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26.  Analgesic use, pain and daytime sedation in people with and without dementia in aged care facilities: a cross-sectional, multisite, epidemiological study protocol 
BMJ Open  2014;4(6):e005757.
Introduction
People living with dementia may experience and express pain in different ways to people without dementia. People with dementia are typically prescribed fewer analgesics than people without dementia indicating a potential difference in how pain is identified and treated in these populations. The objectives of this study are to (1) investigate the prevalence of analgesic load, pain and daytime sedation in people with and without dementia in Australian residential aged care facilities (RACFs), and (2) investigate the clinical and diagnostic associations between analgesic load, pain and daytime sedation in people with and without dementia in Australian RACFs.
Methods/analysis
This will be a cross-sectional study of 300 permanent residents of up to 10 low-level and high-level RACFs in South Australia with and without dementia. Trained study nurses will administer validated and dementia-specific assessments of self-reported and clinician-observed pain, sedation and other clinical and humanistic outcomes. Medicine-use data will be extracted directly from each resident's medication administration chart. Binary and multinominal logistic regression will be used to compute unadjusted and adjusted ORs and 95% CIs for factors associated with pain, analgesic load and daytime sedation. These factors will include dementia severity, behavioural and psychological symptoms, quality of life, resident satisfaction, attitudes towards medicines, activities of daily living and nutritional status.
Ethics and dissemination
Institutional ethics approval has been granted. The findings will be disseminated through public lectures, professional and scientific conferences and in peer-reviewed journal articles. The findings of this study will allow for a better understanding of the prevalence and factors associated with analgesic use, pain and other outcomes in residential care. The findings of this study will be used to inform the development and implementation of strategies to improve the quality of life of people with dementia.
doi:10.1136/bmjopen-2014-005757
PMCID: PMC4067818  PMID: 24948752
Epidemiology; Geriatric Medicine; Pain Management
27.  Correction 
BMJ Open  2014;4(6):e005123corr1.
doi:10.1136/bmjopen-2014-005123corr1
PMCID: PMC4067822  PMID: 24948749
28.  Differences in socioeconomic position, lifestyle and health-related pregnancy characteristics between Pakistani and White British women in the Born in Bradford prospective cohort study: the influence of the woman's, her partner's and their parents’ place of birth 
BMJ Open  2014;4(6):e004805.
Objective
To examine differences between Pakistani and White British women in relation to socioeconomic position, lifestyle and health-related pregnancy characteristics, and to determine whether these differences vary depending on the woman's, her partner's and both of their parents’ place of birth.
Design
Prospective cohort study.
Setting
Bradford, UK
Participants
3656 Pakistani and 3503 White British women recruited to the Born in Bradford study.
Main outcome measures
Socioeconomic position (employment status; level of education; receipt of benefits; housing tenure), lifestyle characteristics (body mass index (BMI) at the start of pregnancy; smoking during pregnancy) and health-related pregnancy characteristics (hypertensive disorders of pregnancy; gestational diabetes; fasting glucose, postload glucose and fasting insulin at ∼27 weeks gestation).
Results
Fewer Pakistani women were employed (OR 0.17, 95% CI 0.15 to 0.19), the difference being markedly less for UK born women. UK born Pakistani women were more likely, and South Asian born less likely, to be educated post 16 than White British women. Smoking was uncommon among Pakistani women, though the difference comparing UK born Pakistani women to White British women was less than for other groups. BMI was lower among Pakistani compared to White British women (adjusted mean difference −1.12, 95% CI −1.43 to −0.81), the difference being greatest when partners were UK born irrespective of the woman’s place of birth. Pakistani women had higher fasting and postload glucose (mean difference 0.20 mmol/L, 95% CI 0.17 to 0.24; 0.37, 95% CI 0.28 to 0.45), higher fasting insulin and were more likely to have gestational diabetes (GDM).
Conclusions
Our results suggest that some socioeconomic, lifestyle and pregnancy characteristics could be beginning to change in response to migration to the UK, with generally beneficial changes, that is, improving education and employment prospects, lower BMI and no evidence that being UK born has further increased the risk of GDM, but some negative, that is, slight increases in smoking.
doi:10.1136/bmjopen-2014-004805
PMCID: PMC4067825  PMID: 24948746
Epidemiology; Ethnicity; Lifestyle
29.  Job burnout among critical care nurses from 14 adult intensive care units in northeastern China: a cross-sectional survey 
BMJ Open  2014;4(6):e004813.
Objectives
The shortage of qualified nurses is one of the critical challenges in the field of healthcare. Among the contributing factors, job burnout has been indicated as a risk factor for the intention to leave. The purpose of this study was to provide a better understanding of the local status and reference data for coping strategies for intensive care unit (ICU)-nurse burnout among Liaoning ICU nurses.
Design
Observational study.
Setting
17 ICUs from 10 tertiary-level hospitals in Liaoning, China.
Participants
431 ICU nurses from 14 ICUs nested in 10 tertiary-level hospitals in Liaoning, China, were invited during October and November 2010.
Primary measures
Burnout was measured using the 22-item Chinese version of Maslach Burnout Inventory-Health Service Survey (MBI-HSS) questionnaires.
Results
14 ICUs responded actively and were included; the response rate was 87.7% among the 486 invited participants from these 17 ICUs. The study population was a young population, with the median age 25 years, IQR 23–28 years and female nurses accounted for the major part (88.5%). 68 nurses (16%) were found to have a high degree of burnout, earning high emotional exhaustion and depersonalisation scores together with a low personal accomplishment score.
Conclusions
The present study indicated a moderate distribution of burnout among ICU nurses in Liaoning, China. An investigation into the burnout levels of this population could bring more attention to ICU caregivers.
doi:10.1136/bmjopen-2014-004813
PMCID: PMC4067832  PMID: 24948747
Burnout; Intensive Care Units; nurses
30.  Drug efficacy in treating stable angina pectoris: a protocol for network meta-analysis of randomised controlled trials 
BMJ Open  2014;4(6):e005453.
Introduction
There were 11 pairwise meta-analysis on the efficacy of β-blockers (including atenolol, propranolol, bisoprolol, metoprolol and nadolol), calcium channel blockers (including amlodipine, diltiazem, felodipine, nifedipine and verapamil), and nitrates (including isosorbide dinitrate, isosorbide mononitrate and nitroglycerin) in treating stable angina pectoris. No network meta-analytic study has been published to evaluate the efficacies of these antianginal drugs. Current clinical guidelines (eg, National Institute of Health and Care Excellence (NICE) clinical guideline 126) are only based on the findings of limited clinical trials and pairwise meta-analysis. This study aims to fill this gap of research by conducting a Bayesian network meta-analysis to compare all these antianginal drugs.
Methods and analyses
Randomised controlled trials (RCT) on the drug therapy of stable angina pectoris with multiple outcome measures, selected from symptomatic relief, ECG tests, exercise tests, heart rates and blood pressures, etc, will be included. Overall effect sizes will be represented as mean differences with 95% credible intervals (CrI) for continuous outcome data and as ORs with 95% CrI for dichotomous outcome data. Bayesian network meta-analysis by WinBUGS will be conducted to compare the efficacies of these drugs. Sensitivity analysis on the quality of RCTs and subgroup analysis on the category of included drugs will be performed.
Ethics and dissemination
Ethical approval is not required because this study includes no confidential personal data and interventions on the patients. Network meta-analysis is based on the RCT reports of eligible drugs in treating stable angina pectoris. The results of this study will be disseminated by an open access and peer-reviewed publication.
Trial registration number
PROSPERO CRD42014007113.
doi:10.1136/bmjopen-2014-005453
PMCID: PMC4067836  PMID: 24948751
31.  Preventive zinc supplementation for children, and the effect of additional iron: a systematic review and meta-analysis 
BMJ Open  2014;4(6):e004647.
Objective
Zinc deficiency is widespread, and preventive supplementation may have benefits in young children. Effects for children over 5 years of age, and effects when coadministered with other micronutrients are uncertain. These are obstacles to scale-up. This review seeks to determine if preventive supplementation reduces mortality and morbidity for children aged 6 months to 12 years.
Design
Systematic review conducted with the Cochrane Developmental, Psychosocial and Learning Problems Group. Two reviewers independently assessed studies. Meta-analyses were performed for mortality, illness and side effects.
Data sources
We searched multiple databases, including CENTRAL and MEDLINE in January 2013. Authors were contacted for missing information.
Eligibility criteria for selecting studies
Randomised trials of preventive zinc supplementation. Hospitalised children and children with chronic diseases were excluded.
Results
80 randomised trials with 205 401 participants were included. There was a small but non-significant effect on all-cause mortality (risk ratio (RR) 0.95 (95% CI 0.86 to 1.05)). Supplementation may reduce incidence of all-cause diarrhoea (RR 0.87 (0.85 to 0.89)), but there was evidence of reporting bias. There was no evidence of an effect of incidence or prevalence of respiratory infections or malaria. There was moderate quality evidence of a very small effect on linear growth (standardised mean difference 0.09 (0.06 to 0.13)) and an increase in vomiting (RR 1.29 (1.14 to 1.46)). There was no evidence of an effect on iron status. Comparing zinc with and without iron cosupplementation and direct comparisons of zinc plus iron versus zinc administered alone favoured cointervention for some outcomes and zinc alone for other outcomes. Effects may be larger for children over 1 year of age, but most differences were not significant.
Conclusions
Benefits of preventive zinc supplementation may outweigh any potentially adverse effects in areas where risk of zinc deficiency is high. Further research should determine optimal intervention characteristics and delivery strategies.
doi:10.1136/bmjopen-2013-004647
PMCID: PMC4067863  PMID: 24948745
Preventive Medicine; Public Health
32.  Correction 
BMJ Open  2014;4(6):e004357corr1.
doi:10.1136/bmjopen-2013-004357corr1
PMCID: PMC4067874  PMID: 24948744
33.  What is the current NHS service provision for patients severely affected by chronic fatigue syndrome/myalgic encephalomyelitis? A national scoping exercise 
BMJ Open  2014;4(6):e005083.
Background
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), in its most severe clinical presentation, can result in patients becoming housebound and bedbound so unable to access most available specialist services. This presents particular clinical risks and treatment needs for which the National Institute for Health and Care Excellence (NICE) advises specialist medical care and monitoring. The extent of National Health Service (NHS) specialist provision in England for severe CFS/ME is currently unknown.
Objectives
To establish the current NHS provision for patients with severe CFS/ME in England.
Setting and participants
All 49 English NHS specialist CFS/ME adult services in England, in 2013.
Method
Cross-sectional survey by email questionnaire.
Primary outcome measures
Adherence to NICE guidelines for severe CFS/ME.
Results
All 49 services replied (100%). 33% (16/49) of specialist CFS/ME services provided no service for housebound patients. 55% (27/49) services did treat patients with severe CFS/ME and their interventions followed the NICE guidelines. The remaining services (12%, 6/49) offered occasional or minimal support where funding allowed. There was one NHS unit providing specialist inpatient CFS/ME provision in England.
Conclusions
Study findings highlight substantial variation in access to specialist care for patients with severe presentation of CFS/ME. Where treatment was provided, this appeared to comply with NICE recommendations for this patient group.
doi:10.1136/bmjopen-2014-005083
PMCID: PMC4078780  PMID: 24984956
Neurology; Primary Care
34.  Are statin trials in diabetes representative of real-world diabetes care: a population-based study on statin initiators in Finland 
BMJ Open  2014;4(6):e005402.
Objective
To assess the representativeness of the Heart Protection Study (HPS) and the Collaborative Atorvastatin Diabetes Study (CARDS) for incident statin users.
Design
A population-based analysis with linked register data.
Setting
Finland.
Population
56 963 patients with diabetes initiating statin use from 2005 to 2008.
Main outcome measures
We determined the proportions of real-world patients who fulfilled the eligibility criteria for HPS and CARDS trials and assessed the cardiovascular disease (CVD) event rates, assumed to reflect the background CVD risk, for those eligible and ineligible. We used descriptive statistics to identify the patient characteristics, lipid-lowering interventions and adherence to statin therapy.
Results
Of the real-world patients, 57% (N=32 582) fulfilled the eligibility criteria for HPS (DM) and 49% (N=20 499) of those without CVD for CARDS. The patients ineligible for HPS (DM) had a higher cumulative risk for CVD events than those eligible, whereas regarding CARDS the cumulative risks were of similar magnitude. The overall CVD event rates seemed to be comparable to those in the reviewed trials. Both trials were under-representative of women and users of antihypertensive agents and metformin. 27% and 29% of real-world patients had an initial statin dose corresponding to <20 mg of simvastatin. The proportions of patients who were deemed adherent were 57% in the real world and 85% in both trials.
Conclusions
Only half of the real-world patients would have qualified for the HPS (DM) and CARDS, limiting their representativeness for clinical practice. Women and users of antihypertensive agents and metformin were under-represented in both trials. These deviations reflect the changes in diabetes treatment over the years and are not expected to modify the average treatment effects of statins on CVD. Prescribing of lower statin doses in clinical practice than used in the trials and lower adherence may, however, attenuate the benefits in the real world.
doi:10.1136/bmjopen-2014-005402
PMCID: PMC4067810  PMID: 24948750
adherence; diabetes; representativeness; randomised controlled trial; statin
35.  Epidemiology of injuries in hurling: a prospective study 2007–2011 
BMJ Open  2014;4(6):e005059.
Objectives
Hurling is a stick handling game which, although native to Ireland, has international reach and presence. The aim of this study was to report incidence and type of injuries incurred by elite male hurling players over five consecutive playing seasons.
Design
Prospective cohort study.
Setting
Male intercounty elite sports teams participating in the National GAA Injury Database, 2007–2011.
Participants
A total of 856 players in 25 county teams were enrolled.
Primary and secondary outcomes
Incidence, nature and mechanism of injury were recorded by team physicians or physiotherapists to a secure online data collection portal. Time-loss injury rates per 1000 training and match play hours were calculated and injury proportions were expressed.
Results
In total 1030 injuries were registered, giving a rate of 1.2 injuries per player. These were sustained by 71% (n=608) of players. Injury incidence rate was 2.99 (95% CI 2.68 to 3.30) per 1000 training hours and 61.75 (56.75 to 66.75) per 1000 match hours. Direct player-to-player contact was recorded in 38.6% injuries, with sprinting (24.5%) and landing (13.7%) the next most commonly reported injury mechanisms. Median duration of time absent from training or games, where the player was able to return in the same season, was 12 days (range 2–127 days). The majority (68.3%) of injuries occurred in the lower limbs, with 18.6% in the upper limbs. The trunk and head/neck regions accounted for 8.6% and 4.1% injuries, respectively. The distribution of injury type was significantly different (p<0.001) between upper and lower extremities: fractures (upper 36.1%, lower 1.5%), muscle strain (upper 5.2%, lower 45.8%).
Conclusions
These data provide stable, multiannual data on injury patterns in hurling, identifying the most common injury problems. This is the first step in applying a systematic, theory-driven injury prevention model in the sport.
doi:10.1136/bmjopen-2014-005059
PMCID: PMC4067887  PMID: 24948748
Athletic Injuries; Sports Medicine; Epidemiology; Incidence
36.  The effect on physical performance of a functional assessment and immediate rehabilitation of acutely admitted elderly patients with reduced functional performance: the design of a randomised clinical trial 
BMJ Open  2014;4(6):e005252.
Introduction
Illness and hospitalisation, even of short duration, pose separate risks for permanently reduced functional performance in elderly medical patients. Functional assessment in the acute pathway will ensure early detection of declining performance and form the basis for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results rehabilitation should begin immediately after discharge.The aim of this study is to investigate the effect of a systematic functional assessment in the emergency department (ED) of elderly medical patients with reduced functional performance when combined with immediate postdischarge rehabilitation.
Method and analysis
The study is a two-way factorial randomised clinical trial. Participants will be recruited among patients admitted to the ED who are above 65 years of age with reduced functional performance. Patients will be randomly assigned to one of four groups: (1) functional assessment and immediate rehabilitation; (2) functional assessment and rehabilitation as usual; (3) assessment as usual and immediate rehabilitation; (4) assessment and rehabilitation as usual.
Primary outcome
30 s chair-stand test administered at admission and 3 weeks after discharge.
Ethics and dissemination
The study has been approved by the Regional Scientific Ethical Committees of Southern Denmark in February 2014. The study findings will be published in peer-reviewed journals and presented at national and international conferences.
Trial registration number:
ClinicalTrials.gov Identifier: NCT02062541.
doi:10.1136/bmjopen-2014-005252
PMCID: PMC4067830  PMID: 24939812
ACCIDENT & EMERGENCY MEDICINE; PRIMARY CARE; REHABILITATION MEDICINE
37.  Termination of pregnancy for maternal indications at the limits of fetal viability: a retrospective cohort study in the Dutch tertiary care centres 
BMJ Open  2014;4(6):e005145.
Objective
Maternal morbidity, either pregnancy related or pre-existent, can become life threatening and of such severity as to warrant termination of pregnancy (TOP). In this situation, chances of fetal survival are usually poor, either because of low gestational age and/or because of the fetal effects of the maternal condition. Examples include severe growth restriction in pre-eclampsia and intrauterine infection due to the very early preterm prelabour rupture of membranes. There are very few reports on the prevalence of TOP for maternal indication at the limits of fetal viability. We investigated the prevalence of and indications for TOP on maternal indication in the 10 tertiary care centres in the Netherlands during the past decade.
Study design
We conducted a retrospective review of the medical records of all women who underwent TOP for maternal indications between 22 and 27 completed weeks of gestation in all 10 tertiary care centres from 2000 to 2009.
Results
During the study period, there were 1 929 470 deliveries; 163 052 (8.4%) of these took place in one of the 10 tertiary care centres and 177 pregnancies were terminated for severe maternal disease, 131 for hypertensive disorders, 29 for intrauterine infection and 17 for other reasons. The mean gestational age at TOP was 171 days (243/7)±10 days. No maternal deaths were recorded. The overall perinatal mortality was 99.4%.
Conclusions
Over a 10-year period, TOP for maternal indications was performed in 1 in 1000 deliveries in the 10 Dutch tertiary care centres. Hypertensive disorders comprised three-quarters of the cases.
doi:10.1136/bmjopen-2014-005145
PMCID: PMC4067813  PMID: 24939810
PERINATOLOGY
38.  The prevalence of type 2 diabetes mellitus among older people in Africa: a systematic review study protocol 
BMJ Open  2014;4(6):e004747.
Introduction
The number of people with diabetes in Africa is projected to increase substantially in the next two decades, due to factors including rapid urbanisation, adoption of unhealthy diets and exercise patterns and the ageing of the population. There are currently uncertainties regarding the incidence, prevalence and management patterns of diabetes in older people across the diversity of African countries. We wish to perform a systematic review to determine the prevalence of type 2 diabetes in Africa in the older individual, over the age of 55 years, reported in studies from 2000 to 2013.
Methods and analyses
A comprehensive literature search among a number of databases will be undertaken, using an African search filter to identify diabetes prevalence studies that were published from 2000 to 2013. Full copies of articles identified by the search, and considered to meet the inclusion criteria, will be obtained for data extraction and synthesis. Statistical analysis of the primary measures, fasting plasma glucose (FPG) and oral glucose tolerance test will include two steps: (1) identification of data sources and documenting estimates and (2) application of the random-effects meta-analysis model to aggregate prevalence estimates and account for between study variability in calculating the overall pooled estimates and 95% CI for diabetes prevalence. Heterogeneity will be evaluated using the I2 statistic to determine the extent of variation in effect estimates that is due to heterogeneity rather than chance. This systematic review will be reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA).
Ethics and dissemination
Ethics is not required for this study, given that this is a protocol for a systematic review, which utilises published data. The findings of this study will be widely disseminated through peer-reviewed publications and conference presentations.
doi:10.1136/bmjopen-2013-004747
PMCID: PMC4067824  PMID: 24939807
Diabetes & Endocrinology
39.  Reliability of demographic and socioeconomic variables in predicting early initiation of breastfeeding: a replication analysis using the Kenya Demographic and Health Survey data 
BMJ Open  2014;4(6):e005194.
Objectives
Examine the reliability of sociodemographic variables in predicting initiation of breastfeeding within an hour of birth (EarlyBF), using data from 1998, 2003 and 2008–2009.
Study design
A replication analysis using the Kenya Demographic and Health Survey (KDHS) data collected in 1998, 2003 and 2008–2009. The candidate predictor variables were child's gender, home or health facility place of birth, vaginal or caesarean mode of birth, urban or rural setting, province of residence, Wealth Index and maternal education, occupation, literacy and media exposure.
Setting
Kenya.
Participants
6375 dyads of mothers aged 15–49 and their children aged 0–23 months (2125 dyads in each of the survey years).
Results
Mode of birth and province were statistically significant predictors of EarlyBF in 1998, 2003 and 2008–2009. Children delivered through caesarean section were non-EarlyBF in 1998 (OR 2.63, 95% CI 1.72 to 4.04), 2003 (OR 3.36, 95% CI 1.83 to 6.16) and 2008 (OR 3.51, 95% CI 2.17 to 5.69). The same was true of those living in the Western province in 1998 (OR 2.67, 95% CI 1.61 to 4.43), 2003 (OR 4.92, 95% CI 3.01 to 8.04) and 2008 (OR 6.07, 95% CI 3.54 to 10.39).
Conclusions
The 1998 KDHS data do not provide the basis for reliable prediction of EarlyBF, with reliability conceptualised as replicability of findings using highly similar data sets from 2003 and 2008–2009. Most of the demographic and socioeconomic variables were unreliable predictors of EarlyBF. We speculate that activities in parts or all of Kenya changed the analysis context in the period between 1998 and 2008–2009, and these changes were of a sufficient magnitude to affect the relationships under investigation. The degree to which this is a general problem in child health research is not known, calling for further research to investigate this methodological issue with other health end points and other data.
doi:10.1136/bmjopen-2014-005194
PMCID: PMC4067828  PMID: 24939811
PUBLIC HEALTH
40.  A mixed methods feasibility study to evaluate the use of a low-intensity, nurse-delivered cognitive behavioural therapy for the treatment of irritable bowel syndrome 
BMJ Open  2014;4(6):e005262.
Introduction
Irritable bowel syndrome (IBS) is characterised by symptoms such as abdominal pain, constipation, diarrhoea and bloating. These symptoms impact on health-related quality of life, result in excess service utilisation and are a significant burden to healthcare systems. Certain mechanisms which underpin IBS can be explained by a biopsychosocial model which is amenable to psychological treatment using techniques such as cognitive behavioural therapy (CBT). While current evidence supports CBT interventions for this group of patients, access to these treatments within the UK healthcare system remains problematic.
Methods and analysis
A mixed methods feasibility randomised controlled trial will be used to assess the feasibility of a low-intensity, nurse-delivered guided self-help intervention within secondary care gastrointestinal clinics. A total of 60 participants will be allocated across four treatment conditions consisting of: high-intensity CBT delivered by a fully qualified cognitive behavioural therapist, low-intensity guided self-help delivered by a registered nurse, self-help only without therapist support and a treatment as usual control condition. Participants from each of the intervention arms of the study will be interviewed in order to identify potential barriers and facilitators to the implementation of CBT interventions within clinical practice settings. Quantitative data will be analysed using descriptive statistics only. Qualitative data will be analysed using a group thematic analysis.
Ethics and dissemination
This study will provide essential information regarding the feasibility of nurse-delivered CBT interventions within secondary care gastrointestinal clinics. The data gathered during this study would also provide useful information when planning a substantive trial and will assist funding bodies when considering investment in substantive trial funding. A favourable opinion for this research was granted by the Nottingham 2 Research Ethics Committee.
Trial registration number
ISRCTN: 83683687 (http://www.controlled-trials.com/ISRCTN83683687).
doi:10.1136/bmjopen-2014-005262
PMCID: PMC4067860  PMID: 24939813
41.  Estimating treatment effects in randomised controlled trials with non-compliance: a simulation study 
BMJ Open  2014;4(6):e005362.
Objective
Randomised controlled trials (RCTs) are often considered as the gold standard for assessing new health interventions. Patients are randomly assigned to receive an intervention or control. The effect of the intervention can be estimated by comparing outcomes between groups, whose prognostic factors are expected to balance by randomisation. However, patients’ non-compliance with their assigned treatment will undermine randomisation and potentially bias the estimate of treatment effect. Through simulation, we aim to compare common approaches in analysing non-compliant data under different non-compliant scenarios.
Settings
Based on a real study, we simulated hypothetical trials by varying three non-compliant factors: the type, randomness and degree of non-compliance. We compared the intention-to-treat (ITT), as-treated (AT), per-protocol (PP), instrumental variable (IV) and complier average casual effect (CACE) analyses to estimate large (50% improvement over the control), moderate (25% improvement) and null (same as the control) treatment effects. Different approaches were compared by the bias of estimate, mean square error (MSE) and 95% coverage of the true value.
Results
For a large or moderate treatment effect, the ITT estimate was considerably biased in all scenarios. The AT, PP, IV and CACE estimates were unbiased when non-compliant behaviours were random. The IV estimate was unbiased when non-compliant behaviours were symmetrically dependent on patients’ conditions. The PP estimate was mostly unbiased when patients in the control group did not have access to the intervention. When the intervention was not different from the control, the ITT was less biased than the other approaches. Similar results were found when comparing the MSE and 95% coverage.
Conclusions
The standard ITT analysis under non-compliance is biased when the intervention has a moderate or large effect. Alternative analyses can provide unbiased or less biased estimates. Based on the results, we make some suggestions on choosing optimal approaches for analysing specific non-compliant scenarios.
doi:10.1136/bmjopen-2014-005362
PMCID: PMC4067862  PMID: 24939814
STATISTICS & RESEARCH METHODS; RANDOMIZED CONTROLLED TRIAL; NON-COMPLIANCE
42.  Current practice of venous thromboembolism prevention in acute trusts: a qualitative study 
BMJ Open  2014;4(6):e005074.
Objective
To explore the current practice of venous thromboembolism (VTE) prevention in acute trusts.
Design
A qualitative research design was used to explore the perceived current practice of thromboprophylaxis, and knowledge and experience of VTE prevention. Data were collected via interviews with personnel from acute trusts and other relevant organisations and charities. Constant comparison was used to generate themes grounded in the data.
Setting
The UK.
Participants
17 participants, sampled due to their expertise and knowledge in the field of VTE, were interviewed for the study.
Results
No one felt directly responsible for VTE risk assessment and treatment in acute trusts. There were concerns whether any action takes place based on the risk assessment. Low levels of VTE knowledge existed throughout the system.
Conclusions
Our study highlights the importance of continuous training to prevent VTE risk assessment being considered a tick box exercise and for clinicians to understand the significance of the procedure to ensure that VTE preventative measures are administered. It is essential that acute trust staff acknowledge that VTE prevention is the responsibility of everyone involved in a patient's care. Concerns remain around prophylaxis treatment, administration and contraindications.
doi:10.1136/bmjopen-2014-005074
PMCID: PMC4067865  PMID: 24939809
QUALITATIVE RESEARCH
43.  Exploring perceived barriers, drivers, impacts and the need for evaluation of public involvement in health and social care research: a modified Delphi study 
BMJ Open  2014;4(6):e004943.
Objective
To explore areas of consensus and conflict in relation to perceived public involvement (PI) barriers and drivers, perceived impacts of PI and ways of evaluating PI approaches in health and social care research.
Background
Internationally and within the UK the recognition of potential benefits of PI in health and social care research is gathering momentum and PI is increasingly identified by organisations as a prerequisite for funding. However, there is relatively little examination of the impacts of PI and how those impacts might be measured.
Design
Mixed method, three-phase, modified Delphi technique, conducted as part of a larger MRC multiphase project.
Sample
Clinical and non-clinical academics, members of the public, research managers, commissioners and funders.
Findings
This study found high levels of consensus about the most important barriers and drivers to PI. There was acknowledgement that tokenism was common in relation to PI; and strong support for the view that demonstrating the impacts and value of PI was made more difficult by tokenistic practice. PI was seen as having intrinsic value; nonetheless, there was clear support for the importance of evaluating its impact. Research team cohesion and appropriate resources were considered essential to effective PI implementation. Panellists agreed that PI can be challenging, but can be facilitated by clear guidance, together with models of good practice and measurable standards.
Conclusions
This study is the first to present empirical evidence of the opinions voiced by key stakeholders on areas of consensus and conflict in relation to perceived PI barriers and drivers, perceived impacts of PI and the need to evaluate PI. As such it further contributes to debate around best practice in PI, the potential for tokenism and how best to evaluate the impacts of PI. These findings have been used in the development of the Public Involvement Impact Assessment Framework (PiiAF), an online resource which offers guidance to researchers and members of the public involved in the PI process.
doi:10.1136/bmjopen-2014-004943
PMCID: PMC4067891  PMID: 24939808
Public Involvement; Barriers and Drivers; Conflict; Consensus; Impacts; Evaluation
44.  A protocol for an exploratory phase I mixed-methods study of enhanced integrated care for care home residents with advanced dementia: the Compassion Intervention 
BMJ Open  2014;4(6):e005661.
Introduction
In the UK approximately 700 000 people are living with, and a third of people aged over 65 will die with, dementia. People with dementia may receive poor quality care towards the end of life. We applied a realist approach and used mixed methods to develop a complex intervention to improve care for people with advanced dementia and their family carers. Consensus on intervention content was achieved using the RAND UCLA appropriateness method and mapped to sociological theories of process and impact. Core components are: (1) facilitation of integrated care, (2) education, training and support, (3) investment from commissioners and care providers. We present the protocol for an exploratory phase I study to implement components 1 and 2 in order to understand how the intervention operates in practice and to assess feasibility and acceptability.
Methods and analysis
An ‘Interdisciplinary Care Leader (ICL)’ will work within two care homes, alongside staff and associated professionals to facilitate service integration, encourage structured needs assessment, develop the use of personal and advance care plans and support staff training. We will use qualitative and quantitative methods to collect data for a range of outcome and process measures to detect effects on individual residents, family carers, care home staff, the intervention team, the interdisciplinary team and wider systems. Analysis will include descriptive statistics summarising process and care home level data, individual demographic and clinical characteristics and data on symptom burden, clinical events and quality of care. Qualitative data will be explored using thematic analysis. Findings will inform a future phase II trial.
Ethics and dissemination
Ethical approval was granted (REC reference 14/LO/0370). We shall publish findings at conferences, in peer-reviewed journals, on the Marie Curie Cancer Care website and prepare reports for dissemination by organisations involved with end-of-life care and dementia.
doi:10.1136/bmjopen-2014-005661
PMCID: PMC4067896  PMID: 24939815
Advanced Dementia; End of Life Care; Complex Intervention; Care Home Residents; Integrated Care
45.  What keeps family physicians busy in Portugal? A multicentre observational study of work other than direct patient contacts 
BMJ Open  2014;4(6):e005026.
Objectives
To quantify the time spent by family physicians (FP) on tasks other than direct patient contact, to evaluate job satisfaction, to analyse the association between time spent on tasks and physician characteristics, the association between the number of tasks performed and physician characteristics and the association between time spent on tasks and job satisfaction.
Design
Cross-sectional, using time-and-motion techniques. Two workdays were documented by direct observation. A significance level of 0.05 was adopted.
Setting
Multicentric in 104 Portuguese family practices.
Participants
A convenience sample of FP, with lists of over 1000 patients, teaching senior medical students and first-year family medicine residents in 2012, was obtained. Of the 217 FP invited to participate, 155 completed the study.
Main outcomes measured
Time spent on tasks other than direct patient contact and on the performance of more than one task simultaneously, the number of direct patient contacts in the office, the number of indirect patient contacts, job satisfaction, demographic and professional characteristics associated with time spent on tasks and the number of different tasks performed, and the association between time spent on tasks and job satisfaction.
Results
FP (n=155) spent a mean of 143.6 min/day (95% CI 135.2 to 152.0) performing tasks such as prescription refills, teaching, meetings, management and communication with other professionals (33.4% of their workload). FP with larger patient lists spent less time on these tasks (p=0.002). Older FP (p=0.021) and those with larger lists (p=0.011) performed fewer tasks. The mean job satisfaction score was 3.5 (out of 5). No association was found between job satisfaction and time spent on tasks.
Conclusions
FP spent one-third of their workday in coordinating care, teaching and managing. Time devoted to these tasks decreases with increasing list size and physician age.
doi:10.1136/bmjopen-2014-005026
PMCID: PMC4067821  PMID: 24934208
Primary Care
46.  Correction 
BMJ Open  2014;4(6):e005390corr1.
doi:10.1136/bmjopen-2014-005390corr1
PMCID: PMC4067823  PMID: 24934209
47.  Multiparametric MRI followed by targeted prostate biopsy for men with suspected prostate cancer: a clinical decision analysis 
BMJ Open  2014;4(6):e004895.
Objective
To compare the diagnostic outcomes of the current approach of transrectal ultrasound (TRUS)-guided biopsy in men with suspected prostate cancer to an alternative approach using multiparametric MRI (mpMRI), followed by MRI-targeted biopsy if positive.
Design
Clinical decision analysis was used to synthesise data from recently emerging evidence in a format that is relevant for clinical decision making.
Population
A hypothetical cohort of 1000 men with suspected prostate cancer.
Interventions
mpMRI and, if positive, MRI-targeted biopsy compared with TRUS-guided biopsy in all men.
Outcome measures
We report the number of men expected to undergo a biopsy as well as the numbers of correctly identified patients with or without prostate cancer. A probabilistic sensitivity analysis was carried out using Monte Carlo simulation to explore the impact of statistical uncertainty in the diagnostic parameters.
Results
In 1000 men, mpMRI followed by MRI-targeted biopsy ‘clinically dominates’ TRUS-guided biopsy as it results in fewer expected biopsies (600 vs 1000), more men being correctly identified as having clinically significant cancer (320 vs 250), and fewer men being falsely identified (20 vs 50). The mpMRI-based strategy dominated TRUS-guided biopsy in 86% of the simulations in the probabilistic sensitivity analysis.
Conclusions
Our analysis suggests that mpMRI followed by MRI-targeted biopsy is likely to result in fewer and better biopsies than TRUS-guided biopsy. Future research in prostate cancer should focus on providing precise estimates of key diagnostic parameters.
doi:10.1136/bmjopen-2014-004895
PMCID: PMC4067835  PMID: 24934207
biopsy; diagnosis; decision trees; prostatic neoplasms
48.  Correction 
BMJ Open  2014;4(6):e004668corr1.
doi:10.1136/bmjopen-2013-004668corr1
PMCID: PMC4067886  PMID: 24934206
49.  Correction 
BMJ Open  2014;4(6):e003965corr1.
doi:10.1136/bmjopen-2013-003965corr1
PMCID: PMC4067888  PMID: 24934204
50.  Effect of a redesigned fracture management pathway and ‘virtual’ fracture clinic on ED performance 
BMJ Open  2014;4(6):e005282.
Objectives
Collaboration between the orthopaedic and emergency medicine (ED) services has resulted in standardised treatment pathways, leaflet supported discharge and a virtual fracture clinic review. Patients with minor, stable fractures are discharged with no further follow-up arranged. We aimed to examine the time taken to assess and treat these patients in the ED along with the rate of unplanned reattendance.
Design
A retrospective study was undertaken that covered 1 year before the change and 1 year after. Prospectively collected administrative data from the electronic patient record system were analysed and compared before and after the change.
Setting
An ED and orthopaedic unit, serving a population of 300 000, in a publicly funded health system.
Participants
2840 patients treated with referral to a traditional fracture clinic and 3374 patients managed according to the newly redesigned protocol.
Outcome measures
Time for assessment and treatment of patients with orthopaedic injuries not requiring immediate operative management, and 7-day unplanned reattendance.
Results
Where plaster backslabs were replaced with removable splints, the consultation time was reduced. There was no change in treatment time for other injuries treated by the new discharge protocol. There was no increase in unplanned ED attendance, related to the injury, within 7 days (p=0.149). There was a decrease in patients reattending the ED due to a missed fracture clinic appointment.
Conclusions
This process did not require any new time resources from the ED staff. This process brought significant benefits to the ED as treatment pathways were agreed. The pathway reduced unnecessary reattendance of patients at face-to-face fracture clinics for a review of stable, self-limiting injuries.
doi:10.1136/bmjopen-2014-005282
PMCID: PMC4067811  PMID: 24928593
Accident & Emergency Medicine; Audit; Health Services Administration & Management; Orthopaedic & Trauma Surgery

Results 26-50 (2355)