination
The Aboriginal Health & Medical Research Council Ethics Committee and university ethics committees approved the study. The results will be published in a peer-reviewed journal and a community report will be disseminated by the ACCHS, and at community forums.
Note about terminology
We use the term Aboriginal and Torres Strait Islander peoples, except where previous research has reported findings from only one group for example, Aboriginal people. Indigenous is used here to refer to Indigenous peoples in the international context, and issues, policies or systems, for example, Indigenous health, Indigenous tobacco control.
doi:10.1136/bmjopen-2014-004887
PMCID: PMC4054635  PMID: 24902729
PREVENTIVE MEDICINE; PUBLIC HEALTH
14.  Predictors of injury mortality: findings from a large national cohort in Thailand 
BMJ Open  2014;4(6):e004668.
Objective
To present predictors of injury mortality by types of injury and by pre-existing attributes or other individual exposures identified at baseline.
Design
5-year prospective longitudinal study.
Setting
Contemporary Thailand (2005–2010), a country undergoing epidemiological transition.
Participants
Data derived from a research cohort of 87 037 distance-learning students enrolled at Sukhothai Thammathirat Open University residing nationwide.
Measures
Cohort members completed a comprehensive baseline mail-out questionnaire in 2005 reporting geodemographic, behavioural, health and injury data. These responses were matched with national death records using the Thai Citizen ID number. Age–sex adjusted multinomial logistic regression was used to calculate ORs linking exposure variables collected at baseline to injury deaths over the next 5 years.
Results
Statistically significant predictors of injury mortality were being male (adjustedOR 3.87, 95% CI 2.39 to 6.26), residing in the southern areas (AOR 1.71, 95% CI 1.05 to 2.79), being a current smoker (1.56, 95% CI 1.03 to 2.37), history of drunk driving (AOR 1.49, 95% CI 1.01 to 2.20) and ever having been diagnosed for depression (AOR 1.91, 95% CI 1.00 to 3.69). Other covariates such as being young, having low social support and reporting road injury in the past year at baseline had moderately predictive AORs ranging from 1.4 to 1.6 but were not statistically significant.
Conclusions
We complemented national death registration with longitudinal data on individual, social and health attributes. This information is invaluable in yielding insight into certain risk traits such as being a young male, history of drunk driving and history of depression. Such information could be used to inform injury prevention policies and strategies.
doi:10.1136/bmjopen-2013-004668
PMCID: PMC4054638  PMID: 24902726
PUBLIC HEALTH
15.  Work stress, work motivation and their effects on job satisfaction in community health workers: a cross-sectional survey in China 
BMJ Open  2014;4(6):e004897.
Objective
It is well documented that both work stress and work motivation are key determinants of job satisfaction. The aim of this study was to examine levels of work stress and motivation and their contribution to job satisfaction among community health workers in Heilongjiang Province, China.
Design
Cross-sectional survey.
Setting
Heilongjiang Province, China.
Participants
The participants were 930 community health workers from six cities in Heilongjiang Province.
Primary and secondary outcome measures
Multistage sampling procedures were used to measure socioeconomic and demographic status, work stress, work motivation and job satisfaction. Logistic regression analysis was performed to assess key determinants of job satisfaction.
Results
There were significant differences in some subscales of work stress and work motivation by some of the socioeconomic characteristics. Levels of overall stress perception and scores on all five work stress subscales were higher in dissatisfied workers relative to satisfied workers. However, levels of overall motivation perception and scores on the career development, responsibility and recognition motivation subscales were higher in satisfied respondents relative to dissatisfied respondents. The main determinants of job satisfaction were occupation; age; title; income; the career development, and wages and benefits subscales of work stress; and the recognition, responsibility and financial subscales of work motivation.
Conclusions
The findings indicated considerable room for improvement in job satisfaction among community health workers in Heilongjiang Province in China. Healthcare managers and policymakers should take both work stress and motivation into consideration, as two subscales of work stress and one subscale of work motivation negatively influenced job satisfaction and two subscales of work motivation positively influenced job satisfaction.
doi:10.1136/bmjopen-2014-004897
PMCID: PMC4054641  PMID: 24902730
Public Health
16.  To ‘Get by’ or ‘get help’? A qualitative study of physicians’ challenges and dilemmas when patients have limited English proficiency 
BMJ Open  2014;4(6):e004613.
Objective
Encounters between patients and physicians who do not speak the same language are relatively common in Canada, particularly in urban settings; this trend is increasing worldwide. Language discordance has important effects on health outcomes, including mortality. This study sought to explore physicians’ experiences of care provision in situations of language discordance in depth.
Design
Qualitative study based on individual interviews. Interview guides elicited physicians’ perspectives on how they determined whether communication could proceed unaided. A descriptive qualitative approach was adopted, entailing inductive thematic analysis.
Participants
22 physicians experienced in treating patients in situations of language discordance were recruited from the emergency and internal medicine departments of an urban tertiary-care hospital.
Setting
Large, inner-city teaching hospital in Toronto, Canada, one of the most linguistically diverse cities internationally.
Results
Determining when to ‘get by’ or ‘get help’ in order to facilitate communication was described as a fluid and variable process. Deciding which strategy to use depended on three inter-related factors: time/time constraints, acuity of situation and ease of use/availability of translation aids. Participants reported at times feeling conflicted about their decisions, portraying some of these clinical encounters as a ‘troubling space’ in which they experienced one or more dilemmas related to real versus ideal practice, responsibility and informed consent.
Conclusions
In situations of language discordance, a physician's decision to ‘get by’ (vs ‘get help’) rests on a judgement of whether communication can be considered ‘good enough’ to proceed and depends on the circumstances of the specific encounter. The tension set up between what is ‘ideal’ and what is practically possible can be experienced as a dilemma by physicians. The study's findings have implications for practice and policy not only in Canada but in other multilingual settings, and indicate that physicians require greater support.
doi:10.1136/bmjopen-2013-004613
PMCID: PMC4054645  PMID: 24902724
Internal Medicine; Qualitative Research
17.  Impact of comorbidity on risk of venous thromboembolism in patients with breast cancer: a Danish population-based cohort study 
BMJ Open  2014;4(6):e005082.
Objectives
To assess the interaction between comorbidity and breast cancer (BC) on the rate of venous thromboembolism (VTE) beyond what can be explained by the independent effects of BC and comorbidity.
Design
Population-based matched cohort study.
Setting
Denmark.
Participants
Danish patients with BC (n=62 376) diagnosed in 1995–2010 and a comparison cohort of women without BC (n=304 803) from the general population were matched to the patients with BC on year of birth in 5-year intervals and on the specific diseases included in the Charlson Comorbidity Index (CCI) and atrial fibrillation and obesity.
Measures
The rate ratios of VTE per 1000 person-years (PY) were computed by comorbidity levels using the CCI, and interaction contrasts (IC) were calculated as a measure of the excess or deficit VTE rate not explained by the independent effects of BC and comorbidity.
Results
Among patients with BC with a CCI score of 1, the 0–1 year VTE rate was 12/1000 PY, and interaction accounted for 10% of the rate (IC=3.2, 95% CI 0.5 to 5.9). Among patients with BC with CCI ≥4, the VTE rate was 17, and interaction accounted for 8% of the rate (IC=1.2, 95% CI −1.8 to 4.2). There was no interaction during 2–5 years of follow-up.
Conclusions
There was only little interaction between BC and the CCI score on the rate of VTE.
doi:10.1136/bmjopen-2014-005082
PMCID: PMC4054647  PMID: 24902734
Epidemiology; Oncology
18.  Non-pharmacological treatments for adult patients with functional constipation: a systematic review protocol 
BMJ Open  2014;4(6):e004982.
Introduction
The aim of this review is to assess the effectiveness, efficacy and safety of non-pharmacological therapies for patients with functional constipation.
Methods and analysis
We will electronically search OVID MEDLINE, EMBASE, Cochrane library, CINAHL, AMED and ISI web of knowledge without any language restrictions. We will also try to obtain literatures from other sources, such as a hand search of library journals or conference abstracts. After searching and screening of the studies, we will run a meta-analysis of the included randomised-controlled trials. We will summarise the results as risk ratio for dichotomous data and standardised or weighted mean difference for continuous data.
Dissemination
This systematic review will summarise current evidence for using non-pharmacological therapies to treat functional constipation, and will be disseminated through peer-review publications or conference presentations.
Trial registration number
PROSPERO 2014: CRD42014006686.
doi:10.1136/bmjopen-2014-004982
PMCID: PMC4054651  PMID: 24902731
Complementary Medicine
19.  Parental perceptions of school-based influenza immunisation in Ontario, Canada: a qualitative study 
BMJ Open  2014;4(6):e005189.
Objective
To understand the perspectives of Ontario parents regarding the advantages and disadvantages of adding influenza immunisation to the currently existing Ontario school-based immunisation programmes.
Design
Descriptive qualitative study.
Participants
Parents of school-age children in Ontario, Canada, who were recruited using a variety of electronic strategies (social media, emails and media releases), and identified as eligible (Ontario resident, parent of one or more school-age children, able to read/write English) on the basis of a screening questionnaire. We used stratified purposeful sampling to obtain maximum variation in two groups: parents who had ever immunised at least one child against influenza or who had never done so. We conducted focus groups (teleconference or internet forum) and individual interviews to collect data. Thematic analysis was used to analyse the data.
Setting
Ontario, Canada.
Results
Of the 55 participants, 16 took part in four teleconference focus groups, 35 in 6 internet forum focus groups and four in individual interviews conducted between October 2012 and February 2013. Participants who stated that a school-based influenza immunisation programme would be worthwhile for their child valued its convenience and its potential to reduce influenza transmission without interfering with the family routine. However, most thought that for a programme to be acceptable, it would need to be well designed and voluntary, with adequate parental control and transparent communication between the key stakeholder groups of public health, schools and parents.
Conclusions
These results will benefit decision-makers in the public health and education sectors as they consider the advantages and disadvantages of immunising children in schools as part of a system-wide influenza prevention approach. Further research is needed to assess the perceptions of school board and public health stakeholders.
doi:10.1136/bmjopen-2014-005189
PMCID: PMC4054656  PMID: 24902736
20.  Patients’ experiences of acupuncture and counselling for depression and comorbid pain: a qualitative study nested within a randomised controlled trial 
BMJ Open  2014;4(6):e005144.
Introduction
Depression and pain frequently occur together and impact on outcomes of existing treatment for depression. Additional treatment options are required. This study aimed to explore patients’ experiences of depression, the processes of change within acupuncture and counselling, and the elements that contributed to longer-term change.
Methods
In a substudy nested within a randomised controlled trial of acupuncture or counselling compared with usual care alone for depression, semistructured interviews of 52 purposively sampled participants were conducted and analysed using thematic analysis.
Results
Differences were reported by participants regarding their experience of depression with comorbid pain compared with depression alone. Along with physical symptoms often related to fatigue and sleep, participants with depression and comorbid pain generally had fewer internal and external resources available to manage their depression effectively. Those who had physical symptoms and were receiving acupuncture commonly reported that these were addressed as part of the treatment. For those receiving counselling, there was less emphasis on physical symptoms and more on help with gaining an understanding of themselves and their situation. Over the course of treatment, most participants in both groups reported receiving support to cope with depression and pain independently of treatment, with a focus on relevant lifestyle and behaviour changes. The establishment of a therapeutic relationship and their active engagement as participants were identified as important components of treatment.
Conclusions
Participants with and without comorbid pain received acupuncture or counselling for depression, and reported specific identifiable treatment effects. The therapeutic relationship and participants’ active engagement in recovery may play distinct roles in driving long-term change. Patients who present with depression and physical symptoms of care may wish to consider a short course of acupuncture to relieve symptoms prior to a referral for counselling if needed.
Trial registration number
ISRCTN63787732.
doi:10.1136/bmjopen-2014-005144
PMCID: PMC4054660  PMID: 24902735
Depression; Pain Management ; Primary Care; Mental Health
21.  START (STrAtegies for RelaTives) coping strategy for family carers of adults with dementia: qualitative study of participants’ views about the intervention 
BMJ Open  2014;4(6):e005273.
Objectives
To analyse the experience of individual family carers of people with dementia who received a manual-based coping strategy programme (STrAtegies for RelaTives, START), demonstrated in a randomised-controlled trial to reduce affective symptoms.
Design
A qualitative study using self-completed questionnaires exploring the experience of the START intervention. Two researchers transcribed, coded and analysed completed questionnaires thematically.
Setting
Three mental health and one neurology dementia clinic in South East England.
Participants
Participants were primary family carers of a patient diagnosed with dementia who provided support at least weekly to their relative. We invited those in the treatment group remaining in the START study at 2 years postrandomisation (n=132) to participate. 75 people, comprising a maximum variation sample, responded.
Primary and secondary outcome measures
(1) Important aspects of the therapy. (2) Continued use of the intervention after the end of the therapy. (3) Unhelpful aspects of the therapy and suggestions for improvement. (4) Appropriate time for intervention delivery.
Results
Carers identified several different components as important: relaxation techniques, education about dementia, strategies to help manage the behaviour of the person with dementia, contact with the therapist and changing unhelpful thoughts. Two-thirds of the participants reported that they continue to use the intervention's techniques at 2-year follow up. Few participants suggested changes to the intervention content, but some wanted more sessions and others wanted the involvement of more family members. Most were happy with receiving the intervention shortly after diagnosis, although some relatives of people with moderate dementia thought it should have been delivered at an earlier stage.
Conclusions
Participants’ varied responses about which aspects of START were helpful suggest that a multicomponent intervention is suited to the differing circumstances of dementia carers, providing a range of potentially helpful strategies. The continued use of the strategies 2 years after receiving the intervention could be a mechanism for the intervention remaining effective.
doi:10.1136/bmjopen-2014-005273
PMCID: PMC4054623  PMID: 24898089
QUALITATIVE RESEARCH
22.  Environments, risk and health harms: a qualitative investigation into the illicit use of anabolic steroids among people using harm reduction services in the UK 
BMJ Open  2014;4(6):e005275.
Objectives
The illicit use of anabolic steroids among the gym population continues to rise, along with the number of steroid using clients attending harm reduction services in the UK. This presents serious challenges to public health. Study objectives were to account for the experiences of anabolic steroid users and investigate how ‘risk environments’ produce harm.
Methods
Qualitative face-to-face interviews with 24 users of anabolic steroids engaged with harm reduction services in the UK.
Results
Body satisfaction was an important factor when deciding to start the use of anabolic steroids. Many users were unaware of the potential dangers of using drugs from the illicit market, whereas some had adopted a range of strategies to negotiate the hazards relating to the use of adulterated products, including self-experimentation to gauge the perceived efficacy and unwanted effects of these drugs. Viewpoints, first-hand anecdotes, norms and practices among groups of steroid users created boundaries of ‘sensible’ drug use, but also promoted practices that may increase the chance of harms occurring. Established users encouraged young users to go to harm reduction services but, at the same time, promoted risky injecting practices in the belief that this would enhance the efficacy of anabolic steroids.
Conclusions
Current steroid-related viewpoints and practices contribute to the risk environment surrounding the use of these drugs and may undermine the goal of current public health strategies including harm reduction interventions. The level of harms among anabolic steroid users are determined by multiple and intertwining factors, in addition to the harms caused by the pharmacological action or injury and illness associated with incorrect injecting techniques.
doi:10.1136/bmjopen-2014-005275
PMCID: PMC4054627  PMID: 24898090
Anabolic Agents; Gym Population; Risk Environments; Harm Reduction
23.  Can you refuse these discounts? An evaluation of the use and price discount impact of price-related promotions among US adult smokers by cigarette manufacturers 
BMJ Open  2014;4(6):e004685.
Objectives
The raising unit price of cigarette has been shown to be one of the most effective ways of reducing cigarette consumption and increasing rates of successful quitting. However, researchers have shown that price-sensitive smokers have used a variety of strategies to mitigate the effect of the rising price of cigarettes on their smoking habits. In particular, 23–34% of adult smokers in the US use cheaper brands, and 18–55% use coupons or promotions. Little is known about the discount use by type of brands. As such, the main purpose of this analysis is to evaluate the uses and price discount effects of these price-related discounts by manufacturers and major brands.
Setting
An analysis based on the cross-sectional 2009–2010 National Adult Tobacco Survey (NATS).
Participants
11 766 current smokers aged 18 or above in the USA.
Primary outcome measures
Price-related discount was defined as smokers who used coupons, rebates, buy-one-get-one-free, two-for-one or any other special promotions for their last cigarettes purchase.
Results
The use of price-related discounts and associated price impact vary widely by cigarette manufacturer and brand. Approximately one of three Camel, one of four Marlboro and one of eight Newport smokers used price-related discounts on their latest cigarette purchases. The average price reductions of discounts offered by Philip Morris (PM) or R.J. Reynolds (RJR) were around 29 cents per pack while that of Lorillard (Newport only) was 24 cents per pack. Cigarette brands that provided significant per pack price reductions include: PM Marlboro (28 cents), RJR brand Camel (41 cents), Doral (50 cents), Kool (73 cents) and Salem (80 cents), and Lorillard Newport (24 cents).
Conclusions
Policies that decrease price-minimisation strategies will benefit public health.
doi:10.1136/bmjopen-2013-004685
PMCID: PMC4054636  PMID: 24898086
Epidemiology; Health Economics; Public Health
24.  Knee moments of anterior cruciate ligament reconstructed and control participants during normal and inclined walking 
BMJ Open  2014;4(6):e004753.
Objectives
Prior injury to the knee, particularly anterior cruciate ligament (ACL) injury, is known to predispose one to premature osteoarthritis (OA). The study sought to explore if there was a biomechanical rationale for this process by investigating changes in external knee moments between people with a history of ACL injury and uninjured participants during walking: (1) on different surface inclines and (2) at different speeds. In addition we assessed functional differences between the groups.
Participants
12 participants who had undergone ACL reconstruction (ACLR) and 12 volunteers with no history of knee trauma or injury were recruited into this study. Peak knee flexion and adduction moments were assessed during flat (normal and slow speed), uphill and downhill walking using an inclined walkway with an embedded Kistler Force plate, and a ten-camera Vicon motion capture system. Knee injury and Osteoarthritis Outcome Score (KOOS) was used to assess function. Multivariate analysis of variance (MANOVA) was used to examine statistical differences in gait and KOOS outcomes.
Results
No significant difference was observed in the peak knee adduction moment between ACLR and control participants, however, in further analysis, MANOVA revealed that ACLR participants with an additional meniscal tear or collateral ligament damage (7 participants) had a significantly higher adduction moment (0.33±0.12 Nm/kg m) when compared with those with isolated ACLR (5 participants, 0.1±0.057 Nm/kg m) during gait at their normal speed (p<0.05). A similar (non-significant) trend was seen during slow, uphill and downhill gait.
Conclusions
Participants with an isolated ACLR had a reduced adductor moment rather an increased moment, thus questioning prior theories on OA development. In contrast, those participants who had sustained associated trauma to other key knee structures were observed to have an increased adduction moment. Additional injury concurrent with an ACL rupture may lead to a higher predisposition to osteoarthritis than isolated ACL deficiency alone.
doi:10.1136/bmjopen-2013-004753
PMCID: PMC4054639  PMID: 24898088
Sports Medicine
25.  Rationale and study design of the Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D): a non-randomised, open label, adaptive dose finding trial 
BMJ Open  2014;4(6):e005559.
Introduction
CD4 T regulatory cells (Tregs) are crucial for the maintenance of self-tolerance and are deficient in many common autoimmune diseases such as type 1 diabetes (T1D). Interleukin 2 (IL-2) plays a major role in the activation and function of Tregs and treatment with ultra-low dose (ULD) IL-2 could increase Treg function to potentially halt disease progression in T1D. However, prior to embarking on large phase II/III clinical trials it is critical to develop new strategies for determining the mechanism of action of ULD IL-2 in participants with T1D. In this mechanistic study we will combine a novel trial design with a clinical grade Treg assay to identify the best doses of ULD IL-2 to induce targeted increases in Tregs.
Method and analysis
Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D) is a single centre non-randomised, single dose, open label, adaptive dose-finding trial. The primary objective of DILT1D is to identify the best doses of IL-2 to achieve a minimal or maximal Treg increase in participants with T1D (N=40). The design has an initial learning phase where pairs of participants are assigned to five preassigned doses followed by an interim analysis to determine the two Treg targets for the reminder of the trial. This will then be followed by an adaptive phase which is fully sequential with an interim analysis after each participant is observed to determine the choice of dose based on the optimality criterion to minimise the determinant of covariance of the estimated target doses. A dose determining committee will review all data available at the interim(s) and then provide decisions regarding the choice of dose to administer to subsequent participants.
Ethics and dissemination
Ethical approval for the study was granted on 18 February 2013.
Results
The results of this study will be reported through peer-reviewed journals, conference presentations and an internal organisational report.
Trial registration numbers
NCT01827735, ISRCTN27852285, DRN767.
doi:10.1136/bmjopen-2014-005559
PMCID: PMC4054640  PMID: 24898091

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