PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (3733)
 

Clipboard (0)
None

Select a Filter Below

Journals
Year of Publication
1.  Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD—‘Assessing QbTest Utility in ADHD’ (AQUA): a randomised controlled trial 
BMJ Open  2014;4(12):e006838.
Introduction
The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current ‘gold standard’ ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome.
Methods and analysis
This multisite randomised controlled trial will recruit young people (aged 6–17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice.
Ethics and dissemination
The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval.
Trial registration number
NCT02209116.
doi:10.1136/bmjopen-2014-006838
PMCID: PMC4256543  PMID: 25448628
ADHD; Continuous Performance Test (CPT); QbTest; Diagnosis; Treatment
2.  ‘Including health in systems responsible for urban planning’: a realist policy analysis research programme 
BMJ Open  2015;5(7):e008822.
Introduction
Realist methods are increasingly being used to investigate complex public health problems. Despite the extensive evidence base clarifying the built environment as a determinant of health, there is limited knowledge about how and why land-use planning systems take on health concerns. Further, the body of research related to the wider determinants of health suffers from not using political science knowledge to understand how to influence health policy development and systems. This 4-year funded programme of research investigates how the land-use planning system in New South Wales, Australia, incorporates health and health equity at multiple levels.
Methods and analysis
The programme uses multiple qualitative methods to develop up to 15 case studies of different activities of the New South Wales land-use planning system. Comparison cases from other jurisdictions will be included where possible and useful. Data collection includes publicly available documentation and purposively sampled stakeholder interviews and focus groups of up to 100 participants across the cases. The units of analysis in each case are institutional structures (rules and mandates constraining and enabling actors), actors (the stakeholders, organisations and networks involved, including health-focused agencies), and ideas (policy content, information, and framing). Data analysis will focus on and develop propositions concerning the mechanisms and conditions within and across each case leading to inclusion or non-inclusion of health. Data will be refined using additional political science and sociological theory. Qualitative comparative analysis will compare cases to develop policy-relevant propositions about the necessary and sufficient conditions needed to include health issues.
Ethics and dissemination
Ethics has been approved by Sydney University Human Research Ethics Committee (2014/802 and 2015/178). Given the nature of this research we will incorporate stakeholders, often as collaborators, throughout. We outline our research translation strategies following best practice approaches.
doi:10.1136/bmjopen-2015-008822
PMCID: PMC4513442  PMID: 26204911
3.  Differences in levels of physical activity between White and South Asian populations within a healthcare setting: impact of measurement type in a cross-sectional study 
BMJ Open  2015;5(7):e006181.
Objective
We investigate differences between White and South Asian (SA) populations in levels of objectively measured and self-reported physical activity.
Design
Cross-sectional study.
Setting
Leicestershire, UK, 2010–2011.
Participants
Baseline data were pooled from two diabetes prevention trials that recruited a total of 4282 participants from primary care with a high risk score for type 2 diabetes. For this study, 2843 White (age=64±8, female=37%) and 243 SA (age=58±9, female=34%) participants had complete physical activity data and were included in the analysis.
Outcome measures
Moderate-intensity to vigorous-intensity physical activity (MVPA) and walking activity were measured using the International Physical Activity Questionnaire (IPAQ), and a combination of piezoelectric pedometer (NL-800) and accelerometer (Actigraph GT3X) were used to objectively measure physical activity.
Results
Compared to White participants, SA participants self-reported less MVPA (30 vs 51 min/day; p<0.001) and walking activity (11 vs 17 min/day; P=0.001). However, there was no difference in objectively measured ambulatory activity (5992 steps/day vs 6157 steps/day; p=0.75) or in time spent in MVPA (18.0 vs 21.5 min/day; p=0.23). Results were largely unaffected when adjusted for age, sex and social deprivation. Compared to accelerometer data, White participants overestimated their time in MVPA by 51 min/day and SA participants by 21 min/day.
Conclusions
SA and White groups undertook similar levels of physical activity when measured objectively despite self-reported estimates being around 40% lower in the SA group. This emphasises the limitations of comparing self-reported lifestyle measures across different populations and ethnic groups.
Trial registration number
Reports baseline data from: Walking Away from Type 2 Diabetes (ISRCTN31392913) and Let's Prevent Diabetes (NCT00677937).
doi:10.1136/bmjopen-2014-006181
PMCID: PMC4513447  PMID: 26204908
SPORTS MEDICINE; EPIDEMIOLOGY
4.  Under-reporting of maternal and perinatal adverse events in New Zealand 
BMJ Open  2015;5(7):e007970.
Objectives
To determine the proportion of maternal and perinatal mortality and morbidity cases, identified by the Perinatal and Maternal Mortality Review Committee (PMMRC), that are also reported within the annual serious adverse events (SAEs) reports published by the Health Quality and Safety Commission (HQSC).
Setting
Nationally collated data from the PMMRC and HQSC, New Zealand.
Participants
Analysis of maternal and perinatal mortality and morbidity data 2009–2012.
Interventions
Every SAE report published by the HQSC from 2009 to 2012 was scrutinised for maternal and perinatal cases using the case history provided by district health boards (DHB). Further detail of each case was requested from each DHB to establish whether they had been identified as maternal or perinatal mortalities or morbidities by the PMMRC.
Primary outcome measure
The proportion of maternal and perinatal mortality and morbidity cases identified by HQSC SAE reports, compared with PMMRC reporting.
Results
58 maternal and perinatal SAEs were identified from the SAE reports 2009–2012. Of these, 50 fit under the PMMRC reporting definitions, all of which were also reported by the PMMRC. In the same time frame, the PMMRC captured 536 potentially avoidable maternal and perinatal mortalities and morbidities that fitted the HQSC SAE definition. Fewer than 9% of maternal and perinatal SAEs are captured by the HQSC SAE reporting process.
Conclusions
The rate of maternal and perinatal adverse event reporting to the HQSC is low and not improving annually, compared with PMMRC reporting of eligible events. This is of concern as these events may not be adequately reviewed locally, and because the SAE report is considered a measure of quality by the DHBs and the HQSC. Currently, the reporting of SAEs to the HQSC cannot be considered a reliable way to monitor or improve the quality of maternity services provided in New Zealand.
doi:10.1136/bmjopen-2015-007970
PMCID: PMC4513534  PMID: 26204910
AUDIT; OBSTETRICS; NEONATOLOGY
5.  Farm environment during infancy and lung function at the age of 31: a prospective birth cohort study in Finland 
BMJ Open  2015;5(7):e007350.
Objectives
Farming as an occupation is considered a risk factor for asthma and reduced lung function. By contrast, living on a farm during infancy has been reported to be associated with lower risk of asthma in adulthood. However, little is known about the association between farming environment during infancy and lung function in adulthood. We aimed to study the prospective longitudinal association between farming environment during infancy and lung function in adulthood.
Design
A prospective birth cohort study.
Setting
Northern Finland.
Participants
5666 participants born in 1966 were followed up at the age of 31 years.
Primary outcome measures
Spirometry at the age of 31 years.
Results
To be born into a farmer’s family was associated with higher forced expiratory volume in 1 s (FEV1) (36 mL; 95% CI 6 to 67 mL) and forced vital capacity (FVC) (40 mL; 95% CI 5 to 75 mL) at the age of 31 years. Contact with farm animals during infancy was associated with higher FEV1. No associations were seen with FEV1/FVC (FEV1/FVC ratio). Having dogs in childhood revealed similar associations. There was a suggestive dose-dependent association with the number of animal species during childhood and higher FEV1 and FVC at adulthood, especially among women.
Conclusions
Farming environment in early life may have a positive impact on lung function in adulthood.
doi:10.1136/bmjopen-2014-007350
PMCID: PMC4513452  PMID: 26201721
EPIDEMIOLOGY; RESPIRATORY MEDICINE (see Thoracic Medicine); OCCUPATIONAL & INDUSTRIAL MEDICINE
6.  ‘You are just left to get on with it’: qualitative study of patient and carer experiences of the transition to secondary progressive multiple sclerosis 
BMJ Open  2015;5(7):e007674.
Objectives
Although the transition to secondary progressive multiple sclerosis (SPMS) is known to be a period of uncertainty for clinicians, who may find progressive disease challenging to objectively identify, little research has explored the experiences of patients and carers specifically during this transition period. Our objective was to explore what patients and their carers understand about their disease stage and describe their experiences and perspectives on the transition to SPMS.
Design
Semistructured qualitative interviews and subsequent validation focus groups were analysed using inductive thematic analysis.
Setting
South East Wales, UK.
Participants
20 patients with MS and 13 carers were interviewed. Eight patients and two carers participated in focus groups.
Results
Four main themes around disease progression were identified. ‘Realisation’ describes how patients came to understand they had SPMS while ‘reaction’ describes their response to this realisation. The ‘realities’ of living with SPMS, including dealing with the healthcare system during this period, were described along with ‘future challenges’ envisaged by patients and carers.
Conclusions
Awareness that the transition to SPMS has occurred, and subsequent emotional reactions and coping strategies, varied widely between patients and their carers. The process of diagnosing the transition was often not transparent and some individuals wanted information to help them understand what the transition to SPMS meant for them.
doi:10.1136/bmjopen-2015-007674
PMCID: PMC4513516  PMID: 26201723
QUALITATIVE RESEARCH; REHABILITATION MEDICINE
7.  Non-invasive prenatal diagnosis using fetal DNA in maternal plasma: a preliminary study for identification of paternally-inherited alleles using single nucleotide polymorphisms 
BMJ Open  2015;5(7):e007648.
Objectives
Single nucleotide polymorphism (SNP) with a mutation can be used to identify the presence of the paternally-inherited wild-type or mutant allele as result of the inheritance of either allele in the fetus and allows the prediction of the fetal genotype. This study aims to identify paternal SNPs located at the flanking regions upstream or downstream from the β-globin gene mutations at CD41/42 (HBB:c.127_130delCTTT), IVS1-5 (HBB:c.92+5G>C) and IVS2-654 (HBB:c.316-197C>T) using free-circulating fetal DNA.
Setting
Haematology Lab, Department of Biomedical Science, University of Malaya.
Participants
Eight couples characterised as β-thalassaemia carriers where both partners posed the same β-globin gene mutations at CD41/42, IVS1-5 and IVS2-654, were recruited in this study.
Outcome measures
Genotyping was performed by allele specific-PCR and the locations of SNPs were identified after sequencing alignment.
Results
Genotype analysis revealed that at least one paternal SNP was present for each of the couples. Amplification on free-circulating DNA revealed that the paternal mutant allele of SNP was present in three fcDNA. Thus, the fetuses may be β-thalassaemia carriers or β-thalassaemia major. Paternal wild-type alleles of SNP were present in the remaining five fcDNA samples, thus indicating that the fetal genotypes would not be homozygous mutants.
Conclusions
This preliminary research demonstrates that paternal allele of SNP can be used as a non-invasive prenatal diagnosis approach for at-risk couples to determine the β-thalassaemia status of the fetus.
doi:10.1136/bmjopen-2015-007648
PMCID: PMC4513519  PMID: 26201722
PUBLIC HEALTH
8.  Is the introduction of violence and injury observatories associated with a reduction of violence in adult populations? Rationale and protocol for a systematic review 
BMJ Open  2015;5(7):e007073.
Introduction
The violence and injury observatories developed in Colombia and found throughout the Americas and Western Europe aim to maximise inter-institutional cooperation, information-sharing, analysis and security policy development initiatives to enhance governance. The purpose of the violence and injury observatories is directed towards preventing crime and violence at the local and regional levels. To date, there has been no systematic review of the literature to present a succinct review of the evidence. We therefore sought to summarise the evidence from existing studies on the contribution of violence and injury observatories towards violence prevention.
Methods and analysis
A number of databases will be searched, supplemented by the same keyword searches in the grey literature. Search terms will include studies published from 1 January 1990 to 30 October 2014. Study quality will be assessed using a validated quality assessment tool. Two researchers will independently assess articles for study eligibility to reduce bias, minimise errors and enhance the reliability of findings. Disagreements will be resolved by consensus among three authors. This review protocol has been published in the PROSPERO International Prospective Register of systematic reviews, registration number 2014:CRD42014009818.
Dissemination
There is a paucity of evidence for the effectiveness of violence and injury observatories and their influence on violence in an adult population. We plan to address this gap in knowledge by way of a systematic review and meta-analysis outlined in this abstract. We anticipate that the results could be used by researchers and policymakers to help inform them of the efficacy of violence and injury observatories and their broader role in contributing to violence prevention.
Trial registration number
CRD42014009818.
doi:10.1136/bmjopen-2014-007073
PMCID: PMC4513469  PMID: 26198425
BIOTECHNOLOGY & BIOINFORMATICS; PUBLIC HEALTH
9.  A mixed methods study of the factors that influence whether intervention research has policy and practice impacts: perceptions of Australian researchers 
BMJ Open  2015;5(7):e008153.
Objectives
To investigate researchers’ perceptions about the factors that influenced the policy and practice impacts (or lack of impact) of one of their own funded intervention research studies.
Design
Mixed method, cross-sectional study.
Setting
Intervention research conducted in Australia and funded by Australia's National Health and Medical Research Council between 2003 and 2007.
Participants
The chief investigators from 50 funded intervention research studies were interviewed to determine if their study had achieved policy and practice impacts, how and why these impacts had (or had not) occurred and the approach to dissemination they had employed.
Results
We found that statistically significant intervention effects and publication of results influenced whether there were policy and practice impacts, along with factors related to the nature of the intervention itself, the researchers’ experience and connections, their dissemination and translation efforts, and the postresearch context.
Conclusions
This study indicates that sophisticated approaches to intervention development, dissemination actions and translational efforts are actually widespread among experienced researches, and can achieve policy and practice impacts. However, it was the links between the intervention results, further dissemination actions by researchers and a variety of postresearch contextual factors that ultimately determined whether a study had policy and practice impacts. Given the complicated interplay between the various factors, there appears to be no simple formula for determining which intervention studies should be funded in order to achieve optimal policy and practice impacts.
doi:10.1136/bmjopen-2015-008153
PMCID: PMC4513518  PMID: 26198428
Health policy; Research Impact; Translational Research; Knowledge Transfer; Intervention Research
10.  Access to healthcare and financial risk protection for older adults in Mexico: secondary data analysis of a national survey 
BMJ Open  2015;5(7):e007877.
Objectives
While the benefits of Seguro Popular health insurance in Mexico relative to no insurance have been widely documented, little has been reported on its effects relative to the pre-existing Social Security health insurance. We analyse the effects of Social Security and Seguro Popular health insurances in Mexico on access to healthcare of older adults, and on financial risk protection to their households, compared with older adults without health insurance.
Setting
Secondary data analysis was performed using the 2012 Mexican Survey of Health and Nutrition (ENSANUT).
Participants
The study population comprised 18 847 older adults and 13 180 households that have an elderly member.
Outcome measures
The dependent variables were access to healthcare given the reported need, the financial burden imposed by health expenditures measured through catastrophic health-related expenditures, and using savings for health-related expenditures. Separate propensity score matching analyses were conducted for each comparison. The analysis for access was performed at the individual level, and the analysis for financial burden at the household level. In each case, matching on a wide set of relevant characteristics was achieved.
Results
Seguro Popular showed a protective effect against lack of access to healthcare for older adults compared with those with no insurance. The average treatment effect on the treated (ATET) was ascertained through using the nearest-neighbour matching (−8.1%, t-stat −2.305) analysis. However, Seguro Popular did not show a protective effect against catastrophic expenditures in a household where an older adult lived. Social Security showed increased access to healthcare (ATET −11.3%, t-stat −3.138), and protective effect against catastrophic expenditures for households with an elderly member (ATET −1.9%, t-stat −2.178).
Conclusions
Seguro Popular increased access to healthcare for Mexican older adults. Social Security showed a significant protective effect against lack of access and catastrophic expenditures compared with those without health insurance.
doi:10.1136/bmjopen-2015-007877
PMCID: PMC4513520  PMID: 26198427
access to healthcare; financial risk protection; health insurance; older adults
11.  Impact of cardiovascular comorbidities on COPD Assessment Test (CAT) and its responsiveness to pulmonary rehabilitation in patients with moderate to very severe COPD: protocol of the Chance study 
BMJ Open  2015;5(7):e007536.
Introduction
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality. Patients with COPD are characterised by a reduced health status, which can be easily assessed by the COPD Assessment Test (CAT). Previous studies show that health status can be worsened by the presence of comorbidities. However, the impact of cardiovascular comorbidities on health status as assessed with CAT is not sufficiently investigated. Therefore, the current study has the following objectives: (1) to study the clinical, (patho)physiological and psychosocial determinants of the CAT, and impact of previously established and/or newly diagnosed cardiovascular comorbidities on health status in tertiary care patients with COPD; (2) to assess the effects of pulmonary rehabilitation on CAT scores in patients with COPD; (3) to develop reference values for the CAT in Dutch elderly patients without COPD; and (4) to validate the CAT in a broad sample of Dutch patients with COPD.
Methods and analysis
The COPD, Health status and Comorbidities (Chance) study is a monocentre study consisting of an observational cross-sectional part and a longitudinal part. Demographic and clinical characteristics will be assessed in primary care, secondary care and tertiary care patients with COPD, and in patients without COPD. To assess health status, the CAT, Clinical COPD Questionnaire (CCQ) and St George's Respiratory Questionnaire (SGRQ) will be used. The longitudinal part consists of a comprehensive pulmonary rehabilitation programme in 500 tertiary care patients. For the cross-sectional part of the study, 150 patients without COPD, 100 primary care patients and 100 secondary care patients will be assessed during a single home visit.
Ethics and dissemination
The Medical Ethical Committee of the Maastricht University Medical Centre+ (MUMC+), Maastricht, the Netherlands (METC 11-3-070), has approved this study. The study has been registered at the Dutch Trial Register (NTR 3416).
doi:10.1136/bmjopen-2014-007536
PMCID: PMC4513521  PMID: 26198426
Chronic Obstructive Pulmonary Disease; COPD assessment test; Health status; Cardiovascular comorbidities
12.  Determining Surgical Complications in the Overweight (DISCOVER): a multicentre observational cohort study to evaluate the role of obesity as a risk factor for postoperative complications in general surgery 
BMJ Open  2015;5(7):e008811.
Introduction
Obesity is increasingly prevalent among patients undergoing surgery. Conflicting evidence exists regarding the impact of obesity on postoperative complications. This multicentre study aims to determine whether obesity is associated with increased postoperative complications following general surgery.
Methods and analysis
This prospective, multicentre cohort study will be performed utilising a collaborative methodology. Consecutive adults undergoing open or laparoscopic, elective or emergency, gastrointestinal, bariatric or hepatobiliary surgery will be included. Day case patients will be excluded. The primary end point will be the overall 30-day major complication rate (Clavien-Dindo grade III–V complications). Data will be collected to risk-adjust outcomes for potential confounding factors, such as preoperative cardiac risk. This study will be disseminated through structured medical student networks using established collaborative methodology. The study will be powered to detect a two-percentage point increase in the major postoperative complication rate in obese versus non-obese patients.
Ethics and dissemination
Following appropriate assessment, an exemption from full ethics committee review has been received, and the study will be registered as a clinical audit or service evaluation at each participating hospital. Dissemination will take place through national and local research collaborative networks.
doi:10.1136/bmjopen-2015-008811
PMCID: PMC4513439  PMID: 26195471
SURGERY
13.  Refractory depression: mechanisms and evaluation of radically open dialectical behaviour therapy (RO-DBT) [REFRAMED]: protocol for randomised trial 
BMJ Open  2015;5(7):e008857.
Introduction
Only 30–40% of depressed patients treated with medication achieve full remission. Studies that change medication or augment it by psychotherapy achieve only limited benefits, in part because current treatments are not designed for chronic and complex patients. Previous trials have excluded high-risk patients and those with comorbid personality disorder. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a novel, transdiagnostic treatment for disorders of emotional over-control. The REFRAMED trial aims to evaluate the effectiveness and cost-effectiveness of RO-DBT for patients with treatment-resistant depression.
Methods and analysis
REFRAMED is a multicentre randomised controlled trial, comparing 7 months of individual and group RO-DBT treatment with treatment as usual (TAU). Our primary outcome measure is depressive symptoms 12 months after randomisation. We shall estimate the cost-effectiveness of RO-DBT by cost per quality-adjusted life year. Causal analyses will explore the mechanisms by which RO-DBT is effective.
Ethics and dissemination
The National Research Ethics Service (NRES) Committee South Central – Southampton A first granted ethical approval on 20 June 2011, reference number 11/SC/0146.
Trial registration number
ISRCTN85784627.
doi:10.1136/bmjopen-2015-008857
PMCID: PMC4513446  PMID: 26187121
Refractory Depression; Radically Open Dialectical Behaviour Therapy; Study Protocol
14.  Identifying acne treatment uncertainties via a James Lind Alliance Priority Setting Partnership 
BMJ Open  2015;5(7):e008085.
Objectives
The Acne Priority Setting Partnership (PSP) was set up to identify and rank treatment uncertainties by bringing together people with acne, and professionals providing care within and beyond the National Health Service (NHS).
Setting
The UK with international participation.
Participants
Teenagers and adults with acne, parents, partners, nurses, clinicians, pharmacists, private practitioners.
Methods
Treatment uncertainties were collected via separate online harvesting surveys, embedded within the PSP website, for patients and professionals. A wide variety of approaches were used to promote the surveys to stakeholder groups with a particular emphasis on teenagers and young adults. Survey submissions were collated using keywords and verified as uncertainties by appraising existing evidence. The 30 most popular themes were ranked via weighted scores from an online vote. At a priority setting workshop, patients and professionals discussed the 18 highest-scoring questions from the vote, and reached consensus on the top 10.
Results
In the harvesting survey, 2310 people, including 652 professionals and 1456 patients (58% aged 24 y or younger), made submissions containing at least one research question. After checking for relevance and rephrasing, a total of 6255 questions were collated into themes. Valid votes ranking the 30 most common themes were obtained from 2807 participants. The top 10 uncertainties prioritised at the workshop were largely focused on management strategies, optimum use of common prescription medications and the role of non-drug based interventions. More female than male patients took part in the harvesting surveys and vote. A wider range of uncertainties were provided by patients compared to professionals.
Conclusions
Engaging teenagers and young adults in priority setting is achievable using a variety of promotional methods. The top 10 uncertainties reveal an extensive knowledge gap about widely used interventions and the relative merits of drug versus non-drug based treatments in acne management.
doi:10.1136/bmjopen-2015-008085
PMCID: PMC4513497  PMID: 26187120
DERMATOLOGY; QUALITATIVE RESEARCH
15.  Anaemia and related nutrient deficiencies after Roux-en-Y gastric bypass surgery: a systematic review and meta-analysis 
BMJ Open  2015;5(7):e006964.
Objective
To obtain a pooled risk estimate on the long-term impact of anaemia and related nutritional deficiencies in patients receiving Roux-en-Y gastric bypass (RYGB) surgery.
Design
Systematic review and meta-analysis.
Data sources
MEDLINE, EMBASE and Cochrane databases were searched to identify English reports published before 16 May 2014.
Eligibility criteria
Articles with case numbers >100, follow-up period >12 months, and complete data from both before and after surgery were selected. Outcomes of interest were changes in baseline measurements of proportion of patients with anaemia, by haemoglobin, haematocrit, ferritin, iron, vitamin B12 and folate levels.
Data collection and analysis
Two reviewers independently reviewed data and selected six prospective and nine retrospective studies with a total of 5909 patients. A random effect model with inverse variance weighting was used to calculate summary estimates of outcomes at 6, 12, 24 and 36 months postoperatively.
Results
Proportion of patients with anaemia was 12.2% at baseline, which, respectively, increased to 20.9% and 25.9% at 12 and 24 months follow-up, consistent with decreases in haemoglobin and haematocrit levels. Although the serum iron level did not change substantially after surgery, the frequency of patients with ferritin deficiency increased from 7.9% at baseline to 13.4% and 23.0% at 12 and 24 months, respectively, postoperation. Vitamin B12 deficiency increased from 2.3% at baseline to 6.5% at 12 months after surgery in those subjects receiving RYGB. There was no obvious increase in folate deficiency.
Conclusions
RYGB surgery is associated with an increased risk of anaemia and deficiencies of iron and vitamin B12, but not folate. Ferritin is more sensitive when serum iron level is within normal range.
doi:10.1136/bmjopen-2014-006964
PMCID: PMC4513480  PMID: 26185175
Roux-en-Y Gastric Bypass; Anemia; Nutritional Anemia; Iron; Ferritin
16.  Ephedrine as add-on therapy for patients with myasthenia gravis: protocol for a series of randomised, placebo-controlled n-of-1 trials 
BMJ Open  2015;5(7):e007863.
Introduction
Myasthenia gravis (MG), a rare neuromuscular disease, is often initially treated using acetylcholinesterase inhibitors. Patients who do not respond adequately depend on the use of corticosteroids or other immunosuppressive medication, but these may have serious side effects. Clinical observations suggest that ephedrine can diminish, postpone or even prevent the need for immunosuppressive therapy when added to acetylcholinesterase inhibitors or low-dose prednisone. In the Netherlands, ephedrine is not licensed for MG nor is reimbursement guaranteed. MG is a rare condition, and ephedrine might be indicated only in a subset of patients. Thus, randomised controlled trials comparing large groups are difficult to conduct. We, therefore, aim to aggregate data from a small series of n-of-1 trials (also known as single patient trials) to assess the effect of ephedrine as add-on treatment for MG.
Methods and analysis
Single-centre, placebo-controlled, double-blind, randomised, multiple crossover n-of-1 studies in 4 adult patients with generalised MG who show inadequate improvement on pyridostigmine and/or immunosuppressive drugs. Each n-of-1 trial has 3 cycles of two 5-day intervention periods. Treatment: 25 mg ephedrine or placebo, twice daily. Main outcome measure: Quantitative Myasthenia Gravis (QMG) test. Statistical analysis: fixed effects linear model for QMG for all patients combined. Secondary outcome measures: Clinical: effects on MG-Composite and MG-Activities of Daily Living (MG-ADL) scales; QMG at individual level; adverse events. Acceptability of trial design: number of patients eligible and enrolled; number of treatment cycles completed; patients’ and caregivers’ experiences.
Ethics and dissemination
This study was approved by the Medical Ethics Committee of Leiden University Medical Center, No. P14.108. Results of the trial will be reported in a peer-reviewed publication. Regulatory stakeholders will comment on the suitability of the trial for market authorisation and reimbursement purposes.
Trial registration number
This study is registered under EudraCT number 2014-001355-23, protocol no. 40960, V.1.0, registration date 27 March 2014.
doi:10.1136/bmjopen-2015-007863
PMCID: PMC4513481  PMID: 26185179
STATISTICS & RESEARCH METHODS; THERAPEUTICS
17.  Assessing the effect of Michigan's smoke-free law on air quality inside restaurants and casinos: a before-and-after observational study 
BMJ Open  2015;5(7):e007530.
Objectives
To assess the effect of Michigan's smoke-free air (SFA) law on the air quality inside selected restaurants and casinos. The hypothesis of the study: if the SFA law is effectively implemented in restaurants and casinos, there will be a significant reduction in the particulate matter PM2.5 measured in the same establishments after the law is implemented.
Setting
Prelaw and postlaw design study.
Participants
78 restaurants in 14 Michigan cities from six major regions of the state, and three Detroit casinos.
Methods
We monitored the real-time PM2.5 in 78 restaurants and three Detroit casinos before the SFA law, and again monitored the same restaurants and casinos after implementation of the law, which was enacted on 1 May 2010.
Primary and secondary outcome measures
Concentration measurements of secondhand smoke (SHS) fine particles (PM2.5) were compared in each restaurant in the prelaw period to measurements of PM2.5 in the same restaurants during the postlaw period. A second comparison was made for PM2.5 levels in three Detroit casinos prelaw and postlaw; these casinos were exempted from the SFA law.
Results
Prelaw data indicated that 85% of the restaurants had poor to hazardous air quality, with the average venue having ‘unhealthy’ air according to Michigan's Air Quality Index for PM2.5. Postlaw, air quality in 93% of the restaurants improved to ‘good’. The differences were statistically significant (p<0.0001). By comparison, the three casinos measured had ‘unhealthy’ air both before and after the law.
Conclusions
The significant air quality improvement in the Michigan restaurants after implementation of the SFA law indicates that the law was very effective in reducing exposure to SHS. Since the Detroit casinos were exempted from the law, the air quality was unchanged, and remained unhealthy in both prelaw and postlaw periods.
doi:10.1136/bmjopen-2014-007530
PMCID: PMC4513515  PMID: 26185176
PUBLIC HEALTH; Smoking and tobacco
18.  Sociodemographic and health behavioural factors associated with access to and utilisation of eye care in Korea: Korea Health and Nutrition Examination Survey 2008–2012 
BMJ Open  2015;5(7):e007614.
Objective
To determine the sociodemographic and health behavioural factors associated with access to and utilisation of eye care in Korea.
Design
Nationwide cross-sectional study
Methods
25 752 Koreans over the age of 30 were assessed from a national representative survey. We analysed independent variables of self-reporting eye clinic visits through multivariable analyses of sociodemographic factors. The time since the last visit to an eye clinic was used to assess access to and utilisation of eye care.
Results
Of the 25 752 respondents, 8237 (32.0%) visited an eye clinic in the past year, 11 028 (42.8%) were seen more than 1 year ago, while 6487 (25.2%) had never seen an ophthalmologist. Eye clinic utilisation was statistically associated with older age, female sex, higher household income, higher education levels, living in an urban area, and having comorbidities including diabetes and hypertension. Middle-aged men between 30 and 49 years were found to be less likely to receive eye care compared to the rest of the population, and the proportion that did plummeted after the financial crisis of 2007.
Conclusions
There is a substantial sociodemographic disparity in eye care utilisation in Korea, and men with low financial income and education level are especially at risk. Use of eye care among middle-aged men has decreased since the global financial crisis that began in 2007, and therefore healthcare policies and public interventions should be targeted at vulnerable groups to promote access to medical care.
doi:10.1136/bmjopen-2015-007614
PMCID: PMC4513532  PMID: 26185177
PREVENTIVE MEDICINE; PUBLIC HEALTH; HEALTH ECONOMICS
19.  Coronary flow reserve during dobutamine stress in Takotsubo stress cardiomyopathy 
BMJ Open  2015;5(7):e007671.
Objectives
Takotsubo stress cardiomyopathy (TSC) is an increasingly recognised and diagnosed disease, although the underlying pathophysiology is still unknown. Our aim was to investigate the effect of the catecholamine dobutamine on coronary flow reserve (CFR) measured non-invasively in patients with TSC and controls. Our hypothesis was that dobutamine stress can induce microvascular dysfunction in patients with a previous episode of TSC.
Setting
This is a case–control study and a substudy of the Stockholm Myocardial Infarction with Normal Coronaries (SMINC) study. Elective dobutamine investigations were performed focusing on non-invasive measurements of CFR. The investigations were performed more than 6 months after the acute event.
Participants
22 patients with a previous episode of TSC and 22 sex-matched and age-matched controls were recruited from the SMINC study. All patients with TSC had a previous normal cardiovascular MR investigation.
Results
CFR at low-dose dobutamine was significantly lower in the TSC group compared with controls, 1.51 and 1.72, respectively (p=0.017). At high-dose dobutamine, CFR was 1.95 and 2.21 in the TSC group and controls, respectively (p=0.098).
Conclusions
We could not confirm that the catecholamine dobutamine induced microvascular dysfunction in patients with TSC. However, we found a small but significant difference in CFR at low-dose dobutamine, which implies that the role of microvascular function in TSC needs to be further explored.
doi:10.1136/bmjopen-2015-007671
PMCID: PMC4513533  PMID: 26185178
20.  Association between secondhand smoke exposure and blood lead and cadmium concentration in community dwelling women: the fifth Korea National Health and Nutrition Examination Survey (2010–2012) 
BMJ Open  2015;5(7):e008218.
Objectives
To assess the association between secondhand smoke exposure and blood lead and cadmium concentration in women in South Korea.
Design
Population-based cross-sectional study.
Setting
South Korea (Korea National Health and Nutrition Examination Survey V).
Participants
1490 non-smoking women who took part in the fifth Korea National Health and Nutrition Examination Survey (2010–2012), in which blood levels of lead and cadmium were measured.
Primary outcome measures
The primary outcome was blood levels of lead and cadmium in accordance with the duration of secondhand smoke exposure.
Results
The adjusted mean level of blood cadmium in women who were never exposed to secondhand smoke was 1.21 (0.02) µg/L. Among women who were exposed less than 1 h/day, the mean cadmium level was 1.13 (0.03) µg/L, and for those exposed for more than 1 h, the mean level was 1.46 (0.06) µg/L. In particular, there was a significant association between duration of secondhand smoke exposure at the workplace and blood cadmium concentration. The adjusted mean level of blood cadmium concentration in the never exposed women's group was less than that in the 1 h and more exposed group, and the 1 h and more at workplace exposed group: 1.20, 1.24 and 1.50 µg/L, respectively. We could not find any association between lead concentration in the blood and secondhand smoke exposure status.
Conclusions
This study showed that exposure to secondhand smoke and blood cadmium levels are associated. Especially, there was a significant association at the workplace. Therefore, social and political efforts for reducing the exposure to secondhand smoke at the workplace are needed in order to promote a healthier working environment for women.
doi:10.1136/bmjopen-2015-008218
PMCID: PMC4513535  PMID: 26185180
TOXICOLOGY; OCCUPATIONAL & INDUSTRIAL MEDICINE; PRIMARY CARE
21.  The inter-relationship among economic activities, environmental degradation, material consumption and population health in low-income countries: a longitudinal ecological study 
BMJ Open  2015;5(7):e006183.
Objectives
The theory of ecological unequal exchange explains how trade and various forms of economic activity create the problem of environmental degradation, and lead to the deterioration of population health. Based on this theory, our study examined the inter-relationship among economic characteristics, ecological footprints, CO2 emissions, infant mortality rates and under-5 mortality rates in low-income countries.
Design
A longitudinal ecological study design.
Setting
Sixty-six low-income countries from 1980 to 2010 were included in the analyses. Data for each country represented an average of 23 years (N=1497).
Data sources
Data were from the World Development Indicators, UN Commodity Trade Statistics Database, Global Footprint Network and Polity IV Project.
Analyses
Linear mixed models with a spatial power covariance structure and a correlation that decreased over time were constructed to accommodate the repeated measures. Statistical analyses were conducted separately by sub-Saharan Africa, Latin America and other regions.
Results
After controlling for country-level sociodemographic characteristics, debt and manufacturing, economic activities were positively associated with infant mortality rates and under-5 mortality rates in sub-Saharan Africa. By contrast, export intensity and foreign investment were beneficial for reducing infant and under-5 mortality rates in Latin America and other regions. Although the ecological footprints and CO2 emissions did not mediate the relationship between economic characteristics and health outcomes, export intensity increased CO2 emissions, but reduced the ecological footprints in sub-Saharan Africa. By contrast, in Asia, the Middle East and North Africa, although export intensity was positively associated with the ecological footprints and also CO2 emissions, the percentage of exports to high-income countries was negatively associated with the ecological footprints.
Conclusions
This study suggested that environmental protection and economic development are important for reducing infant and under-5 mortality rates in low-income countries.
doi:10.1136/bmjopen-2014-006183
PMCID: PMC4513441  PMID: 26179643
SOCIAL MEDICINE
22.  The importance of a medical chaperone: a quality improvement study exploring the use of a note stamp in a tertiary breast surgery unit 
BMJ Open  2015;5(7):e007319.
Objectives
The project aim was to determine current use and documentation of medical chaperones within a major breast service unit. It explored ways of improving adherence to professional guidelines concerning chaperones.
Setting
The single centre quality improvement project was completed in a tertiary breast service unit in North West London. It was a three-stage project with initial audit in October 2013, 1st postintervention cycle in November 2013 and 2nd postintervention cycle in October 2014.
Participants
In each study cycle, data were collected from entries in clinic notes until at least 155 encounters with documented clinical examination were analysed. All notes were of female patients.
Interventions
(1) Intervention 1st cycle: presentation and discussion of chaperone guidelines alongside reminder posters and introduction of note stamp. (2) Intervention 2nd cycle: note stamp alone.
Primary and secondary outcome measures
Documentation of chaperone offer, documentation of patient preference regarding chaperone, identifier (name or signature) of chaperone present and gender of examining clinician.
Results
In the 1st postintervention cycle, 69.95% documentation of chaperone offer was recorded, p<0.001, CI (59.04% to 80.76%). This result was replicated in the 2nd postintervention cycle a year later with 74.86% documentation of chaperone offer recorded, p<0.001, CI (66.41% to 83.31%). The 4.91% difference was insignificant; p=0.294, CI (14.03% to 4.21%).
Conclusions
The authors suggest that a proforma approach to medical chaperones is an effective means of ensuring adherence to best practice guidelines. A stamp, or similar, that can be embedded into documentation structure is an effective example of such an approach. Improved documentation allows any problems with adherence to guidelines to be more easily identified, helping to ensure the safeguarding of patients and staff involved in intimate examinations.
doi:10.1136/bmjopen-2014-007319
PMCID: PMC4513443  PMID: 26179645
Chaperone; Intimate examination; Breast Examination; Quality Improvement
23.  Adherence to guidelines on antibiotic treatment for respiratory tract infections in various categories of physicians: a retrospective cross-sectional study of data from electronic patient records 
BMJ Open  2015;5(7):e008096.
Objective
To study how prescription patterns concerning respiratory tract infections differ between interns, residents, younger general practitioners (GPs), older GPs and locums.
Design
Retrospective study of structured data from electronic patient records.
Setting
Data were obtained from 53 health centres and 3 out-of-hours units in Jönköping County, Sweden, through their common electronic medical record database.
Participants
All physicians working in primary care during the 2-year study period (1 November 2010 to 31 October 2012).
Outcome measures
Physicians’ adherence to current guidelines for respiratory tract infections regarding the use of antibiotics.
Results
We found considerable differences in prescribing patterns between physician categories. The recommended antibiotic, phenoxymethylpenicillin, was more often prescribed by interns, residents and younger GPs, while older GPs and locums to a higher degree prescribed broad-spectrum antibiotics. The greatest differences were seen when the recommendation in guidelines was to refrain from antibiotics, as for acute bronchitis. Interns and residents most often followed guidelines, while compliance in descending order was: young GPs, older GPs and locums. We also noticed that male doctors were somewhat overall more restrictive with antibiotics than female doctors.
Conclusions
In general, primary care doctors followed national guidelines on choice of antibiotics when treating respiratory tract infections in children but to a lesser degree when treating adults. Refraining from antibiotics seems harder. Adherence to national guidelines could be improved, especially for acute bronchitis and pneumonia. This was especially true for older GPs and locums whose prescription patterns were distant from the prevailing guidelines.
doi:10.1136/bmjopen-2015-008096
PMCID: PMC4513445  PMID: 26179648
PUBLIC HEALTH
24.  Clinical practice guidelines for hypertension in China: a systematic review of the methodological quality 
BMJ Open  2015;5(7):e008099.
Objective
Clinical practice guidelines (CPGs) provide clinicians with specific recommendations for practice, but due to the increasing number of CPGs developed by diverse organisations over the past few years, there are concerns about the quality of some CPGs. This paper proposes a systematic review of the methodological quality of the CPGs for hypertension that were developed in China.
Design
A systematic review of CPGs for the management of hypertension in adult patients in China.
Data resources
Chinese electronic databases, Chinese guideline websites and Google Scholar were searched, and the reference lists of relevant publications were also screened for additional information. CPGs for the management of hypertension in adult patients were identified. The main characteristics of the CPGs were extracted, and the scaled Appraisal of Guidelines, REsearch and Evaluation II (AGREE II) domain percentages were independently evaluated by two reviewers.
Results
A total of 17 CPGs, with publication dates ranging from 2001 to 2011, were identified. There was considerable variation in the quality of the CPGs across the AGREE II domains. Overall, the domains of ‘rigor of development’ and ‘editorial independence’ were poorly addressed, with an average score of 18% and 16%, respectively. Also less well addressed were the ‘stakeholder involvement’ and ‘applicability’ domains, for which the average domain scores were 28% and 20%, respectively. The CPGs performance was less problematic in the domains of ‘scope and purpose’ and ‘clarity and presentation’, with a median of 41% for both. After considering the domain scores, 8 CPGs could be recommended with modification for use.
Conclusions
There is considerable room for improvement of the methodological quality of CPGs for hypertension in China. Greater efforts should to be devoted to ensure the explicit and transparent reporting of potential conflicts of interest of stakeholders, and to consider the quality of the evidence and grade recommendations in the CPG development process.
doi:10.1136/bmjopen-2015-008099
PMCID: PMC4513449  PMID: 26179649
25.  A comparison study on the prevalence of obesity and its associated factors among city, township and rural area adults in China 
BMJ Open  2015;5(7):e008417.
Objectives
To explore the association of dietary behaviour factors on obesity among city, township and rural area adults.
Setting
A stratified cluster sampling technique was employed in the present cross-sectional study. On the basis of socioeconomic characteristics, two cities, two townships and two residential villages were randomly selected where the investigation was conducted.
Participants
A total of 1770 city residents, 2071 town residents and 1736 rural area residents participated in this survey.
Primary and secondary outcome measures
Dietary data were collected through interviews with each household member. Anthropometric values were measured. Participants with a body mass index (BMI) of ≥28.0 kg/m2 were defined as obesity.
Results
The prevalence of obesity was 10.1%, 7.3% and 6.5% among city, township and rural area adults, respectively. Correlation analysis showed that for adults living in cities, the daily intake of rice and its products, wheat flour and its products, light coloured vegetables, pickled vegetables, nut, pork and sauce was positively correlated with BMI (r=0.112, 0.084, 0.109, 0.129, 0.077, 0.078, 0.125, p<0.05), while the daily intake of tubers, dried beans, milk and dairy products was negatively correlated with BMI (r=−0.086, −0.078, −0.116, p<0.05). For township residents, the daily intake of vegetable oil, salt, chicken essence, monosodium glutamate and sauce was positively correlated with BMI (r=0.088, 0.091, 0.078, 0.087, 0.189, p<0.05). For rural area residents, the daily intake of pork, fish and shrimp, vegetable oil and salt was positively correlated with BMI (r=0.087, 0.122, 0.093, 0.112, p<0.05), while the daily intake of dark coloured vegetables was negatively correlated with BMI (r=−0.105, p<0.05).
Conclusions
The prevalence of obesity was higher among city residents than among township and rural area residents. The findings of this study indicate that demographic and dietary factors could be associated with obesity among adults. Healthy dietary behaviour should be promoted and the ongoing monitoring of population nutrition and health status remains crucially important.
doi:10.1136/bmjopen-2015-008417
PMCID: PMC4513451  PMID: 26179650
NUTRITION & DIETETICS; PREVENTIVE MEDICINE; PUBLIC HEALTH

Results 1-25 (3733)