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26.  HIV research productivity and structural factors associated with HIV research output in European Union countries: a bibliometric analysis 
BMJ Open  2015;5(2):e006591.
To assess HIV/AIDS research productivity in the 27 countries of the European Union (EU), and the structural level factors associated with levels of HIV/AIDS research productivity.
A bibliometric analysis was conducted with systematic search methods used to locate HIV/AIDS research publications (period of 1 January 2002 to 31 December 2011; search databases: MEDLINE (Ovid, PubMed), EMBASE, ISI-Thomson Web of Science; no language restrictions).
The publication rate (number of HIV/AIDS research publications per million population in 10 years) and the rate of articles published in HIV/AIDS journals and selected journals with moderate to very high (IF ≥3) 5-year impact factors were used as markers for HIV research productivity. A negative binomial regression model was fitted to assess the impact of structural level factors (sociodemographic, health, HIV prevalence and research/development indicators) associated with the variation in HIV research productivity.
The total numbers of HIV/AIDS research publications in 2002–2011 by country ranged from 7 to 9128 (median 319). The median publication rate (per million population in 10 years) was 45 (range 5–150) for all publications. Across all countries, 16% of the HIV/AIDS research was published in HIV/AIDS journals and 7% in selected journals with IF ≥3. Indicators describing economic (gross domestic product), demographic (size of the population) and epidemiological (HIV prevalence) conditions as well as overall scientific activity (total research output) in a country were positively associated with HIV research productivity.
HIV research productivity varies noticeably across EU countries, and this variation is associated with recognisable structural factors.
PMCID: PMC4322208  PMID: 25649212
27.  Association between sense of coherence in adolescence and social benefits later in life: a 12-year follow-up study 
BMJ Open  2015;5(1):e006489.
Local government concerns over expenditure on social and healthcare are growing. The aim of the present study was to explore the association between a weak ‘sense of coherence’ (SOC) in teens and their subsequent risk of receiving social and healthcare benefits during young adulthood, and to monitor how SOC developed during this period.
Prospective cohort study.
North Denmark Region.
773 Pupils from seventh and eighth forms who answered a questionnaire in 1998.
Outcome measures
Different social benefits (from the Danish DREAM database embracing disbursed public social benefits). Change in SOC score from 1998 to 2010.
722 had answered seven items of the original SOC-13 questionnaire (denoted by SOC-7). Girls with a weak SOC-7 (the lowest 1st quartile) in 1998 had a significantly increased risk of receiving unemployment benefits (RR 1.3 (1.1 to 1.6)), social assistance (RR 1.8 (1.3 to 2.5)) and sickness benefits (RR 1.5 (1.2 to 2.0)) compared with girls with a strong SOC-7. For boys, only minor protective and non-significant differences were found. The SOC answers from 1998 and 2010 were compared (n=394). SOC increased significantly and mostly in girls.
SOC-7 may serve as a predictor for social life event outcomes and hence facilitate an early identification and a selective approach to support teenage girls with a weak SOC. From adolescence to young adulthood, SOC-7 was of a relatively unstable nature.
PMCID: PMC4316432  PMID: 25643701
28.  Chinese herbal medicine for resistant hypertension: a systematic review 
BMJ Open  2015;5(1):e005355.
This study aimed to summarise the current evidence from randomised control trials (RCTs) concerning treatment of patients with resistant hypertension with Chinese herbal medicine (CHM).
Seven databases, including the Cochrane Library, PubMed, EMBASE, CNKI, VIP, CBM and Wanfang, were systematically searched from their inception to March 2014 for RCTs investigating treatment of resistant hypertension in which CHM was used either as a monotherapy or in combination with conventional medicine versus placebo, no intervention or conventional medicine.
Five trials containing 446 hypertensive patients were identified. The methodological quality of most trials was evaluated as generally low. All included trials compared CHM plus antihypertensive drugs with antihypertensive drugs alone for resistant hypertension. Formulations of CHM included tablet, decoction and injection. It was found that, compared with antihypertensive drugs alone, CHM (tablet) plus antihypertensive drugs resulted in clinically, but not statistically, significant reductions in systolic blood pressure (SBP; weighted mean difference (WMD)=−10.32 mm Hg; 95% CI −21.10 to 0.46; p=0.06) and diastolic blood pressure (DBP; WMD=−3.30 mm Hg; 95% CI −7.66 to 1.06; p=0.14). CHM (decoction) plus antihypertensive drugs also produced a clinically meaningful, but not statistically significant, reduction in SBP (WMD=−12.56 mm Hg; 95% CI −26.83 to 1.71; p=0.08), and did significantly decrease DBP (WMD=−7.89 mm Hg; 95% CI −11.74 to −4.04; p<0.0001). There were no significant differences in SBP (WMD=−3.50 mm Hg; 95% CI −8.95 to 1.95; p=0.21) and DBP (WMD=1.00 mm Hg; 95% CI −1.39 to 3.39; p=0.41) between CHM (injection) plus the antihypertensive drugs group and antihypertensive drugs alone. The safety of CHM remained uncertain.
No definite conclusions about the effectiveness and safety of CHM for resistant hypertension could be drawn. More rigorously designed trials are warranted.
PMCID: PMC4316421  PMID: 25636788
Chinese herbal medicine; resistant hypertension; systematic review
29.  Methamphetamine and cannabis abuse in adolescence: a quasi-experimental study on specific and long-term neurocognitive effects 
BMJ Open  2015;5(1):e005833.
Methamphetamine abuse affects brain structure and function. Although methamphetamine and cannabis are commonly abused together, few studies have investigated the differential neurocognitive consequences of methamphetamine abuse with or without cannabis. Furthermore, the effects of drug use on the developing adolescent brain remain poorly understood. We compared neurocognitive function between adolescents with ‘pure’ methamphetamine abuse, those with comorbid methamphetamine and cannabis abuse, and healthy controls at baseline and follow-up.
Individuals residing in the greater Cape Town region, between the ages of 13 and 18 years, were recruited into either Methamphetamine only group (Meth-only; n=10), Methamphetamine and cannabis group (Meth-cann; n=10) or healthy control (n=20) groups using a quasi-experimental design. All participants underwent a comprehensive neurocognitive assessment. Substance-use variables and psychiatric symptom counts were also recorded. A portion of the Meth-only and control participants completed 12-month follow-up assessments.
While the Meth-cann group demonstrated widespread neurocognitive deficits at baseline, these deficits were restricted to the self-monitoring domain in the Meth-only group at baseline and at follow-up.
Methamphetamine abuse with cannabis abuse is associated with significantly more neurocognitive impairment than methamphetamine abuse alone, and such deficits may be enduring.
PMCID: PMC4316423  PMID: 25636791
methamphetamine; cannabis; neurocognition; adolescence; externalizing
30.  Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: a randomised clinical trial 
BMJ Open  2015;5(1):e006867.
In resource-poor settings, the standard of care to inform labour management is the partograph plus Pinard stethoscope for intermittent fetal heart rate (FHR) monitoring. We compared FHR monitoring in labour using a novel, robust wind-up handheld Doppler with the Pinard as a primary screening tool for abnormal FHR on perinatal outcomes.
Prospective equally randomised clinical trial.
The labour and delivery unit of a teaching hospital in Kampala, Uganda.
Of the 2042 eligible antenatal women, 1971 women in active term labour, following uncomplicated pregnancies, were randomised to either the standard of care or not.
Intermittent FHR monitoring using Doppler.
Primary outcome measures
Incidence of FHR abnormality detection, intrapartum stillbirth and neonatal mortality prior to discharge.
Age, parity, gestational age, mode of delivery and newborn weight were similar between study groups. In the Doppler group, there was a significantly higher rate of FHR abnormalities detected (incidence rate ratio (IRR)=1.61, 95% CI 1.13 to 2.30). However, in this group, there were also higher though not statistically significant rates of intrapartum stillbirths (IRR=3.94, 0.44 to 35.24) and neonatal deaths (IRR=1.38, 0.44 to 4.34).
Routine monitoring with a handheld Doppler increased the identification of FHR abnormalities in labour; however, our trial did not find evidence that this leads to a decrease in the incidence of intrapartum stillbirth or neonatal death.
Trial registration number
Clinical (1000031587).
PMCID: PMC4316429  PMID: 25636792
31.  Placebo effects in trials evaluating 12 selected minimally invasive interventions: a systematic review and meta-analysis 
BMJ Open  2015;5(1):e007331.
To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms.
A systematic review and meta-analysis.
Data sources and study selection
We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014.
Data synthesis
Effect sizes (ES) in the active and placebo arms in the trials’ primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered.
We included 21 trials involving 2519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R2 of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration.
The generally small differences in ES between active treatment and sham suggest that non-specific mechanisms, including placebo, are major predictors of the observed effects. Adverse events related to sham procedures were mainly minor and short-lived. Ethical arguments frequently raised against sham-controlled trials were generally not substantiated.
PMCID: PMC4316431  PMID: 25636794
32.  Socioeconomic deprivation and survival after stroke in China: a systematic literature review and a new population-based cohort study 
BMJ Open  2015;5(1):e005688.
To assess the association of socioeconomic deprivation (SED) with survival after stroke in China.
A systematic literature review and a new population-based cohort study.
Setting and participants
In urban and rural communities in Anhui, China, 2978 residents aged ≥60 years took part in baseline investigation and were followed up for 5 years; five published studies were identified for a systematic review.
Primary and secondary outcome measures
167 of 2978 participants (5.6%) had doctor-diagnosed stroke at baseline or 1 year later. All-cause mortality in the follow-up.
In the Anhui cohort follow-up of 167 patients with stroke, 64 (38.3%) died. Multivariate adjusted hazard ratio (HR) of mortality in patients with educational level of less than or equal to primary school was 1.88 (95% CI 1.05 to 3.36) compared to those having more than primary school education. Increased HR of mortality in patients living in a rural area was at borderline significant (1.64, 0.97 to 2.78), but the HR in patients with lower levels of occupation and income was not significant. Published studies showed a significant increase in stroke mortality in relation to some SED indicators. Pooled relative risk (RR) of mortality in patients with low education was 3.07 (1.27 to 7.34), in patients with low income 1.58 (1.50 to 1.65) and in patients living in rural areas 1.47 (1.37 to 1.58).
The evidence suggests the presence of a mortality gradient after stroke for material as well as social forms of deprivation in China. Inequalities in survival after stroke persist and need to be taken into account when implementing intervention programmes.
PMCID: PMC4316438  PMID: 25636790
33.  Prevalence of smoking restrictions and child exposure to secondhand smoke in cars and homes: a repeated cross-sectional survey of children aged 10–11 years in Wales 
BMJ Open  2015;5(1):e006914.
Small increases in smoking restrictions in cars and homes were reported after legislation prohibiting smoking in public places. Few studies examine whether these changes continued in the longer term. This study examines changes in restrictions on smoking in cars and homes, and child exposure to secondhand smoke (SHS) in these locations, since 2008 postlegislation surveys in Wales.
State-maintained primary schools in Wales (n=75).
Children aged 10–11 years (year 6) completed CHETS (CHild exposure to Environmental Tobacco Smoke) Wales surveys in 2007 (n=1612) and 2008 (n=1605). A replication survey (CHETS Wales 2) was conducted in 2014, including 1601 children.
Primary outcome variable
Children's reports of whether smoking was allowed in their car or home and exposure to SHS in a car or home the previous day.
The percentage of children who reported that smoking was allowed in their family vehicle fell from 18% to 9% in 2014 (OR=0.42; 95% CI 0.33 to 0.54). The percentage living in homes where smoking was allowed decreased from 37% to 26% (OR=0.30; 95% CI 0.20 to 0.43). Among children with a parent who smoked, one in five and one in two continued to report that smoking was allowed in their car and home. The percentage reporting SHS exposure in a car (OR=0.52; 95% CI 0.38 to 0.72) or home (OR=0.44; 95% CI 0.36 to 0.53) the previous day also fell. Children from poorer families remained less likely to report smoking restrictions.
Smoking in cars and homes has continued to decline. Substantial numbers of children continue to report that smoking is allowed in cars and homes, particularly children from poorer families. A growing number of countries have legislated, or plan to legislate, banning smoking in cars carrying children. Attention is needed to the impact of legislation on child health and health inequalities, and reducing smoking in homes.
PMCID: PMC4316441  PMID: 25636793
34.  Incidence of renal replacement therapy for diabetic nephropathy in the Netherlands: Dutch diabetes estimates (DUDE)-3 
BMJ Open  2015;5(1):e005624.
Describe the incidence, prevalence and survival of patients needing renal replacement therapy (RRT) for end-stage renal disease (ESRD) due to diabetes mellitus (DM)-related glomerulosclerosis or nephropathy (diabetic nephropathy, DN) in the Netherlands.
Using the national registry for RRT (RENINE-registry), data of all Dutch individuals initiating RRT for ESRD and having DN as primary diagnosis in the period 2000–2012 were obtained.
Observational study in the Netherlands.
Patients with ESRD needing RRT for DN.
Outcome measurements
Age and gender adjusted incidence and prevalence of RRT for DN in the period 2000–2012. In addition, trends in time and patient's survival were examined.
The prevalence of DM in the general population increased from approximately 466 000 in 2000 to 815 000 in 2011. The number of individuals who started RRT with DN as primary diagnosis was 17.4 per million population (pmp) in 2000 and 19.1 pmp in 2012, with an annual percentage change (APC) of 0.8% (95% CI −0.4 to 2.0). For RRT due to type 1 DN, the incidence decreased from 7.3 to 3.5 pmp (APC −4.8%, 95% CI −6.5 to −3.1) while it increased for type 2 DN from 10.1 to 15.6 pmp (APC 3.1%, 95% CI 1.3 to 4.8). After 2009, the prevalence of RRT for DN remained stable (APC 1.0%, 95% CI −0.4 to 2.5). Compared to the period 2000–2004, patients initiating RRT and dialysis in 2005–2009 had better survival, HRs 0.8 (95% CI 0.7 to 0.8) and 0.8 (95% CI 0.7 to 0.9), respectively, while survival after kidney transplantation remained stable, HR 0.8, 95% CI 0.5 to 1.1).
Over the last decade, the incidence of RRT for DN was stable, with a decrease in RRT due to type 1 DN and an increase due to type 2 DN, while survival increased.
PMCID: PMC4316478  PMID: 25636789
35.  NSAIDs, statins, low-dose aspirin and PPIs, and the risk of oesophageal adenocarcinoma among patients with Barrett's oesophagus: a population-based case–control study 
BMJ Open  2015;5(1):e006640.
Non-steroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), low-dose aspirin and statins may decrease the risk of oesophageal adenocarcinoma (OAC) among patients with Barrett's oesophagus (BO). However, previous studies did not adequately address bias and confounding. Our objective was to estimate the risk of OAC among patients with BO exposed to NSAIDs, statins and PPIs.
Case–control study nested within a BO cohort.
Two primary care databases (the UK and the Netherlands (NL)).
Cases were adults ≥18 years of age with OAC or high-grade dysplasia (HGD) diagnosis ≥1 year after BO diagnosis. Controls were matched on age, sex, year of BO diagnosis and database.
Drug use was assessed from BO diagnosis until matching date.
Outcome measure
Adjusted ORs with 95% CI were calculated by conditional logistic regression.
Within the BO cohort (n=15 134), 45 OAC (UK: 40, NL: 5) and 12 HGD cases (NL: 12) were identified. ORa for OAC during NSAID use was 1.2 (95% CI 0.6 to 2.5) and during statin use for >3 years 0.5 (95% CI 0.1 to 1.7). When including HGD cases (n=57), ORa for NSAID use was 0.9 (95% CI 0.5 to 1.8) and for statin use >3 years 0.5 (95% CI 0.1 to 1.7). Higher doses of statins showed lower estimates for OAC and HGD, though not statistically significant. Low-dose aspirin and PPIs did not significantly decrease the risk of OAC and HGD.
In this population-based nested case–control study, use of NSAIDs, PPIs, low-dose aspirin or statins did not reduce the risk of HGD and OAC among patients with BO. These findings indicate that for an unselected group of patients with BO chemoprevention by use of drugs to reduce progression to HGD and OAC should not be directly considered as routine care.
PMCID: PMC4316430  PMID: 25633286
36.  A history of diabetes but not hyperglycaemia during exacerbation of obstructive lung disease has impact on long-term mortality: a prospective, observational cohort study 
BMJ Open  2015;5(1):e006794.
Hyperglycaemia is very common during exacerbations of asthma and chronic obstructive pulmonary disease (COPD). However, its clinical significance is not clear. The objective of the present study was to assess whether exacerbation-associated hyperglycaemia affects long-term mortality in these patients.
A prospective, observational cohort study.
A single hospital in eastern Finland.
153 consecutive patients who were hospitalised due to mild to moderate obstructive lung disease exacerbation (110 with asthma and 43 with COPD) and who survived at least 30 days.
Plasma glucose levels were recorded seven times during the first day on the ward. Several possible confounders were also recorded. The median follow-up time was 6 years and 2 months.
During the follow-up, 57 (37%) of the patients died. Previously diagnosed diabetes was strongly associated with elevated mortality (adjusted HR (aHR) 3.03 (1.28 to 7.18). The highest fasting glucose value (aHR 1.10 (1.01 to 1.20) per 1 mmol/L) and the highest postprandial glucose value ((aHR 1.07 (1.00 to 1.16)) were also associated with late mortality. However, the associations between highest glucose values and mortality vanished when the diagnosis of diabetes was included in the same model. Within the patients without diabetes, neither fasting (aHR 0.92 (0.42 to 2.02)) nor postprandial ((aHR 1.04 (0.50 to 2.12)) hyperglycaemia was associated with late mortality. There were no statistically significant differences in the underlying causes of death between the patients with and without diabetes.
A history of diabetes but not hyperglycaemia during exacerbation of obstructive lung disease has impact on long-term mortality.
PMCID: PMC4316436  PMID: 25633287
RESPIRATORY MEDICINE (see Thoracic Medicine)
37.  Why do some people with type 2 diabetes who are using insulin have poor glycaemic control? A qualitative study 
BMJ Open  2015;5(1):e006407.
To explore factors influencing poor glycaemic control in people with type 2 diabetes using insulin.
Research design
A qualitative method comprising in-depth individual interviews. A semistructured interview guide was used. The interviews were audiorecorded, transcribed verbatim and analysed using a thematic approach.
Seventeen people with type 2 diabetes using insulin with glycated haemoglobin (HbA1c) ≥9% for >1 year.
The Primary Care Clinic and Diabetes Clinic in the University of Malaya Medical Centre (UMMC), Malaysia.
Data analysis uncovered four themes: lifestyle challenges in adhering to medical recommendations; psychosocial and emotional hurdles; treatment-related factors; lack of knowledge about and self-efficacy in diabetes self-care.
Factors that explain the poor glycaemic control in people with type 2 diabetes using insulin were identified. Healthcare providers could use these findings to address patients’ concerns during consultations and help to improve glycaemic control.
PMCID: PMC4316456  PMID: 25633285
38.  Hazardous alcohol consumption among university students in Ireland: a cross-sectional study 
BMJ Open  2015;5(1):e006045.
There is considerable evidence of a cultural shift towards heavier alcohol consumption among university students, especially women. The aim of this study is to investigate the prevalence and correlates of hazardous alcohol consumption (HAC) among university students with particular reference to gender and to compare different modes of data collection in this population.
A large Irish university.
A cross-sectional study using a classroom distributed paper questionnaire.
A total of 2275 undergraduates completed the classroom survey, 84% of those in class and 51% of those registered for the relevant module.
Main outcome measures
Prevalence of HAC measured using the Alcohol Use Disorders Identification Test for Consumption (AUDIT-C) and the proportion of university students reporting 1 or more of 13 adverse consequences linked to HAC. HAC was defined as an AUDIT-C score of 6 or more among males and 5 or more among females.
In the classroom sample, 66.4% (95% CI 64.4 to 68.3) reported HAC (65.2% men and 67.3% women). In women, 57.4% met HAC thresholds for men. Similar patterns of adverse consequences were observed among men and women. Students with a hazardous consumption pattern were more likely to report smoking, illicit drug use and being sexually active.
The findings highlight the high prevalence of HAC among university students relative to the general population. Public policy measures require review to tackle the short-term and long-term risks to physical, mental and social health and well-being.
PMCID: PMC4316479  PMID: 25633284
39.  Protocol of a longitudinal cohort study on physical activity behaviour in physically disabled patients participating in a rehabilitation counselling programme: ReSpAct 
BMJ Open  2015;5(1):e007591.
Stimulating physical activity behaviour in persons with a physical disability is important, especially after discharge from rehabilitation. A tailored counselling programme covering both the period of the rehabilitation treatment and the first months at home seems on the average effective. However, a considerable variation in response is observed in the sense that some patients show a relevant beneficial response while others show no or only a small response on physical activity behaviour. The Rehabilitation, Sports and Active lifestyle (ReSpAct) study aims to estimate the associations of patient and programme characteristics with patients’ physical activity behaviour after their participation in a tailored counselling programme.
Methods and analysis
A questionnaire-based nationwide longitudinal prospective cohort study is conducted. Participants are recruited from 18 rehabilitation centres and hospitals in The Netherlands. 2000 participants with a physical disability or chronic disease will be followed during and after their participation in a tailored counselling programme. Programme outcomes on physical activity behaviour and patient as well as programme characteristics that may be associated with differences in physical activity behaviour after programme completion are being assessed. Data collection takes place at baseline and 14, 33 and 52 weeks after discharge from rehabilitation.
Ethics and dissemination
The study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Groningen and at individual participating institutions. All participants give written informed consent. The study results will provide new insights into factors that may help explain the differences in physical activity behaviour of patients with a physical disability after they have participated in the same physical activity and sports stimulation programme. Thereby, it will support healthcare professionals to tailor their guidance and care to individual patients in order to stimulate physical activity after discharge in a more efficient and effective way.
Trial registration number
PMCID: PMC4316554  PMID: 25633288
40.  Setting research priorities to improve the health of children and young people with neurodisability: a British Academy of Childhood Disability-James Lind Alliance Research Priority Setting Partnership 
BMJ Open  2015;5(1):e006233.
To engage young people, parent carers and clinicians in a systematic process to identify and prioritise research questions regarding ways to improve the health and well-being of children and young people with neurodisability.
British Academy of Childhood Disability (BACD)-James Lind Alliance research priority setting partnership bringing together patients, carers and clinicians as equal stakeholders.
UK health service and community.
The BACD Strategic Research Group formed the partnership. A Steering Group was established; charity and professional partner organisations were recruited. Suggestions were gathered in an open survey and from research recommendations for statutory guidance. Items were aggregated to formulate indicative research questions and verified as uncertainties from research evidence. An interim survey was used to rank the questions to shortlist topics. A mixed group of stakeholders discussed the top 25 questions at the final priority setting workshop agreeing a final rank order and the top 10 research priorities.
Partner organisations were 13 charities and 8 professional societies. 369 people submitted suggestions (40% non-clinicians). 76 people participated in the interim prioritisation (26 parents, 1 young person, 10 charity representatives, 39 clinicians); 22 took part in the final workshop (3 young people, 7 parents, 3 charity representatives, 9 professionals).
The top three research priorities related to (1) establishing the optimal frequency and intensity (dose) for mainstream therapies, (2) means for selecting and encouraging use of communication strategies and (3) ways to improve children's attitudes towards disability. The top 10 included evaluating interventions to promote mobility, self-efficacy, mental health, continence, physical fitness, educational inclusion and reduce impacts of sleep disturbance.
The methodology provided a systematic and transparent process to identify research priorities that included stakeholders that have typically not contributed to setting the research agenda. The top 10 and other topics identified provide a resource for researchers and agencies that fund research
PMCID: PMC4316435  PMID: 25631309
41.  Protocol for a human in vivo model of acute cigarette smoke inhalation challenge in smokers with COPD: monitoring the nasal and systemic immune response using a network biology approach 
BMJ Open  2015;5(1):e005750.
Cigarette smoke contributes to a diverse range of diseases including chronic obstructive pulmonary disease (COPD), cardiovascular disorders and many cancers. There currently is a need for human challenge models, to assess the acute effects of a controlled cigarette smoke stimulus, followed by serial sampling of blood and respiratory tissue for advanced molecular profiling. We employ precision sampling of nasal mucosal lining fluid by absorption to permit soluble mediators measurement in eluates. Serial nasal curettage was used for transcriptomic analysis of mucosal tissue.
Methods and analysis
Three groups of strictly defined patients will be studied: 12 smokers with COPD (GOLD Stage 2) with emphysema, 12 matched smokers with normal lung function and no evidence of emphysema, and 12 matched never smokers with normal spirometry. Patients in the smoking groups are current smokers, and will be given full support to stop smoking immediately after this study. In giving a controlled cigarette smoke stimulus, all patients will have abstained from smoking for 12 h, and will smoke two cigarettes with expiration through the nose in a ventilated chamber. Before and after inhalation of cigarette smoke, a series of samples will be taken from the blood, nasal mucosal lining fluid and nasal tissue by curettage. Analysis of plasma nicotine and metabolites in relation to levels of soluble inflammatory mediators in nasal lining fluid and blood, as well as assessing nasal transcriptomics, ex vivo blood platelet aggregation and leucocyte responses to toll-like receptor agonists will be undertaken.
Development of acute cigarette smoke challenge models has promise for the study of molecular effects of smoking in a range of pathological processes.
Ethics and dissemination
This study was approved by the West London National Research Ethics Committee (12/LO/1101). The study findings will be presented at conferences and will be reported in peer-reviewed journals.
PMCID: PMC4316420  PMID: 25631307
42.  The POPPY Research Programme protocol: investigating opioid utilisation, costs and patterns of extramedical use in Australia 
BMJ Open  2015;5(1):e007030.
Opioid prescribing is increasing in many countries. In Australia, there is limited research on patterns of prescribing and access, or the outcomes associated with this use. The aim of this research programme is to use national dispensing data to estimate opioid use and costs, including problematic or extramedical use in the Australian population.
Methods and analysis
In a cohort of persons dispensed at least one opioid in 2013, we will estimate monthly utilisation and costs of prescribed opioids, overall and according to individual opioid formulations and strengths. In a cohort of new opioid users, commencing therapy between 1 July 2009 and 31 December 2013, we will examine patterns of opioid use including initiation of therapy, duration of treatment and concomitant use of opioids and other prescribed medicines. We will also examine patterns of extramedical opioid use based on indicators including excess dosing, use of more than one opioid concomitantly, doctor/pharmacy shopping and accelerated time to prescription refill.
Ethics and dissemination
This protocol was approved by the NSW Population and Health Services Ethics Committee (March 2014) and data access approved by the Department of Human Services External Review Evaluation Committee (June 2014). This will be one of the first comprehensive Australian studies with the capability to investigate individual patterns of use and track extramedical use. In the first instance our analysis will be based on 5 years of dispensing data but will be expanded with ongoing annual data updates. This research has the capability to contribute significantly to pharmaceutical policy within Australia and globally. In particular, the trajectory of extramedical prescription-opioid use has been the subject of limited research to date. The results of this research will be published widely in general medical, pharmacoepidemiology, addiction and psychiatry journals.
PMCID: PMC4316424  PMID: 25631315
43.  Efficacy of psychosocial interventions for psychological and pregnancy outcomes in infertile women and men: a systematic review and meta-analysis 
BMJ Open  2015;5(1):e006592.
To evaluate the evidence on the efficacy of psychosocial interventions for improving pregnancy rates and reducing distress for couples in treatment with assisted reproductive technology (ART).
Systematic review and meta-analysis.
Data sources
PsycINFO, PubMed, EMBASE, CINAHL, Web of Science and The Cochrane Library between 1978 and April 2014.
Study selection
Studies were considered eligible if they evaluated the effect of any psychosocial intervention on clinical pregnancy and/or distress in infertile participants, used a quantitative approach and were published in English.
Data extraction
Study characteristics and results were extracted and the methodological quality was assessed. Effect sizes (ES; Hedges g) were pooled using a random effects model. Heterogeneity was assessed using the Q statistic and I2, and publication bias was evaluated using Egger’s method. Possible moderators and mediators were explored with meta-analyses of variances (ANOVAs) and meta-regression.
We identified 39 eligible studies (total N=2746 men and women) assessing the effects of psychological treatment on pregnancy rates and/or adverse psychological outcomes, including depressive symptoms, anxiety, infertility stress and marital function. Statistically significant and robust overall effects of psychosocial intervention were found for both clinical pregnancy (risk ratio=2.01; CI 1.48 to 2.73; p<0.001) and combined psychological outcomes (Hedges g=0.59; CI 0.38 to 0.80; p=0.001). The pooled ES for psychological outcomes were generally larger for women (g: 0.51 to 0.73) than men (0.13 to 0.34), but the difference only reached statistical significance for depressive symptoms (p=0.004). Meta-regression indicated that larger reductions in anxiety were associated with greater improvement in pregnancy rates (Slope 0.19; p=0.004). No clear-cut differences were found between effects of cognitive–behavioural therapy (CBT; g=0.84), mind–body interventions (0.61) and other intervention types (0.50).
The present meta-analysis suggests that psychosocial interventions for couples in treatment for infertility, in particular CBT, could be efficacious, both in reducing psychological distress and in improving clinical pregnancy rates.
PMCID: PMC4316425  PMID: 25631310
Infertility; Psychosocial intervention; distress; pregnancy
44.  Adoption factors associated with electronic health record among long-term care facilities: a systematic review 
BMJ Open  2015;5(1):e006615.
The Health Information Technology for Economic and Clinical Health (HITECH) Act created incentives for adopting electronic health records (EHRs) for some healthcare organisations, but long-term care (LTC) facilities are excluded from those incentives. There are realisable benefits of EHR adoption in LTC facilities; however, there is limited research about this topic. The purpose of this systematic literature review is to identify EHR adoption factors for LTC facilities that are ineligible for the HITECH Act incentives.
We conducted systematic searches of Cumulative Index of Nursing and Allied Health Literature (CINAHL) Complete via Ebson B. Stephens Company (EBSCO Host), Google Scholar and the university library search engine to collect data about EHR adoption factors in LTC facilities since 2009.
Search results were filtered by date range, full text, English language and academic journals (n=22).
Multiple members of the research team read each article to confirm applicability and study conclusions.
Primary and secondary outcome measures
Researchers identified common themes across the literature: specifically facilitators and barriers to adoption of the EHR in LTC.
Results identify facilitators and barriers associated with EHR adoption in LTC facilities. The most common facilitators include access to information and error reduction. The most prevalent barriers include initial costs, user perceptions and implementation problems.
Similarities span the system selection phases and implementation process; of those, cost was the most common mentioned. These commonalities should help leaders in LTC facilities align strategic decisions to EHR adoption. This review may be useful for decision-makers attempting successful EHR adoption, policymakers trying to increase adoption rates without expanding incentives and vendors that produce EHRs.
PMCID: PMC4316426  PMID: 25631311
45.  A scoping review protocol to map the research foci trends in tobacco control over the last decade 
BMJ Open  2015;5(1):e006643.
Tobacco dependence and smoke exposure have been global epidemics with health consequences recognised by the US Surgeon General since the 1960s and 1970s, respectively. During this period, a vast body of research evidence has emerged including many reviews of primary research studies targeting various tobacco control strategies. Published review studies synthesise primary evidence, providing a rich source for mapping the broad range of topics and research foci along with revealing areas of evidence deficits. In this paper, we outline our scoping review protocol to systematically review published review articles specific to tobacco control and primary prevention over the last 10 years.
Methods and analysis
Using Arksey and O'Malley's scoping review methodology as a guide, our scoping review of published reviews begins by searching several databases: PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and the Educational Resources Information Centre (ERIC). Our multidisciplinary team has formulated search strategies and two reviewers will independently screen eligible studies for final study selection. Bibliographic data and abstract content will be collected and analysed using a tool developed iteratively by the research team.
Ethics and dissemination
A scoping review of published review articles is a novel approach for examining the breadth of literature regarding tobacco control strategies and, as a secondary analysis, does not require ethics approval. We anticipate results will identify research gaps as well as novel ideas for primary prevention research specific to tobacco control strategies concerning intervention, programming and policy. Although this is our first step in establishing a foundation for a research agenda, we will be disseminating results through journals and conferences targeting primary care providers and tobacco control.
PMCID: PMC4316427  PMID: 25631312
46.  Help-seeking intentions and subsequent 12-month mental health service use in Chinese primary care patients with depressive symptoms 
BMJ Open  2015;5(1):e006730.
To identify the factors associated with 12-month mental health service use in primary care patients with depressive symptoms.
Cross-sectional followed by 12-month cohort study.
Setting and participants
10 179 adult patients were recruited from the waiting rooms of 59 primary care clinics across Hong Kong to complete a questionnaire which screened for depression. 518 screened-positive participants formed the cohort and were telephoned at 3, 6 and 12 months to monitor mental health service use.
Primary and secondary outcomes
▸ Help-seeking preferences;
▸ Intention to seek help from a healthcare professional;
▸ 12-month mental health service use.
At baseline, when asked who they would seek help from if they thought they were depressed, respondents preferred using friends and family (46.5%) over a psychiatrist (24.9%), psychologist (22.8%) or general practitioner (GP; 19.9%). The presence of depressive symptoms was associated with a lower intention to seek help from family and friends but had no effect on intention to seek help from a healthcare professional. Over 12 months, 24.3% of the screened-positive cohort reported receiving services from a mental health professional. Factors associated with service use included identification of depression by the GP at baseline, having a past history of depression or other mental illness, and being a public sector patient. Having a positive intention to seek professional help or more severe depressive symptoms at baseline was not associated with a greater likelihood of receiving treatment.
Mental health service use appears to be very low in this setting with only one in four primary care patients with depressive symptoms receiving treatment from a psychiatrist, GP or psychologist over a year. To help reduce the burden of illness, better detection of depressive disorders is needed especially for patients who may be undertreated such as those with no prior diagnosis of depression and those with more severe symptoms.
PMCID: PMC4316433  PMID: 25631313
47.  Understanding the motivation and performance of community health volunteers involved in the delivery of health programmes in Kampala, Uganda: a realist evaluation protocol 
BMJ Open  2015;5(1):e006752.
The recruitment of community health volunteers to support the delivery of health programmes is a well-established approach in many countries, particularly where health services are not readily available. However, studies on management of volunteers are scarce and current research on human resource management of volunteers faces methodological challenges. This paper presents the protocol of a realist evaluation that aims at identifying the factors influencing the performance of community health volunteers involved in the delivery of a Red Cross immunisation programme in Kampala (Uganda) with a specific focus on motivation.
Methods and analysis
The realist evaluation cycle structures the protocol. To develop the theoretical basis for the evaluation, the authors conducted interviews and reviewed the literature on community health volunteers’ performance, management and organisational behaviour. This led to the formulation of the initial programme theory, which links the intervention inputs (capacity-building strategies) to the expected outcomes (positive work behaviour) with mechanisms that point in the direction of drivers of motivation. The contextual elements include components such as organisational culture, resource availability, etc. A case study design will be adopted. We define a case as a Red Cross branch, run by a programme manager, and will select two cases at the district level in Kampala. Mixed methods will be used in data collection, including individual interviews of volunteers, participant observation and document review. The thematic analysis will be based on the initial programme theory and will seek for context-mechanism-outcome configurations. Findings from the two cases will be compared.
We discuss the scope for applying realist evaluation and the methodological challenges we encountered in developing this protocol.
Ethics and dissemination
The study was approved by the Ethical Committee at Rennes University Hospital, France. Results will be published in scientific journals, and communicated to respondents and relevant institutions.
PMCID: PMC4316434  PMID: 25631314
48.  A validation study of a new classification algorithm to identify rheumatoid arthritis using administrative health databases: case–control and cohort diagnostic accuracy studies. Results from the RECord linkage On Rheumatic Diseases study of the Italian Society for Rheumatology 
BMJ Open  2015;5(1):e006029.
To develop and validate a new algorithm to identify patients with rheumatoid arthritis (RA) and estimate disease prevalence using administrative health databases (AHDs) of the Italian Lombardy region.
Case–control and cohort diagnostic accuracy study.
In a randomly selected sample of 827 patients drawn from a tertiary rheumatology centre (training set), clinically validated diagnoses were linked to administrative data including diagnostic codes and drug prescriptions. An algorithm in steps of decreasing specificity was developed and its accuracy assessed calculating sensitivity/specificity, positive predictive value (PPV)/negative predictive value, with corresponding CIs. The algorithm was applied to two validating sets: 106 patients from a secondary rheumatology centre and 6087 participants from the primary care. Alternative algorithms were developed to increase PPV at population level. Crude and adjusted prevalence estimates taking into account algorithm misclassification rates were obtained for the Lombardy region.
The algorithms included: RA certification by a rheumatologist, certification for other autoimmune diseases by specialists, RA code in the hospital discharge form, prescription of disease-modifying antirheumatic drugs and oral glucocorticoids. In the training set, a four-step algorithm identified clinically diagnosed RA cases with a sensitivity of 96.3 (95% CI 93.6 to 98.2) and a specificity of 90.3 (87.4 to 92.7). Both external validations showed highly consistent results. More specific algorithms achieved >80% PPV at the population level. The crude RA prevalence in Lombardy was 0.52%, and estimates adjusted for misclassification ranged from 0.31% (95% CI 0.14% to 0.42%) to 0.37% (0.25% to 0.47%).
AHDs are valuable tools for the identification of RA cases at the population level, and allow estimation of disease prevalence and to select retrospective cohorts.
PMCID: PMC4316439  PMID: 25631308
49.  Correction 
BMJ Open  2015;5(1):e004546corr1.
PMCID: PMC4316440  PMID: 25631306
50.  Diagnostic performance of reproducible chest wall tenderness to rule out acute coronary syndrome in acute chest pain: a prospective diagnostic study 
BMJ Open  2015;5(1):e007442.
Acute chest pain (ACP) is a leading cause of hospital emergency unit consultation. As there are various underlying conditions, ranging from musculoskeletal disorders to acute coronary syndrome (ACS), thorough clinical diagnostics are warranted. The aim of this prospective study was to assess whether reproducible chest wall tenderness (CWT) on palpation in patients with ACP can help to rule out ACS.
In this prospective, double-blinded diagnostic study, all consecutive patients assessed in the emergency unit at the University Hospital Zurich because of ACP between July 2012 and December 2013 were included when a member of the study team was present. Reproducible CWT on palpation was the initial step and was recorded before further examinations were initiated. The final diagnosis was adjudicated by a study-independent physician.
121 patients (60.3% male, median age 47 years, IQR 34–66.5 years) were included. The prevalence of ACS was 11.6%. Non-reproducible CWT had a high sensitivity of 92.9% (95% CI 66.1% to 98.8%) for ACS and the presence of reproducible CWT ruled out ACS (p=0.003) with a high negative predictive value (98.1%, 95% CI 89.9% to 99.7%). Conversely non-reproducible CWT ruled in ACS with low specificity (48.6%, 95% CI 38.8% to 58.5%) and low positive predictive value (19.1%, 95% CI 10.6% to 30.5%).
This prospective diagnostic study supports the concept that reproducible CWT helps to rule out ACS in patients with ACP in an early stage of the evaluation process. However, ACS and other diagnoses should be considered in patients with a negative CWT test.
Trial registration number NCT01724996.
PMCID: PMC4316553  PMID: 25631316
chest wall tenderness; acute chest pain; thoracic pain; emergency admission

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