PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (151)
 

Clipboard (0)
None
Journals
Year of Publication
Document Types
1.  Attitudes and perceptions of medical students about family medicine in Spain: protocol for a cross-sectional survey 
BMJ Open  2011;1(2):e000231.
Background
Despite the fact that family medicine (FM) has become established as a specialty in the past 25 years, this has not been reflected in the inclusion of the specialty in the majority of medical schools in Spain. Almost 40% of the students will work in primary care but, in spite of this, most universities do not have an assessed placement as such. There are only specific practice periods in health centres or some student-selected components with little weight in the overall curricula.
Objectives
To evaluate the attitudes and perceptions of medical students about FM in the health system and their perception about the need for specific training in FM at the undergraduate level. To explore change over time of these attitudes and perceptions and to examine potential predictive factors for change. Finally, we will review what teaching activity in FM is offered across the Spanish schools of medicine.
Methods
Descriptive cross-sectional survey. Each one of the different analyses will consist of two surveys: one for all the students in the first, third and fifth year of medical school in all the Spanish schools of medicine asking about their knowledge, perceptions and attitudes in relation to primary care and FM. There will be an additional survey for the coordinating faculty of the study in each university about the educational activities related to FM that are carried out in their centres. The repetition of the study every 2 years will allow for an analysis of the evolution of the cohort of students until they receive their degree and the potential predictive factors.
Discussion
This study will provide useful information for strategic planning decisions, content and educational methodology in medical schools in Spain and elsewhere. It will also help to evaluate the influence of the ongoing changes in FM, locally and at the European level, on the attitudes and perceptions of the students towards FM in Spain.
Article summary
Article focus
There is a need to explore further the reasons for which students choose a specific specialty for training and future practice. This protocol outlines the design of a cross-sectional survey to evaluate attitudes and perceptions of medical students about family medicine.
The project will assess the potential impact of medical school teaching on the final profiles of students, both in perceptions and expectations and in the choice of specialty.
Key messages
This is a protocol of a multicentre survey that will take place in Spanish medical schools. The study includes a survey for students and one for the coordinators of family medicine in each centre.
The repetition of the student survey every 2 years will allow for an analysis of the evolution of student cohorts until the end of their studies.
The results of this study will provide valuable information for curriculum development related to family medicine in the different schools of medicine and will help to prioritise those activities that are likely to be most effective for promoting this specialty.
Strengths and limitations of this study
The research team for this study includes coordinating faculty from 22 of the 27 universities throughout Spain. The study will be repeated every 2 years and will explore change over time of the issues addressed.
The principal limitations of this study are related to its design, of observational nature. The results observed will serve as hypotheses generating and cannot be regarded as definitive. Finally, the fact that the survey will be anonymous will impede the evaluation, at an individual level, of change over time.
doi:10.1136/bmjopen-2011-000231
PMCID: PMC3278481  PMID: 22189348
2.  The polypill in the primary prevention of cardiovascular disease: cost-effectiveness in the Dutch population 
BMJ Open  2011;1(2):e000363.
Objectives
The aim of the present study was to estimate the cost-effectiveness of the polypill in the primary prevention of cardiovascular disease.
Design
A health economic modelling study.
Setting
Primary healthcare in the Netherlands.
Participants
Simulated individuals from the general Dutch population, aged 45–75 years.
Interventions
Opportunistic screening followed by prescription of the polypill to eligible individuals. Eligibility was defined as having a minimum 10-year risk of cardiovascular death as assessed with the Systematic Coronary Risk Evaluation function of alternatively 5%, 7.5% or 10%. Different versions of the polypill were considered, depending on composition: (1) the Indian polycap, with three different types of blood pressure-lowering drugs, a statin and aspirin; (2) as (1) but without aspirin and (3) as (2) but with a double statin dose. In addition, a scenario of (targeted) separate antihypertensive and/or statin medication was simulated.
Primary outcome measures
Cases of acute myocardial infarction or stroke prevented, quality-adjusted life years (QALYs) gained and the costs per QALY gained. All interventions were compared with usual care.
Results
All scenarios were cost-effective with an incremental cost-effectiveness ratio between €7900 and 12 300 per QALY compared with usual care. Most health gains were achieved with the polypill without aspirin and containing a double dose of statins. With a 10-year risk of 7.5% as the threshold, this pill would prevent approximately 3.5% of all cardiovascular events.
Conclusions
Opportunistic screening based on global cardiovascular risk assessment followed by polypill prescription to those with increased risk offers a cost-effective strategy. Most health gain is achieved by the polypill without aspirin and a double statin dose.
Article summary
Article focus
Cardiovascular diseases continue to be still a major, partly preventable, cause of illness and death.
A polypill that lowers by targeting several risk factors simultaneously is in line with the concept that the aim in primary prevention should be to bring down ‘global’ cardiovascular risk.
The aim of this study was to estimate the potential cost-effectiveness of polypill prescription after opportunistic screening.
Key messages
The results of this study suggest that opportunistic screening and offering a polypill to people with a minimum 10-year risk of cardiovascular mortality of alternatively 5%, 7.5% or 10% is a cost-effective strategy.
A polypill without aspirin but with a double dose of simvastatin leads to most health gains at all risk thresholds considered. At a 10-year risk of cardiovascular death of ≥7.5%, such a strategy would lead to an estimated decrease in the incidence of myocardial infarction and stroke of about 3.5%, at a cost of €8900 per quality-adjusted life year.
Opportunistic screening of the population of ≥40 years to select individuals with a mild to moderately increased risk for cardiovascular diseases, followed by polypill prescription would prevent approximately 3.5% of all cardiovascular events.
Strengths and limitations of this study
Strong point of the study is that different compositions of the polypill have been modelled. Also, realistic estimates for adherence and compliance have been used.
As only preliminary results of a phase II clinical trial on efficacy of the polypill were available, we had to apply mathematical modelling to estimate cost-effectiveness. This provides insight into the range of health benefits that can be expected. Pending results with regard to established clinical endpoints from large-scale phase III trials, the results of this study should not be taken as a precise estimate of the cost-effectiveness of the polypill.
doi:10.1136/bmjopen-2011-000363
PMCID: PMC3278482  PMID: 22189351
3.  Clinical decision making in spinal fusion for chronic low back pain. Results of a nationwide survey among spine surgeons 
BMJ Open  2011;1(2):e000391.
Objectives
To assess the use of prognostic patient factors and predictive tests in clinical decision making for spinal fusion in patients with chronic low back pain.
Design and setting
Nationwide survey among spine surgeons in the Netherlands.
Participants
Surgeon members of the Dutch Spine Society were questioned on their surgical treatment strategy for chronic low back pain.
Primary and secondary outcome measures
The surgeons' opinion on the use of prognostic patient factors and predictive tests for patient selection were addressed on Likert scales, and the degree of uniformity was assessed. In addition, the influence of surgeon-specific factors, such as clinical experience and training, on decision making was determined.
Results
The comments from 62 surgeons (70% response rate) were analysed. Forty-four surgeons (71%) had extensive clinical experience. There was a statistically significant lack of uniformity of opinion in seven of the 11 items on prognostic factors and eight of the 11 items on predictive tests, respectively. Imaging was valued much higher than predictive tests, psychological screening or patient preferences (all p<0.01). Apart from the use of discography and long multisegment fusions, differences in training or clinical experience did not appear to be of significant influence on treatment strategy.
Conclusions
The present survey showed a lack of consensus among spine surgeons on the appreciation and use of predictive tests. Prognostic patient factors were not consistently incorporated in their treatment strategy either. Clinical decision making for spinal fusion to treat chronic low back pain does not have a uniform evidence base in practice. Future research should focus on identifying subgroups of patients for whom spinal fusion is an effective treatment, as only a reliable prediction of surgical outcome, combined with the implementation of individual patient factors, may enable the instalment of consensus guidelines for surgical decision making in patients with chronic low back pain.
Article summary
Article focus
What is the level of professional consensus among spine surgeons regarding spinal fusion surgery for chronic low back pain?
How are tests for patient selection appreciated and to what extent are they used in clinical practice?
Are prognostic patient factors incorporated in the process of surgical decision making for chronic low back pain?
Key messages
In clinical practice, there is no professional consensus on surgical treatment strategy for chronic low back pain.
Prognostic patient factors as well as tests for patient selection are not consistently used in clinical decision making for spinal fusion.
Because of a lack of consensus on spinal fusion strategy for chronic low back pain in clinical practice, no guidelines for proper patient counselling can be installed at present.
Strengths and limitations of this study
A survey among physicians provides valuable insight in the actual decision-making process in clinical practice. Understanding contributory factors in treatment strategy may help in the creation of consensus guidelines.
The introduction of an interviewer bias could be avoided by the use of a neutral intermediary instead of direct questions from peers in spine surgery.
This study focused on surgeon members of the Dutch Spine Society whose practice may not reflect that of all surgeons performing spinal fusion for chronic low back pain. Moreover, no information on conservative treatment options was acquired.
To define consensus, we chose for uniformity of opinion of at least 70%, which we considered to be sufficient for implementation in guidelines. Such a cut-off level remains arbitrary.
doi:10.1136/bmjopen-2011-000391
PMCID: PMC3278483  PMID: 22189352
4.  Helping pregnant women make better decisions: a systematic review of the benefits of patient decision aids in obstetrics 
BMJ Open  2011;1(2):e000261.
Objectives
Patient decision aids can be used to support pregnant women engaging in shared decisions, but little is known about their effects in obstetrics. The authors aimed to evaluate the effects of patient decision aids designed for pregnant women on clinical and psychosocial outcomes.
Design
Systematic review. Data on all outcomes were extracted and summarised. All studies were critically appraised for potential sources of bias and, when possible to obtain, the reported decision aids were evaluated. Meta-analysis was not possible due to the heterogeneity of outcomes in primary studies and the small number of studies.
Data sources
Electronic searches were performed using Medline, Embase, the Cochrane Library and Medion databases from inception until December 2010. Reference lists of all included articles were also examined and key experts contacted.
Eligibility criteria for selecting studies
Eligibility criteria included randomised controlled trials, which reported on patient decision aids for women facing any treatment decision in pregnancy published in English. Studies evaluating health education material that did not address women's values and preferences were excluded.
Results
Patient decision aids have been developed for decisions about prenatal testing, vaginal birth after Caesarean section, external cephalic version and labour analgesia. Use of decision aids is associated with a number of positive effects including reduced anxiety, lower decisional conflict, improved knowledge, improved satisfaction and increased perception of having made an informed choice.
Conclusions
Patient decision aids have the potential to improve obstetric care. However, currently the evidence base is limited by the small number of studies, the quality of the studies and because they involved heterogeneous decision aids, patient groups and outcomes.
Article summary
Article focus
Engaging pregnant women in shared decision making has become a priority for maternity care but remains a challenge for many health professionals.
Patient decision aids can be used to facilitate patient involvement in decision making and improve clinical practice. They are interventions, which provide information about options and outcomes as well as clarifying the user's values. However, little is known about their effects in obstetrics.
We aimed to evaluate the effects of decision aids designed for pregnant women on clinical and psychosocial outcomes.
Key messages
Eleven randomised controlled trials were identified investigating the effects of patient decision aids on a range of outcomes.
Use of patient decision aids was associated with a number of positive effects including: reduced anxiety (three studies), improved knowledge (seven studies), improved satisfaction (two studies), increased perception of having made an informed choice (one study) and lower decisional conflict (five studies).
Further research is needed to expand this limited evidence base and to develop better outcomes to assess the quality of decision making.
Strengths and limitations of this study
This is the first systematic review of patient decision aids in obstetrics and provides a comprehensive and critical review of the available evidence.
A number of potential benefits supporting the use of decision aids in clinical practice were identified.
The limited evidence base was demonstrated aiming to stimulate the development of further decision aids and research into evaluation and implementation of them.
There is need to be cautious in interpreting the potential benefit of decision aids in routine practice in pregnancy due to the limitations of the small number of randomised controlled trials and the inconsistencies in their results.
Meta-analysis could not be performed due to the small sample size and heterogeneity of primary outcomes chosen.
doi:10.1136/bmjopen-2011-000261
PMCID: PMC3334824  PMID: 22189349
5.  Oxytocin during labour and risk of severe postpartum haemorrhage: a population-based, cohort-nested case–control study 
BMJ Open  2011;1(2):e000514.
Objectives
Postpartum haemorrhage (PPH) is a major cause of maternal mortality and morbidity worldwide. Experimental studies support the hypothesis that oxytocin administration during labour, a common although not evidence-based practice, may increase the risk of atonic PPH. The clinical studies, however, are inconclusive. The objectives of this study was to investigate the association between the level of oxytocin exposure during labour and the risk of severe PPH and to explore whether the prophylactic use of oxytocin after birth modifies this association.
Design
Population-based, cohort-nested case–control study.
Setting
106 French hospitals from December 2004 through November 2006.
Participants
Women with term singleton vaginal deliveries, after an uncomplicated pregnancy. Cases were 1483 women with severe PPH, defined by peripartum change in haemoglobin of ≥4 g/dl or need for blood transfusion. Controls were 1758 women from a random sample of parturients without PPH.
Main outcome measures
The independent association between the level of oxytocin during labour and the risk of severe PPH was tested and quantified with ORs through two-level multivariable logistic regression modelling.
Results
Oxytocin was administered during labour to 73% of cases and 61% of controls (crude OR: 1.7, 95% CI 1.5 to 2.0). After adjustment for all potential confounders, oxytocin during labour was associated with a significantly higher risk of severe PPH (adjusted OR: 1.8, 95% CI 1.3 to 2.6) in women who did not receive prophylactic oxytocin after delivery; the OR for haemorrhage increased from 1 to 5 according to the level of oxytocin exposure. In women who had prophylactic oxytocin after delivery, this association was significant only for the highest exposure categories.
Conclusions
Oxytocin during labour appears to be an independent risk factor for severe PPH. The results emphasise the need for guidelines clarifying the evidence-based indications for this procedure and the minimal useful regimens.
Article summary
Article focus
Postpartum haemorrhage is the main component of maternal morbidity, and increase in its incidence is reported.
Experimental studies support the hypothesis that oxytocin administration during labour, a common although not evidence-based practice, may increase the risk of atonic postpartum haemorrhage.
The clinical studies, however, are inconclusive.
Key messages
In this study, oxytocin during labour appears to be an independent risk factor for severe Postpartum haemorrhage, with a dose-related association.
Our results emphasise the need for guidelines clarifying the evidence-based indications for this procedure and the minimal useful regimens.
Strengths and limitations
Source population: large population-based cohort; representativity of cases and controls.
Detailed data on oxytocin administration during labour collected from medical files.
Detailed data on potential confounders.
Inherent limitation of observational studies: residual confounding cannot be excluded, although all potential confounders were taken into account.
doi:10.1136/bmjopen-2011-000514
PMCID: PMC3334825  PMID: 22189353
6.  Use and usefulness of guidelines for sickness certification: results from a national survey of all general practitioners in Sweden 
BMJ Open  2011;1(2):e000303.
Objectives
Diagnoses-specific sickness certification guidelines were recently introduced in Sweden. The aim of this study was to investigate to which extent general practitioners (GPs) used these guidelines and how useful they found them, 1 year after introduction.
Design
A cross-sectional questionnaire study. A comprehensive questionnaire about sickness certification practices in 2008 was sent to all physicians living and working in Sweden (n=36 898, response rate 60.6%). In all, 19.7% (n=4394) of the responders worked as GPs.
Setting
Primary healthcare in all Sweden.
Participants
The participating GPs who had consultations concerning sickness certification at least a few times a year (n=4278, 97%).
Main outcome measures
Descriptive statistics and prevalence ratios for the 11 questionnaire items about the use and usefulness of the sickness certification guidelines.
Results
A majority (76.2%) of the GPs reported that they used the guidelines. In addition, 65.4% and 43.5% of those GPs reported that the guidelines had facilitated their contacts with patients and social insurance officers, respectively. The guidelines also helped nearly one-third (31.5%) of the GPs to develop their competence and improve the quality of their management of sickness certification consultations (33.5%). About half experienced some problems when using the guidelines and 43.7% wanted better competence in using them. A larger proportion of non-specialists and of GPs with fewer sickness certification consultations had benefitted from the guidelines.
Conclusions
The national sickness certification guidelines implemented in Sweden were widely used by GPs already a year after introduction. Also, the GPs consider the guidelines useful in several respects, for example, in patient contacts and for competence development.
Article summary
Article focus
Sweden recently introduced national sickness certification guidelines. We investigated:
To what extent did the general practitioners use them 1 year later?
How useful did the general practitioners find them?
Key messages
Already after 1 year, most general practitioners used the guidelines and benefited extensively from them
Two-thirds of the general practitioners reported that the guidelines had facilitated their patient contacts and one-third that it facilitated their contacts with social insurance, other healthcare staff and employers
One-third stated that the guidelines had been helpful in competence development and improved the quality of their management of sickness certification cases
Strengths and limitations of this study
Strengths were the large study group and that all general practitioners in Sweden were included. Also, internationally this is the, so far, without comparison largest study of general practitioner's sickness certification practices. However, the non-response rate of 39% was a limitation, and we have no way of knowing if the non-responders differed with regard to use of the guidelines. However, only 11 of the 163 items in the questionnaire concerned the guidelines, why there is no reason to believe that no response was related to use of the guidelines.
doi:10.1136/bmjopen-2011-000303
PMCID: PMC3244659  PMID: 22189350
7.  Disaster-related injury and predictors of health complaints after exposure to a natural disaster: an online survey 
BMJ Open  2011;1(2):e000248.
Objectives
To study short- and long-term effects of experiencing a disaster in repatriated injured survivors and the differential effect of injury, need for medical treatment, loss of loved ones and danger to life on both physical and mental health.
Design
Prospective online study.
Setting
Open online survey among Dutch survivors of the 2004 Asian tsunami.
Participants
Of the estimated total of 464 Dutch survivors, the authors recruited 144 unique respondents (59 men and 85 women) with a total of 175 assessments made in various time periods.
Main outcome measures
Health outcomes were Symptom Checklist 90 (SCL-90), Impact of Event Scale (original version, in Dutch) and Beck Depression Inventory II. Correlations were calculated with socio-demographic as well as disaster-related factors: physical injury, medical care, loss of loved ones and duration of threat to life. Assessments were clustered in four post-disaster time periods (0–3, 4–6, 7–30 and 31–48 months).
Results
Across these periods, SCL-90 scores were significantly higher than the reference population (p<0.001), with a significant linear downward trend between the groups over time (p=0.001). The same pattern occurred for the Impact of Event Scale (p<0.001) and the Beck Depression Inventory II (p=0.002). Physical injury, medical care or loss of loved ones was not associated with higher total SCL-90 scores or somatic subscores. Both duration of threat to life and female sex were correlated with all measured outcome parameters.
Conclusions
Exposure to the 2004 Asian tsunami had significant short- and long-term impacts on health complaints in a group of repatriated Dutch tsunami victims. Cross-sectionally, there was a trend towards recovery over 4 years, although 22% still reported high psychological and physical distress 4 years post-disaster. Duration of danger to life and female sex were associated with more physical and mental health complaints. In this study, neither disaster-related injury nor loss of loved ones resulted in negative health outcomes.
Article summary
Article focus
Disasters are traumatic events that may result in a wide range of physical and mental health consequences. The aim of this paper was to study short- and long-term effects in injured disaster survivors.
Our hypothesis was that physical injury and psychological trauma (eg, loss of loved ones) would be determinants for physical and mental health outcomes after the disaster.
Key messages
Despite a trend towards recovery between the cross-sectional groups over 4 years, the 2004 tsunami had significant short- and long-term impacts on health complaints in a Dutch group of tsunami victims.
Physical injury or loss of loved ones did not necessarily result in negative health outcomes.
Duration of danger to life was a predictor for traumatic stress symptoms, general health complaints as well as depressive symptoms over a 4-year period.
Strengths and limitations of this study
One of the few studies of long-term physical and mental health impact of natural disasters and the differential effects of being wounded, danger to life and loss of loved ones.
Combined approach: research on physical as well as mental health—unique set up with a survey on an online post-disaster web service, combined with other features.
Limitations: post-disaster study limited options for longitudinal research.
doi:10.1136/bmjopen-2011-000248
PMCID: PMC3244663  PMID: 22185804
8.  Feasibility of a structured group education session to improve self-management of blood pressure in people with chronic kidney disease: an open randomised pilot trial 
BMJ Open  2011;1(2):e000381.
Objectives
We aimed to test, at pilot level, a structured group educational intervention to improve self-management of blood pressure in people with chronic kidney disease (CKD). The current paper explores patient acceptability of the intervention.
Design
This was an open randomised pilot trial. Participants were randomly assigned to either:
A control group (n=41) receiving standard clinical management of hypertension.
An intervention group (n=40) receiving standard clinical care plus the educational intervention.
Setting
Renal outpatient clinics at a single study centre.
Participants
Patients with early CKD and hypertension were identified and approached for recruitment.
Intervention
An evidence-based structured group educational intervention (CHEERS) using the principles of social cognitive theory to improve knowledge and self-management skills.
Outcomes
Recruitment, uptake of the intervention and patient satisfaction were evaluated to explore patient acceptability of the intervention and to determine any differences between patients regarding recruitment and retention.
Measures
Data on age, sex and ethnicity were collected for all patients approached to take part. For recruited patients, data were also collected on self-efficacy (ability to self-manage). Reasons given by patients declining to take part were recorded. Patients attending the educational session also completed an evaluation form to assess satisfaction.
Results
A total of 267 patients were approached, and 30% were randomly assigned. Lack of time (48%) and lack of interest (44%) were the main reasons cited for non-participation in the study. Men were significantly more likely to be recruited (p=0.048). The intervention was rated enjoyable and useful by 100% of participants. However, 37.5% of the intervention group failed to attend the educational session after recruitment. Participants failing to attend were significantly more likely to be older (p=0.039) and have lower self-efficacy (p=0.034).
Conclusion
The findings suggest that delivering and evaluating an effective structured group educational intervention to promote better blood pressure control in patients with CKD would be challenging in the current context of kidney care.
Article summary
Article focus
Assessment of the feasibility of a complex educational intervention for people with kidney disease, focusing on patient recruitment, retention and satisfaction.
Key messages
The paper highlights the importance of pilot work and the need to assess patient acceptability in the design of complex educational interventions for patients with kidney disease.
Findings suggest the need to create, as part of routine kidney care, a culture of patient empowerment and education with continued support.
The paper also suggests a need to identify those patients with CKD who lack motivation and confidence so that help and support can be tailored more effectively.
Strengths and limitations of this study
The paper presents a robust evaluation of patient acceptability of a proposed structured group intervention to improve blood pressure control in people with CKD.
A limitation of the study is the non-blinding of the patients and the evaluator due to the nature and practicalities of the research.
Another limitation was the evaluation form used to assess patient satisfaction, which did not provide sufficient information to assess this outcome in more detail.
doi:10.1136/bmjopen-2011-000381
PMCID: PMC3244657  PMID: 22184589
9.  Increase in physical activity and cardiometabolic risk profile change during lifestyle intervention in primary healthcare: 1-year follow-up study among individuals at high risk for type 2 diabetes 
BMJ Open  2011;1(2):e000292.
Objectives
To investigate the association between increase in physical activity and changes in cardiometabolic risk factors during a lifestyle intervention programme in routine clinical settings.
Design
Prospective follow-up.
Setting
400 primary healthcare centres and occupational healthcare outpatient clinics in Finland.
Participants
Individuals at high risk for type 2 diabetes identified in the implementation project of the national diabetes prevention programme (FIN-D2D) and participating in baseline and 1-year follow-up visits. Final study group comprised the 1871 non-diabetic participants who responded at follow-up visit to a question on stability versus increase of physical activity.
Interventions
Lifestyle intervention.
Primary outcome measures
Cardiometabolic risk factors (body composition, blood pressure and those measured from fasting venous blood samples) measured at baseline and follow-up visits.
Results
Of the participants, 310 (16.6% of all responders) reported at follow-up having clearly increased their physical activity during the past year, while 1380 (73.8%) had been unable to increase their physical activity. Those who increased their activity decreased their weight by 3.6 kg (95% CI 2.9 to 4.3, age and sex adjusted, p<0.001) and waist circumference by 3.6 cm (95% CI 2.9 to 4.3, p<0.001) more than those who did not increase their activity. Similarly, those who increased their physical activity had greater reductions in total cholesterol (group difference in reduction 0.17 mmol/l, 95% CI 0.06 to 0.28, p=0.002), low-density lipoprotein cholesterol (0.16 mmol/l, 95% CI 0.06 to 0.26, p=0.001), low-density lipoprotein/high-density lipoprotein ratio (0.17, 95% CI 0.08 to 0.25, p<0.001) as well as fasting glucose (0.09 mmol/l, 95% CI 0.03 to 0.15, p=0.004) and 2 h glucose levels (0.36 mmol/l, 95% CI 0.17 to 0.55, p=0.023) than those who did not increase their physical activity.
Conclusion
Increasing physical activity seems to be an important feature of cardiometabolic risk reduction among individuals at high risk for type 2 diabetes participating in preventive interventions in routine clinical settings.
Article summary
Article focus
There is evidence from randomised controlled trials that supervised exercise interventions improve cardiometabolic risk factor levels.
It is not known how knowledge from intensive interventions of randomised clinical trials can be applied in various real-life clinical settings with limited resources.
In this paper, we report the results of an analysis of physical activity changes and their association to cardiometabolic risk factors among individual at high risk for type 2 diabetes and participating in preventive lifestyle intervention in routine clinical settings of primary healthcare.
Key messages
Less than one-fifth of the participants reported at ‘1-year’ follow-up having clearly increased their physical activity during the past year.
Those who increased their activity improved clearly their cardiometabolic risk profile including reductions of waist circumference and fasting low-density lipoprotein cholesterol and glucose levels, which result persisted after the adjustment for dietary change.
Increasing physical activity seems to be an important feature of cardiometabolic risk reduction among individuals at high risk for type 2 diabetes participating in preventive interventions in routine clinical settings.
Strengths and limitations
FIN-D2D is the first national effort to implement the prevention of diabetes in a primary healthcare setting.
Follow-up data on the changes in physical activity are available from a subgroup of participants.
The limitations of this report include that physical activity changes are documented by a questionnaire.
doi:10.1136/bmjopen-2011-000292
PMCID: PMC3244658  PMID: 22184585
10.  Serum vitamin D levels among patients in a clinical oncology practice compared to primary care patients in the same community: a case–control study 
BMJ Open  2011;1(2):e000397.
Objectives
Low serum vitamin D levels have been associated with risk for certain malignancies, but studies have not directly analysed levels between community oncology and primary care practices. The purpose of this study was to compare serum vitamin D levels in patients at a community oncology practice with non-cancer patients at a primary care practice.
Design
Retrospective case–control study. 25-Hydroxyvitamin D levels were ordered for screening in both cancer and non-cancer patients. Levels were compared in univariate and multivariate analyses adjusted for age, body mass index and season of blood draw.
Setting
A community-based radiation oncology centre and a community-based primary care practice: both located in Northeastern Pennsylvania, USA.
Participants
170 newly diagnosed cancer patients referred for initial consultation at the community oncology centre from 21 November 2008 to 18 May 2010, and 170 non-cancer patients of the primary care practice who underwent screening for hypovitaminosis D for the first time from 1 January 2009 to 31 December 2009.
Primary and secondary outcome measures
The primary outcome measure was mean serum vitamin D level, and the secondary outcome measures were frequencies of patients with vitamin D levels <20 ng/ml and levels <30 ng/ml.
Results
The oncology patients had a significantly lower mean serum vitamin D level (24.9 ng/ml) relative to a cohort of non-cancer primary care patients (30.6 ng/ml, p<0.001) from the same geographical region. The relationship retained significance after adjustment for age, body mass index and season of blood draw in multivariate analysis (p=0.001). Levels <20 and <30 ng/ml were more frequent in the oncology patients (OR (95% CI)=2.59 (1.44 to 4.67) and 2.04 (1.20 to 3.46), respectively) in multivariate analysis.
Conclusions
Cancer patients were found to have low vitamin D levels relative to a similar cohort of non-cancer primary care patients from the same geographical region.
Article summary
Article focus
Our study sought to analyse vitamin D levels in large outpatient oncology and primary care centres.
Key messages
Multiple levels of evidence suggest an association between low vitamin D and cancer.
Our findings of low vitamin D among the oncology patients add practical relevance to this association since we analysed patients at community clinics.
Providers caring for cancer patients should be aware of an increased incidence of hypovitaminosis D at the community level.
Strengths and limitations
Limitations include a relatively small sample size, lack of data on comorbid conditions of the primary care group, lack of data on vitamin D measurement and lack of data on supplementation or treatment that may have affected vitamin D levels.
Strengths include a community-based sample in both primary care and oncology patients and control of age, body mass index, latitude, time and season of blood draw and geographical region of both patient groups.
doi:10.1136/bmjopen-2011-000397
PMCID: PMC3244660  PMID: 22184590
11.  Factors associated with depressive state in patients with myasthenia gravis: a multicentre cross-sectional study 
BMJ Open  2011;1(2):e000313.
Objectives
The objective of this study was to examine clinical factors associated with depressive state in patients with myasthenia gravis (MG).
Design
Cross-sectional study.
Setting and participants
We evaluated 287 consecutive cases of MG seen at six neurological centres located in Eastern Japan.
Outcome measures
All MG patients completed the Japanese version of the Beck Depression Inventory–Second Edition (BDI-II). Disease severity was determined according to the MG Foundation of America (MGFA) quantitative MG score, MG activities of daily living scale and MG composite scale (MG composite). Clinical state following treatment was categorised according to MGFA postintervention status. Associations between detailed clinical parameters of MG and BDI-II score were then examined statistically.
Results
Mean BDI-II score for patients with MG (11.0±8.1) did not differ substantially from and overlapped with that reported as the Japanese standard (8.7±6.4). The mean +2 SDs for the Japanese standard is 21.5, approximately equal to the cut-off level indicative of moderate or worse depression (>20 points) in the original English version. We thus defined BDI-II >21.5 as depressive state, with a frequency of 13.6% in patients with MG. Multivariate logistic regression analysis revealed current dose of oral prednisolone (OR 1.09, 95% CI 1.02 to 1.17; p=0.01), unchanged MGFA postintervention status (OR 3.55, 95% CI 1.18 to 10.71; p=0.02), time since onset (OR 0.93, 95% CI 0.87 to 0.99; p=0.03) and MG composite (OR 1.16, 95% CI 1.00 to 1.34; p=0.046) as factors independently associated with depressive state in MG.
Conclusions
Dose of oral corticosteroids appears to represent the major factor associated with depressive state in MG. Unchanged status despite treatment and early disease stage are also significant background factors for depressive state, along with disease severity.
Article summary
Article focus
Background factors associated with depressive state in MG were statistically examined.
Key messages
Dose of oral corticosteroids appears to represent the major factor associated with depressive state in MG. Unchanged status despite treatment and early disease stage are also significant background factors for depressive state, along with disease severity.
Achieving early improvement of disease by adequate MG therapy without long-term use of higher dose oral corticosteroids may be important to avoiding depressive state in patients with MG.
Strengths and limitations of this study
Strength: this study probably is the first to systematically and statistically examine the associations between detailed disease-related parameters of MG and depressive state.
Limitation: predictive modelling cannot be strictly performed on this cross-sectional sample. Weakness: the absence of social factors as variables.
doi:10.1136/bmjopen-2011-000313
PMCID: PMC3244661  PMID: 22184587
12.  Suicide by burning in the South Asian origin population in England and Wales a secondary analysis of a national data set 
BMJ Open  2011;1(2):e000326.
Objectives
A descriptive analysis of suicide by burning in England and Wales in the general population and in people of South Asian origin.
Design
A cross-sectional secondary analysis of a national data set.
Setting
A population study of all those who died by suicide in England and Wales between 1993 and 2003 inclusive.
Participants
All cases of suicide and undetermined intent identified by the Office for National Statistics for England and Wales. A computer algorithm was used to identify people of the South Asian origin from their names. There were 55 140 suicides in the UK between 1993 and 2003. The ratio of male to female suicides was 3:1. There were 1455 South Asian suicides identified by South Asian Name and Group Recognition Algorithm.
Primary and secondary outcome measures
Death by suicide and undetermined intent, as determined by Coroner's Inquest. ICD9 codes E958.1 and E988.1 and ICD10 codes X76 and Y26.
Results
1.77% of suicides in the general population and 8.45% of suicides in the South Asian origin population were by burning. The suicide rate by burning was 0.8/100 000 person-years for England and Wales and 2.9/100 000 person-years for the South Asian origin population. The odds of suicide by burning were increased in the South Asian group as a whole (OR 3.06, 95% CI 2.30 to 4.08). Those born in Asia and Africa were at higher risk than those born in the UK (OR 2.69, 95% CI 2.01 to 3.60 and OR 2.10, 95% CI 1.46 to 3.01, respectively). The increased risk was for those aged 25–64 years.
Conclusion
Suicide by burning remains a significant issue in the South Asian origin working-age population in England and Wales. A prevention strategy could target working-age people of South Asian origin born abroad as they are at the highest risk. More in depth research on the reasons for using this method may help to identify possible prevention strategies.
Article summary
Article focus
A descriptive analysis of suicide by burning in the UK.
A description of suicide by burning in those of South Asian origin in the UK.
Key messages
Suicide by burning is a significant issue in the South Asian population in England and Wales.
The working-age population is at particular risk with those born abroad, especially those born in South Asian countries, having the highest odds.
Though the risk is more elevated in South Asian women when compared with the rest of the population, there are more male suicides using this method overall.
Strengths and limitations of this study
This study used a contemporary national data set.
Using name recognition software rather than place of birth allowed better identification of the South Asian population of the UK.
The data used did not allow for confounders to be taken into account when analysing differences between ethnic groups.
Because administrative data were used, in-depth information on the reasons for choosing this method of suicide were not available.
doi:10.1136/bmjopen-2011-000326
PMCID: PMC3244662  PMID: 22184588
13.  Chronic kidney disease: a large-scale population-based study of the effects of introducing the CKD-EPI formula for eGFR reporting 
BMJ Open  2011;1(2):e000308.
Objective
To evaluate the effects of introducing the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for estimated glomerular filtration rate (eGFR) reporting in the adult population in routine clinical practice with clinician-directed testing.
Design
Retrospective study of all creatinine measurements and calculation of eGFRs using Modification of Diet in Renal Disease (MDRD) and CKD-EPI formulae.
Setting
General population, Oxfordshire, UK.
Participants
An unselected population of around 660 000.
Interventions
Reporting of eGFRs using MDRD or CKD-EPI formulae.
Primary and secondary outcome measures
Evaluation of the effects of the CKD-EPI formula on the prevalence of different stages of chronic kidney disease (CKD).
Results
The CKD-EPI formula reduced the prevalence of CKD (stages 2–5) by 16.4% in patients tested in primary care. At the important stage 2–stage 3 cut-off, there was a relative reduction of 7.5% in the prevalence of CKD stages 3–5 from 15.7% to 14.5%. The CKD-EPI formula reduced the prevalence of CKD stages 3–5 in those aged <70 but increased it at ages >70. Above 70 years, the prevalence of stages 3–5 was similar with both equations for women (around 41.2%) but rose in men from 33.3% to 35.5%. CKD stages 4–5 rose by 15% due exclusively to increases in the over 70s, which could increase specialist referral rates. The CKD classification of 18.3% of all individuals who had a creatinine measurement was altered by a change from the MDRD to the CKD-EPI formula. In the UK population, the classification of up to 3 million patients could be altered, the prevalence of CKD could be reduced by up to 1.9 million and the prevalence of CKD stages 3–5 could fall by around 200 000.
Conclusions
Introduction of the CKD-EPI formula for eGFR reporting will reduce the prevalence of CKD in a primary care setting with current testing practice but will raise the prevalence in the over 70s age group. This has implications for clinical practice, healthcare policy and current prevalence-based funding arrangements.
Article summary
Article focus
Estimated glomerular filtration rates form the basis for clinical and health policy decisions in chronic kidney disease.
The new CKD-EPI formula for estimated glomerular filtration rates estimates renal function better than the Modification of Diet in Renal Disease formula in current use.
We have studied the effects of using the CKD-EPI formula in a UK population of over half a million.
Key messages
Overall, the CKD-EPI formula produces higher better estimated glomerular filtration rates, which reduces the diagnosis of chronic kidney disease. However, in men older than 70 years, it produces lower worse estimated glomerular filtration rates and increases the number with chronic kidney disease stages 3–5.
Our results predict a net reduction of around 200 000 in the numbers with chronic kidney disease stages 3–5 in the UK. This would reduce the primary care chronic kidney disease registers, inappropriate disease labelling and patient monitoring.
The chronic kidney disease classification of up to 3 million patients could be altered by the use of the CKD-EPI formula in the UK.
Strengths and limitations of this study
The study is large and unbiased. All primary care samples taken during the study period were analysed, so the results represent current clinical testing practice.
Estimated glomerular filtration rates are sufficient to diagnose chronic kidney disease stages 3–5, but stages 1–2 also require proteinuria or a structural abnormality, which cannot be assessed in this study. However, a change in estimated glomerular filtration rate can still alter the classification of stage 1 or 2.
doi:10.1136/bmjopen-2011-000308
PMCID: PMC3244664  PMID: 22184586
14.  Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics 
BMJ Open  2011;1(2):e000252.
Objective
To investigate the feasibility of conducting clinics for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in schools.
Design
School-based clinical project.
Participants
Children aged 11–16 years were enrolled in three state secondary schools in England.
Main outcome measures
Number of children newly diagnosed as having CFS/ME.
Methods
Attendance officers identified children missing ≥20% of school in a 6-week term without a known cause, excluding those with a single episode off school, a known medical illness explaining the absence or known to be truanting. Children with fatigue were referred to a specialist CFS/ME service for further assessment. The authors compared children with CFS/ME identified through school-based clinics with those referred via health services. Outcomes of CFS/ME were evaluated at 6 weeks and 6 months.
Results
461 of the 2855 enrolled children had missed ≥20% school over a 6-week period. In 315, of whom three had CFS/ME, the reason for absence was known. 112 of the 146 children with unexplained absence attended clinical review at school; two had been previously diagnosed as having CFS/ME and 42 were referred on to a specialist clinic, where 23 were newly diagnosed as having CFS/ME. Therefore, 28 of the 2855 (1.0%) children had CFS/ME. Children with CFS/ME identified through surveillance had been ill for an amount of time comparable to those referred via health services but had less fatigue (mean difference 4.4, 95% CI 2.2 to 6.6), less disability (mean difference −5.7, 95% CI −7.9 to −3.5) and fewer symptoms (mean difference 1.86, 95% CI 0.8 to 2.93). Of 19 children followed up, six had fully recovered at 6 weeks and a further six at 6 months.
Conclusions
Chronic fatigue is an important cause of unexplained absence from school. Children diagnosed through school-based clinics are less severely affected than those referred to specialist services and appear to make rapid progress when they access treatment.
Article summary
Article focus
Hypothesis: many children with CFS/ME remain undiagnosed and untreated, despite evidence that treatment is effective in children.
Research question: are school-based clinics a feasible way to identify children with CFS/ME and offer treatment?
Key messages
1.0% of enrolled children missed ≥20% of school because of CFS/ME.
Fewer than one in five children with CFS/ME had received a diagnosis and been offered treatment.
Children with CFS/ME who were detected through school-based clinics were less severely affected than children referred via health services and appeared to do well once treated.
Strengths and limitations of this study
Children were offered assessment regardless of how their absence had been classified.
All children given a diagnosis of CFS/ME were screened for other medical and emotional causes of fatigue and were prospectively characterised and followed up.
School clinics were conducted in three schools in the south west, which has a well-established specialist CFS/ME service. Results may not be generalisable to regions without a CFS/ME service or to regions with different socioeconomic factors that impact on school attendance.
doi:10.1136/bmjopen-2011-000252
PMCID: PMC3244656  PMID: 22155938
15.  The value of intervening for intimate partner violence in South African primary care: project evaluation 
BMJ Open  2011;1(2):e000254.
Objectives
Intimate partner violence (IPV) is an important contributor to the burden of disease in South Africa. Evidence-based approaches to IPV in primary care are lacking. This study evaluated a project that implemented a South African protocol for screening and managing IPV. This article reports primarily on the benefits of this intervention from the perspective of women IPV survivors.
Design
This was a project evaluation involving two urban and three rural primary care facilities. Over 4–8 weeks primary care providers screened adult women for a history of IPV within the previous 24 months and offered referral to the study nurse. The study nurse assessed and managed the women according to the protocol. Researchers interviewed the participants 1 month later to ascertain adherence to their care plan and their views on the intervention.
Results
In total, 168 women were assisted and 124 (73.8%) returned for follow-up. Emotional (139, 82.7%), physical (115, 68.5%), sexual (72, 42.9%) and financial abuse (72, 42.9%) was common and 114 (67.9%) were at high/severe risk of harm. Adherence to the management plan ranged from testing for syphilis 10/25 (40.0%) to consulting a psychiatric nurse 28/58 (48.3%) to obtaining a protection order 28/28 (100.0%). Over 75% perceived all aspects of their care as helpful, except for legal advice from a non-profit organisation. Women reported significant benefits to their mental health, reduced alcohol abuse, improved relationships, increased self-efficacy and reduced abusive behaviour. Two characteristics seemed particularly important: the style of interaction with the nurse and the comprehensive nature of the assessment.
Conclusion
Female IPV survivors in primary care experience benefit from an empathic, comprehensive approach to assessing and assisting with the clinical, mental, social and legal aspects. Primary care managers should find ways to integrate this into primary care services and evaluate it further.
Article summary
Article focus
Did women experiencing IPV find assessment and management in primary care beneficial?
What aspects of their care plan did they adhere to?
What aspects of their care plan did they find most helpful?
Key messages
Women diagnosed with IPV in primary care perceive benefit from an intervention characterised by both empathic, non-judgemental and a comprehensive approach to the clinical, mental, social and legal aspects.
Women reported benefits to their mental health, alcohol use, relationships and experience of abusive behaviour.
IPV survivors were most proactive about securing protection orders, laying criminal charges and testing for pregnancy post-intervention.
Strengths and limitations of this study
A comprehensive biopsychosocial and forensic intervention in primary care was tested, securing follow-up that revealed its value.
The study was conducted under usual working conditions and resource availability making the findings applicable to the primary care context.
Although the study only involved five purposely selected facilities, the rural/urban mix makes it likely that these are fairly typical.
Obsequiousness bias was reduced by different researchers conducting the follow-up interviews.
Follow-up after 1 month is too short to predict the longer-term consequences of the intervention.
The study measured the effect of the intervention on the abuse indirectly via participant self-reports.
doi:10.1136/bmjopen-2011-000254
PMCID: PMC3236818  PMID: 22146888
16.  Do urology journals enforce trial registration? A cross-sectional study of published trials 
BMJ Open  2011;1(2):e000430.
Objectives
(1) To assess endorsement of trial registration in author instructions of urology-related journals and (2) to assess whether randomised controlled trials (RCTs) in the field of urology were effectively registered.
Design
Cross-sectional study of author instructions and published trials.
Setting
Journals publishing in the field of urology.
Participants
First, the authors analysed author instructions of 55 urology-related journals indexed in ‘Journal Citation Reports 2009’ (12/2010). The authors divided these journals in two groups: those requiring and those not mentioning trial registration as a precondition for publication. Second, the authors chose the five journals with the highest impact factor (IF) from each group.
Intervention
MEDLINE search to identify RCTs published in these 10 journals in 2009 (01/2011); search of the clinical trials meta-search interface of WHO (International Clinical Trials Registry Platform) for RCTs that lacked information about registration (01–03/2011). Two authors independently assessed the information.
Outcome measures
Proportion of journals providing advice about trial registration and proportion of trials registered.
Results
Of 55 journals analysed, 26 (47.3%) provided some editorial advice about trial registration. Journals with higher IFs were more likely to mention trial registration explicitly (p=0.015). Of 106 RCTs published in 2009, 63 were registered (59.4%) with a tendency to an increase after 2005 (83.3%, p=0.035). 71.4% (30/42) of the RCTs that were published in journals mentioning and requiring registration, and 51.6% (33/64) of the RCTs that were published in journals that did not mention trial registration explicitly were registered. This difference was statistically significant (p=0.04).
Conclusions
The existence of a statement about trial registration in author instructions resulted in a higher proportion of registered RCTs in those journals. Journals with higher IFs were more likely to mention trial registration.
Article summary
Article focus
Trial registration can increase scientific transparency, but its implementation in specialty fields such as urology is unclear.
To assess the endorsement of trial registration in the author instructions of urology-related journals.
To assess whether randomised controlled trials in the field were effectively registered.
Key messages
A statement of trial registration in author instructions resulted in a higher proportion of registered randomised controlled trials.
Journals with high impact factors were more likely to mention trial registration.
We suggest, though, that ensuring trial registration is not the responsibility only of the editors. Medical scientists should realise that trial registration is necessary to contribute to transparency in research.
Strength and limitations of this study
Two authors independently assessed information regarding editorial advice about trial registration and identified the randomised controlled trials.
Potential bias occurred if registered randomised controlled trials were reported without giving a registration number and we could not identify them in the meta-search interface of WHO (International Clinical Trials Registry Platform).
Results might not be representative of the uro-nephrological field as a whole and reported figures may overestimate compliance with trial registration.
doi:10.1136/bmjopen-2011-000430
PMCID: PMC3236819  PMID: 22146890
17.  Publication trends in newspapers and scientific journals for SSRIs and suicidality: a systematic longitudinal study 
BMJ Open  2011;1(2):e000290.
Background
In the period 2003–2008, the regulatory authorities issued several warnings restricting the use of selective serotonin re-uptake inhibitors (SSRIs) in paediatrics, in reaction to safety concerns regarding the risk of suicidality. In this study, the SSRIs and suicidality controversy serves as a template to analyse the long-term publication trends regarding the benefit/risk profile of medications. The aim is to ascertain differences (in terms of numbers, categories and timing) between negative and positive newspaper and journal articles on SSRIs and suicidality and to ascertain correlations between changes in the reports and regulatory warnings.
Methods
A systematic review of scientific articles (Embase) and the Netherlands (NL) and the UK newspapers (LexisNexis) was performed between 2000 and 2010. Categorisation was done by ‘effect’ (related treatment effect), ‘type of article’ and ‘age group’. The articles' positive-to-negative effect ratio was determined. Differences in distribution of effect categories were analysed across sources, type of article and age group using the Mann–Whitney (two subgroups) or Kruskal–Wallis test (three or more).
Findings
In total, 1141 articles were categorised: 352 scientific, 224 Dutch and 565 British newspaper articles. Scientific articles were predominantly on research and were positive, whereas newspaper articles were negative (ratios=3.50—scientific, 0.69—NL and 0.94—UK; p<0.001). Articles on paediatrics were less positive in scientific journals and more negative in newspapers (ratios=2.29—scientific, 0.26—NL and 0.20—UK; p<0.001), while articles on adults were positive overall (ratios=10.0—scientific, 1.06—NL and 1.70—UK; p<0.001). In addition, negative-effect reporting trends were exacerbated following regulatory warnings and were generally opinion articles, both in scientific journals and in newspapers (2003/2004 and after 2007).
Interpretation
The authors found a positive publication tendency inherent in journal research articles. This apparent positive publication bias present in scientific journals, however, does not seem to prevent the dissemination of ‘bad’ news about medications. The negative tendency present in Dutch and British newspapers was perceivable in the paediatrics group and during the warnings, indicating that national news media have informed the public about this international drug safety controversy on time.
Article summary
Article focus
Publication trends of the benefit/risk profile of medications might differ in time and during a drug safety case.
We analysed the long-term dynamics of publication trends in the context of the SSRIs and suicidality controversy.
The number of articles (in terms of positive, negative and neutral, as well as the type of article and age groups) were analysed in scientific journals and the Netherlands and the UK dailies from January 2000 to December 2009.
Key messages
We found a positive publication tendency in scientific journals that did not influence the dissemination of negative news in newspapers in the Netherlands and the UK.
The negative tendency in newspapers was predominant in paediatrics and during the warnings.
The public was informed on time about this drug safety controversy, although the information conveyed was not uniform (from scientific journals to newspapers).
Strengths and limitations of this study
Definition of the categories is limited by the researchers' criteria.
Two independent scorers reviewed the articles to avoid subjectivity during scoring.
More than 95% agreements between both research scorers were documented.
doi:10.1136/bmjopen-2011-000290
PMCID: PMC3236820  PMID: 22146889
18.  Employment status and work-related problems of gastrointestinal cancer patients at diagnosis: a cross-sectional study 
BMJ Open  2011;1(2):e000190.
Objective
To assess the employment status of patients with gastrointestinal cancer at diagnosis and to examine work-related problems of employed patients.
Design
New, consecutive patients were included at the Gastrointestinal Oncology Center Amsterdam, a one-stop, rapid access diagnostic assessment centre. Patients were interviewed on their employment status by a nurse. If (self-) employed, patients were asked to self-report on work-related problems, perceived distress (0–10), cancer-related problems, fatigue (MFI-20, range 4–20) and work ability (three WAI questions, range 0–10).
Results
Of all 333 included new consecutive patients (age range 32–89 years), 95 patients (28%) were (self-) employed at time of diagnosis, 179 (54%) were pensioners, and 59 were not working (18%). For the assessment of work-related problems, 45 (47%) of these 95 employed patients with cancer participated. Their mean age was 56 years, and patients had oesophageal/stomach (49%), colorectal (18%) or hepatic/pancreatic/biliary cancer (33%). Half of the employed patients (49%) were still at work, while 51% were on sick leave. The main reasons for sick leave were stress (35%), (scheduled) operation (26%), fatigue (17%) and pain (13%). Most patients on sick leave (70%) had no contact with their own occupational physician, although the majority (67%) would like to continue to work. Work-related problems were experienced by 73% of working patients. The mean work ability was 5.4, the mean general fatigue score was 11.5, and the mean distress score was 4.7. Employed patients on sick leave reported a lower work ability, more fatigue and higher distress but no more cancer-related problems compared with those still working.
Conclusion
A quarter of all patients with gastrointestinal cancer seen at an oncological centre are employed at time of diagnosis, and of these employed patients, 73% experience work-related problems. During diagnosis and treatment, information and support on work-related issues should be offered to patients with cancer as an essential part of high-quality oncological care.
Article summary
Article focus
This article focuses on the employment status of patients with gastrointestinal cancer at time of diagnosis and examines employment status and work-related problems of employed patients with gastrointestinal cancer.
Key messages
A quarter of all patients with gastrointestinal cancer seen at an oncological centre are employed at the time of diagnosis.
Of these employed patients, 73% experience work-related problems.
During diagnosis and treatment, information and support on work-related issues should be offered to cancer patients as an essential part of high-quality oncological care.
Strengths and limitations of this study
The strength of this study is the inclusion of all new, consecutive patients at time of diagnosis.
The patients included received highly specialised oncological care provided by our medical centre, mainly focusing on secondary and tertiary referral. This might have limited the generalisibility of our study.
The response rate of 47% in the work-related problems study could have biased the results, but the patients who participated were of the same age as and with similar diagnoses to those who did not participate.
doi:10.1136/bmjopen-2011-000190
PMCID: PMC3236817  PMID: 22138895
19.  Survival of drug resistant tuberculosis patients in Lithuania: retrospective national cohort study 
BMJ Open  2011;1(2):e000351.
Objective
To establish risk factors influencing survival of patients with multidrug-resistant and extensively drug-resistant tuberculosis (MDR/XDRTB).
Design
All MDR/XDRTB cases (n=1809) reported from 2002 to 2008 in Lithuania with a known outcome were included in the survival analysis.
Results
Median survival for MDRTB and XDRTB patients was 4.1 (95% CI 3.7 to 4.4) and 2.9 (95% CI 2.2 to 3.9) years. In a multivariable analysis adjusting for other patient characteristics, the difference in survival between MDRTB and XDRTB patients was not significant (HR=1.29 (0.91 to 1.81)). Older age (HR=4.80 (3.16 to 7.29)) for 60+ vs <30 years, rural living (HR=1.20 (1.02 to 1.40)), alcohol use (HR=1.49 (1.13 to 1.96)) for alcoholic versus moderate use, unemployment (HR=1.79 (1.31 to 2.46)), lower education levels (HR=1.50 (1.08 to 2.07)) for primary level versus tertiary level, cavitary disease (HR=1.54 (1.29 to 1.83)) and being smear positive at the time of MDR/XDRTB diagnosis (HR=1.47 (1.19 to 1.82)) were associated with poorer survival. HIV positivity significantly affected survival (HR=3.44 (1.92 to 6.19)) for HIV positive versus HIV negative; HR=1.60 (1.28 to 2.01) for HIV not tested versus HIV negative). There was no difference in survival of patients who acquired MDR/XDRTB during treatment compared with patients with primary MDR/XDRTB (HR=1.01 (0.85 to 1.19)). Treatment with a second-line drug improved survival (HR=0.40 (0.34 to 0.47)). In a subgroup with genotyped TB strains, a Beijing family of strains was associated with poorer survival (HR=1.71 (1.19 to 2.47)).
Conclusions
Social factors, rural living, HIV infection and Beijing strain family impact on survival. Survival of MDR/XDRTB patients is short. Rapid drug resistance identification, early administration of appropriate treatment and achieving high cure rates, expansion of HIV testing and antiretroviral treatment are necessary for optimal management of MDR/XDRTB.
Article summary
Article focus
The Baltic States have consistently had one of the world's highest rates of drug resistant tuberculosis (TB) including multidrug- and extensively drug-resistant tuberculosis (MDR/XDRTB) despite an extensive tuberculosis control programmes.
Patients with TB in Lithuania show a relatively high mortality for unknown reasons.
The study analyses factors influencing survival of patients with MDR/XDRTB in Lithuania.
Key messages
Patients with MDR/XDRTB show a poor survival regardless of HIV status, but there was no significant difference between MDRTB and XDRTB.
Patients infected with Beijing TB family strains and co-infected with HIV with underlying social problems have worse survival. However, only few TB patients are tested for HIV.
Addressing accompanying social and health problems (eg, alcohol dependency), access to care in rural settings and expansion of HIV testing and antiretroviral treatment are necessary to improve survival.
Strength and limitations of the study
This is the first national study to analyse 7 years of national surveillance data covering a large cohort of MDR/XDRTB patients.
The study demonstrates the value of long-term survival cohorts, as well as pointing to the absence of comparable UK data.
Limitations: limited data on HIV status (due to the low HIV testing coverage in the early years of the TB programme) and limited genotyping data for the XDRTB isolates.
doi:10.1136/bmjopen-2011-000351
PMCID: PMC3225583  PMID: 22123922
20.  A randomised controlled pilot study of standardised counselling and cost-free pharmacotherapy for smoking cessation among stroke and TIA patients 
BMJ Open  2011;1(2):e000366.
Background
Tobacco use is a major risk factor for recurrent stroke. The provision of cost-free quit smoking medications has been shown to be efficacious in increasing smoking abstinence in the general population.
Objective
The objective of this pilot study was to assess the feasibility and obtain preliminary data on the effectiveness of providing cost-free quit smoking pharmacotherapy and counselling to smokers identified in a stroke prevention clinic.
Trial design
Cluster randomised controlled trial.
Methods
All patients seen at the Ottawa Hospital Stroke Prevention Clinic who smoked more five or more cigarettes per day, were ready to quit smoking in the next 30 days, and were willing to use pharmacotherapy were invited to participate in the study. All participants were advised to quit smoking and treated using a standardised protocol including counselling and pharmacotherapy. Participants were randomly assigned to either a prescription only usual care group or an experimental group who received a 4-week supply of cost-free quit smoking medications and a prescription for medication renewal. All patients received follow-up counselling. The primary outcome was biochemically validated quit rates at 26 weeks. The research coordinator conducting outcome assessment was blind to group allocation.
Results
Of 219 smokers screened, 73 were eligible, 28 consented and were randomised, and 25 completed the 26-week follow-up assessment. All 28 patients randomised were included in the analysis. The biochemically validated 7-day point prevalence abstinence rate in the experimental group compared to the usual care group was 26.6% vs 15.4% (adjusted OR 2.00, 95% CI 0.33 to 13.26; p=0.20).
Conclusions
It would be feasible to definitively evaluate this intervention in a large multi-site trial.
Trial registration number
http://ClinicalTrials.gov # UOHI2010-1.
Article summary
Article focus
To assess the feasibility of and obtain preliminary data on the effectiveness of providing cost-free quit smoking pharmacotherapy and counselling to smokers identified in a stroke prevention clinic.
Key messages
This pilot study provides preliminary data to inform the design of a larger study to assess the efficacy of providing cost-free quit smoking medications to smokers with transient ischaemic attack (TIA) and stroke.
The study was underpowered to achieve statistically significant results.
It would be feasible to definitively evaluate this intervention in a large multi-site trial.
Strengths and limitations of this study
This is the first study to examine the efficacy of providing a starter kit of cost-free pharmacotherapy to patients at high risk of stroke who are ready to quit smoking.
The strengths of this study include the randomised control trial design.
The study also provides previously unavailable descriptive information on smokers with TIA and stroke.
The study limitations include the small sample size, a 40% rate of patient enrolment and the fact that study participants were from a single stroke prevention clinic, which may limit generalisability.
doi:10.1136/bmjopen-2011-000366
PMCID: PMC3225588  PMID: 22123923
21.  Experiences with general practitioners described by families of children with intellectual disabilities and challenging behaviour: a qualitative study 
BMJ Open  2011;1(2):e000304.
Objective
To investigate parents' experiences of follow-up by general practitioners (GPs) of children with intellectual disabilities (ID) and comorbid behavioural and/or psychological problems.
Design
Qualitative study based on in-depth interviews with parents of children with ID and a broad range of accompanying health problems.
Setting
County centred study in Norway involving primary and specialist care.
Participants
Nine parents of seven children with ID, all received services from an assigned GP and a specialist hospital department. Potential participants were identified by the specialist hospital department and purposefully selected by the authors to represent both genders and a range of diagnoses, locations and assigned GPs.
Results
Three clusters of experiences emerged from the analysis: expectations, relationships and actual use. The participants had low expectations of the GPs' competence and involvement with their child, and primarily used the GP for the treatment of simple somatic problems. Only one child regularly visited their GP for general and mental health check-ups. The participants' experience of their GPs was that they did not have time and were not interested in the behavioural and mental problems of these children.
Conclusions
Families with children with ID experience a complex healthcare system in situations where they are vulnerable to lack of information, involvement and competence. GPs are part of a stable service system and are in a position to provide security, help and support to these families. Parents' experiences could be improved by regular health checks for their children and GPs being patient, taking time and showing interest in challenging behaviour.
Article summary
Article focus
The aim of this study was to investigate the experiences with general practitioners (GPs) of the parents of children with intellectual disabilities (ID) in order to identify important areas for improvement and suggest fields for further exploration.
Key messages
This study shows that families with children with ID have low expectations of their child's assigned GP, and that their total healthcare needs are not met.
GPs should carry out regular health checks and be prepared to take a longer time than usual for consultations.
When children with ID have comorbid challenging behaviour and/or mental health problems, GPs seem to avoid discussing these issues during consultations.
Strengths and limitations of this study
Participants were of both genders and had a range of diagnoses, experienced diverse challenges and lived in different locations (rural or city).
Our findings are in line with a relatively small number of similar studies in this field.
Sufficient data were collected quickly, so only a small group of participants were interviewed.
doi:10.1136/bmjopen-2011-000304
PMCID: PMC3225589  PMID: 22123921
22.  Predictors of early death in female patients with breast cancer in the UK: a cohort study 
BMJ Open  2011;1(2):e000247.
Objective
To identify factors predicting early death in women with breast cancer.
Design
Cohort study.
Setting
29 trusts across seven cancer networks in the North Thames area.
Participants
15 037 women with primary breast cancer diagnosed between January 1996 and December 2005.
Methods
Logistic regression analyses to determine predictors of early death and factors associated with lack of surgical treatment.
Main exposures
Age at diagnosis, mode of presentation, ethnicity, disease severity, comorbidities, treatment and period of diagnosis in relation to the Cancer Plan (the NHS's strategy in 2000 for investment in and reform of cancer services).
Main outcome measures
Death from any cause within 1 year of diagnosis, and receipt of surgical treatment.
Results
By 31 December 2006, 4765 women had died, 980 in the year after diagnosis. Older age and disease severity independently predicted early death. Women over 80 were more likely to die early than women under 50 (OR 8.05, 95% CI 5.96 to 10.88). Presence of distant metastases on diagnosis increased the odds of early death more than eightfold (OR 8.41, 95% CI 6.49 to 10.89). Two or more recorded comorbidities were associated with a nearly fourfold increase. There was a significant decrease in odds associated with surgery (OR 0.29, 95% CI 0.24 to 0.35). Independently of disease severity and comorbidities, women over 70 were less likely than those under 50 to be treated surgically and this was even more pronounced in those aged over 80 (OR 0.09, 95% CI 0.07 to 0.10). Other factors independently associated with a reduced likelihood of surgery included a non-screening presentation, non-white ethnicity and additional comorbidities.
Conclusions
These findings may partially explain the survival discrepancies between the UK and other European countries in female patients with breast cancer. The study identifies a group of women with a particularly poor prognosis for whom interventions aiming at early detection may be targeted.
Article summary
Article focus
Several studies have shown that the UK has lower survival for breast cancer than some other European countries with a similar expenditure on healthcare.
Differences have been shown to occur mainly in older patients and in the first year after diagnosis.
Several reasons/explanations have been proposed.
Key messages
This study shows that patients with breast cancer dying in the first year after diagnosis are more likely to be older and have more advanced disease and existing comorbidities.
Surgical treatment and (to a lesser extent) radiotherapy and tamoxifen usage were associated with a reduced risk of early death.
The likelihood of receiving surgery was inversely related to age, independently of comorbidity and disease severity.
These findings suggest that early detection, management of comorbidities and optimisation of treatment of older patients are important target areas to improve outcomes.
Strengths and limitations of this study
This is a large cohort of women with a diagnosis of breast cancer, and the results may be generalisable to women treated for breast cancer in the UK during the same time period.
Many variables that may be related to both risk factors and outcomes have not been assessed in this study. However, their correlation with death within a year would have to be very strong to explain the strong associations seen in our data.
doi:10.1136/bmjopen-2011-000247
PMCID: PMC3227804  PMID: 22123920
23.  Tobacco consumption and secondhand smoke exposure in vehicles: a cross-sectional study 
BMJ Open  2011;1(2):e000418.
Objectives
To estimate the prevalence of tobacco consumption and secondhand smoke (SHS) exposure in private cars, commercial vehicles and taxis in the city of Barcelona in Spain.
Design setting and participants
We carried out an observational cross-sectional study in 2011. We selected a systematic sample of 2442 private cars, commercial vehicles and taxis on 40 public roads regulated by traffic lights in all 10 districts of Barcelona. We calculated the prevalence rates and 95% CIs of smoking and SHS exposure in cars, and the corresponding ORs adjusting for the potential confounding variables.
Results
The prevalence of tobacco consumption was 5.5% (95% CI 4.6% to 6.4%) and was greater for commercial vehicles (9.8%; 95% CI 7.1% to 12.5%). The prevalence of SHS exposure was 5.2% (95% CI 3.8% to 6.6%) and 2.2% (95% CI 0.5% to 3.9%) of passengers under 14 years of age were exposed to SHS in vehicles.
Conclusions
This study highlights the need to promote public health measures aimed at reducing tobacco consumption in vehicles, especially in the presence of children, as well as enforcement of the current Spanish law against smoking in commercial vehicles and taxis.
Article summary
Article focus
Tobacco consumption and secondhand smoke (SHS) exposure in vehicles should be targeted because of the high concentrations of SHS due to the confined environment.
Tobacco consumption while driving can also increase the risk of traffic accidents due to driver distraction.
Few studies have used direct observation to examine the consumption of tobacco and SHS exposure in vehicles.
Key messages
Reducing smoking in vehicles in the presence of children must be prioritised.
Smoking laws should be enforced in commercial vehicles and taxis.
Smoking in vehicles should be recognised by legislation as a distraction.
Strengths and limitations of this study
The main limitation of this study is the inherent observer bias, especially as regards variables such as age, where physical appearance can result in misclassification by the observer.
Obtaining a truly random and representative sample of vehicles in circulation in a city is difficult.
This observational study avoids the information bias generated by the use of self-reported questionnaires.
A pilot study found that direct observational studies are useful for monitoring smoking by motor vehicle drivers.
doi:10.1136/bmjopen-2011-000418
PMCID: PMC3225587  PMID: 22119753
24.  Sensor recorded changes in rates of hand washing with soap in response to the media reports of the H1N1 pandemic in Britain 
BMJ Open  2011;1(2):e000127.
Objectives
To examine how the frequency of information regarding a real disease threat influences hand washing with soap.
Design and setting
The authors installed wireless devices in highway service station lavatories in England to record the proportion of individuals washing hands with soap from May 2009 to January 2010.
Participants
Participants were users of men's and women's toilets. Combined there was an average of 6800 participant entrances into the lavatories daily.
Primary outcome measure
The primary outcome measure is the proportion of soap usage to the number of entries into the lavatories.
Results
Hand-washing rates were positively related to both H1NI coverage in blogs and the news; however, these relationships were stronger for men than for women.
Conclusions
Hand washing with soap increases proportionally to the frequency of media key words related to H1N1. Women's hand washing was more strongly associated with incidence of media keywords than men's.
Article summary
Article focus
How does hand washing change as a function of media messages regarding the severity of a contagious disease?
Do men and women wash hands to different degrees as a function of media regarding contagious disease?
Do conventional media sources or weblogs better track hand-washing behaviour?
Key messages
Hand washing with soap increased as a function of the frequency of media about H1N1.
For women, there was a stronger relationship between media and hand washing.
Blogs more closely tracked hand washing as opposed to conventional media sources.
Strengths and limitations of this study
The study used a sensor system rather than self-report or observation.
The study could have benefited from recording hand washing before the media regarding H1N1 began.
Some gaps in data collection occurred in one set of toilets in the fall.
doi:10.1136/bmjopen-2011-000127
PMCID: PMC3225584  PMID: 22116088
25.  Incidence, time and determinants of tuberculosis treatment default in Yaounde, Cameroon: a retrospective hospital register-based cohort study 
BMJ Open  2011;1(2):e000289.
Objectives
High rates of antituberculosis treatment discontinuation have been reported in some areas of Africa. The aim of this study was to determine the rate, time to and determinants of antituberculosis treatment default in Yaounde.
Design
This was a retrospective cohort study based on hospital registers. Tuberculosis treatment default or antituberculosis treatment discontinuation was defined as any interruption of treatment for at least 2 months following treatment initiation. Sociodemographic and clinical predictors of treatment discontinuation were investigated with the use of Cox regressions models.
Setting
This study was carried out in the tuberculosis diagnosis and treatment centre at Yaounde Jamot Hospital, which serves as a referral centre for tuberculosis and respiratory diseases for the capital city of Cameroon (Yaounde) and surrounding areas.
Participants
All (1688) patients started on antituberculosis treatment at the centre between January and December 2009 were enrolled. Outcome measures were antituberculosis treatment default and time to treatment default.
Results
Of the 1688 included patients, 337 (20%) defaulted from treatment, 86 (5.1%) died, treatment failed in 6 (0.4%) and 104 (6.2%) were transferred. Therefore, treatment was successfully completed in 1154 (68.4%) patients. Median duration to treatment discontinuation was 90 days (IQR 30–150), and 62% of treatment discontinuation occurred during the continuation phase. Hospitalisation during the intensive phase (adjusted HR 0.69; 95% CI 0.54 to 0.89) and non-consenting for HIV screening (1.65; 1.24 to 2.21) were the main determinants of defaulting from treatment in multivariable analysis.
Conclusions
The default incidence rate is relatively high in this centre and treatment discontinuation occurs frequently during the continuation phase of treatment. Action is needed to improve adherence to treatment when received on an ambulatory basis, to clarify the association between HIV testing and antituberculosis treatment default, and to identify other potential determinants of treatment discontinuation in this setting.
Article summary
Article focus
To determine the rates, time to and determinants of antituberculosis treatment discontinuation in the era of directly observed treatment in sub-Saharan Africa, using the situation in Cameroon as an example.
Key messages
Antituberculosis treatment success rates remain sub-optimal in sub-Saharan Africa, a region which has the highest global incidence rates of tuberculosis.
Treatment discontinuation is one of the main reasons for the high tuberculosis rates, but has not recently been fully explored in Africa.
Knowledge of the determinants of antituberculosis treatment discontinuation is critical for informing health service and policy solutions needed to improve the outcomes of care for tuberculosis and contain the spread of the disease.
Strengths and limitations of this study
This was a large cohort study with 1688 participants.
This was also a retrospective study which lacked some key information.
doi:10.1136/bmjopen-2011-000289
PMCID: PMC3225586  PMID: 22116091

Results 1-25 (151)