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26.  Effects of drug price reduction and prescribing restrictions on expenditures and utilisation of antihypertensive drugs in Korea 
BMJ Open  2015;5(7):e006940.
To evaluate the quantitative effects of the drug price reduction on pharmaceutical expenditures and the new guidelines to restrict prescribing on drug utilisation for antihypertensive drugs.
We used an interrupted time series design with the National patient sample data of Health Insurance Review and Assessment Service in South Korea.
54 295 participants who were with primary hypertension from the National patient sample data of Health Insurance Review and Assessment Service were included. The study period was from March 2011 to December 2013. The dependent variables were antihypertensive drug costs, antihypertensive drug cost per prescribing day, daily drug utilisation, average number of drugs per month, percentage of original drugs per prescription, drug overutilisation and prohibited combinations. Segmented regression analysis was used.
The drug price reduction reduced expenditure (US$−1.51, −10.2%), and the new guidelines reduced expenditures even more (US$−2.13; −16.2%). These policies saved US$4.22 (28%) of antihypertensive drug costs per patient in December 2013 compared to March 2012. Drug price reduction policy was introduced in April 2012. We established the policy effect by comparing it before (March 2012) with after(21 months later-December 2012). The effects of the guidelines decreased expenditures, daily drug utilisation and the average number of drugs per month more than did the drug price reduction.
Both policies saved money. The guidelines were more effective over time and had fewer side effects such as increasing daily drug utilisation and number of drugs than the effects of drug price reduction.
PMCID: PMC4513484  PMID: 26179644
antihypertensive drug; direct price control; reimbursement restriction; pharmaceutical expenditures; drug utilization
27.  Development and validation of a screening tool to predict the risk of chronic low back pain in patients presenting with acute low back pain: a study protocol 
BMJ Open  2015;5(7):e007916.
Around 40% of people presenting to primary care with an episode of acute low back pain develop chronic low back pain. In order to reduce the risk of developing chronic low back pain, effective secondary prevention strategies are needed. Early identification of at-risk patients allows clinicians to make informed decisions based on prognostic profile, and researchers to select appropriate participants for secondary prevention trials. The aim of this study is to develop and validate a prognostic screening tool that identifies patients with acute low back pain in primary care who are at risk of developing chronic low back pain. This paper describes the methods and analysis plan for the development and validation of the tool.
The prognostic screening tool will be developed using methods recommended by the Prognosis Research Strategy (PROGRESS) Group and reported using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement. In the development stage, we will use data from 1248 patients recruited for a prospective cohort study of acute low back pain in primary care. We will construct 3 logistic regression models to predict chronic low back pain according to 3 definitions: any pain, high pain and disability at 3 months. In the validation stage, we will use data from a separate sample of 1643 patients with acute low back pain to assess the performance of each prognostic model. We will produce validation plots showing Nagelkerke R2 and Brier score (overall performance), area under the curve statistic (discrimination) and the calibration slope and intercept (calibration).
Ethics and dissemination
Ethical approval from the University of Sydney Ethics Committee was obtained for both of the original studies that we plan to analyse using the methods outlined in this protocol (Henschke et al, ref 11-2002/3/3144; Williams et al, ref 11638).
PMCID: PMC4513486  PMID: 26179647
28.  Effectiveness of community-based peer-led diabetes self-management programmes (COMP-DSMP) for improving clinical outcomes and quality of life of adults with diabetes in primary care settings in low and middle-income countries (LMIC): a systematic review and meta-analysis 
BMJ Open  2015;5(7):e007635.
Globally, an estimated 380 million people live with diabetes today—80% in low-income and middle-income countries. The Middle East, Western Pacific, Sub-Saharan Africa and South-East Asia remain the most affected regions where economic development has transformed lifestyles, people live longer and there is an increase in the adult population. Although peer support has been used in different conditions with varied results, yet there is limited evidence to date supporting its effectiveness, particularly for individuals with diabetes. In this review, we will focus on community-based peer-led diabetes self-management programmes (COMP-DSMP) and examine the implementation strategies and diabetes-related health outcomes associated with them in LMIC primary healthcare settings.
Methods and analysis
In accordance with reporting equity-focused systematic reviews PRISMA-P (preferred reporting items for systematic review and meta-analysis protocols 2015 checklist) guidelines, a systematic review with meta-analysis of randomised controlled trials (RCTs), non-randomised controlled trials, quasi-randomised controlled trials (CCTs) that involve contact with an individual or group of peers (paid or voluntary). Electronic searches will be performed in The Cochrane Library, MEDLINE, PubMed, SCOUPS, CINAHL and PsycINFO Database for the period January up to July 2000 along with manual searches in the reference lists of relevant papers. The analyses will be performed based on baseline data from RCTs, CCTs and preintervention and postintervention means or proportions will be reported for both intervention and control groups, and the absolute change from baseline will be calculated, together with 95% CIs. For dichotomous outcomes, the relative risk of the outcome will be presented compared to the control group. The risk difference will be calculated, which is the absolute difference in the proportions in each treatment group.
Ethics and dissemination
Ethics is not required for this study, given that this is a protocol for a systematic review, which utilises published data. The findings of this study will be widely disseminated through peer-reviewed publications and conference presentations.
Trial registration number
PROSPERO (2014:CRD42014007531).
PMCID: PMC4513536  PMID: 26179646
29.  Assessing Cognitive behavioural Therapy in Irritable Bowel (ACTIB): protocol for a randomised controlled trial of clinical-effectiveness and cost-effectiveness of therapist delivered cognitive behavioural therapy and web-based self-management in irritable bowel syndrome in adults 
BMJ Open  2015;5(7):e008622.
Irritable bowel syndrome (IBS) affects 10–22% of the UK population, with England's annual National Health Service (NHS) costs amounting to more than £200 million. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive behaviour therapy (CBT) and self-management can be helpful, but availability is limited.
Methods and analysis
To determine the clinical- and cost-effectiveness of therapist delivered cognitive behavioural therapy (TCBT) and web-based CBT self-management (WBCBT) in IBS, 495 participants with refractory IBS will be randomised to TCBT plus treatment as usual (TAU); WBCBT plus TAU; or TAU alone. The two CBT programmes have similar content. However, TCBT consists of six, 60 min telephone CBT sessions with a therapist over 9 weeks, at home, and two ‘booster’ 1 hour follow-up phone calls at 4 and 8 months (8 h therapist contact time). WBCBT consists of access to a previously developed and piloted WBCBT management programme (Regul8) and three 30 min therapist telephone sessions over 9 weeks, at home, and two ‘booster’ 30 min follow-up phone calls at 4 and 8 months (2½ h therapist contact time). Clinical effectiveness will be assessed by examining the difference between arms in the IBS Symptom Severity Score (IBS SSS) and Work and Social Adjustment Scale (WASAS) at 12 months from randomisation. Cost-effectiveness will combine measures of resource use with the IBS SSS at 12 months and quality-adjusted life years.
Ethics and dissemination
This trial has full ethical approval. It will be disseminated via peer reviewed publications and conference presentations. The results will enable clinicians, patients and health service planners to make informed decisions regarding the management of IBS with CBT.
Trial registration number
PMCID: PMC4513538  PMID: 26179651
30.  Correction 
BMJ Open  2015;5(7):e006946corr1.
PMCID: PMC4513444  PMID: 26173714
31.  Correction 
BMJ Open  2015;5(7):e006688corr1.
PMCID: PMC4513448  PMID: 26173713
32.  “Test me and treat me”—attitudes to vitamin D deficiency and supplementation: a qualitative study 
BMJ Open  2015;5(7):e007401.
Lay interest in vitamin D and the potential benefits of supplementation is considerable, but little information exists concerning lay knowledge, beliefs and attitudes towards vitamin D to inform public health initiatives and professional guidance.
Qualitative focus group study.
58 adults capturing diversity in disease status, gender, age and ethnicity.
A large general practice in east London.
Many respondents lacked knowledge about vitamin D, including dietary sources and government recommendations. Most were positive about sun exposure, but confused by ambiguous health messages about risks and benefits of sunshine. Medicalised views of vitamin D were prominent, notably from those in favour of supplementation, who talked of “doses”, “side effects” and “regular testing.” Fortification of food with vitamin D was controversial, with opposing utilitarian (better overall for the majority) and libertarian (freedom to choose) views.
Knowledge about vitamin D was limited. Clearer messages are needed about risks and benefits of sun exposure. Testing and supplementation by health professionals, while potentially useful in some high-risk groups, have contributed to a medicalised view of vitamin D. Health policy should address the public's need for clear information on sources and effects of vitamin D, including risks and benefits of sun exposure, and take account of divergent views on fortification. Professional guidance is needed on testing and supplementation to counter inappropriate medicalisation.
PMCID: PMC4513450  PMID: 26173717
33.  Impact of alprazolam in allostatic load and neurocognition of patients with anxiety disorders and chronic stress (GEMA): observational study protocol 
BMJ Open  2015;5(7):e007231.
The allostatic load model explains the additive effects of multiple biological processes that accelerate pathophysiology related to stress, particularly in the central nervous system. Stress-related mental conditions such as anxiety disorders and neuroticism (a well-known stress vulnerability factor), have been linked to disturbances of hypothalamo–pituitary–adrenal with cognitive implications. Nevertheless, there are controversial results in the literature and there is a need to determine the impact of the psychopharmacological treatment on allostatic load parameters and in cognitive functions. Gador study of Estres Modulation by Alprazolam, aims to determine the impact of medication on neurobiochemical variables related to chronic stress, metabolic syndrome, neurocognition and quality of life in patients with anxiety, allostatic load and neuroticism.
In this observational prospective phase IV study, highly sympthomatic patients with anxiety disorders (six or more points in the Hamilton-A scale), neuroticism (more than 18 points in the Neo five personality factor inventory (NEO-FFI) scale), an allostatic load (three positive clinical or biochemical items at Crimmins and Seeman criteria) will be included. Clinical variables of anxiety, neuroticism, allostatic load, neurobiochemical studies, neurocognition and quality of life will be determined prior and periodically (1, 2, 4, 8, and 12 weeks) after treatment (on demand of alprazolam from 0.75 mg/day to 3.0 mg/day). A sample of n=55/182 patients will be considered enough to detect variables higher than 25% (pretreatment vs post-treatment or significant correlations) with a 1-ß power of 0–80. t Test and/or non-parametric test, and Pearson's test for correlation analysis will be determined.
Ethics and dissemination
This study protocol was approved by an Independent Ethics Committee of FEFyM (Foundation for Pharmacological Studies and Drugs, Buenos Aires) and by regulatory authorities of Argentina (ANMAT, Dossier # 61 409–8 of 20 April 2009), following the law of Habeas Data and psychotherapeutic drug control.
Trial registration number
GEMA 20811.
PMCID: PMC4513478  PMID: 26173716
34.  Barriers to uptake among high-risk individuals declining participation in lung cancer screening: a mixed methods analysis of the UK Lung Cancer Screening (UKLS) trial 
BMJ Open  2015;5(7):e008254.
The current study aimed to identify the barriers to participation among high-risk individuals in the UK Lung Cancer Screening (UKLS) pilot trial.
The UKLS pilot trial is a randomised controlled trial of low-dose CT (LDCT) screening that has recruited high-risk people using a population approach in the Cambridge and Liverpool areas.
High-risk individuals aged 50–75 years were invited to participate in UKLS. Individuals were excluded if a LDCT scan was performed within the last year, if they were unable to provide consent, or if LDCT screening was unable to be carried out due to coexisting comorbidities.
Outcome measures
Statistical associations between individual characteristics and UKLS uptake were examined using multivariable regression modelling. In those who completed a non-participation questionnaire (NPQ), thematic analysis of free-text data was undertaken to identify reasons for not taking part, with subsequent exploratory linkage of key themes to risk factors for non-uptake.
Comparative data were available from 4061 high-risk individuals who consented to participate in the trial and 2756 who declined participation. Of those declining participation, 748 (27.1%) completed a NPQ. Factors associated with non-uptake included: female gender (OR=0.64, p<0.001), older age (OR=0.73, p<0.001), current smoking (OR=0.70, p<0.001), lower socioeconomic group (OR=0.56, p<0.001) and higher affective risk perception (OR=0.52, p<0.001). Among non-participants who provided a reason, two main themes emerged reflecting practical and emotional barriers. Smokers were more likely to report emotional barriers to participation.
A profile of risk factors for non-participation in lung screening has emerged, with underlying reasons largely relating to practical and emotional barriers. Strategies for engaging high-risk, hard-to-reach groups are critical for the equitable uptake of a potential future lung cancer screening programme.
Trial registration number
The UKLS trial was registered with the International Standard Randomised Controlled Trial Register under the reference 78513845.
PMCID: PMC4513485  PMID: 26173719
Lung cancer; Screening; Barriers; High-risk; UKLS
35.  Epidemiology of HEV in the Mediterranean basin: 10-year prevalence in Italy 
BMJ Open  2015;5(7):e007110.
The present study is aimed at describing the seroprevalence and exploring potential risk factor(s) for hepatitis E virus (HEV) in participants who voluntarily underwent anti-HIV antibody testing.
Study design
Seroprevalence study.
The HIV prevention unit at the National Institute for Infectious Diseases Lazzaro Spallanzani, serving as a referral centre for HIV infection in Lazio, an Italian Region with about 5.6 million inhabitants.
Participants are a random sample of all subjects who receive counselling and undergo serological tests for anti-HIV antibody (Ab) between 2002 and 2011.
Risk factors and outcome
A set of 16 epidemiological variables (risk factors) were assessed for association with positivity to anti-HEV IgG (outcome).
Between 2002 and 2011, 27 351 serum specimens and related epidemiological information were collected; of these 1116 were randomly selected and analysed. The overall anti-HEV IgG prevalence was 5.38% (60 out of 1116) with evidence of potential heterogeneity between years of sampling (p=0.055). Multivariate analysis provided evidence that anti-HEV IgG prevalence increases by 4% per year of participants’ age (95% CI 1% to 7%, p=0.002). In addition, men who have sex with men and participants who were born outside Italy have an OR for past HEV infection that is about two times higher than in those who were not (p=0.040 and p=0.027, respectively). Analysis of temporal trend showed that variation of anti-HEV IgG can be well explained by a cubic logistic regression model, which describes the variation of prevalence over time as a fluctuation within a 3-year period (p=0.032).
This study provides new evidence that besides the orofecal and zoonotic routes, intimate contacts between males may be a significant mode of HEV transmission.
PMCID: PMC4513512  PMID: 26173715
36.  Medical versus surgical methods of early abortion: protocol for a systematic review and environmental scan of patient decision aids 
BMJ Open  2015;5(7):e007966.
Currently, we lack understanding of the content, quality and impact of patient decision aids to support decision-making between medical and surgical methods of early abortion. We plan to undertake a systematic review of peer-reviewed literature to identify, appraise and describe the impact of early abortion method decision aids evaluated quantitatively (Part I), and an environmental scan to identify and appraise other early abortion method decision aids developed in the US (Part II).
Methods and analysis
For the systematic review, we will search PubMed, Cochrane Library, CINAHL, EMBASE and PsycINFO databases for articles describing experimental and observational studies evaluating the impact of an early abortion method decision aid on women's decision-making processes and outcomes. For the environmental scan, we will identify decision aids by supplementing the systematic review search with Internet-based searches and key informant consultation. The primary reviewer will assess all studies and decision aids for eligibility, and a second reviewer will also assess a subset of these. Both reviewers will independently assess risk of bias in the studies and abstract data using a piloted form. Finally, both reviewers will assess decision aid quality using the International Patient Decision Aid Standards criteria, ease of readability using Flesch/Flesch-Kincaid tests, and informational content using directed content analysis.
Ethics and dissemination
As this study does not involve human subjects, ethical approval will not be sought. We aim to disseminate the findings in a scientific journal, via academic and/or professional conferences and among the broader community to contribute knowledge about current early abortion method decision-making support.
Trial registration number
This protocol is registered in the International Prospective Register of Systematic Reviews (CRD42015016717).
PMCID: PMC4513513  PMID: 26173718
37.  Age correction in monitoring audiometry: method to update OSHA age-correction tables to include older workers 
BMJ Open  2015;5(7):e007561.
The US Occupational Safety and Health Administration (OSHA) Noise Standard provides the option for employers to apply age corrections to employee audiograms to consider the contribution of ageing when determining whether a standard threshold shift has occurred. Current OSHA age-correction tables are based on 40-year-old data, with small samples and an upper age limit of 60 years. By comparison, recent data (1999–2006) show that hearing thresholds in the US population have improved. Because hearing thresholds have improved, and because older people are increasingly represented in noisy occupations, the OSHA tables no longer represent the current US workforce. This paper presents 2 options for updating the age-correction tables and extending values to age 75 years using recent population-based hearing survey data from the US National Health and Nutrition Examination Survey (NHANES). Both options provide scientifically derived age-correction values that can be easily adopted by OSHA to expand their regulatory guidance to include older workers.
Regression analysis was used to derive new age-correction values using audiometric data from the 1999–2006 US NHANES. Using the NHANES median, better-ear thresholds fit to simple polynomial equations, new age-correction values were generated for both men and women for ages 20–75 years.
The new age-correction values are presented as 2 options. The preferred option is to replace the current OSHA tables with the values derived from the NHANES median better-ear thresholds for ages 20–75 years. The alternative option is to retain the current OSHA age-correction values up to age 60 years and use the NHANES-based values for ages 61–75 years.
Recent NHANES data offer a simple solution to the need for updated, population-based, age-correction tables for OSHA. The options presented here provide scientifically valid and relevant age-correction values which can be easily adopted by OSHA to expand their regulatory guidance to include older workers.
PMCID: PMC4513440  PMID: 26169804
38.  Group Medical Visits (GMVs) in primary care: an RCT of group-based versus individual appointments to reduce HbA1c in older people 
BMJ Open  2015;5(7):e007441.
Type 2 diabetes mellitus (T2DM) affects more than 1.1 million Canadians aged ≥65 years. Group Medical Visits are an emerging health service delivery method. Recent systematic reviews show that they can significantly reduce glycated haemoglobin (HbA1c) levels, but Group Visits have not been evaluated within primary care. We intend to determine the clinical effectiveness, quality of life and economic implications of Group Medical Visits within a primary care setting for older people with T2DM.
Methods and analysis
A 2-year proof-of-concept, single-blinded (measurement team) randomised control trial to test the efficacy of Group Medical Visits in an urban Canadian primary care setting. Participants ≥65 years old with T2DM (N=128) will be equally randomised to either eight groups of eight patients each (Group Medical Visits; Intervention) or to Individual visits (Standard Care; Controls). Those administering cointerventions are not blinded to group assignment. Our sample size is based on estimates of variance (±1.4% for HbA1c) and effect size (0.9/1.4=0.6) from the literature and from our own preliminary data. Forty participants per group will provide a β likelihood of 0.80, assuming an α of 0.05. A conservative estimation of an effect size of 0.7/1.4 changes the N in the power calculation to 59 per group. Hence, we aim to enrol 64 participants in each study arm. We will use intention-to-treat analysis and compare mean HbA1c (% glycosylated HbA1c) (primary outcome) of Intervention/Control participants at 12 months, 24 months and 1 year postintervention on selected clinical, patient-rated and economic measures.
Trial registration number
PMCID: PMC4513482  PMID: 26169803
39.  Observational study of sleep, respiratory mechanics and quality of life in patients with non-cystic fibrosis bronchiectasis: a protocol study 
BMJ Open  2015;5(7):e008183.
Bronchiectasis is a chronic disorder characterised by permanent and irreversible abnormal dilation of the bronchi and bronchioles, primarily caused by repeated cycles of pulmonary infections and inflammation, which lead to reduced mucociliary clearance and to the excessive production of sputum. Patients with non-cystic fibrosis bronchiectasis may be predisposed to hypoxemia during sleep, or to symptoms that may lead to arousals and thereby reduce the quality of life, because of the irreversible dilation of the bronchi and the presence of secretions and airflow obstruction.
Methods and analysis
For this cross-sectional observational study, patients with a clinical diagnosis of non-cystic fibrosis bronchiectasis will be recruited from the Bronchiectasis Clinic of the Pneumology Department of the Santa Casa de Misericordia Hospital and the Federal University of São Paulo (São Paulo, Brazil). Patients of either sex will be included if high-resolution CT of the thorax and classic sweat test confirms they have non-cystic fibrosis bronchiectasis, are between 18 and 80 years old, use long-acting bronchodilators, are clinically stable for a least 1 month, agree to participate in the study and they sign a statement of informed consent. The first part of the study will involve a clinical evaluation, maximal respiratory pressures, spirometry and the Saint George's Respiratory Questionnaire. The Sleep Laboratory of the Master's and Doctoral Postgraduate Program in Rehabilitation Sciences of the Nove de Julho University (São Paulo, Brazil) will perform the polysomnographic studies, Berlin Questionnaire, Epworth Sleepiness Scale, waist and neck circumferences, modified Mallampati classification and tonsil index.
Ethics and dissemination
This protocol has been approved by the Human Research Ethics Committees of Santa Casa de Misericordia Hospital (process number 178/2012) and Human Research Ethics Committee of Nove de Julho University (process number 370474/2010). All participants will sign a statement of informed consent. The study findings will be published in peer-reviewed journals and presented at conferences.
PMCID: PMC4513483  PMID: 26169808
40.  Protocol for a systematic review of the effects of interventions to inform or educate caregivers about childhood vaccination in low and middle-income countries 
BMJ Open  2015;5(7):e008113.
Despite their proven effectiveness in reducing childhood infectious diseases, the uptake of vaccines remains suboptimal in low and middle-income countries. Identifying strategies for transmitting accurate vaccine information to caregivers would boost childhood vaccination coverage in these countries. The purpose of this review is to assess the effects on childhood vaccination coverage of interventions for informing or educating caregivers about the importance of vaccines in low and middle-income countries, as defined by the World Bank.
Methods and analysis
Eligible study designs include randomised controlled trials (RCTs) as well as non-randomised controlled trials (non-RCTs). We will conduct a comprehensive search of both peer-reviewed and grey literature available up to 31 May 2015. We will search PubMed, Scopus, Cochrane Central Register of Controlled Trials, Web of Science, Cumulative Index of Nursing and Allied Health, prospective trial registries and reference lists of relevant publications. Two authors will independently screen the search output, retrieve full texts of potentially eligible studies and assess the latter against predefined inclusion criteria. Disagreements between the two authors will be resolved through consensus and arbitration by a third author. We will pool data from studies with homogenous interventions and outcomes, using random-effects meta-analysis. We will assess statistical heterogeneity using the χ2 test of homogeneity (with significance defined at the 10% α-level) and quantify it using Higgins’ inconsistency index. We will explore the cause of any observed statistical heterogeneity using subgroup analysis, with subgroups defined by study design (RCTs vs non-RCTs) and type of intervention (information vs educational interventions).
Ethics and dissemination
The proposed systematic review will collect and analyse secondary data that are not associated with individuals. The review will make a significant contribution to the knowledge base of interventions for improving childhood vaccination coverage in low and middle-income countries.
Protocol registration number
PROSPERO, CRD42014010141.
PMCID: PMC4513514  PMID: 26169807
Community child health; Public health
41.  Statin use in adults at high risk of cardiovascular disease mortality: cross-sectional analysis of baseline data from The Irish Longitudinal Study on Ageing (TILDA) 
BMJ Open  2015;5(7):e008017.
This study aims to examine the extent to which statins are used by adults at high risk of cardiovascular disease (CVD) compared to European clinical guidelines. The high-risk groups examined are those with (1) known CVD, (2) known diabetes and (3) a high or very high risk (≥5%) of CVD mortality based on Systematic COronary Risk Evaluation (SCORE).
This study is cross-sectional in design using data from the first wave (2009–2011) of The Irish Longitudinal Study on Ageing (TILDA).
Setting and participants
The sample (n=3372) is representative of community living adults aged 50–64 years in Ireland.
Statins were used by 68.6% (95% CI 61.5% to 75.8%) of those with known CVD, 57.4% (95% CI 49.1% to 65.7%) of those with known diabetes and by 19.7% (95% CI 13.0% to 26.3%) of adults with a SCORE risk ≥5%. Over a third (38.5%, 95% CI 31.0% to 46.0%) of those with known CVD, 46.8% (95% CI 38.4% to 55.1%) of those with known diabetes and 85.2% (95% CI 79.3% to 91.1%) of those with a SCORE risk ≥5% were at or above the low-density lipoprotein cholesterol (LDL-C) target of 2.5 mmol/L specified in the 2007 European guidelines.
Despite strong evidence and clinical guidelines recommending the use of statins for secondary prevention, a gap exists between guidelines and practice in this cohort. It is also of concern that a low proportion of adults with a SCORE risk ≥5% were taking statins. A policy response that strengthens secondary prevention, and improves risk assessment and shared decision-making in the primary prevention of CVD is required.
PMCID: PMC4513517  PMID: 26169806
42.  Non-medical use of prescription pain relievers among high school students in China: a multilevel analysis 
BMJ Open  2015;5(7):e007569.
Given the differences between general high school (GHS) and vocational high school (VHS) students, this study aimed to investigate the lifetime prevalence of non-medical use of prescription pain relievers (NMUPPR) among high school students as well as the associations between NMUPPR and individual-level factors and school category.
A cross-sectional study was conducted in GHS and VHS students in 2012 in Chongqing, and 11 906 students’ questionnaires were completed and qualified for the survey. Self-reported NMUPPR and information regarding individual-level determinants and school category were collected. A multilevel multivariate logistic regression model was fitted to explore independent predictors of NMUPPR.
The total lifetime prevalence of NMUPPR was 11.3%, and NMUPPR was more prevalent among VHS students (15.8%) compared with GHS students (9.8%). Overall, the results indicated that VHS students were more likely to be involved in NMUPPR (adjusted OR (AOR)=1.64, 95% CI 1.42 to 1.89). Regarding the individual-level predictors of NMUPPR, below-average family economic status was negatively correlated with NMUPPR (AOR=0.77, 95% CI 0.60 to 0.98), and students with more pocket money were more likely to be engaged in NMUPPR. Students who had difficult family relationships, had poor relationships with teachers, had parents or friends who engaged in non-medical prescription drug use, and considered or attempted suicide were more likely to be engaged in NMUPPR.
NMUPPR among high school students is a multidetermined phenomenon. The current findings indicate that VHS students are an important subgroup of adolescents and highlight the need for additional research as well as targeted prevention and intervention programmes for NMUPPR.
PMCID: PMC4513537  PMID: 26169805
EPIDEMIOLOGY; EDUCATION & TRAINING (see Medical Education & Training)
43.  Effectiveness of a low-intensity telephone counselling intervention on an untreated metabolic syndrome detected by national population screening in Korea: a non-randomised study using regression discontinuity design 
BMJ Open  2015;5(7):e007603.
Whether low-intensity telephone-counselling interventions can improve cardiometabolic risk factors in screen-detected people with metabolic syndrome (MetS) is unclear. The aim of this study was to evaluate the effectiveness of a low-intensity, telephone-counselling programme on MetS implemented by the National Health Insurance Service (NHIS) of Korea using regression discontinuity design.
A nationwide non-randomised intervention study with a regression discontinuity design. A retrospective analysis using data from NHIS.
NHIS, Korea from January 2011 to June 2013.
5 378 558 beneficiaries with one or more MetS components by NHIS criteria detected by population screening were enrolled in the NHIS MetS Management Programme in 2012. Of these, 1 147 695 underwent annual follow-up examinations until June 2013 (‘control group’ which received control intervention, n=855 870; ‘eligible group’ which was eligible for counselling, n=291 825; ‘intervention group’ which participated in telephone counselling among eligible groups, n=23 968).
Main outcome measures
Absolute changes in MetS components, weight and body mass index (BMI) were analysed. Multiple regression analyses were applied using the analysis of covariance model (baseline measurements as covariates).
Low-intensity telephone counselling was associated with decreased systolic BP (−0.85 mm Hg, 95% CI −1.02 to −0.68), decreased diastolic BP (−0.63 mm Hg, −95% CI −0.75 to −0.50), decreased triglyceride (−1.57 mg/dL, 95% CI −2.89 to −0.25), reduced waist circumference (−0.09 cm, 95% CI −0.16 to −0.02), reduced weight (−0.19 kg, 95% CI −0.24 to −0.15) and reduced BMI (−0.07 kg/m2, 95% CI −0.09 to −0.05), when comparing the intervention and control groups. When individuals with low high-density lipoprotein cholesterol were analysed, the intervention was also associated with increased HDL cholesterol (0.90 mg/dL, 95% CI 0.51 to 1.29).
Low-intensity telephone counselling programmes could yield improvements in the following year on blood pressure, lipid profiles, weight and body mass index in untreated patients detected at the population screening. However, the improvements may be very modest and the clinical relevance of these small improvements may be limited.
PMCID: PMC4499681  PMID: 26163030
44.  Qualitative approach to patient-reported outcomes in oncology: protocol of a French study 
BMJ Open  2015;5(7):e008042.
The past decade has been characterised by movement from a doctor-centred to a patient-centred approach to treatment outcomes, in which doctors try to see the illness through their patients’ eyes. Patients, family members and doctors are the three participants in cancer care, but their perspectives about what have been helpful during cancer treatment have never simultaneously and explicitly compared in the same qualitative study. The aim of this study project is to explore patients’ perspectives about the care they receive, as well as families’ and doctors’ perspectives about what have been helpful for the patient. These three points of view will be compared and contrasted in order to analyse the convergences and divergences in these perspectives.
Methods and analysis
This is a national multicentre qualitative study. Participants will be constituted by three different subsamples: (1) patients with cancer (skin, breast, urological and lung cancers), (2) their relatives, and (3) their referring physicians. Recruitment will follow the purposive sample technique, and the final sample size will be determined by data saturation. Data will be collected through open-ended semistructured interviews and independently analysed with NVivo V.10 software by three researchers according to the principles of Interpretative Phenomenological Analysis.
Ethics and dissemination
The research protocol received approval from the University Paris Descartes review board (IRB number: 20140600001072), and participants will provide written consent. To the best of our knowledge, this is the first study to focus on the simultaneous exploration of the separate points of view of patients, families and doctors about the care received during the cancer care journey. We expect that our findings will help to improve communication and relationships between doctors, patients and families. Comparison of these three points of view will provide information about the convergences and divergences of these perspectives and how to address the needs of all three groups.
PMCID: PMC4499697  PMID: 26163035
45.  Diet quality and adherence to a healthy diet in Japanese male workers with untreated hypertension 
BMJ Open  2015;5(7):e008404.
As Japanese societies rapidly undergo westernisation, the prevalence of hypertension is increasing. We investigated the association between dietary quality and the prevalence of untreated hypertension in Japanese male workers.
Design and methods
We conducted a cross-sectional study of 433 male workers who completed a brief food frequency questionnaire. Adherence to the WHO-based Healthy Diet Indicator (HDI), the American Heart Association 2006 Diet and Lifestyle Recommendations, the Dietary Approaches to Stop Hypertension (DASH) diet, and Mediterranean-style diet was assessed using four adherence indexes (HDI score, AI-84 score, DASH score and MED score). Hypertension classes were classified into three categories: non-hypertension, untreated hypertension and treated hypertension (ie, taking antihypertensive medication).
The prevalence of untreated hypertension and treated hypertension was 22.4% and 8.5%, respectively. Patients with untreated hypertension had significantly lower HDI and AI-84 scores compared with non-hypertension. DASH and MED scores across the three hypertension classes were comparable. After adjusting for age, energy intake, smoking habit, alcohol drinking, physical activity and salt intake, a low adherence to HDI and a lowest quartile of AI-84 score were associated with a significantly higher prevalence of untreated hypertension, with an OR of 3.33 (95% CI 1.39 to 7.94, p=0.007) and 2.23 (1.09 to 4.53, p=0.027), respectively.
A lower dietary quality was associated with increased prevalence of untreated hypertension in Japanese male workers. Our findings support a potential beneficial impact of nutritional assessment using diet qualities.
PMCID: PMC4499706  PMID: 26163037
46.  A research protocol for developing a Point-Of-Care Key Evidence Tool ‘POCKET’: a checklist for multidimensional evidence reporting on point-of-care in vitro diagnostics 
BMJ Open  2015;5(7):e007840.
Point-of-care in vitro diagnostics (POC-IVD) are increasingly becoming widespread as an acceptable means of providing rapid diagnostic results to facilitate decision-making in many clinical pathways. Evidence in utility, usability and cost-effectiveness is currently provided in a fragmented and detached manner that is fraught with methodological challenges given the disruptive nature these tests have on the clinical pathway. The Point-of-care Key Evidence Tool (POCKET) checklist aims to provide an integrated evidence-based framework that incorporates all required evidence to guide the evaluation of POC-IVD to meet the needs of policy and decisionmakers in the National Health Service (NHS).
Methods and analysis
A multimethod approach will be applied in order to develop the POCKET. A thorough literature review has formed the basis of a robust Delphi process and validation study. Semistructured interviews are being undertaken with POC-IVD stakeholders, including industry, regulators, commissioners, clinicians and patients to understand what evidence is required to facilitate decision-making. Emergent themes will be translated into a series of statements to form a survey questionnaire that aims to reach a consensus in each stakeholder group to what needs to be included in the tool. Results will be presented to a workshop to discuss the statements brought forward and the optimal format for the tool. Once assembled, the tool will be field-tested through case studies to ensure validity and usability and inform refinement, if required. The final version will be published online with a call for comments. Limitations include unpredictable sample representation, development of compromise position rather than consensus, and absence of blinding in validation exercise.
Ethics and dissemination
The Imperial College Joint Research Compliance Office and the Imperial College Hospitals NHS Trust R&D department have approved the protocol. The checklist tool will be disseminated through a PhD thesis, a website, peer-reviewed publication, academic conferences and formal presentations.
PMCID: PMC4499707  PMID: 26163033
47.  How social inequalities impact the course of treatment and care for patients with type 2 diabetes mellitus: study protocol for a qualitative cross-sectional study from the patient's perspective 
BMJ Open  2015;5(7):e008670.
Studies from various scientific disciplines have demonstrated that socioeconomic inequalities in type 2 diabetes mellitus negatively affect groups with a low socioeconomic status. Furthermore, socioeconomic inequalities also exist in terms of access to, and utilisation and perceived quality of, diabetological care. The aim of this qualitative study, which focuses on the patient's perspective, is to provide insights into the ways socioeconomic inequalities impact the course of treatment and care of patients with type 2 diabetes mellitus. The study aims to develop an understanding of how socioeconomic inequalities in care arise.
Methods and analysis
A cross-sectional qualitative study will be conducted using a sample of about 20 patients with type 2 diabetes mellitus aged 18 and older. Patients will be recruited successively from the University Hospital in Halle/Saale, Germany, a general practitioner's office, and in a specialised diabetological practice. The patients will be interviewed personally once, using semistructured qualitative interviews. All interviews will be recorded, transcribed, and analysed based on Grounded Theory.
Ethics and dissemination
All interviewees will receive comprehensive written information about the study and sign a declaration of consent prior to the interview. The study will comply rigorously with data protection legislation. The research team has obtained the approval of the Ethical Review Committee at the MLU Halle-Wittenberg, Germany. The results of the study will be published in high-quality, peer-reviewed international journals, presented at several congresses and used for developing follow-up research projects.
Trial registration number
This study has been registered with the German Clinical Trials Register and assigned DRKS00007847.
PMCID: PMC4499710  PMID: 26163038
type 2 diabetes mellitus; socioeconomic status; health services accessibility; utilization of health services; perceived quality of care
48.  Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial 
BMJ Open  2015;5(7):e006564.
To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants.
Randomised, double-blind, placebo-controlled trial.
Community setting in rural India.
LBW infants aged 3–7 days.
Infants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months.
Main outcome measure
Possible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians.
668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063).
Daily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants.
Trial registration number
The study is registered at the Clinical Trial Registry of India (CTRI/2008/091/000049).
PMCID: PMC4499724  PMID: 26163028
49.  Emergency supply of prescription-only medicines to patients by community pharmacists: a mixed methods evaluation incorporating patient, pharmacist and GP perspectives 
BMJ Open  2015;5(7):e006934.
To evaluate and inform emergency supply of prescription-only medicines by community pharmacists (CPs), including how the service could form an integral component of established healthcare provision to maximise adherence.
Mixed methods. 4 phases: prospective audit of emergency supply requests for prescribed medicines (October–November 2012 and April 2013); interviews with CPs (February–April 2013); follow-up interviews with patients (April–May 2013); interactive feedback sessions with general practice teams (October–November 2013).
22 community pharmacies and 6 general practices in Northwest England.
27 CPs with experience of dealing with requests for emergency supplies; 25 patients who received an emergency supply of a prescribed medicine; 58 staff at 6 general practices.
Clinical audit in 22 pharmacies over two 4-week periods reported that 526 medicines were requested by 450 patients. Requests peaked over a bank holiday and around weekends. A significant number of supplies were made during practice opening hours. Most requests were for older patients and for medicines used in long-term conditions. Difficulty in renewing repeat medication (forgetting to order, or prescription delays) was the major reason for requests. The majority of medicines were ‘loaned’ in advance of a National Health Service (NHS) prescription. Interviews with CPs and patients indicated that continuous supply had a positive impact on medicines adherence, removing the need to access urgent care. General practice staff were surprised and concerned by the extent of emergency supply episodes.
CPs regularly provide emergency supplies to patients who run out of their repeat medication, including during practice opening hours. This may aid adherence. There is currently no feedback loop, however, to general practice. Patient care and interprofessional communication may be better served by the introduction of a formally structured and funded NHS emergency supply service from community pharmacies, with ongoing optimisation of repeat prescribing.
PMCID: PMC4499725  PMID: 26163029
50.  Reducing and managing faecal incontinence in people with advanced dementia who are resident in care homes: protocol for a realist synthesis 
BMJ Open  2015;5(7):e007728.
Faecal incontinence (FI) is the involuntary loss of liquid or solid stool that is a social or hygienic problem. The prevalence of FI in residents of care homes is high, but it is not an inevitable consequence of old age or dementia. There is good evidence on risk factors, but few studies provide evidence about effective interventions. There is a need to understand how, why, and in what circumstances particular programmes to reduce and manage FI are effective (or not) for people with dementia. The purpose of this review is to identify which (elements of the) interventions could potentially be effective, and examine the barriers and facilitators to the acceptability, uptake and implementation of interventions designed to address FI in people with dementia who are resident in care homes.
Methods and analysis
A realist synthesis approach to review the evidence will be used which will include studies on continence, person-centred care, implementation research in care homes, workforce and research on care home culture. An iterative four-stage approach is planned. Phase 1: development of an initial programme theory or theories that will be ‘tested’ through a first scoping of the literature and consultation with five stakeholder groups (care home providers, user representatives, academics and practice educators, clinicians with a special interest in FI and continence specialists). Phase 2: a systematic search and analysis of published and unpublished evidence to test and develop the programme theories identified in phase 1. Phase 3: validation of programme theory/ies with a purposive sample of participants from phase 1.
Ethics and dissemination
The overall protocol does not require ethical review. The University research ethics committee will review interviews conducted as part of phase 1 and 3. The final fourth phase will synthesise and develop recommendations for practice and develop testable hypotheses for further research.
PMCID: PMC4499729  PMID: 26163032

Results 26-50 (3733)