PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (615)
 

Clipboard (0)
None
Journals
Year of Publication
1.  Flemish adolescents’ perceptions of cigarette plain packaging: a qualitative study with focus group discussions 
BMJ Open  2012;2(6):e001424.
Objectives
To find out whether there is a potential impact of the appearance of a plain cigarette package on the smoking perceptions and behavioural intentions of Flemish adolescents.
Design
We performed a cross-sectional study using the qualitative method of focus group discussions.
Setting
Flemish adolescents.
Participants
We performed eight focus group discussions, in which 55 adolescents took part, 32 female and 23 male. Inclusion criteria were: Flemish male and female 15-year-olds to 16-year-olds and 17-year-olds to 18-year-olds attending regular high-school education or vocational training who were current or had ever been smokers.
Outcome measure (planned as well as measured)
The opinions and perceptions of young Flemish smokers regarding the impact of cigarette packaging on their smoking behaviour.
Results
Plain packages are perceived as less attractive, cheap and unreliable for young people. Because of the unattractiveness of the plain packaging, the health warnings catch the eye much more strongly.
Conclusions
In this first scientific study in Flanders on this topic, it emerged that plain packaging could be a strong policy tool to reduce the number of adolescents starting smoking. Validation of these findings by conducting a quantitative survey in the same target group is recommended.
doi:10.1136/bmjopen-2012-001424
PMCID: PMC3532973  PMID: 23242481
Public Health; Qualitative Research; Preventive Medicine
2.  The ethics of unlinked anonymous testing of blood: views from in-depth interviews with key informants in four countries 
BMJ Open  2012;2(6):e001427.
Objectives
In this study we explore the ethical issues around unlinked anonymous testing (UAT) of blood, a method of seroprevalence surveillance for infectious diseases. Our study focused on UAT for HIV, although UAT can be used for other infectious diseases. The objectives of the research were to gain a better understanding of the views of key informants in countries adopting different UAT testing strategies, and to use the findings of the research to inform health policy.
Design
Qualitative study using in-depth interviews and ethical analysis.
Setting
Four countries using different strategies around UAT of blood for HIV (the UK, the USA, the Netherlands and Norway).
Participants
Twenty-three key informants in the four countries.
Results
Participants from the four countries have different views on UAT of blood, and the approaches and policies on UAT adopted by different countries have been historically and culturally determined. We use our findings to explore the relationship between public health policy and ethics, framing our discussion in relation to two important contemporary debates: informed consent for participation in medical and public health research; and the balance between the individual good and the public good.
Conclusions
Qualitative research and ethical analysis of UAT of blood in different countries has yielded important findings for consideration by policy makers. The policy of UAT of blood for HIV and other diseases in the UK needs reconsideration in the light of these findings.
doi:10.1136/bmjopen-2012-001427
PMCID: PMC3532979  PMID: 23263019
Public Health; Medical Ethics
3.  A cross-sectional study to identify organisational processes associated with nurse-reported quality and patient safety 
BMJ Open  2012;2(6):e001967.
Objectives
The purpose of this study was to identify organisational processes and structures that are associated with nurse-reported patient safety and quality of nursing.
Design
This is an observational cross-sectional study using survey methods.
Setting
Respondents from 31 Norwegian hospitals with more than 85 beds were included in the survey.
Participants
All registered nurses working in direct patient care in a position of 20% or more were invited to answer the survey. In this study, 3618 nurses from surgical and medical wards responded (response rate 58.9). Nurses' practice environment was defined as organisational processes and measured by the Nursing Work Index Revised and items from Hospital Survey on Patient Safety Culture.
Outcome measures
Nurses' assessments of patient safety, quality of nursing, confidence in how their patients manage after discharge and frequency of adverse events were used as outcome measures.
Results
Quality system, nurse–physician relation, patient safety management and staff adequacy were process measures associated with nurse-reported work-related and patient-related outcomes, but we found no associations with nurse participation, education and career and ward leadership. Most organisational structures were non-significant in the multilevel model except for nurses’ affiliations to medical department and hospital type.
Conclusions
Organisational structures may have minor impact on how nurses perceive work-related and patient-related outcomes, but the findings in this study indicate that there is a considerable potential to address organisational design in improvement of patient safety and quality of care.
doi:10.1136/bmjopen-2012-001967
PMCID: PMC3533052  PMID: 23263021
4.  The effectiveness of smoking cessation interventions in smokers with cerebrovascular disease: a systematic review 
BMJ Open  2012;2(6):e002022.
Objective
The main objective of this study was to determine the effectiveness of smoking cessation interventions (SCIs) for increasing cessation rates in smokers with cerebrovascular disease.
Design
Systematic review. Two independent reviewers searched information sources and assessed studies for inclusion/exclusion criteria.
Eligibility criteria for included studies
Randomised control trials, conducted prior to the 22 May 2012 investigating SCIs in smokers with cerebrovascular disease, were included. No age or ethnicity limitations were applied in order to be as inclusive as possible.
Methods
We followed the PRISMA statement approach to identify relevant randomised control studies. Due to the variability of interventions used in the reported studies, a meta-analysis was not conducted.
Results
Of 852 identified articles, 4 articles fit the inclusion criteria describing the outcome in 354 patients. The overall cessation rate with an SCI was 23.9% (42 of 176) while without one was 20.8% (37 of 178).
Conclusions
There are a limited number of reported intervention studies that explore this area of secondary stroke prevention. Furthermore, of those intervention studies that were found, only two implemented evidence-based approaches to smoking cessation. A meta-analysis was not conducted because of the variability of interventions in the reported studies. Larger studies with homogeneous interventions are needed to determine how effective SCIs are in increasing cessation in smokers with established cerebrovascular disease.
doi:10.1136/bmjopen-2012-002022
PMCID: PMC3533053  PMID: 23263022
epidemiology; systematic review; smoking cessation; stroke < neurology
5.  Correction 
BMJ Open  2012;2(6):e001752corr1.
doi:10.1136/bmjopen-2012-001752corr1
PMCID: PMC3569111  PMID: 23263020
6.  National survey of US primary care physicians’ perspectives about causes of obesity and solutions to improve care 
BMJ Open  2012;2(6):e001871.
Objective
To describe physician perspectives on the causes of and solutions to obesity care and identify differences in these perspectives by number of years since completion of medical school.
Design
National cross-sectional online survey from 9 February to 1 March 2011.
Setting
USA.
Participants
500 primary care physicians.
Main Measures
We evaluated physician perspectives on: (1) causes of obesity, (2) competence in treating obese patients, (3) perspectives on the health professional most qualified to help obese patients lose or maintain weight and (4) solutions for improving obesity care.
Results
Primary care physicians overwhelmingly supported additional training (such as nutrition counselling) and practice-based changes (such as having scales report body mass index) to help them improve their obesity care. They also identified nutritionists/dietitians as the most qualified providers to care for obese patients. Physicians with fewer than 20 years since completion of medical school were more likely to identify lack of information about good eating habits and lack of access to healthy food as important causes of obesity. They also reported feeling relatively more successful helping obese patients lose weight. The response rate for the survey was 25.6%.
Conclusions
Our results indicate a perceived need for improved medical education related to obesity care.
doi:10.1136/bmjopen-2012-001871
PMCID: PMC3533040  PMID: 23257776
Medical Education & Training; Internal Medicine
7.  Dying to be famous: retrospective cohort study of rock and pop star mortality and its association with adverse childhood experiences 
BMJ Open  2012;2(6):e002089.
Objectives
Rock and pop fame is associated with risk taking, substance use and premature mortality. We examine relationships between fame and premature mortality and test how such relationships vary with type of performer (eg, solo or band member) and nationality and whether cause of death is linked with prefame (adverse childhood) experiences.
Design
A retrospective cohort analysis based on biographical data. An actuarial methodology compares postfame mortality to matched general populations. Cox survival and logistic regression techniques examine risk and protective factors for survival and links between adverse childhood experiences and cause of death, respectively.
Setting
North America and Europe.
Participants
1489 rock and pop stars reaching fame between 1956 and 2006.
Outcomes
Stars’ postfame mortality relative to age-, sex- and ethnicity-matched populations (USA and UK); variations in survival with performer type, and in cause of mortality with exposure to adverse childhood experiences.
Results
Rock/pop star mortality increases relative to the general population with time since fame. Increases are greater in North American stars and those with solo careers. Relative mortality begins to recover 25 years after fame in European but not North American stars. Those reaching fame from 1980 onwards have better survival rates. For deceased stars, cause of death was more likely to be substance use or risk-related in those with more adverse childhood experiences.
Conclusions
Relationships between fame and mortality vary with performers’ characteristics. Adverse experiences in early life may leave some predisposed to health-damaging behaviours, with fame and extreme wealth providing greater opportunities to engage in risk-taking. Millions of youths wish to emulate their icons. It is important they recognise that substance use and risk-taking may be rooted in childhood adversity rather than seeing them as symbols of success.
doi:10.1136/bmjopen-2012-002089
PMCID: PMC3533086  PMID: 23253869
Public Health; Epidemiology; Occupational & Industrial Medicine
8.  Transdiagnostic, affect-focused, psychodynamic, guided self-help for depression and anxiety through the internet: study protocol for a randomised controlled trial 
BMJ Open  2012;2(6):e002167.
Introduction
Cognitive behaviour therapy delivered in the format of guided self-help via the internet has been found to be effective for a range of conditions, including depression and anxiety disorders. Recent results indicate that guided self-help via the internet is a promising treatment format also for psychodynamic therapy. However, to date and to our knowledge, no study has evaluated internet-delivered psychodynamic therapy as a transdiagnostic treatment. The affect-phobia model of psychopathology by McCullough et al provides a psychodynamic conceptualisation of a range of psychiatric disorders. The aim of this study will be to test the effects of a transdiagnostic guided self-help treatment based on the affect-phobia model in a sample of clients with depression and anxiety.
Methods and analysis
This study will be a randomised controlled trial with a total sample size of 100 participants. The treatment group receives a 10-week, psychodynamic, guided self-help treatment based on the transdiagnostic affect-phobia model of psychopathology. The treatment consists of eight text-based treatment modules and includes therapist contact in a secure online environment. Participants in the control group receive similar online therapist support without any treatment modules. Outcome measures are the 9-item Patient Health Questionnaire Depression Scale and the 7-item Generalised Anxiety Disorder Scale (GAD-7). Process measures that concerns emotional processing and mindfulness are included. All outcome and process measures will be administered weekly via the internet and at 6-month follow-up.
Discussion
This trial will add to the body of knowledge on internet-delivered psychological treatments in general and to psychodynamic treatments in particular. We also hope to provide new insights in the effectiveness and working mechanisms of psychodynamic therapy based on the affect-phobia model.
doi:10.1136/bmjopen-2012-002167
PMCID: PMC3533089  PMID: 23257775
9.  Evaluating the impact and use of Transparent Reporting of Evaluations with Non-randomised Designs (TREND) reporting guidelines 
BMJ Open  2012;2(6):e002073.
Introduction
Accurate and full reporting of evaluation of interventions in health research is needed for evidence synthesis and informed decision-making. Evidence suggests that biases and incomplete reporting affect the assessment of study validity and the ability to include this data in secondary research. The Transparent Reporting of Evaluations with Non-randomised Designs (TREND) reporting guideline was developed to improve the transparency and accuracy of the reporting of behavioural and public health evaluations with non-randomised designs. Evaluations of reporting guidelines have shown that they can be effective in improving reporting completeness. Although TREND occupies a niche within reporting guidelines, and despite it being 8 years since publication, no study yet has assessed its impact on reporting completeness or investigated what factors affect its use by authors and journal editors. This protocol describes two studies that aim to redress this.
Methods and analysis
Study 1 will use an observational design to examine the uptake and use of TREND by authors, and by journals in their instructions to authors. A comparison of reporting completeness and study quality of papers that do and do not use TREND to inform reporting will be made. Study 2 will use a cross-sectional survey to investigate what factors inhibit or facilitate authors’ and journal editors’ use of TREND. Semistructured interviews will also be conducted with a subset of authors and editors to explore findings from study 1 and the surveys in greater depth.
Ethics and dissemination
These studies will generate evidence of how implementation and dissemination of the TREND guideline has affected reporting completeness in studies with experimental, non-randomised designs within behavioural and public health research. The project has received ethics approval from the Research Ethics Committee of the Peninsula College of Medicine and Dentistry, Universities of Exeter and Plymouth.
doi:10.1136/bmjopen-2012-002073
PMCID: PMC3533093  PMID: 23257774
Public Health; Qualitative Research
10.  The influence of the food environment on overweight and obesity in young children: a systematic review 
BMJ Open  2012;2(6):e001538.
Background and objective
The increasing prevalence of childhood obesity has led to interest in its prevention, particularly through school-based and family-based interventions in the early years. Most evidence reviews, to date, have focused on individual behaviour change rather than the ‘obesogenic environment’.
Objective
This paper reviews the evidence on the influence of the food environment on overweight and obesity in children up to 8 years.
Data sources
Electronic databases (including MEDLINE, EMBASE, Cochrane Controlled Trials Register (CCTR), DARE, CINAHL and Psycho-Info) and reference lists of original studies and reviews were searched for all papers published up to 31 August 2011.
Study selection
Study designs included were either population-based intervention studies or a longitudinal study. Studies were included if the majority of the children studied were under 9 years, if they related to diet and if they focused on prevention rather than treatment in clinical settings.
Data extraction
Data included in the tables were characteristics of participants, aim, and key outcome results. Quality assessment of the selected studies was carried out to identify potential bias and an evidence ranking exercise carried out to prioritise areas for future public health interventions.
Data synthesis
Thirty-five studies (twenty-five intervention studies and ten longitudinal studies) were selected for the review. There was moderately strong evidence to support interventions on food promotion, large portion sizes and sugar-sweetened soft drinks.
Conclusions
Reducing food promotion to young children, increasing the availability of smaller portions and providing alternatives to sugar-sweetened soft drinks should be considered in obesity prevention programmes aimed at younger children. These environment-level interventions would support individual and family-level behaviour change.
doi:10.1136/bmjopen-2012-001538
PMCID: PMC3532982  PMID: 23253872
Preventive Medicine; Public Health
11.  Effectiveness of involving the private medical sector in the National TB Control Programme in Bangladesh: evidence from mixed methods 
BMJ Open  2012;2(6):e001534.
Objectives
In Bangladesh, private healthcare is common and popular, regardless of income or area of residence, making the private sector an important player in health service provision. Although the private sector offers a good range of health services, tuberculosis (TB) care in the private sector is poor. We conducted research in Dhaka, between 2004 and 2008, to develop and evaluate a public–private partnership (PPP) model to involve private medical practitioners (PMPs) within the National TB Control Programme (NTP)'s activities. Since 2008, this PPP model has been scaled up in two other big cities, Chittagong and Sylhet. This paper reports the results of this development, evaluation and scale-up.
Design
Mixed method, observational study design. We used NTP service statistics to compare the TB control outcomes between intervention and control areas. To capture detailed insights of PMPs and TB managers about the process and outcomes of the study, we conducted in-depth interviews, focus group discussions and workshops.
Setting
Urban setting, piloted in four areas in Dhaka city; later scaled up in other areas of Dhaka and in two major cities.
Findings
The partnership with PMPs yielded significantly increased case finding of sputum smear-positive TB cases. Between 2004 and 2010, 703 participating PMPs referred 3959 sputum smear-positive TB cases to the designated Directly Observed Treatment, Short-course (DOTS) centres, contributing about 36% of all TB cases in the project areas. There was a steady increase in case notification rates in the project areas following implementation of the partnership.
Conclusions
The PPP model was highly effective in improving access and quality of TB care in urban settings.
doi:10.1136/bmjopen-2012-001534
PMCID: PMC3532984  PMID: 23253871
Public Health
12.  Obstructive airway disease and edentulism in the atherosclerosis risk in communities (ARIC) study 
BMJ Open  2012;2(6):e001615.
Objectives
We examined the potential association between prior chronic obstructive pulmonary disease (COPD) and edentulism, and whether the association varied by COPD severity using data from the Dental Atherosclerosis Risk in Communities Study.
Design
Cross-sectional.
Setting
Community dwelling subjects from four US communities.
Participants and measurements
Cases were identified as edentulous (without teeth) and subjects with one or more natural teeth were identified as dentate. COPD cases were defined by spirometry measurements that showed the ratio of forced expiratory volume (1 s) to vital capacity to be less than 0.7. The severity of COPD cases was also determined using a modified Global Initiative for Chronic Obstructive Lung Disease classification criteria (GOLD stage I–IV). Multiple logistic regression was used to examine the association between COPD and edentulism, while adjusting for age, gender, centre/race, ethnicity, education level, income, diabetes, hypertension, coronary heart disease and congestive heart failure, body mass index, smoking, smokeless tobacco use and alcohol consumption.
Results
13 465 participants were included in this analysis (2087 edentulous; 11 378 dentate). Approximately 28.3% of edentulous participants had prior COPD compared with 19.6% among dentate participants (p<0.0001). After adjustment for potential confounders, we observed a 1.3 (1.08 to 1.62) and 2.5 (1.68 to 3.63) fold increased risk of edentulism among GOLD II and GOLD III/IV COPD, respectively, as compared with the non-COPD/dentate referent. Given the short period of time between the measurements of COPD (visit 2) and dentate status (visit 4) relative to the natural history of both diseases, neither temporality nor insight as to the directionality of the association can be ascertained.
Conclusions
We found a statistically significant association between prior COPD and edentulism, with evidence of a positive incremental effect seen with increasing GOLD classification.
doi:10.1136/bmjopen-2012-001615
PMCID: PMC3533002  PMID: 23253873
Pulmonary disease; Edentulism; Chronic Obstructive disease; bronchitis
13.  Impact of prior probabilities of MRSA as an infectious agent on the accuracy of the emerging molecular diagnostic tests: a model simulation 
BMJ Open  2012;2(6):e001804.
Objectives
Traditional microbiology identification takes 48–72 h to complete. This lag forces clinicians to rely on broad-spectrum empiric coverage. To address this gap, manufacturers are developing rapid molecular diagnostics (RMD). We hypothesised that RMD's accuracy is more dependent upon population risk of harbouring the culprit pathogen than to their sensitivity and specificity.
Design
A mathematical model.
Setting and participants
We used the range of risks (5–50%) for methicillin-resistant Staphylococcus aureus (MRSA) among patients hospitalised with complicated skin and skin structure infections (cSSSI), pneumonia or sepsis.
Main outcome measures
We modelled the impact of changing a test's characteristics on its positive (PPV) and negative (NPV) predictive values, and hence the risk of overtreatment or undertreatment, within strata of an organism's population prevalence. MRSA diagnostics provided assumptions for the test sensitivity and specificity (95–99%). Scenarios with low sensitivity and specificity (90%), and best-case and worst-case scenarios normalised to the annual universe of populations of interest, were examined.
Results
With a low prevalence (5%) and high test specificity, the PPV was 84%. Conversely, with 50% prevalence and 95% test specificity the PPV rose to ≥95%. Even when the test's specificity and sensitivity were both 90%, in a high-risk population both PPV and NPV were ∼90%. In the worst-case scenario, 150 000 patients with cSSSI, pneumonia and sepsis annually were at risk for inappropriate treatment, 91% of these at risk for over-treatment. In the best-case scenario, 81% of 18 000 patients at risk for inappropriate coverage were subject to overtreatment.
Conclusions
Although promising for limiting exposure to excessive antimicrobial coverage, RMDs alone will not solve the issue of inappropriate, and particularly overtreatment. Increasing pretest probability as a strategy to minimise antibiotic abuse results in more accurate patient classification than does developing a test with near-perfect characteristics. The healthcare community must build robust evidence and information technology infrastructure to guide appropriate use of such testing.
doi:10.1136/bmjopen-2012-001804
PMCID: PMC3533025  PMID: 23253875
Epidemiology
14.  Home-based cardiac rehabilitation is an attractive alternative to no cardiac rehabilitation for elderly patients with coronary heart disease: results from a randomised clinical trial 
BMJ Open  2012;2(6):e001820.
Objective
To compare home-based cardiac rehabilitation (CR) with usual care (control group with no rehabilitation) in elderly patients who declined participation in centre-based CR.
Design
Randomised clinical trial with 12 months follow-up and mortality data after 5.5 years (mean follow-up 4½ years).
Setting
Rehabilitation unit, Department of Cardiology, Copenhagen, Denmark.
Participants
Elderly patients ≥65 years with coronary heart disease.
Intervention
A physiotherapist made home visits in order to develop an individualised exercise programme that could be performed at home and surrounding outdoor area. Risk factor intervention, medical adjustment, physical and psychological assessments were offered at baseline and after 3, 6 and 12 months.
Main outcome measurements
The primary outcome was 6 min walk test (6MWT). Secondary outcomes were blood pressure, body composition, cholesterol profile, cessation of smoking, health-related quality of life (HRQoL), anxiety and depression.
Results
40 patients participated. The study population was characterised by high age (median age 77 years, range 65–92 years) and high level of comorbidity. Patients receiving home-based CR had a significant increase in the primary outcome 6MWT of 33.5 m (95% CI: 6.2 to 60.8, p=0.02) at 3 months, whereas the usual care group did not significantly improve, but with no significant differences between the groups. At 12 months follow-up, there was a decline in 6MWT in both groups; −55.2 m (95% CI: 18.7 to 91.7, p<0.01) in the home group and −52.1 m (95% CI: −3.0 to 107.1, p=0.06) in the usual care group. There were no significant differences in blood pressure, body composition, cholesterol profile, cessation of smoking or HRQoL after 3, 6 and 12 months follow-up.
Conclusions
Participation in home-based CR improved exercise capacity among elderly patients with coronary heart disease, but there was no significant difference between the home intervention and the control group. In addition, no significant difference was found in the secondary outcomes. When intervention ceased, the initial increase in exercise capacity was rapidly lost.
doi:10.1136/bmjopen-2012-001820
PMCID: PMC3533030  PMID: 23253876
Cardiology
15.  Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report 
BMJ Open  2012;2(6):e001249.
Objective
Administering medication to hospitalised infants and children is a complex process at high risk of error. Failure mode and effect analysis (FMEA) is a proactive tool used to analyse risks, identify failures before they happen and prioritise remedial measures. To examine the hazards associated with the process of drug delivery to children, we performed a proactive risk-assessment analysis.
Design and setting
Five multidisciplinary teams, representing different divisions of the paediatric department at Padua University Hospital, were trained to analyse the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure and plan changes in practices.
Primary outcome
To identify higher-priority potential failure modes as defined by RPNs and planning changes in clinical practice to reduce the risk of patients harm and improve safety in the process of medication use in children.
Results
In all, 37 higher-priority potential failure modes and 71 associated causes and effects were identified. The highest RPNs related (>48) mainly to errors in calculating drug doses and concentrations. Many of these failure modes were found in all the five units, suggesting the presence of common targets for improvement, particularly in enhancing the safety of prescription and preparation of endovenous drugs. The introductions of new activities in the revised process of administering drugs allowed reducing the high-risk failure modes of 60%.
Conclusions
FMEA is an effective proactive risk-assessment tool useful to aid multidisciplinary groups in understanding a process care and identifying errors that may occur, prioritising remedial interventions and possibly enhancing the safety of drug delivery in children.
doi:10.1136/bmjopen-2012-001249
PMCID: PMC3533113  PMID: 23253870
Qualitative Research; Pediatrics; Drugs Administration
16.  An international measure of awareness and beliefs about cancer: development and testing of the ABC 
BMJ Open  2012;2(6):e001758.
Objectives
To develop an internationally validated measure of cancer awareness and beliefs; the awareness and beliefs about cancer (ABC) measure.
Design and setting
Items modified from existing measures were assessed by a working group in six countries (Australia, Canada, Denmark, Norway, Sweden and the UK). Validation studies were completed in the UK, and cross-sectional surveys of the general population were carried out in the six participating countries.
Participants
Testing in UK English included cognitive interviewing for face validity (N=10), calculation of content validity indexes (six assessors), and assessment of test–retest reliability (N=97). Conceptual and cultural equivalence of modified (Canadian and Australian) and translated (Danish, Norwegian, Swedish and Canadian French) ABC versions were tested quantitatively for equivalence of meaning (≥4 assessors per country) and in bilingual cognitive interviews (three interviews per translation). Response patterns were assessed in surveys of adults aged 50+ years (N≥2000) in each country.
Main outcomes
Psychometric properties were evaluated through tests of validity and reliability, conceptual and cultural equivalence and systematic item analysis. Test–retest reliability used weighted-κ and intraclass correlations. Construction and validation of aggregate scores was by factor analysis for (1) beliefs about cancer outcomes, (2) beliefs about barriers to symptomatic presentation, and item summation for (3) awareness of cancer symptoms and (4) awareness of cancer risk factors.
Results
The English ABC had acceptable test–retest reliability and content validity. International assessments of equivalence identified a small number of items where wording needed adjustment. Survey response patterns showed that items performed well in terms of difficulty and discrimination across countries except for awareness of cancer outcomes in Australia. Aggregate scores had consistent factor structures across countries.
Conclusions
The ABC is a reliable and valid international measure of cancer awareness and beliefs. The methods used to validate and harmonise the ABC may serve as a methodological guide in international survey research.
doi:10.1136/bmjopen-2012-001758
PMCID: PMC3547316  PMID: 23253874
early detection of cancer; cancer early diagnosis; validation studies; cross-cultural comparison; reliability and validity
17.  Assessing the knowledge of sudden unexpected death in the young among Canadian medical students and recent graduates: a cross-sectional study 
BMJ Open  2012;2(6):e001798.
Objective
To determine the level of knowledge concerning Sudden Unexpected Death in the Young (SUDY) among Canadian medical students and recent graduates (≤5 years after graduating).
Design
A cross-sectional study was conducted by distributing a standardised, multiple choice, online questionnaire which assessed basic knowledge of SUDY.
Setting
Canadian medical schools and residency training programmes.
Participants
614 Canadian medical students (in either their penultimate or final year) and recent graduates (≤5 years after graduating) completed an anonymous online questionnaire.
Primary and secondary outcome measures
The level of knowledge regarding molecular aetiology, clinical presentation, pharmacological management and modes of inheritance of six of the commonest conditions causing SUDY, including hypertrophic cardiomyopathy (HCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia (CPVT), long QT syndrome (LQT) and Wolff-Parkinson White syndrome (WPW), were compared between medical students and recent graduates. Questions were broken down into basic knowledge and advanced categories and analysed as a secondary outcome measure.
Results
Of 614 responses, approximately two-thirds were answered by recent graduates, who generally scored 10% higher on all subject categories than medical students. Overall, questions regarding HCM were best answered (40%), followed by WPW syndrome (32%), CPVT (30%), ARVC (23%), Brugada syndrome (21%) and LQT syndrome (17%). Questions categorised as basic knowledge were answered 30% and 39% correctly in medical student and recent graduate groups, respectively, and those in the advanced category were answered 20% and 25% correctly.
Conclusions
Survey respondents fared poorly when answering questions regarding SUDY, which may be a reflection of inadequate medical education regarding these disorders. Standardised teaching regarding SUDY needs to occupy a stronger focus in Canadian medical curricula in order to prevent more unnecessary deaths by these syndromes in the future.
doi:10.1136/bmjopen-2012-001798
PMCID: PMC3533023  PMID: 23242483
18.  Representativeness of the dabigatran, apixaban and rivaroxaban clinical trial populations to real-world atrial fibrillation patients in the United Kingdom: a cross-sectional analysis using the General Practice Research Database 
BMJ Open  2012;2(6):e001768.
Objective
Three oral anticoagulants have reported study results for stroke prevention in patients with atrial fibrillation (AF) (dabigatran etexilate, rivaroxaban and apixaban); all demonstrated superiority or non-inferiority compared with warfarin (RE-LY, ARISTOTLE and ROCKET-AF). This study aimed to assess the representativeness for the real-world AF population, particularly the population eligible for anticoagulants.
Design
A cross-sectional database analysis.
Setting
Dataset derived from the General Practice Research Database (GPRD).
Primary and secondary outcomes measure
The proportion of real-world patients with AF who met the inclusion/exclusion criteria for RE-LY, ARISTOTLE and ROCKET-AF were compared. The results were then stratified by risk of stroke using CHADS2 and CHA2DS2-VASc.
Results
83 898 patients with AF were identified in the GPRD. For the population at intermediate or high risk of stroke and eligible for anticoagulant treatment (CHA2DS2-VASc ≥1; n=78 783 (94%)), the proportion eligible for inclusion into RE-LY (dabigatran etexilate) was 68% (95% CI 67.7% to 68.3%; n=53 640), compared with 65% (95% CI 64.7% to 65.3%; n=51 163) eligible for ARISTOTLE (apixaban) and 51% (95% CI 50.7% to 51.4%; n=39 892) eligible for ROCKET-AF (rivaroxaban). Using the CHADS2 method of risk stratification, for the population at intermediate or high risk of stroke and eligible for anticoagulation treatment (CHADS2 ≥1; n=71 493 (85%)), the proportion eligible for inclusion into RE-LY was 74% (95% CI 73.7% to 74.3%; n=52 783), compared with 72% (95% CI 71.7% to 72.3%; n=51 415) for ARISTOTLE and 56% (95% CI 55.6% to 56.4%; n=39 892) for ROCKET-AF.
Conclusions
Patients enrolled within RE-LY and ARISTOTLE were more reflective of the ‘real-world’ AF population in the UK, in contrast with patients enrolled within ROCKET-AF who were a more narrowly defined group of patients at higher risk of stroke. Differences between trials should be taken into account when considering the applicability of findings from randomised clinical trials. However, assessing representativeness is not a substitute for assessing generalisibility, that is, how well clinical trial results would translate into effectiveness and safety in everyday routine care.
doi:10.1136/bmjopen-2012-001768
PMCID: PMC3533028  PMID: 23242482
19.  Attitudes and beliefs about hand hygiene among paediatric residents: a qualitative study 
BMJ Open  2012;2(6):e002188.
Background
Despite the knowledge that contaminated hands play an important role in the transmission of healthcare-associated pathogens, and that hand hygiene (HH) reduces the transmission of these organisms, healthcare worker's adherence with HH is poor.
Objective
To understand the common beliefs and attitudes held by paediatric residents about HH.
Design
Qualitative study design.
Setting
Tertiary care paediatric hospital in Edmonton, Canada.
Methods
Semistructured interviews were conducted and themes were identified from interviews.
Participants
22 paediatric residents.
Results
Paediatric residents self-reported their HH adherence at 70–99% and perceived hospital-wide adherence at 45–80%. Four major themes were identified during interviews including the importance of role modelling, balancing time spent on HH with other competing factors, self-protection as a driving factor for HH and cues as an important part of habit that stimulate HH.
Conclusions
Staff physicians were viewed as integral to initiating group HH events, but at times, the first person in the room acted as a role model for the rest of the group. In certain instances, such as a cardiac arrest, decreased adherence with HH was viewed as acceptable. Residents engaged in HH to protect their own health. Residents relied on personal cues, which they integrated into their own HH habit. Future HH adherence strategies should ensure that the physician training environments permit the formation of good attitudes and habits towards HH. There are no additional data available.
doi:10.1136/bmjopen-2012-002188
PMCID: PMC3533101  PMID: 23242484
Paediatrics; Qualitative Research
20.  The older the better: are elderly study participants more non-representative? A cross-sectional analysis of clinical trial and observational study samples 
BMJ Open  2012;2(6):e000833.
Objective
Study participants can differ from the target population they are taken to represent. We sought to investigate whether older age magnifies such differences, examining age-trends, among study participants, in self-rated level of activity compared to others of the same age.
Design
Cross-sectional examination of the relation of participant age to reported ‘relative activity’ (ie, compared to others of the same age), a bidirectionally correlated proxy for relative vitality, in exemplars of randomised and observational studies.
Setting
University of California, San Diego (UCSD)
Participants
2404 adults aged 40–79 including employees of UCSD, and their partners (San Diego Population Study, observational study). 1016 adults (aged 20-85) not on lipid medications and without known heart disease, diabetes, cancer or HIV (UCSD Statin Study, randomised trial).
Measurements
Self-rated activity relative to others’ age, 5-point Likert Scale, was evaluated by age decade, and related via correlation and regression to a suite of health-relevant subjective and objective outcomes.
Results
Successively older participants reported successively greater activity relative to others of their age (greater departure from the norm for their age), p<0.001 in both studies. Relative activity significantly predicted (in regression adjusted for age) actual activity (times/week exercised), and numerous self-rated and objective health-predictors. These included general self-rated health, CES-D (depression score), sleep, tiredness, energy; body mass index, waist circumference, serum glucose, high-density lipoprotein-cholesterol, triglycerides and white cell count. Indeed, some health-predictor associations with age in participants were ‘paradoxical,’ consistent with greater apparent health in older age—for study participants.
Conclusions
Study participants may not be representative of the population they are intended to reflect. Our results suggest that departures from representativeness may be amplified with increasing age. Consequently, the older the age, the greater the disparity may be between what is recommended based on ‘evidence, ’ and what is best for the patient.
Trial Registration
UCSD Statin Study—Clinicaltrials.gov # NCT00330980 (http://ClinicalTrials.gov)
doi:10.1136/bmjopen-2012-000833
PMCID: PMC3533104  PMID: 23242479
21.  Managing waiting times in diagnostic medical imaging 
BMJ Open  2012;2(6):e001255.
Objective
This paper aims to analyse the variation in the delivery of diagnostic imaging services in order to suggest possible solutions for the reduction of waiting times, increase the quality of services and reduce financial costs.
Design
This study provides a logic model to manage waiting times in a regional context. Waiting times measured per day were compared on the basis of the variability in the use rates of CT and MRI examinations in Tuscany for the population, as well as on the basis of the capacity offered with respect to the number of radiologists available. The analysis was performed at the local health authority level to support the decision-making process of local managers.
Setting
Diagnostic imaging services, in particular the CT and MRI examinations. The study involved all the 12 local health authorities that provide services for 3.7 million inhabitants of the Italian Tuscany Region.
Primary and secondary outcome measures
Participants: the study uses regional administrative data on outpatients and survey data on inpatient diagnostic examinations in order to measure productivity.
Primary and secondary outcome measures
The study uses the volumes per 1000 inhabitants, the days of waiting times and the number of examinations per radiologist. Variability was measured using the traditional SD measures.
Results
A significant variation in areas considered homogeneous in terms of age, gender or mortality may indicate that the use of radiological services is not optimal and underuse or overuse occurs and that there is room for improvement in the service organisation.
Conclusions
Considering that there is a high level of variability among district use rates and waiting times, this study provides managers with a specific tool to find the cause of the problem, identify a possible solution, assess the financial impact and initiate the eventual reduction of waste.
doi:10.1136/bmjopen-2012-001255
PMCID: PMC3533122  PMID: 23242480
Health Services Administration & Management
22.  Hookah's new popularity among US college students: a pilot study of the characteristics of hookah smokers and their Facebook displays 
BMJ Open  2012;2(6):e001709.
Objectives
(1) To confirm the prevalence of hookah use among US college students. (2) To identify substances commonly smoked in hookahs and other substance use characteristics of hookah smokers. (3) Given the powerful influence of Facebook and its potential role in promoting behaviours, to assess the prevalence of hookah references on Facebook profiles.
Design
Cross-sectional study.
Setting
Two large US universities; www.Facebook.com.
Participants
307 Facebook profiles were coded and 216 of these profile owners completed an online survey. On average, participants were 18.8 years old (SD=0.7), women (54%), Caucasian (70.4%) and approximately half were from each university.
Outcome measures
Lifetime and frequency of hookah use, substance smoked in hookah, cigarette and marijuana use, hookah references displayed on Facebook.
Results
27.8% of participants endorsed hookah use; there were no significant differences between age, gender, race or university for hookah use. Hookah users reported smoking tobacco (78%), hash (12%) and both tobacco and marijuana/hash (10%) in their hookah. Compared with non-hookah smokers, hookah smokers were more likely to report using cigarettes (OR=3.41, 95%CI=1.2 to 9.64) and marijuana (OR=15.01, 95%CI=6.5 to 34.65). Hookah references were present on 5% of Facebook profiles.
Conclusions
More than one quarter of college students smoke hookah. Most smoke tobacco in their hookah, and hookah smoking is associated with polysubstance use. Hookah may present new risks for nicotine addiction in this population.
doi:10.1136/bmjopen-2012-001709
PMCID: PMC3533013  PMID: 23242241
Public Health; Paediatrics
23.  Vitamin D3 supplementation in patients with frequent respiratory tract infections: a randomised and double-blind intervention study 
BMJ Open  2012;2(6):e001663.
Background
Low serum levels of 25-hydroxyvitamin D3 are associated with an increased risk of respiratory tract infections (RTIs). Clinical trials with vitamin D3 against various infections have been carried out but data are so far not conclusive. Thus, there is a need for additional randomised controlled trials of effects of vitamin D3 on infections.
Objective
To investigate if supplementation with vitamin D3 could reduce infectious symptoms and antibiotic consumption among patients with antibody deficiency or frequent RTIs.
Design
A double-blind randomised controlled trial.
Setting
Karolinska University Hospital, Huddinge.
Participants
140 patients with antibody deficiency (selective IgA subclass deficiency, IgG subclass deficiency, common variable immune disorder) and patients with increased susceptibility to RTIs (>4 bacterial RTIs/year) but without immunological diagnosis.
Intervention
Vitamin D3 (4000 IU) or placebo was given daily for 1 year.
Primary and secondary outcome measures
The primary endpoint was an infectious score based on five parameters: symptoms from respiratory tract, ears and sinuses, malaise and antibiotic consumption. Secondary endpoints were serum levels of 25-hydroxyvitamin D3, microbiological findings and levels of antimicrobial peptides (LL-37, HNP1–3) in nasal fluid.
Results
The overall infectious score was significantly reduced for patients allocated to the vitamin D group (202 points) compared with the placebo group (249 points; adjusted relative score 0.771, 95% CI 0.604 to 0.985, p=0.04).
Limitations
A single study centre, small sample size and a selected group of patients. The sample size calculation was performed using p=0.02 as the significance level whereas the primary and secondary endpoints were analysed using the conventional p=0.05 as the significance level.
Conclusions
Supplementation with vitamin D3 may reduce disease burden in patients with frequent RTIs.
doi:10.1136/bmjopen-2012-001663
PMCID: PMC3533016  PMID: 23242238
Infectious Diseases; Bacteriology; Respiratory Medicine (see Thoracic Medicine)
24.  Protocol for a phase III randomised trial of image-guided intensity modulated radiotherapy (IG-IMRT) and conventional radiotherapy for late small bowel toxicity reduction after postoperative adjuvant radiation in Ca cervix 
BMJ Open  2012;2(6):e001896.
Introduction
External beam radiation followed by vaginal brachytherapy (±chemotherapy) leads to reduction in the risk of local recurrence and improves progression-free survival in patients with adverse risk factors following Wertheim's hysterectomy albeit at the risk of late bowel toxicity. Intensity Modulated Radiotherapy (IMRT) results in reduction in bowel doses and has potential to reduce late morbidity, however, needs to be confirmed prospectively in a randomised trial. The present randomised trial tests reduction if any in late small bowel toxicity with the use of IMRT in postoperative setting.
Methods and analysis
Patients more than 18 years of age who need adjuvant (chemo) radiation will be eligible. Patients with residual pelvic or para-aortic nodal disease, history of multiple abdominal surgeries or any other medical bowel condition will be excluded. The trial will randomise patients into standard radiation or IMRT. The primary aim is to compare differences in late grades II–IV bowel toxicity between the two arms. The secondary aims of the study focus on evaluating correlation of dose–volume parameters and late toxicity and quality of life. The trial is planned as a multicentre randomised study. The trial is designed to detect a 13% difference in late grades II–IV bowel toxicity with an α of 0.05 and β of 0.80. A total of 240 patients will be required to demonstrate the aforesaid difference.
Ethics and dissemination
The trial is approved by institutional ethics review board and will be routinely monitored as per standard guidelines. The study results will be disseminated via peer reviewed scientific journals, conference presentations and submission to regulatory authorities.
Registration
The trial is registered with clinicaltrials.gov (NCT 01279135).
doi:10.1136/bmjopen-2012-001896
PMCID: PMC3533039  PMID: 23242243
25.  Consensus views on implementation and measurement of enhanced recovery after surgery in England: Delphi study 
BMJ Open  2012;2(6):e001878.
Objective
The Department of Health's Enhanced Recovery Partnership Programme (ERPP) started a spread and adoption scheme of Enhanced Recovery After Surgery (ERAS) throughout England. In preparation for widespread adoption the ERPP wished to obtain expert consensus on appropriate outcome measures for ERAS, emerging techniques being widely adopted and proposed methods for the continued development and sustainability of ERAS in the National Health Service. The aim of this study was to interrogate expert opinion and define areas of consensus on these issues.
Design
A Delphi technique using three rounds of reiterative questionnaires was used to obtain consensus.
Participants
Experts were chosen from teams with experience of delivering a successful ERAS programme across different surgical specialties and across various disciplines.
Setting
The first two rounds of the questionnaire were completed online and a final, third round was undertaken in a meeting using interactive voting.
Results
86 experts took part in this study. Consensus statements agreed that patient experience data should be recorded, analysed and reviewed at regular ERAS meetings. Recent developments in regional analgesia, the increased use of intraoperative monitoring for fluid management and cardio-pulmonary exercise testing were the main emerging techniques identified. National standards for those outcome measures would be welcomed. To sustain success in ERAS, the experts highlighted clinical champions and the presence of a dedicated ERAS facilitator as essential elements. For future networking, a unanimous agreement was achieved on the formation a national network to facilitate spread and adoption of ERAS and to promote research and education across surgery.
Conclusions
Consensus was achieved on regular measurement and review of patient experience in ERAS. Agreement was reached on the role of regional analgesia and the use of oesophageal Doppler for intraoperative goal-directed fluid therapy. In order to facilitate the further spread and adoption of best practices and to promote research and education, an ERAS-UK network was recommended.
doi:10.1136/bmjopen-2012-001878
PMCID: PMC3533042  PMID: 23242242
Enhanced Recovery After Surgery; Consensus Views; Perioperative care; Patient feedback; Oesophageal doppler; CPEX testing

Results 1-25 (615)