The 100 most-cited articles in BMJ Open, 2016

Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www.equator-network.org/reporting-guidelines/stard Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30…

OBJECTIVES: The aim of this study was to develop a critical appraisal (CA) tool that addressed study design and reporting quality as well as the risk of bias in cross-sectional studies (CSSs). In addition, the aim was to produce a help document to guide the non-expert user through the tool. DESIGN: An initial scoping review of the published literature and key epidemiological texts was undertaken prior to the formation of a Delphi panel to establish key components for a CA tool for CSSs. A consensus of 80% was required from the Delphi panel for any component to be included in the final tool. RESULTS: An initial list of 39 components was identified through examination of existing resources. An international Delphi panel of 18 medical and veterinary experts was established. After 3 rounds of the Delphi process, the Appraisal tool for Cross-Sectional Studies (AXIS tool) was developed by consensus and consisted of 20 components. A detailed explanatory document was also developed with the tool, giving expanded explanation of each question and providing simple interpretations and examples…

OBJECTIVES: Evaluating the variation in the strength of the effect across studies is a key feature of meta-analyses. This variability is reflected by measures like τ(2) or I(2), but their clinical interpretation is not straightforward. A prediction interval is less complicated: it presents the expected range of true effects in similar studies. We aimed to show the advantages of having the prediction interval routinely reported in meta-analyses. DESIGN: We show how the prediction interval can help understand the uncertainty about whether an intervention works or not. To evaluate the implications of using this interval to interpret the results, we selected the first meta-analysis per intervention review of the Cochrane Database of Systematic Reviews Issues 2009-2013 with a dichotomous (n=2009) or continuous (n=1254) outcome, and generated 95% prediction intervals for them. RESULTS: In 72.4% of 479 statistically significant (random-effects p<0.05) meta-analyses in the Cochrane Database 2009-2013 with heterogeneity (I(2)>0), the 95% prediction interval suggested that the intervention…

OBJECTIVES: There is little consensus regarding the burden of pain in the UK. The purpose of this review was to synthesise existing data on the prevalence of various chronic pain phenotypes in order to produce accurate and contemporary national estimates. DESIGN: Major electronic databases were searched for articles published after 1990, reporting population-based prevalence estimates of chronic pain (pain lasting >3 months), chronic widespread pain, fibromyalgia and chronic neuropathic pain. Pooled prevalence estimates were calculated for chronic pain and chronic widespread pain. RESULTS: Of the 1737 articles generated through our searches, 19 studies matched our inclusion criteria, presenting data from 139 933 adult residents of the UK. The prevalence of chronic pain, derived from 7 studies, ranged from 35.0% to 51.3% (pooled estimate 43.5%, 95% CIs 38.4% to 48.6%). The prevalence of moderate-severely disabling chronic pain (Von Korff grades III/IV), based on 4 studies, ranged from 10.4% to 14.3%. 12 studies stratified chronic pain prevalence by age group, demonstrating a trend…

OBJECTIVE: To conduct a systematic review and series of meta-analyses on the association between HIV-related stigma and health among people living with HIV. DATA SOURCES: A structured search was conducted on 6 electronic databases for journal articles reporting associations between HIV-related stigma and health-related outcomes published between 1996 and 2013. STUDY ELIGIBILITY CRITERIA: Controlled studies, cohort studies, case-control studies and cross-sectional studies in people living with HIV were considered for inclusion. OUTCOME MEASURES: Mental health (depressive symptoms, emotional and mental distress, anxiety), quality of life, physical health, social support, adherence to antiretroviral therapy, access to and usage of health/social services and risk behaviours. RESULTS: 64 studies were included in our meta-analyses. We found significant associations between HIV-related stigma and higher rates of depression, lower social support and lower levels of adherence to antiretroviral medications and access to and usage of health and social services. Weaker relationships were…

OBJECTIVES: To investigate the contribution of ultra-processed foods to the intake of added sugars in the USA. Ultra-processed foods were defined as industrial formulations which, besides salt, sugar, oils and fats, include substances not used in culinary preparations, in particular additives used to imitate sensorial qualities of minimally processed foods and their culinary preparations. DESIGN: Cross-sectional study. SETTING: National Health and Nutrition Examination Survey 2009-2010. PARTICIPANTS: We evaluated 9317 participants aged 1+ years with at least one 24 h dietary recall. MAIN OUTCOME MEASURES: Average dietary content of added sugars and proportion of individuals consuming more than 10% of total energy from added sugars. DATA ANALYSIS: Gaussian and Poisson regressions estimated the association between consumption of ultra-processed foods and intake of added sugars. All models incorporated survey sample weights and adjusted for age, sex, race/ethnicity, family income and educational attainment. RESULTS: Ultra-processed foods comprised 57.9% of energy intake, and…

OBJECTIVE: The majority of cardiovascular diagnoses in the Danish National Patient Registry (DNPR) remain to be validated despite extensive use in epidemiological research. We therefore examined the positive predictive value (PPV) of cardiovascular diagnoses in the DNPR. DESIGN: Population-based validation study. SETTING: 1 university hospital and 2 regional hospitals in the Central Denmark Region, 2010-2012. PARTICIPANTS: For each cardiovascular diagnosis, up to 100 patients from participating hospitals were randomly sampled during the study period using the DNPR. MAIN OUTCOME MEASURE: Using medical record review as the reference standard, we examined the PPV for cardiovascular diagnoses in the DNPR, coded according to the International Classification of Diseases, 10th Revision. RESULTS: A total of 2153 medical records (97% of the total sample) were available for review. The PPVs ranged from 64% to 100%, with a mean PPV of 88%. The PPVs were ≥90% for first-time myocardial infarction, stent thrombosis, stable angina pectoris, hypertrophic cardiomyopathy, arrhythmogenic right…

OBJECTIVE: Investigators within many disciplines are using measures of well-being, but it is not always clear what they are measuring, or which instruments may best meet their objectives. The aims of this review were to: systematically identify well-being instruments, explore the variety of well-being dimensions within instruments and describe how the production of instruments has developed over time. DESIGN: Systematic searches, thematic analysis and narrative synthesis were undertaken. DATA SOURCES: MEDLINE, EMBASE, EconLit, PsycINFO, Cochrane Library and CINAHL from 1993 to 2014 complemented by web searches and expert consultations through 2015. ELIGIBILITY CRITERIA: Instruments were selected for review if they were designed for adults (≥18 years old), generic (ie, non-disease or context specific) and available in an English version. RESULTS: A total of 99 measures of well-being were included, and 196 dimensions of well-being were identified within them. Dimensions clustered around 6 key thematic domains: mental well-being, social well-being, physical well-being, spiritual…

OBJECTIVES: There is now good evidence that central obesity carries more health risks compared with total obesity assessed by body mass index (BMI). It has therefore been suggested that waist circumference (WC), a proxy for central obesity, should be included with BMI in a 'matrix' to categorise health risk. We wanted to compare how the adult UK population is classified using such a 'matrix' with that using another proxy for central obesity, waist-to-height ratio (WHtR), using a boundary value of 0.5. Further, we wished to compare cardiometabolic risk factors in adults with 'healthy' BMI divided according to whether they have WHtR below or above 0.5. SETTING, PARTICIPANTS AND OUTCOME MEASURES: Recent data from 4 years (2008-2012) of the UK National Diet and Nutrition Survey (NDNS) (n=1453 adults) were used to cross-classify respondents on anthropometric indices. Regression was used to examine differences in levels of risk factors (triglycerides (TG), total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), TC: HDL, glycated haemoglobin (HbA1c), fasting…

OBJECTIVES: To investigate whether there is an association between differences in travel time/travel distance to healthcare services and patients' health outcomes and assimilate the methodologies used to measure this. DESIGN: Systematic Review. We searched MEDLINE, Embase, Web of Science, Transport database, HMIC and EBM Reviews for studies up to 7 September 2016. Studies were excluded that included children (including maternity), emergency medical travel or countries classed as being in the global south. SETTINGS: A wide range of settings within primary and secondary care (these were not restricted in the search). RESULTS: 108 studies met the inclusion criteria. The results were mixed. 77% of the included studies identified evidence of a distance decay association, whereby patients living further away from healthcare facilities they needed to attend had worse health outcomes (eg, survival rates, length of stay in hospital and non-attendance at follow-up) than those who lived closer. 6 of the studies identified the reverse (a distance bias effect) whereby patients living at a…

OBJECTIVE: To assess the effects of use of cannabis during pregnancy on maternal and fetal outcomes. DATA SOURCES: 7 electronic databases were searched from inception to 1 April 2014. Studies that investigated the effects of use of cannabis during pregnancy on maternal and fetal outcomes were included. STUDY SELECTION: Case-control studies, cross-sectional and cohort studies were included. DATA EXTRACTION AND SYNTHESIS: Data synthesis was undertaken via systematic review and meta-analysis of available evidence. All review stages were conducted independently by 2 reviewers. MAIN OUTCOMES AND MEASURES: Maternal, fetal and neonatal outcomes up to 6 weeks postpartum after exposure to cannabis. Meta-analyses were conducted on variables that had 3 or more studies that measured an outcome in a consistent manner. Outcomes for which meta-analyses were conducted included: anaemia, birth weight, low birth weight, neonatal length, placement in the neonatal intensive care unit, gestational age, head circumference and preterm birth. RESULTS: 24 studies were included in the review. Results of the…

OBJECTIVE: To evaluate among stakeholders the support for the new, dynamic concept of health, as published in 2011: 'Health as the ability to adapt and to self-manage', and to elaborate perceived indicators of health in order to make the concept measurable. DESIGN: A mixed methods study: a qualitative first step with interviews and focus groups, followed by a quantitative survey. PARTICIPANTS: Representatives of seven healthcare stakeholder domains, for example, healthcare providers, patients with a chronic condition and policymakers. The qualitative study involved 140 stakeholders; the survey 1938 participants. RESULTS: The new concept was appreciated, as it addresses people as more than their illness and focuses on strengths rather than weaknesses. Caution is needed as the concept requires substantial personal input of which not everyone is capable. The qualitative study identified 556 health indicators, categorised into six dimensions: bodily functions, mental functions and perception, spiritual/existential dimension, quality of life, social and societal participation, and daily…

OBJECTIVES: Pharmacists play a role in providing medication reconciliation. However, data on effectiveness on patients' clinical outcomes appear inconclusive. Thus, the aim of this study was to systematically investigate the effect of pharmacist-led medication reconciliation programmes on clinical outcomes at hospital transitions. DESIGN: Systematic review and meta-analysis. METHODS: We searched PubMed, MEDLINE, EMBASE, IPA, CINHAL and PsycINFO from inception to December 2014. Included studies were all published studies in English that compared the effectiveness of pharmacist-led medication reconciliation interventions to usual care, aimed at improving medication reconciliation programmes. Meta-analysis was carried out using a random effects model, and subgroup analysis was conducted to determine the sources of heterogeneity. RESULTS: 17 studies involving 21,342 adult patients were included. Eight studies were randomised controlled trials (RCTs). Most studies targeted multiple transitions and compared comprehensive medication reconciliation programmes including telephone…

PURPOSE: The South London and Maudsley National Health Service (NHS) Foundation Trust Biomedical Research Centre (SLaM BRC) Case Register and its Clinical Record Interactive Search (CRIS) application were developed in 2008, generating a research repository of real-time, anonymised, structured and open-text data derived from the electronic health record system used by SLaM, a large mental healthcare provider in southeast London. In this paper, we update this register's descriptive data, and describe the substantial expansion and extension of the data resource since its original development. PARTICIPANTS: Descriptive data were generated from the SLaM BRC Case Register on 31 December 2014. Currently, there are over 250,000 patient records accessed through CRIS. FINDINGS TO DATE: Since 2008, the most significant developments in the SLaM BRC Case Register have been the introduction of natural language processing to extract structured data from open-text fields, linkages to external sources of data, and the addition of a parallel relational database (Structured Query Language) output.…

OBJECTIVES: To assess the status of menstrual hygiene management (MHM) among adolescent girls in India to determine unmet needs. DESIGN: Systematic review and meta-analysis. We searched PubMed, The Global Health Database, Google Scholar and references for studies published from 2000 to September 2015 on girls' MHM. SETTING: India. PARTICIPANTS: Adolescent girls. OUTCOME MEASURES: Information on menarche awareness, type of absorbent used, disposal, hygiene, restrictions and school absenteeism was extracted from eligible materials; a quality score was applied. Meta-analysis was used to estimate pooled prevalence (PP), and meta-regression to examine the effect of setting, region and time. RESULTS: Data from 138 studies involving 193 subpopulations and 97,070 girls were extracted. In 88 studies, half of the girls reported being informed prior to menarche (PP 48%, 95% CI 43% to 53%, I(2) 98.6%). Commercial pad use was more common among urban (PP 67%, 57% to 76%, I(2) 99.3%, n=38) than rural girls (PP 32%, 25% to 38%, I(2) 98.6%, n=56, p<0.0001), with use increasing over time (p<0.0001).…

OBJECTIVE: Historically, alcohol use and related harms are more prevalent in men than in women. However, emerging evidence suggests the epidemiology of alcohol use is changing in younger cohorts. The current study aimed to systematically summarise published literature on birth cohort changes in male-to-female ratios in indicators of alcohol use and related harms. METHODS: We identified 68 studies that met inclusion criteria. We calculated male-to-female ratios for 3 broad categories of alcohol use and harms (any alcohol use, problematic alcohol use and alcohol-related harms) stratified by 5-year birth cohorts ranging from 1891 to 2001, generating 1568 sex ratios. Random-effects meta-analyses produced pooled sex ratios within these 3 categories separately for each birth cohort. FINDINGS: There was a linear decrease over time in the sex ratio for all 3 categories of alcohol use and related harms. Among those born in the early 1900s, males were 2.2 (95% CI 1.9 to 2.5) times more likely than females to consume alcohol, 3.0 (95% CI 1.5 to 6.0) times more likely to drink alcohol in ways…

OBJECTIVES: The number of quit attempts it takes a smoker to quit successfully is a commonly reported figure among smoking cessation programmes, but previous estimates have been based on lifetime recall in cross-sectional samples of successful quitters only. The purpose of this study is to improve the estimate of number of quit attempts prior to quitting successfully. DESIGN: We used data from 1277 participants who had made an attempt to quit smoking in the Ontario Tobacco Survey, a longitudinal survey of smokers followed every 6 months for up to 3 years beginning in 2005. We calculated the number of quit attempts prior to quitting successfully under four different sets of assumptions. Our expected best set of assumptions incorporated a life table approach accounting for the declining success rates for subsequent observed quit attempts in the cohort. RESULTS: The estimated average number of quit attempts expected before quitting successfully ranged from 6.1 under the assumptions consistent with prior research, 19.6 using a constant rate approach, 29.6 using the method with the…

Objective Smartphone games that aim to alter health behaviours are common, but there is uncertainty about how to achieve this. We systematically reviewed health apps containing gaming elements analysing their embedded behaviour change techniques. Methods Two trained researchers independently coded apps for behaviour change techniques using a standard taxonomy. We explored associations with user ratings and price. Data sources We screened the National Health Service (NHS) Health Apps Library and all top-rated medical, health and wellness and health and fitness apps (defined by Apple and Google Play stores based on revenue and downloads). We included free and paid English language apps using ‘gamification’ (rewards, prizes, avatars, badges, leaderboards, competitions, levelling-up or health-related challenges). We excluded apps targeting health professionals. Results 64 of 1680 (4%) health apps included gamification and met inclusion criteria; only 3 of these were in the NHS Library. Behaviour change categories used were: feedback and monitoring (n=60, 94% of apps), reward and threat…

OBJECTIVE: To measure test accuracy of non-invasive prenatal testing (NIPT) for Down, Edwards and Patau syndromes using cell-free fetal DNA and identify factors affecting accuracy. DESIGN: Systematic review and meta-analysis of published studies. DATA SOURCES: PubMed, Ovid Medline, Ovid Embase and the Cochrane Library published from 1997 to 9 February 2015, followed by weekly autoalerts until 1 April 2015. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: English language journal articles describing case-control studies with ≥ 15 trisomy cases or cohort studies with ≥ 50 pregnant women who had been given NIPT and a reference standard. RESULTS: 41, 37 and 30 studies of 2012 publications retrieved were included in the review for Down, Edwards and Patau syndromes. Quality appraisal identified high risk of bias in included studies, funnel plots showed evidence of publication bias. Pooled sensitivity was 99.3% (95% CI 98.9% to 99.6%) for Down, 97.4% (95.8% to 98.4%) for Edwards, and 97.4% (86.1% to 99.6%) for Patau syndrome. The pooled specificity was 99.9% (99.9% to 100%) for all three…

OBJECTIVE: In most developed countries, substantial disparities exist in access to mental health services for black and minority ethnic (BME) populations. We sought to determine perceived barriers to accessing mental health services among people from these backgrounds to inform the development of effective and culturally acceptable services to improve equity in healthcare. DESIGN AND SETTING: Qualitative study in Southeast England. PARTICIPANTS: 26 adults from BME backgrounds (13 men, 13 women; aged >18 years) were recruited to 2 focus groups. Participants were identified through the registers of the Black and Minority Ethnic Community Partnership centre and by visits to local community gatherings and were invited to take part by community development workers. Thematic analysis was conducted to identify key themes about perceived barriers to accessing mental health services. RESULTS: Participants identified 2 broad themes that influenced access to mental health services. First, personal and environmental factors included inability to recognise and accept mental health problems,…

BACKGROUND: Second victims are healthcare workers who experience emotional distress following patient adverse events. Studies indicate the need to develop organisational support programmes for these workers. The RISE (Resilience In Stressful Events) programme was developed at the Johns Hopkins Hospital to provide this support. OBJECTIVE: To describe the development of RISE and evaluate its initial feasibility and subsequent implementation. Programme phases included (1) developing the RISE programme, (2) recruiting and training peer responders, (3) pilot launch in the Department of Paediatrics and (4) hospital-wide implementation. METHODS: Mixed-methods study, including frequency counts of encounters, staff surveys and evaluations by RISE peer responders. Descriptive statistics were used to summarise demographic characteristics and proportions of responses to categorical, Likert and ordinal scales. Qualitative analysis and coding were used to analyse open-ended responses from questionnaires and focus groups. RESULTS: A baseline staff survey found that most staff had experienced an…

OBJECTIVES: We present a novel way of classifying and comparing measures of social relationships to help readers interpret the growing literature on loneliness and social isolation and to provide researchers with a starting point to guide their choice of measuring tool. METHODS: Measures of social relationships used in epidemiological studies were identified from two systematic reviews-one review on the association between social relationships and health and social care service use, and a second review on the association between social relationships and health. Questions from each measure were retrieved and tabulated to derive a classification of social relationship measures. RESULTS: We present a classification of measures according to two dimensions: (1) whether instruments cover structural or functional aspects of social relationships and (2) the degree of subjectivity asked of respondents. We explain how this classification can be used to clarify the remit of the many questionnaires used in the literature and to compare them. CONCLUSIONS: Different dimensions of social…

OBJECTIVE: It is well known that total cholesterol becomes less of a risk factor or not at all for all-cause and cardiovascular (CV) mortality with increasing age, but as little is known as to whether low-density lipoprotein cholesterol (LDL-C), one component of total cholesterol, is associated with mortality in the elderly, we decided to investigate this issue. SETTING, PARTICIPANTS AND OUTCOME MEASURES: We sought PubMed for cohort studies, where LDL-C had been investigated as a risk factor for all-cause and/or CV mortality in individuals ≥60 years from the general population. RESULTS: We identified 19 cohort studies including 30 cohorts with a total of 68 094 elderly people, where all-cause mortality was recorded in 28 cohorts and CV mortality in 9 cohorts. Inverse association between all-cause mortality and LDL-C was seen in 16 cohorts (in 14 with statistical significance) representing 92% of the number of participants, where this association was recorded. In the rest, no association was found. In two cohorts, CV mortality was highest in the lowest LDL-C quartile and with…

INTRODUCTION: Remote video consultations between clinician and patient are technically possible and increasingly acceptable. They are being introduced in some settings alongside (and occasionally replacing) face-to-face or telephone consultations. METHODS: To explore the advantages and limitations of video consultations, we will conduct in-depth qualitative studies of real consultations (microlevel) embedded in an organisational case study (mesolevel), taking account of national context (macrolevel). The study is based in 2 contrasting clinical settings (diabetes and cancer) in a National Health Service (NHS) acute trust in London, UK. Main data sources are: microlevel--audio, video and screen capture to produce rich multimodal data on 45 remote consultations; mesolevel--interviews, ethnographic observations and analysis of documents within the trust; macrolevel--key informant interviews of national-level stakeholders and document analysis. Data will be analysed and synthesised using a sociotechnical framework developed from structuration theory. ETHICS APPROVAL: City Road and…

OBJECTIVE: The purpose of our study was to evaluate the association between short and long sleep duration and all-cause and cardiovascular mortality among elderly individuals. DESIGN: Systematic review and meta-analysis of population-based cohort studies. SETTING: Articles were retrieved from international and national electronic databases. STUDY SELECTION: Studies were identified in PubMed, EMBASE, LILACS (Latin American and Caribbean Health Sciences Literature), IBECS (Bibliographic Index on Health Sciences from Spain) and CAPES (PhD thesis repository) between 1980 and 2015. Studies which met all criteria were eligible: participants aged 60 years or over, assessment of sleep duration as 24 h, nighttime or daytime sleep, evaluation of all-cause or cause-specific mortality, population-based cohort studies conducted on representative samples. There was no language restriction and studies published as abstracts were excluded. DATA EXTRACTION: Data were analysed using the Comprehensive Meta-Analysis software (V.3.3.070), and summary estimates (relative risk (RR), 95% CI) were…

OBJECTIVE: To update previous systematic review of predictive models for 28-day or 30-day unplanned hospital readmissions. DESIGN: Systematic review. SETTING/DATA SOURCE: CINAHL, Embase, MEDLINE from 2011 to 2015. PARTICIPANTS: All studies of 28-day and 30-day readmission predictive model. OUTCOME MEASURES: Characteristics of the included studies, performance of the identified predictive models and key predictive variables included in the models. RESULTS: Of 7310 records, a total of 60 studies with 73 unique predictive models met the inclusion criteria. The utilisation outcome of the models included all-cause readmissions, cardiovascular disease including pneumonia, medical conditions, surgical conditions and mental health condition-related readmissions. Overall, a wide-range C-statistic was reported in 56/60 studies (0.21-0.88). 11 of 13 predictive models for medical condition-related readmissions were found to have consistent moderate discrimination ability (C-statistic ≥0.7). Only two models were designed for the potentially preventable/avoidable readmissions and had C-statistic…

OBJECTIVE: To investigate trends in incident and prevalent diagnoses of type 2 diabetes mellitus (T2DM) and its pharmacological treatment between 2000 and 2013. DESIGN: Analysis of longitudinal electronic health records in The Health Improvement Network (THIN) primary care database. SETTING: UK primary care. PARTICIPANTS: In total, we examined 8,838,031 individuals aged 0-99 years. OUTCOME MEASURES: The incidence and prevalence of T2DM between 2000 and 2013, and the effect of age, sex and social deprivation on these measures were examined. Changes in prescribing patterns of antidiabetic therapy between 2000 and 2013 were also investigated. RESULTS: Overall, 406,344 individuals had a diagnosis of T2DM, of which 203,639 were newly diagnosed between 2000 and 2013. The incidence of T2DM rose from 3.69 per 1000 person-years at risk (PYAR) (95% CI 3.58 to 3.81) in 2000 to 3.99 per 1000 PYAR (95% CI 3.90 to 4.08) in 2013 among men; and from 3.06 per 1000 PYAR (95% CI 2.95 to 3.17) to 3.73 per 1000 PYAR (95% CI 3.65 to 3.82) among women. Prevalence of T2DM more than doubled from 2.39% (95%…

OBJECTIVES: Explore how patient-reported experience measures (PREMs) are collected, communicated and used to inform quality improvement (QI) across healthcare settings. DESIGN: Systematic review. SETTING: Various primary and secondary care settings, including general practice, and acute and chronic care hospitals. PARTICIPANTS: A full range of patient populations from (children through to the elderly) and staff (from healthcare practitioners to senior managers). METHODS: Scientific databases were searched (CINAHL, PsycINFO, MEDLINE and Cochrane Libraries) as was grey literature. Qualitative and quantitative studies describing collection of PREM data and subsequent QI actions in any healthcare setting were included. Risk of bias was assessed using established criteria. Of 5312 initial hits, 32 full texts were screened, and 11 were included. RESULTS: Patient experience data were most commonly collected through surveys and used to identify small areas of incremental change to services that do not require a change to clinician behaviour (eg, changes to admission processes and producing…

OBJECTIVES: To review systematically the evidence of age-related macular degeneration (AMD) affecting real-world visual ability and quality of life (QoL). To explore trends in specific topics within this body of the literature. DESIGN: Systematic review. METHODS: A systematic literature search was carried out using MEDLINE, EMBASE, CINAHL, PsycINFO, PsychARTICLES and Health and Psychosocial Instruments for articles published up to January 2015 for studies including people diagnosed with AMD, assessing real-world visual ability or QoL as an outcome. Two researchers screened studies for eligibility. Details of eligible studies including study design, characteristics of study population and outcomes measured were recorded in a data extraction table. All included studies underwent quality appraisal using the Mixed Methods Appraisal Tool 2011 Version (MMAT). RESULTS: From 5284 studies, 123 were eligible for inclusion. A range of approaches were identified, including performance-based methods, quantitative and qualitative patient-reported outcome measures (PROMs). AMD negatively affects…

OBJECTIVE: Many published meta-analyses are underpowered. We explored the role of trial sequential analysis (TSA) in assessing the reliability of conclusions in underpowered meta-analyses. METHODS: We screened The Cochrane Database of Systematic Reviews and selected 100 meta-analyses with a binary outcome, a negative result and sufficient power. We defined a negative result as one where the 95% CI for the effect included 1.00, a positive result as one where the 95% CI did not include 1.00, and sufficient power as the required information size for 80% power, 5% type 1 error, relative risk reduction of 10% or number needed to treat of 100, and control event proportion and heterogeneity taken from the included studies. We re-conducted the meta-analyses, using conventional cumulative techniques, to measure how many false positives would have occurred if these meta-analyses had been updated after each new trial. For each false positive, we performed TSA, using three different approaches. RESULTS: We screened 4736 systematic reviews to find 100 meta-analyses that fulfilled our inclusion…

OBJECTIVES: Although sex and relationship education (SRE) represents a key strand in policies to safeguard young people and improve their sexual health, it currently lacks statutory status, government guidance is outdated and a third of UK schools has poor-quality SRE. We aimed to investigate whether current provision meets young people's needs. DESIGN: Synthesis of qualitative studies of young people's views of their school-based SRE. SETTING: Eligible studies originated from the UK, Ireland, the USA, Australia, New Zealand, Canada, Japan, Iran, Brazil and Sweden. PARTICIPANTS: Studies of students aged 4-19 in full-time education, young adults ≤19 (not necessarily in full-time education) or adults ≤25 if recalling their experiences of school-based SRE. RESULTS: -69 publications were identified, with 55 remaining after quality appraisal (representing 48 studies). The synthesis found that although sex is a potent and potentially embarrassing topic, schools appear reluctant to acknowledge this and attempt to teach SRE in the same way as other subjects. Young people report feeling…

OBJECTIVE: Diabetes represents a significant challenge for Chinese healthcare providers. Healthcare decision-making is generally based on many data sources, including randomised controlled and real-world studies; however, good-quality data from Chinese diabetes patients are scarce. We performed an initial validation to assess the representativeness of one source of real-world data-the Diabetes Adelphi Disease Specific Programme (DSP) in China. SETTING: China, UK. PARTICIPANTS: The Chinese DSP included 2060 patients with previously diagnosed type 2 diabetes mellitus (T2DM) sampled by 200 physicians. The reference Chinese population comprised 238 639 patients with previously diagnosed T2DM. The UK DSP contained 1481 patients with T2DM sampled by 125 physicians; the reference UK population comprised 289 patients with diabetes. PRIMARY AND SECONDARY OUTCOMES: The primary outcome was comparison of unweighted China DSP and reference data for sex, body mass index (BMI), blood pressure (BP), patients achieving glycosylated haemoglobin (HbA1c)<7%, total cholesterol, coronary heart disease…

OBJECTIVE: To explore medication-related burden (MRB) and patients' lived experience with medicines (PLEM) without regard to particular medication therapies or medical conditions. DESIGN: Systematic review and metasynthesis of qualitative studies. DATA SOURCES: MEDLINE, EMBASE, International Pharmaceutical Abstracts, PsycINFO, Global health, CINAHL and Web of Science were searched from January 2000 to August 2014 using medication burden and patients' lived experience terms. SYNTHESIS METHODS: Synthesis was undertaken following metaethnography methods and a comparative thematic analysis technique. RESULTS: 34 articles from 12 countries with a total of 1144 participants were included. 3 major inter-related themes emerged central to PLEM: MRB, medication related beliefs and medication taking practice. The negative impact of MRB, due to its interference on patients' daily lives and effects on well-being, its influence on patients' beliefs and behaviours, and a potential risk for drug-related problems (DRPs) was evident. This resulted in non-adherence and poorer outcomes (unachieved…

UNLABELLED: : Exercise classes provide a range of benefits to older adults, reducing risk of illness, promoting functional ability and improving well-being. However, to be effective and achieve long-term outcomes, exercise needs to be maintained. Adherence is poor and reporting of adherence differs considerably between studies. OBJECTIVE: To explore how adherence to exercise classes for older people is defined in the literature and devise a definition for pooling data on adherence in future studies. DESIGN: Methodological review of the approaches used to measure adherence. METHODS: A review of the literature was carried out using narrative synthesis, based on systematic searches of MEDLINE, EMBASE, CINAHL and PsychINFO. 2 investigators identified eligible studies and extracted data independently. RESULTS: 37 papers including 34 studies were identified. 7 papers (7 studies) defined adherence as completion (retention). 30 papers (27 studies) identified adherence using attendance records. 12 papers (11 studies) based adherence on duration of exercise and 5 papers (4 studies) specified…

OBJECTIVES: US and UK suicide prevention strategies suggest that bereavement by the suicide of a relative or friend is a risk factor for suicide. However, evidence is lacking that the risk exceeds that of any sudden bereavement, is specific to suicide, or applies to peer suicide. We conducted the first controlled UK-wide study to test the hypothesis that young adults bereaved by suicide have an increased risk of suicidal ideation and suicide attempt compared with young adults bereaved by other sudden deaths. DESIGN: National cross-sectional study. SETTING: Staff and students at 37 UK higher educational institutions in 2010. PARTICIPANTS: 3432 eligible respondents aged 18-40 exposed to sudden bereavement of a friend or relative after the age of 10. EXPOSURES: Bereavement by suicide (n=614), by sudden unnatural causes (n=712) and by sudden natural causes (n=2106). PRIMARY OUTCOME MEASURES: Incident suicidal ideation and suicide attempt. FINDINGS: Adults bereaved by suicide had a higher probability of attempting suicide (adjusted OR (AOR)=1.65; 95% CI 1.12 to 2.42; p=0.012) than those…

OBJECTIVES: To estimate the prevalence of, and explore potential risk factors for, taste and smell dysfunction in the general population of the USA. DESIGN: A cross-sectional study. SETTING: A cross-sectional analysis of data collected in the National Health and Nutrition Examination Survey (NHANES 2013-2014). PARTICIPANTS: A total of 3519 men and women aged 40 years and older who participated in NHANES 2013-2014. MAIN OUTCOME MEASURES: Using the NHANES Pocket Smell Test, smell impairment was defined as failing to correctly identify 6 or more of the 8 odours. Taste impairment was defined as failing to correctly identify quinine or sodium chloride. RESULTS: The estimated prevalence was 13.5% for smell impairment, 17.3% for taste impairment and 2.2% for taste and smell impairment. For smell, but not taste, prevalence estimates increased with age and were higher in men and ethnic minorities. In backward stepwise logistic regression, low educational attainment, low family income and a history of asthma or cancer were independently associated with a higher prevalence of smell impairment,…

OBJECTIVE: Surgical complications may affect patients psychologically due to challenges such as prolonged recovery or long-lasting disability. Psychological distress could further delay patients' recovery as stress delays wound healing and compromises immunity. This review investigates whether surgical complications adversely affect patients' postoperative well-being and the duration of this impact. METHODS: The primary data sources were 'PsychINFO', 'EMBASE' and 'MEDLINE' through OvidSP (year 2000 to May 2012). The reference lists of eligible articles were also reviewed. Studies were eligible if they measured the association of complications after major surgery from 4 surgical specialties (ie, cardiac, thoracic, gastrointestinal and vascular) with adult patients' postoperative psychosocial outcomes using validated tools or psychological assessment. 13,605 articles were identified. 2 researchers independently extracted information from the included articles on study aims, participants' characteristics, study design, surgical procedures, surgical complications, psychosocial outcomes…

OBJECTIVES: Simultaneously define diet, physical activity, television (TV) viewing, and sleep duration across cardiometabolic disease groups, and investigate clustering of non-diet lifestyle behaviours. DESIGN: Cross-sectional observational study. SETTING: 22 UK Biobank assessment centres across the UK. PARTICIPANTS: 502,664 adults aged 37-63 years old, 54% women. 4 groups were defined based on disease status; 'No disease' (n=103,993), 'cardiovascular disease' (CVD n=113,469), 'Type 2 diabetes without CVD' (n=4074) and 'Type 2 diabetes + CVD' (n=11,574). MAIN OUTCOMES: Diet, physical activity, TV viewing and sleep duration. RESULTS: People with 'CVD' report low levels of physical activity (<918 MET min/week, OR (95% CI) 1.23 (1.20 to 1.25)), high levels of TV viewing (>3 h/day; 1.42 (1.39 to 1.45)), and poor sleep duration (<7, >8 h/night; 1.37 (1.34 to 1.39)) relative to people without disease. People with 'Type 2 diabetes + CVD' were more likely to report low physical activity (1.71 (1.64 to 1.78)), high levels of TV viewing (1.92 (1.85 to 1.99)) and poor sleep duration (1.52…

DESIGN AND OBJECTIVES: Every organisation has a unique culture. There is a widely held view that a positive organisational culture is related to positive patient outcomes. Following the Preferred Reporting Items for Systematic Review and Meta-Analyses statement, we systematically reviewed and synthesised the evidence on the extent to which organisational and workplace cultures are associated with patient outcomes. SETTING: A variety of healthcare facilities, including hospitals, general practices, pharmacies, military hospitals, aged care facilities, mental health and other healthcare contexts. PARTICIPANTS: The articles included were heterogeneous in terms of participants. This was expected as we allowed scope for wide-ranging health contexts to be included in the review. PRIMARY AND SECONDARY OUTCOME MEASURES: Patient outcomes, inclusive of specific outcomes such as pain level, as well as broader outcomes such as patient experience. RESULTS: The search strategy identified 2049 relevant articles. A review of abstracts using the inclusion criteria yielded 204 articles eligible for…

OBJECTIVE: To evaluate the prevalence and risk factors of dry eye disease (DED) in workers using visual display terminals (VDT). DESIGN: Systematic review and meta-analysis. DATA SOURCES: We searched PubMed, Cochrane Library, Embase and Science Direct databases for studies reporting DED prevalence in VDT workers. RESULTS: 16 of the 9049 identified studies were included, with a total of 11,365 VDT workers. Despite a global DED prevalence of 49.5% (95% CI 47.5 to 50.6), ranging from 9.5% to 87.5%, important heterogeneity (I(2)=98.8%, p<0.0001) was observed. Variable diagnosis criteria used within studies were: questionnaires on symptoms, tear film anomalies and corneoconjunctival epithelial damage. Some studies combined criteria to define DED. Heterogeneous prevalence was associated with stratifications on symptoms (I(2)=98.7%, p<0.0001), tears (I(2)=98.5%, p<0.0001) and epithelial damage (I(2)=96.0%, p<0.0001). Stratification of studies with two criteria adjusted the prevalence to 54.0% (95% CI 52.1 to 55.9), whereas studies using three criteria resulted in a prevalence of 11.6% (95%…

Objectives Approaches to measuring intimate partner violence (IPV) in populations often privilege physical violence, with poor assessment of other experiences. This has led to underestimating the scope and impact of IPV. The aim of this study was to develop a brief, reliable and valid self-report measure of IPV that adequately captures its complexity. Design Mixed-methods instrument development and psychometric testing to evolve a brief version of the Composite Abuse Scale (CAS) using secondary data analysis and expert feedback. Setting Data from 5 Canadian IPV studies; feedback from international IPV experts. Participants 31 international IPV experts including academic researchers, service providers and policy actors rated CAS items via an online survey. Pooled data from 6278 adult Canadian women were used for scale development. Primary/secondary outcome measures Scale reliability and validity; robustness of subscales assessing different IPV experiences. Results A 15-item version of the CAS has been developed (Composite Abuse Scale (Revised)—Short Form, CAS R -SF), including 12…

OBJECTIVES: To describe the role patient expectations play in general practitioners (GPs) antibiotic prescribing for upper respiratory tract infections (URTI). METHODS: Concurrent explanatory mixed methods approach using a cross-sectional survey and semistructured interviews. SETTINGS: Primary care GPs in Australia. PARTICIPANTS: 584 GPs (response rate of 23.6%) completed the cross-sectional survey. 32 GPs were interviewed individually. OUTCOME MEASURE: Prescribing of antibiotics for URTI. RESULTS: More than half the GP respondents to the survey in Australia self-reported that they would prescribe antibiotics for an URTI to meet patient expectations. Our qualitative findings suggest that 'patient expectations' may be the main reason given for inappropriate prescribing, but it is an all-encompassing phrase that includes other reasons. These include limited time, poor doctor-patient communication and diagnostic uncertainty. We have identified three role archetypes to explain the behaviour of GPs in reference to antibiotic prescribing for URTIs. The main themes emerging from the…

OBJECTIVES: This is a pilot study to investigate the type and severity of emotional distress in women after early pregnancy loss (EPL), compared with a control group with ongoing pregnancies. The secondary aim was to assess whether miscarriage or ectopic pregnancy impacted differently on the type and severity of psychological morbidity. DESIGN: This was a prospective survey study. Consecutive women were recruited between January 2012 and July 2013. We emailed women a link to a survey 1, 3 and 9 months after a diagnosis of EPL, and 1 month after the diagnosis of a viable ongoing pregnancy. SETTING: The Early Pregnancy Assessment Unit (EPAU) of a central London teaching hospital. PARTICIPANTS: We recruited 186 women. 128 had a diagnosis of EPL, and 58 of ongoing pregnancies. 11 withdrew consent, and 11 provided an illegible or invalid email address. MAIN OUTCOME MEASURES: Post-traumatic stress disorder (PTSD) was measured using the Post-traumatic Diagnostic Scale (PDS), and anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). RESULTS: Response rates were…

OBJECTIVES: Social determinants can have a major impact on health and as a consequence substantial inequalities are seen between and within countries. The study of inequalities between countries relies on having accurate and consistent measures of deprivation across the country borders. However, in the UK most socioeconomic deprivation measures are not comparable between countries. We give a method of adjusting the Indices of Multiple Deprivation (IMD) for use across the UK, describe the deprivation of each UK country, and show the problems introduced by naïvely using country-specific deprivation measures in a UK-wide analysis of mortality rates. SETTING/PARTICIPANTS: 42 148 geographic areas covering the population of the UK. OUTCOME MEASURES: Adjusted IMD scores based on the income and employment domains of country-specific IMD scores, adjusting for the contribution of other domains. The mortality rate among people aged under 75 years standardised to the UK age structure was compared between country-specific and UK-adjusted IMD quintiles. RESULTS: Of the constituent countries of…

OBJECTIVES: Evidence comparing the effectiveness of surgical and conservative treatment of symptomatic lumbar disc herniation is controversial. We sought to compare short-term and long-term effectiveness of surgical and conservative treatment in sciatica symptom severity and quality of life in patients with lumbar disc herniation in a routine clinical setting. METHODS: A prospective cohort study of a routine clinical practice registry consisting of 370 patients. Outcome measures were the North American Spine Society questionnaire and the 36-Item Short-Form Health Survey to assess patient-reported back pain, physical function, neurogenic symptoms and quality of life. Primary outcomes were back pain at 6 and 12 weeks. Standard open discectomy was assessed versus conservative interventions at 6, 12, 52 and 104 weeks. We filled in missing outcome variable values with multiple imputation, accounted for repeated measures within patients with mixed-effects models and adjusted baseline group differences in relevant prognostic indicators by inverse probability of treatment weighting.…

OBJECTIVES: (1) To evaluate the prevalence of polypharmacy (5-9 medicines) and excessive polypharmacy (10+ medicines) and (2) to determine associated demographic and clinical characteristics in an ageing population with intellectual disabilities (IDs). DESIGN: Observational cross-sectional study. SETTING: Wave One (2009/2010) of the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA). PARTICIPANTS: A nationally representative sample of 753 persons with ID, aged between 41 and 90 years. Participants/proxy reported medicines (prescription and over the counter) taken on a regular basis; medication data was available for 736 participants (98%). MAIN OUTCOME MEASURES/INTERVENTIONS: Participants were divided into those with no polypharmacy (0-4 medicines), polypharmacy (5-9 medicines) and excessive polypharmacy (10+ medicines). Medication use patterns were analysed according to demographic variables and reported chronic conditions. A multinomial logistic regression model identified factors associated with polypharmacy (5-9 medicines) and excessive…

INTRODUCTION: Many antidepressants are indicated for the treatment of major depression. Two network meta-analyses have provided the most comprehensive assessments to date, accounting for both direct and indirect comparisons; however, these reported conflicting interpretation of results. Here, we present a protocol for a systematic review and network meta-analysis aimed at updating the evidence base and comparing all second-generation as well as selected first-generation antidepressants in terms of efficacy and acceptability in the acute treatment of major depression. METHODS AND ANALYSIS: We will include all randomised controlled trials reported as double-blind and comparing one active drug with another or with placebo in the acute phase treatment of major depression in adults. We are interested in comparing the following active agents: agomelatine, amitriptyline, bupropion, citalopram, clomipramine, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, nefazodone, paroxetine, reboxetine, sertraline, trazodone, venlafaxine,…

OBJECTIVES: Self-harm is a major health problem in many countries, with potential adverse outcomes including suicide and other causes of premature death. It is important to monitor national trends in this behaviour. We examined trends in non-fatal self-harm and its management in England during the 13-year period, 2000-2012. DESIGN AND SETTING: This observational study was undertaken in the three centres of the Multicentre Study of Self-harm in England. Information on all episodes of self-harm by individuals aged 15 years and over presenting to five general hospitals in three cities (Oxford, Manchester and Derby) was collected through face-to-face assessment or scrutiny of emergency department electronic databases. We used negative binomial regression models to assess trends in rates of self-harm and logistic regression models for binary outcomes (eg, assessed vs non-assessed patients). PARTICIPANTS: During 2000-2012, there were 84,378 self-harm episodes (58.6% by females), involving 47,048 persons. RESULTS: Rates of self-harm declined in females (incidence rate ratio (IRR) 0.98; 95%…

OBJECTIVES: To assess why articles are retracted from BioMed Central journals, whether retraction notices adhered to the Committee on Publication Ethics (COPE) guidelines, and are becoming more frequent as a proportion of published articles. DESIGN/SETTING: Retrospective cross-sectional analysis of 134 retractions from January 2000 to December 2015. RESULTS: 134 retraction notices were published during this timeframe. Although they account for 0.07% of all articles published (190 514 excluding supplements, corrections, retractions and commissioned content), the rate of retraction is rising. COPE guidelines on retraction were adhered to in that an explicit reason for each retraction was given. However, some notices did not document who retracted the article (eight articles, 6%) and others were unclear whether the underlying cause was honest error or misconduct (15 articles, 11%). The largest proportion of notices was issued by the authors (47 articles, 35%). The majority of retractions were due to some form of misconduct (102 articles, 76%), that is, compromised peer review (44…

OBJECTIVE: The statistical analysis for a 2-arm randomised controlled trial (RCT) with a baseline outcome followed by a few assessments at fixed follow-up times typically invokes traditional analytic methods (eg, analysis of covariance (ANCOVA), longitudinal data analysis (LDA)). 'Constrained' longitudinal data analysis (cLDA) is a well-established unconditional technique that constrains means of baseline to be equal between arms. We use an analysis of fasting lipid profiles from the Group Medical Clinics (GMC) longitudinal RCT on patients with diabetes to illustrate applications of ANCOVA, LDA and cLDA to demonstrate theoretical concepts of these methods including the impact of missing data. METHODS: For the analysis of the illustrated example, all models were fit using linear mixed models to participants with only complete data and to participants using all available data. RESULTS: With complete data (n=195), 95% CI coverage are equivalent for ANCOVA and cLDA with an estimated 11.2 mg/dL (95% CI -19.2 to -3.3; p=0.006) lower mean low-density lipoprotein (LDL) cholesterol in GMC…

OBJECTIVES: Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes. DESIGN: 3-arm single-site open cluster randomised controlled pilot study. SETTING: 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System. PARTICIPANTS: Primary schoolgirls 14-16 years, experienced 3 menses, no precluding disability, and resident in the study area. INTERVENTIONS: 1 insertable menstrual cup, or monthly sanitary pads, against 'usual practice' control. All participants received puberty education preintervention, and hand wash soap during intervention. Schools received hand wash soap. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: school attrition (drop-out, absence); secondary: sexually transmitted infection (STI) (Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoea), reproductive tract infection (RTI) (bacterial vaginosis, Candida albicans); safety: toxic shock syndrome, vaginal Staphylococcus aureus. RESULTS: Of 751 girls enrolled 644 were followed-up for a median of 10.9…

OBJECTIVE: To review the evidence for existing prognostic models in acute pulmonary embolism (PE) and determine how valid and useful they are for predicting patient outcomes. DESIGN: Systematic review and meta-analysis. DATA SOURCES: OVID MEDLINE and EMBASE, and The Cochrane Library from inception to July 2014, and sources of grey literature. ELIGIBILITY CRITERIA: Studies aiming at constructing, validating, updating or studying the impact of prognostic models to predict all-cause death, PE-related death or venous thromboembolic events up to a 3-month follow-up in patients with an acute symptomatic PE. DATA EXTRACTION: Study characteristics and study quality using prognostic criteria. Studies were selected and data extracted by 2 reviewers. DATA ANALYSIS: Summary estimates (95% CI) for proportion of risk groups and event rates within risk groups, and accuracy. RESULTS: We included 71 studies (44,298 patients). Among them, 17 were model construction studies specific to PE prognosis. The most validated models were the PE Severity Index (PESI) and its simplified version (sPESI). The…

OBJECTIVES: To systematically review the effectiveness of community pharmacy-delivered interventions for alcohol reduction, smoking cessation and weight management. DESIGN: Systematic review and meta-analyses. 10 electronic databases were searched from inception to May 2014. STUDY DESIGN: randomised and non-randomised controlled trials; controlled before/after studies, interrupted times series. INTERVENTION: any relevant intervention set in a community pharmacy, delivered by the pharmacy team. No restrictions on duration, country, age, or language. RESULTS: 19 studies were included: 2 alcohol reduction, 12 smoking cessation and 5 weight management. Study quality rating: 6 'strong', 4 'moderate' and 9 'weak'. 8 studies were conducted in the UK, 4 in the USA, 2 in Australia, 1 each in 5 other countries. Evidence from 2 alcohol-reduction interventions was limited. Behavioural support and/or nicotine replacement therapy are effective and cost-effective for smoking cessation: pooled OR was 2.56 (95% CI 1.45 to 4.53) for active intervention vs usual care. Pharmacy-based interventions…

OBJECTIVES: The association of volunteering with well-being has been found in previous research, but mostly among older people. The aim of this study was to examine the association of volunteering with mental well-being among the British population across the life course. DESIGN: British Household Panel Survey, a population-based longitudinal study. SETTING: UK. PARTICIPANTS: 66 343 observations (person-years). MAIN OUTCOME MEASURES: Mental well-being was measured by using the General Health Questionnaire (GHQ-12 or GHQ); high values denote high mental disorder. Four groups of volunteering participation were created: frequent (once a week), infrequent (once a month/several times a year), rare (once or less a year) and never. Multilevel linear models were used to analyse variations in mental well-being over the life course by levels of volunteering. RESULTS: When not considering age, those who engaged in volunteering regularly appeared to experience higher levels of mental well-being than those who never volunteered. To explore the association of volunteering with the GHQ across the…

OBJECTIVES: The clinical impact of preoperative physiotherapy on recovery after joint replacement remains controversial. This systematic review aimed to assess the clinical impact of prehabilitation before joint replacement. DESIGN: We searched PubMed, Embase and Cochrane CENTRAL up to November 2015 for randomised controlled trials comparing prehabilitation versus no prehabilitation before joint replacement surgery. Postoperative pain and function scores were converted to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function subscales (0-100, high scores indicate worse outcome). Random effects meta-analysis was performed to calculate weighted mean differences (WMD, 95% CI), subgrouped by hip and knee surgery. PRIMARY AND SECONDARY OUTCOMES: Postoperative pain and function scores, time to resume activities of daily living, quality of life, length of hospital stay, total cost, patient satisfaction, postoperative complications, any adverse events and discontinuations. RESULTS: Of 22 studies (1492 patients), 18 had high risk of bias. Prehabilitation…

OBJECTIVES: To examine the association between marital status and dementia in a cohort of young-old (50-64) and middle-old (65-74) adults, and also whether this may differ by gender. DESIGN: Prospective population-based study with follow-up time of up to 10 years. SETTING: Swedish national register-based study. PARTICIPANTS: 2,288,489 individuals, aged 50-74 years, without prior dementia diagnosis at baseline. Dementia was identified using the Swedish National Patient Register and the Cause of Death Register. OUTCOME MEASURES: The influence of marital status on dementia was analysed using Cox proportional hazards models, adjusted stepwise for multiple covariates (model 1: adjusted for age and gender; and model 2: additionally adjusted for having adult children, education, income and prior cardiovascular disease). RESULTS: During follow-up, 31,572 individuals in the study were identified as demented. Cox regression showed each non-married subcategory to be associated with a significantly higher risk of dementia than the married group, with the highest risk observed among people in…

OBJECTIVE: To summarise the evidence regarding the effectiveness of integrated care interventions in reducing hospital activity. DESIGN: Umbrella review of systematic reviews and meta-analyses. SETTING: Interventions must have delivered care crossing the boundary between at least two health and/or social care settings. PARTICIPANTS: Adult patients with one or more chronic diseases. DATA SOURCES: MEDLINE, Embase, ASSIA, PsycINFO, HMIC, CINAHL, Cochrane Library (HTA database, DARE, Cochrane Database of Systematic Reviews), EPPI-Centre, TRIP, HEED, manual screening of references. OUTCOME MEASURES: Any measure of hospital admission or readmission, length of stay (LoS), accident and emergency use, healthcare costs. RESULTS: 50 reviews were included. Interventions focused on case management (n=8), chronic care model (CCM) (n=9), discharge management (n=15), complex interventions (n=3), multidisciplinary teams (MDT) (n=10) and self-management (n=5). 29 reviews reported statistically significant improvements in at least one outcome. 11/21 reviews reported significantly reduced emergency…

RATIONALE: Medical masks are commonly used by sick individuals with influenza-like illness (ILI) to prevent spread of infections to others, but clinical efficacy data are absent. OBJECTIVE: Determine whether medical mask use by sick individuals with ILI protects well contacts from related respiratory infections. SETTING: 6 major hospitals in 2 districts of Beijing, China. DESIGN: Cluster randomised controlled trial. PARTICIPANTS: 245 index cases with ILI. INTERVENTION: Index cases with ILI were randomly allocated to medical mask (n=123) and control arms (n=122). Since 43 index cases in the control arm also used a mask during the study period, an as-treated post hoc analysis was performed by comparing outcomes among household members of index cases who used a mask (mask group) with household members of index cases who did not use a mask (no-mask group). MAIN OUTCOME MEASURE: Primary outcomes measured in household members were clinical respiratory illness, ILI and laboratory-confirmed viral respiratory infection. RESULTS: In an intention-to-treat analysis, rates of clinical…

OBJECTIVES: To (1) quantify levels of subjective health literacy in people with long-term health conditions (diabetes, cardiovascular disease, chronic obstructive pulmonary disease, musculoskeletal disorders, cancer and mental disorders) and compare these to levels in the general population and (2) examine the association between health literacy, socioeconomic characteristics and comorbidity in each long-term condition group. DESIGN: Population-based survey in the Central Denmark Region (n=29,473). MAIN OUTCOME MEASURES: Health literacy was measured using two scales from the Health Literacy Questionnaire (HLQ): (1) Ability to understand health information and (2) Ability to actively engage with healthcare providers. RESULTS: People with long-term conditions reported more difficulties than the general population in understanding health information and actively engaging with healthcare providers. Wide variation was found between disease groups, with people with cancer having fewer difficulties and people with mental health disorders having more difficulties in actively engaging with…

OBJECTIVE: Since its birth about 30 years ago, Narrative Medicine approach has increased in popularity in the medical context as well as in other disciplines. This paper aims to review Narrative Medicine research studies on patients' and their caregivers' illness experience. SETTING AND PARTICIPANTS: MEDLINE, Psycinfo, EBSCO Psychological and Behavioural Science, The Cochrane Library and CINAHL databases were searched to identify all the research studies which focused on the Narrative Medicine approach reported in the title, in the abstract and in the keywords the words 'Narrative Medicine' or 'Narrative-based Medicine'. PRIMARY AND SECONDARY OUTCOME MEASURES: number of participants, type of disease, race and age of participants, type of study, dependent variables, intervention methods, assessment. RESULTS: Of the 325 titles screened, we identified 10 research articles fitting the inclusion criteria. Our systematic review showed that research on Narrative Medicine has no common specific methodology: narrative in Medicine is used as an intervention protocol as well as an assessment…

OBJECTIVES: To determine chronic opioid use pre-THA (total hip arthroplasty) and post-THA, and risk factors for persistent or new chronic opioid use post-THA. DESIGN: Retrospective cohort study. SETTING: Australian Government Department of Veterans' Affairs health claims database. PARTICIPANTS: 9525 patients who had an elective unilateral THA between 1/01/2001 and 12/31/2012. PRIMARY OUTCOME MEASURE: Chronic opioid use. Defined as 90 days of continuous opioid use or 120 days of non-continuous use. RESULTS: Pre-THA, 6.2% (n=593) of patients were chronic users, while 5.2% (n=492) were post-THA. Among the 492 postoperative chronic users, 302 (61%) were chronic users pre-THA and post-THA and 190 (39%) became new chronic users after surgery. Risk factors for persistent chronic use were younger age (OR=0.96, 95% CI 0.93 to 0.99/1-year increment), back pain (OR=1.99, 95% CI 1.20 to 3.23), diabetes (OR=3.52, 95% CI 1.05 to 11.8), hypnotics use (OR=2.52, 95% CI 1.48 to 4.30) and higher pre-THA opioid exposure (compared with opioid use for 94-157 days, 157-224 days (OR=3.75, 95% CI 2.28 to…

INTRODUCTION: The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. OBJECTIVE: To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). METHODS: Drug approval data were downloaded from the EMA website and the 'Drugs@FDA' database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. RESULTS: Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA…

PURPOSE: The Royal College of General Practitioners Research and Surveillance Centre (RCGP RSC) is one of the longest established primary care sentinel networks. In 2015, it established a new data and analysis hub at the University of Surrey. This paper evaluates the representativeness of the RCGP RSC network against the English population. PARTICIPANTS AND METHOD: The cohort includes 1 042 063 patients registered in 107 participating general practitioner (GP) practices. We compared the RCGP RSC data with English national data in the following areas: demographics; geographical distribution; chronic disease prevalence, management and completeness of data recording; and prescribing and vaccine uptake. We also assessed practices within the network participating in a national swabbing programme. FINDINGS TO DATE: We found a small over-representation of people in the 25-44 age band, under-representation of white ethnicity, and of less deprived people. Geographical focus is in London, with less practices in the southwest and east of England. We found differences in the prevalence of…

OBJECTIVES: To compare the acute effects of uninterrupted sitting with sitting interrupted by brief bouts of light-intensity walking on self-reported fatigue, cognition, neuroendocrine biomarkers and cardiometabolic risk markers in overweight/obese adults. DESIGN: Randomised two-condition crossover trial. SETTING: Laboratory study conducted in Melbourne, Australia. PARTICIPANTS: 19 overweight/obese adults (45-75 years). INTERVENTIONS: After an initial 2 h period seated, participants consumed a meal-replacement beverage and completed (on 2 days separated by a 6-day washout period) each condition over the next 5 h: uninterrupted sitting (sedentary condition) or sitting with 3 min bouts of light-intensity walking every 30 min (active condition). PRIMARY OUTCOME MEASURES: Self-reported fatigue, executive function and episodic memory at 0 h, 4 h and 7 h. SECONDARY OUTCOME MEASURES: Neuroendocrine biomarkers and cardiometabolic risk markers (blood collections at 0 h, 4 h and 7 h, blood pressure and heart rate measured hourly and interstitial glucose measured using a continuous glucose…

OBJECTIVES: While there is good evidence for associations between short-term exposure to ozone and a range of adverse health outcomes, the evidence from narrative reviews for long-term exposure is suggestive of associations with respiratory mortality only. We conducted a systematic, quantitative evaluation of the evidence from cohort studies, reporting associations between long-term exposure to ozone and mortality. METHODS: Cohort studies published in peer-reviewed journals indexed in EMBASE and MEDLINE to September 2015 and PubMed to October 2015 and cited in reviews/key publications were identified via search strings using terms relating to study design, pollutant and health outcome. Study details and estimate information were extracted and used to calculate standardised effect estimates expressed as HRs per 10 ppb increment in long-term ozone concentrations. RESULTS: 14 publications from 8 cohorts presented results for ozone and all-cause and cause-specific mortality. We found no evidence of associations between long-term annual O3 concentrations and the risk of death from all…

OBJECTIVES: Current musculoskeletal outcome tools are fragmented across different healthcare settings and conditions. Our objectives were to develop and validate a single musculoskeletal outcome measure for use throughout the pathway and patients with different musculoskeletal conditions: the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ). SETTING: A consensus workshop with stakeholders from across the musculoskeletal community, workshops and individual interviews with a broad mix of musculoskeletal patients identified and prioritised outcomes for MSK-HQ inclusion. Initial psychometric validation was conducted in four cohorts from community physiotherapy, and secondary care orthopaedic hip, knee and shoulder clinics. PARTICIPANTS: Stakeholders (n=29) included primary care, physiotherapy, orthopaedic and rheumatology patients (n=8); general practitioners, physiotherapists, orthopaedists, rheumatologists and pain specialists (n=7), patient and professional national body representatives (n=10), and researchers (n=4). The four validation cohorts included 570…

OBJECTIVES: To describe implementation of a new national preventive programme to reduce cardiovascular morbidity. DESIGN: Observational study over 4 years (April 2009--March 2013). SETTING: 655 general practices across England from the QResearch database. PARTICIPANTS: Eligible adults aged 40-74 years including attendees at a National Health Service (NHS) Health Check. INTERVENTION: NHS Health Check: routine structured cardiovascular check with support for behavioural change and in those at highest risk, treatment of risk factors and newly identified comorbidity. RESULTS: Of 1.68 million people eligible for an NHS Health Check, 214 295 attended in the period 2009-12. Attendance quadrupled as the programme progressed; 5.8% in 2010 to 30.1% in 2012. Attendance was relatively higher among older people, of whom 19.6% of those eligible at age 60-74 years attended and 9.0% at age 40-59 years. Attendance by population groups at higher cardiovascular disease (CVD) risk, such as the more socially disadvantaged 14.9%, was higher than that of the more affluent 12.3%. Among attendees 7844 new…

OBJECTIVES: Systematic review and meta-analysis of published observational cohort studies. To quantify the increased risk smokers have of experiencing a delayed and/or non-union in fractures, spinal fusion, osteotomy, arthrodesis or established non-unions. SETTING: Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Allied and Complementary Medicine Database (AMED) and Web of Science Core Collection from 1966 to 2015. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS AND INTERVENTIONS: Observational cohort studies that reported adult smokers and non-smokers with delayed and/or non-union or time to union of the fracture, spinal fusion, osteotomy, arthrodesis or established non-union were eligible. DATA EXTRACTION AND OUTCOME MEASURES: 2 authors screen titles, abstracts and full papers. Data were extracted by 1 author and checked independently by a second. The relative risk ratios of smoking versus non-smoking and the mean difference in time to union patients developing a delayed and/or non-union were calculated. RESULTS: The search identified…

OBJECTIVE: Danish medical registries are widely used for cardiovascular research, but little is known about the data quality of cardiac interventions. We computed positive predictive values (PPVs) of codes for cardiac examinations, procedures and surgeries registered in the Danish National Patient Registry during 2010-2012. DESIGN: Population-based validation study. SETTING: We randomly sampled patients from 1 university hospital and 2 regional hospitals in the Central Denmark Region. PARTICIPANTS: 1239 patients undergoing different cardiac interventions. MAIN OUTCOME MEASURE: PPVs with medical record review as reference standard. RESULTS: A total of 1233 medical records (99% of the total sample) were available for review. PPVs ranged from 83% to 100%. For examinations, the PPV was overall 98%, reflecting PPVs of 97% for echocardiography, 97% for right heart catheterisation and 100% for coronary angiogram. For procedures, the PPV was 98% overall, with PPVs of 98% for thrombolysis, 92% for cardioversion, 100% for radiofrequency ablation, 98% for percutaneous coronary intervention,…

OBJECTIVE: To determine the association between subjective social status (SSS), or the individual's perception of his or her position in the social hierarchy, and the odds of coronary artery disease (CAD), hypertension, diabetes, obesity and dyslipidaemia. STUDY DESIGN: Systematic review and meta-analysis. METHODS: We searched PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, SocINDEX, Web of Science and reference lists of all included studies up to October 2014, with a verification search in July 2015. Inclusion criteria were original studies in adults that reported odds, risk or hazard ratios of at least one outcome of interest (CAD, hypertension, diabetes, obesity or dyslipidaemia), comparing 'lower' versus 'higher' SSS groups, where SSS is measured on a self-anchoring ladder. ORs were pooled using a random-effects model. RESULTS: 10 studies were included in the systematic review; 9 of these were included in the meta-analysis. In analyses unadjusted for objective socioeconomic status (SES) measures such as income, education or occupation, the pooled OR comparing the bottom versus the…

INTRODUCTION: Ageing--along with its associated physiological and pathological changes--places individuals at a higher risk of multimorbidity and treatment-related complications. Today, polypharmacy, a common and important problem related to drug use, occurs subsequent to this multimorbidity in the elderly in all populations. In recent decades, several scientific investigations have studied polypharmacy and its correlates, using different approaches and definitions, and their results have been inconclusive. Differences in definitions and approaches in these studies form a barrier against reaching a conclusion regarding the risk factors and consequences of polypharmacy. It is therefore imperative to establish an appropriate definition of polypharmacy. METHODS AND ANALYSIS: A systematic review will be conducted using PubMed, Scopus, Web of Science, EMBASE, PsycINFO and AgeLine bibliographic databases, as well as the grey literature on polypharmacy in older adults to answer these two questions: What definitions in the literature are being used for polypharmacy in older people?, and…

Objectives To study Mesoamerican nephropathy (MeN) and its risk factors in three hot occupations. Design Cross-sectional. Setting Chinandega and León municipalities, a MeN hotspot on the Nicaraguan Pacific coast, January–February 2013. Participants 194 male workers aged 17–39 years: 86 sugarcane cutters, 56 construction workers, 52 small-scale farmers. Outcome measures (1) Differences between the three occupational groups in prevalences/levels of socioeconomic, occupational, lifestyle and health risk factors for chronic kidney disease (CKD) and in biomarkers of kidney function and hydration; (2) differences in prevalences/levels of CKD risk factors between workers with reduced estimated glomerular filtration rate (eGFR CKD-EPI <80 mL/min/1.73 m 2 ) and workers with normal kidney function (eGFR CKD-EPI ≥80 mL/min/1.73 m 2 ). Results Sugarcane cutters were more exposed to heat and consumed more fluid on workdays and had less obesity, lower blood sugar, lower blood pressure and a better lipid profile. Reduced eGFR occurred in 16%, 9% and 2% of sugarcane cutters, construction workers…

OBJECTIVES: To explore the barriers to cervical cancer screening, focusing on religious and cultural factors, in order to inform group-specific interventions that may improve uptake of cervical cancer screening programmes. DESIGN: We conducted four focus group discussions among Muslim and Christian women in Nigeria. SETTING: Discussions were conducted in two hospitals, one in the South West and the other in the North Central region of Nigeria. PARTICIPANTS: 27 Christian and 22 Muslim women over the age of 18, with no diagnosis of cancer. RESULTS: Most participants in the focus group discussions had heard about cervical cancer except Muslim women in the South Western region who had never heard about cervical cancer. Participants believed that wizardry, multiple sexual partners and inserting herbs into the vagina cause cervical cancer. Only one participant knew about the human papillomavirus. Among the Christian women, the majority of respondents had heard about cervical cancer screening and believed that it could be used to prevent cervical cancer. Participants mentioned religious…

OBJECTIVES: There is no consensus on whether studies with no observed events in the treatment and control arms, the so-called both-armed zero-event studies, should be included in a meta-analysis of randomised controlled trials (RCTs). Current analytic approaches handled them differently depending on the choice of effect measures and authors' discretion. Our objective is to evaluate the impact of including or excluding both-armed zero-event (BA0E) studies in meta-analysis of RCTs with rare outcome events through a simulation study. METHOD: We simulated 2500 data sets for different scenarios varying the parameters of baseline event rate, treatment effect and number of patients in each trial, and between-study variance. We evaluated the performance of commonly used pooling methods in classical meta-analysis-namely, Peto, Mantel-Haenszel with fixed-effects and random-effects models, and inverse variance method with fixed-effects and random-effects models-using bias, root mean square error, length of 95% CI and coverage. RESULTS: The overall performance of the approaches of including or…

OBJECTIVES: This cross-sectional study aimed to explore job satisfaction among healthcare staff in Guangdong following the health system reforms in 2009, and to investigate the association between job satisfaction and work stress, work-family conflict and doctor-patient relationship. DESIGN: Cross-sectional survey. SETTING: The Fifth National Health Service Survey was carried out in Guangdong, China. PARTICIPANTS: All participants in this study were healthcare staff including physicians, nurses and public health staff from hospitals, health service centres and health clinics. A total of 6583 questionnaires were distributed and collected. After excluding the incomplete questionnaires, 5845 questionnaires were included for the analysis. OUTCOME MEASURES: Sociodemographic information and scores for evaluating job satisfaction, work stress, work-family conflict and doctor-patient relationship were obtained using the questionnaire developed by the National Health and Family Planning Commission of the People's Republic of China. To assess the significantly associated factors on job…

OBJECTIVES: To examine whether the association between emotional support and indicators of health and quality of life differs between Canadian and Latin American older adults. DESIGN: Cross-sectional analysis of the International Mobility in Aging Study (IMIAS). Social support from friends, family members, children and partner was measured with a previously validated social network and support scale (IMIAS-SNSS). Low social support was defined as ranking in the lowest site-specific quartile. Prevalence ratios (PR) of good health, depression and good quality of life were estimated with Poisson regression models, adjusting for age, gender, education, income and disability in activities of daily living. SETTING: Kingston and Saint-Hyacinthe in Canada, Manizales in Colombia and Natal in Brazil. PARTICIPANTS: 1600 community-dwelling adults aged 65-74 years, n=400 at each site. OUTCOME MEASURES: Likert scale question on self-rated health, Center for Epidemiological Studies Depression Scale and 10-point analogical quality-of-life (QoL) scale. RESULTS: Relationships between social support…

OBJECTIVE: To summarise existing systematic reviews that assess the effects of non-pharmacological, pharmacological and alternative therapies on activities of daily living (ADL) function in people with dementia. DESIGN: Overview of systematic reviews. METHODS: A systematic search in the Cochrane Database of Systematic Reviews, DARE, Medline, EMBASE and PsycInfo in April 2015. Systematic reviews of randomised controlled trials conducted in people with Alzheimer's disease or dementia measuring the impact on ADL function were included. Methodological quality of the systematic reviews was independently assessed by two authors using the AMSTAR tool. The quality of evidence of the primary studies for each intervention was assessed using GRADE. RESULTS: A total of 23 systematic reviews were included in the overview. The quality of the reviews varied; however most (65%) scored 8/11 or more on the AMSTAR tool, indicating high quality. Interventions that were reported to be effective in minimising decline in ADL function were: exercise (6 studies, 289 participants, standardised mean…

OBJECTIVES: The primary objective was to describe Ugandan schoolgirls' menstrual hygiene management (MHM) practices and estimate the prevalence of inadequate MHM. Second, to assess the relative contribution of aspects of MHM to health, education and psychosocial outcomes. DESIGN: Secondary analysis of survey data collected as part of the final follow-up from a controlled trial of reusable sanitary pad and puberty education provision was used to provide a cross-sectional description of girls' MHM practices and assess relationships with outcomes. SETTING: Rural primary schools in the Kamuli district, Uganda. PARTICIPANTS: Participants were 205 menstruating schoolgirls (10-19 years) from the eight study sites. PRIMARY AND SECONDARY OUTCOME MEASURES: The prevalence of adequate MHM, consistent with the concept definition, was estimated using dimensions of absorbent used, frequency of absorbent change, washing and drying procedures and privacy. Self-reported health, education (school attendance and engagement) and psychosocial (shame, insecurity, embarrassment) outcomes hypothesised to…

OBJECTIVES: Investigate the work-life balance of doctors in training in the UK from the perspectives of trainers and trainees. DESIGN: Qualitative semistructured focus groups and interviews with trainees and trainers. SETTING: Postgraduate medical training in London, Yorkshire and Humber, Kent, Surrey and Sussex, and Wales during the junior doctor contract dispute at the end of 2015. Part of a larger General Medical Council study about the fairness of postgraduate medical training. PARTICIPANTS: 96 trainees and 41 trainers. Trainees comprised UK graduates and International Medical Graduates, across all stages of training in 6 specialties (General Practice, Medicine, Obstetrics and Gynaecology, Psychiatry, Radiology, Surgery) and Foundation. RESULTS: Postgraduate training was characterised by work-life imbalance. Long hours at work were typically supplemented with revision and completion of the e-portfolio. Trainees regularly moved workplaces which could disrupt their personal lives and sometimes led to separation from friends and family. This made it challenging to cope with…

OBJECTIVE: The main objective of this study was to determine the relationship between the characteristics of nurses' work environments in hospitals in the Spanish National Health System (SNHS) with nurse reported quality of care, and how care was provided by using different shifts schemes. The study also examined the relationship between job satisfaction, burnout, sleep quality and daytime drowsiness of nurses and shift work. METHODS: This was a multicentre, observational, descriptive, cross-sectional study, centred on a self-administered questionnaire. The study was conducted in seven SNHS hospitals of different sizes. We recruited 635 registered nurses who worked on day, night and rotational shifts on surgical, medical and critical care units. Their average age was 41.1 years, their average work experience was 16.4 years and 90% worked full time. A descriptive and bivariate analysis was carried out to study the relationship between work environment, quality and safety care, and sleep quality of nurses working different shift patterns. RESULTS: 65.4% (410) of nurses worked on a…

BACKGROUND: Approximately 15 million babies were born preterm worldwide in 2010 and in England in 2014 there were 52 249 preterm births. Preterm babies are at increased risk of poor outcomes and this can put enormous strain on the family. OBJECTIVE: This study aimed to test the hypothesis that giving birth preterm affects maternal health, mood and well-being, and alters women's feelings and perceptions about their baby. METHODS: Data collected in a population-based survey of maternity care in England in 2014 were used. Women were randomly selected and asked about their pregnancy, birth and postnatal experience when their babies were about 3 months of age. Descriptive statistics were produced, and logistic regression used to estimate ORs, adjusted for key confounders.Main outcome measures-Women's self-reported postnatal health, Edinburgh Postnatal Depression Scale, women's perceptions of their baby. RESULTS: 4578 women returned completed questionnaires. Of these, 42 (0.9%) had babies born before 32 weeks' gestation and 243 (5.5%) at 32-36 weeks. Comparing the three gestational age…

OBJECTIVES: To evaluate the impact of dietary sodium and potassium (Na-K) ratio on mortality from total and subtypes of stroke, cardiovascular disease (CVD) and all causes, using 24-year follow-up data of a representative sample of the Japanese population. SETTING: Prospective cohort study. PARTICIPANTS: In the 1980 National Cardiovascular Survey, participants were followed for 24 years (NIPPON DATA80, National Integrated Project for Prospective Observation of Non-communicable Disease And its Trends in the Aged). Men and women aged 30-79 years without hypertensive treatment, history of stroke or acute myocardial infarction (n=8283) were divided into quintiles according to dietary Na-K ratio assessed by a 3-day weighing dietary record at baseline. Age-adjusted and multivariable-adjusted HRs were calculated using the Mantel-Haenszel method and Cox proportional hazards model. PRIMARY OUTCOME MEASURES: Mortality from total and subtypes of stroke, CVD and all causes. RESULTS: A total of 1938 deaths from all causes were observed over 176 926 person-years. Na-K ratio was significantly and…

OBJECTIVES: Retirement constitutes a major life transition that poses significant challenges to health, with many retirees experiencing a precipitous decline in health status following retirement. We examine the extent to which membership in social groups following retirement determines quality of life and mortality. DESIGN: The longitudinal impact of the number of social group memberships before and after the transition to retirement was assessed on retirees' quality of life and risk of death 6 years later. SETTING: Nationally representative cohort study of older adults living in England. PARTICIPANTS: Adults who underwent the transition to retirement (N=424). A matched control group (N=424) of participants who had comparable demographic and health characteristics at baseline but did not undergo the transition to retirement were also examined. OUTCOME MEASURES: Analyses examined participants' quality of life and mortality during a period of 6 years. RESULTS: Retirees who had two group memberships prior to retirement had a 2% risk of death in the first 6 years of retirement if they…

OBJECTIVE: To assess the adequacy of reporting of non-inferiority trials alongside the consistency and utility of current recommended analyses and guidelines. DESIGN: Review of randomised clinical trials that used a non-inferiority design published between January 2010 and May 2015 in medical journals that had an impact factor >10 (JAMA Internal Medicine, Archives Internal Medicine, PLOS Medicine, Annals of Internal Medicine, BMJ, JAMA, Lancet and New England Journal of Medicine). DATA SOURCES: Ovid (MEDLINE). METHODS: We searched for non-inferiority trials and assessed the following: choice of non-inferiority margin and justification of margin; power and significance level for sample size; patient population used and how this was defined; any missing data methods used and assumptions declared and any sensitivity analyses used. RESULTS: A total of 168 trial publications were included. Most trials concluded non-inferiority (132; 79%). The non-inferiority margin was reported for 98% (164), but less than half reported any justification for the margin (77; 46%). While most chose two…

OBJECTIVES: (A) To gain insights into the experiences of patients invited to view their doctors' visit notes, with a focus on those who review multiple notes; (B) to examine the relationships among fully transparent electronic medical records and quality of care, the patient-doctor relationship, patient engagement, self-care, self-management skills and clinical outcomes. DESIGN: Mixed methods qualitative study: analyses of survey data, including content analysis of free-text answers, and quantitative-descriptive measures combined with semistructured individual interviews, patient activation measures, and member checks. SETTING: Greater Boston, USA. PARTICIPANTS: Patients cared for by primary care physicians (PCPs) at the Beth Israel Deaconess Medical Center who had electronic access to their PCP visit notes. Among those submitting surveys, 576 free-text answers were identified and analysed (414 from female patients, 162 from male patients; 23-88 years). In addition, 13 patients (9 female, 4 male; 58-87 years) were interviewed. RESULTS: Patient experiences indicate improved…

OBJECTIVE: To examine patterns of energy drink consumption by children and young people, attitudes towards these drinks, and any associations with health or other outcomes. DESIGN: Rapid evidence assessment and narrative synthesis. DATA SOURCES: 9 electronic bibliographic databases, reference lists of relevant studies and searches of the internet. RESULTS: A total of 410 studies were located, with 46 meeting the inclusion criteria. The majority employed a cross-sectional design, involved participants aged 11-18 years, and were conducted in North America or Europe. Consumption of energy drinks by children and young people was found to be patterned by gender, with boys consuming more than girls, and also by activity levels, with the highest consumption observed in the most and least sedentary individuals. Several studies identified a strong, positive association between the use of energy drinks and higher odds of health-damaging behaviours, as well as physical health symptoms such as headaches, stomach aches, hyperactivity and insomnia. There was some evidence of a dose-response…

OBJECTIVES: The aim of this study was to evaluate the peripapillary and parafoveal perfusion of young, healthy myopic subjects with spectral domain optical coherence tomography (OCT) angiography. DESIGN: A prospective comparative study was conducted from December 2014 to January 2015. SETTING: Participants recruited from a population-based study performed by the Eye, Ear, Nose and Throat Hospital of Fudan University in Shanghai. PARTICIPANTS: A total of 78 Chinese normal subjects (78 eyes) with different refraction were included. Myopia was divided into 4 groups on the basis of the refractive status: 20 eyes with emmetropia (mean spherical equivalent (MSE) 0.50D to -0.50D), 20 eyes with mild myopia (MSE -0.75D to -2.75D), 20 eyes with moderate myopia (MSE -3.00D to -5.75D), and 18 eyes with high myopia (MSE≤-6.00D). MAIN OUTCOME MEASURES: Peripapillary and parafoveal retinal and choroidal perfusion parameters and their relationships with axial length (AL) and retinal nerve fibre layer (RNFL) thickness were analysed. RESULTS: Significant differences were found for the retinal flow…

OBJECTIVE AND DESIGN: We conducted a systematic review and meta-analysis to evaluate the incidence of adverse events in the emergency department (ED) during procedural sedation in the paediatric population. Randomised controlled trials and observational studies from the past 10 years were included. We adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. SETTING: ED. PARTICIPANTS: Children. INTERVENTIONS: Procedural sedation. OUTCOMES: Adverse events like vomiting, agitation, hypoxia and apnoea. Meta-analysis was performed with random-effects model and reported as incidence rates with 95% CIs. RESULTS: A total of 1177 studies were retrieved for screening and 258 were selected for full-text review. 41 studies reporting on 13 883 procedural sedations in 13 876 children (≤18 years) were included. The most common adverse events (all reported per 1000 sedations) were: vomiting 55.5 (CI 45.2 to 65.8), agitation 17.9 (CI 12.2 to 23.7), hypoxia 14.8 (CI 10.2 to 19.3) and apnoea 7.1 (CI 3.2 to 11.0). The need to intervene with either bag valve…

OBJECTIVE: Because of the lack of head-to-head trials, the aim was to indirectly compare sodium glucose transporter-2 (SGLT-2) inhibitors in the treatment of type 2 diabetes. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: MEDLINE and EMBASE were searched from January 2005 to January 2015. ELIGIBILITY CRITERIA: Randomised controlled trials assessing the efficacy of SGLT-2 inhibitors in patients with type 2 diabetes inadequately controlled with diet and exercise alone or metformin monotherapy. Minimum duration 24 weeks. Indirect comparison was undertaken using Bayesian methods. RESULTS: In monotherapy, a greater proportion of patients achieved a glycated haemoglobin (HbA1c) level of <7% on canagliflozin 300 mg than on canagliflozin 100 mg (risk ratio (RR) 0.72%, 95% credible intervals (CrI) 0.59% to 0.87%) and dapagliflozin 10 mg (RR 0.63, 95% CrI 0.48 to 0.85) but there were no significant differences compared with either dose of empagliflozin. In monotherapy, canagliflozin 300 mg reduced HbA1c more than other SGLT-2 inhibitors (mean difference ranged from 0.20%…

OBJECTIVE: To investigate whether cannabis use is associated with increased risk of relapse, as indexed by number of hospital admissions, and whether antipsychotic treatment failure, as indexed by number of unique antipsychotics prescribed, may mediate this effect in a large data set of patients with first episode psychosis (FEP). DESIGN: Observational study with exploratory mediation analysis. SETTING: Anonymised electronic mental health record data from the South London and Maudsley NHS Foundation Trust. PARTICIPANTS: 2026 people presenting to early intervention services with FEP. EXPOSURE: Cannabis use at presentation, identified using natural language processing. MAIN OUTCOME MEASURES: admission to psychiatric hospital and clozapine prescription up to 5 years following presentation. MEDIATOR: Number of unique antipsychotics prescribed. RESULTS: Cannabis use was present in 46.3% of the sample at first presentation and was particularly common in patients who were 16-25, male and single. It was associated with increased frequency of hospital admission (incidence rate ratio 1.50,…

OBJECTIVE: To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use. DESIGN: Open-label, assessor blind, randomised controlled trial. SETTING: 2 public hospitals in Sydney, Australia. POPULATION: 176 nulliparous women with low-risk pregnancies, attending hospital-based antenatal clinics. METHODS AND INTERVENTION: The Complementary Therapies for Labour and Birth protocol, based on the She Births and acupressure for labour and birth courses, incorporated 6 evidence-based complementary medicine techniques: acupressure, visualisation and relaxation, breathing, massage, yoga techniques, and facilitated partner support. Randomisation occurred at 24-36 weeks' gestation, and participants attended a 2-day antenatal education programme plus standard care, or standard care alone. MAIN OUTCOME MEASURES: Rate of analgesic epidural use. Secondary: onset of labour, augmentation, mode of birth, newborn outcomes. RESULTS: There was a significant difference in epidural use between the 2 groups: study…

INTRODUCTION: Type 1 diabetes can be diagnosed at an early presymptomatic stage by the detection of islet autoantibodies. The Fr1da study aims to assess whether early staging of type 1 diabetes (1) is feasible at a population-based level, (2) prevents severe metabolic decompensation observed at the clinical manifestation of type 1 diabetes and (3) reduces psychological distress through preventive teaching and care. METHODS AND ANALYSIS: Children aged 2-5 years in Bavaria, Germany, will be tested for the presence of multiple islet autoantibodies. Between February 2015 and December 2016, 100 000 children will be screened by primary care paediatricians. Islet autoantibodies are measured in capillary blood samples using a multiplex three-screen ELISA. Samples with ELISA results >97.5th centile are retested using reference radiobinding assays. A venous blood sample is also obtained to confirm the autoantibody status of children with at least two autoantibodies. Children with confirmed multiple islet autoantibodies are diagnosed with pre-type 1 diabetes. These children and their parents…

OBJECTIVES: To investigate whether intergroup contact in addition to education is more effective than education alone in reducing stigma of mental illness in adolescents. DESIGN: A pragmatic cluster randomised controlled trial compared education alone with education plus contact. Blocking was used to randomly stratify classes within schools to condition. Random allocation was concealed, generated by a computer algorithm, and undertaken after pretest. Data was collected at pretest and 2-week follow-up. Analyses use an intention-to-treat basis. SETTING: Secondary schools in Birmingham, UK. PARTICIPANTS: The parents and guardians of all students in year 8 (age 12-13 years) were approached to take part. INTERVENTIONS: A 1-day educational programme in each school led by mental health professional staff. Students in the 'contact' condition received an interactive session with a young person with lived experience of mental illness. OUTCOMES: The primary outcome was students' attitudinal stigma of mental illness. Secondary outcomes included knowledge-based stigma, mental health literacy,…

OBJECTIVES: We examined the level of agreement between biomedical and self-reported measurements of hypertension and diabetes in a Chinese national community sample, and explored associations of the agreement and possible contextual effects among provinces and geographic regions in China. DESIGN: Secondary analysis of a cohort sample. SETTING AND PARTICIPANTS: Community samples were drawn from the national baseline survey of the China Health and Retirement Longitudinal Study (CHARLS, 2011-2012) through multistage probability sampling, which included households with members 45 years of age or above with a total sample size of 17,708 individuals. OUTCOME MEASURES: Sensitivity, specificity and κ were used as measurements of agreements or validity; variance of validity measures among provinces and communities was estimated using random-effects models. RESULTS: Self-reports for hypertension and diabetes showed high specificity (96.3% and 98.3%, respectively) but low sensitivity (56.3% and 61.5%, respectively). Agreement between self-reported data and biomedical measurements was moderate…

OBJECTIVES: Many countries are facing provider shortages and imbalances in primary care or are projecting shortfalls for the future, triggered by the rise in chronic diseases and multimorbidity. In order to assess the potential of nurse practitioners (NPs) in expanding access, we analysed the size, annual growth (2005-2015) and the extent of advanced practice of NPs in 6 Organisation for Economic Cooperation and Development (OECD) countries. DESIGN: Cross-country data analysis of national nursing registries, regulatory bodies, statistical offices data as well as OECD health workforce and population data, plus literature scoping review. SETTING/PARTICIPANTS: NP and physician workforces in 6 OECD countries (Australia, Canada, Ireland, the Netherlands, New Zealand and USA). PRIMARY AND SECONDARY OUTCOME MEASURES: The main outcomes were the absolute and relative number of NPs per 100 000 population compared with the nursing and physician workforces, the compound annual growth rates, annual and median percentage changes from 2005 to 2015 and a synthesis of the literature on the extent of…

OBJECTIVES: To examine associations between mortality and registered nurse (RN) staffing in English hospital trusts taking account of medical and healthcare support worker (HCSW) staffing. SETTING: Secondary care provided in acute hospital National Health Service (NHS) trusts in England. PARTICIPANTS: Two data sets are examined: Administrative data from 137 NHS acute hospital trusts (staffing measured as beds per staff member). A cross-sectional survey of 2917 registered nurses in a subsample of 31 trusts (measured patients per ward nurse). OUTCOME MEASURE: Risk-adjusted mortality rates for adult patients (administrative data). RESULTS: For medical admissions, higher mortality was associated with more occupied beds per RN (RR 1.22, 95% CI 1.04 to 1.43, p=0.02) and per doctor (RR 1.10, 95% CI 1.05 to 1.15, p <0.01) employed by the trust whereas, lower HCSW staffing was associated with lower mortality (RR 0.95, 95% CI 0.91 to 1.00, p=0.04). In multivariable models the relationship was statistically significant for doctors (RR 1.08, 95% CI 1.02 to 1.15, p=0.02) and HCSWs (RR 0.93, 95%…

OBJECTIVES: To systematically review studies of the epidemiology of tinnitus and hyperacusis in children and young people, in order to determine the methodological differences implicated in the variability of prevalence estimates and the influence of population characteristics on childhood tinnitus and hyperacusis. DATA SOURCES: Articles were retrieved from PubMed, EMBASE and Scopus databases and from the relevant reference lists using the methods described in the study protocol, which has previously been published. Reporting Items for Systematic Review (PRISMA) guidelines were followed. ELIGIBILITY CRITERIA: Studies addressing childhood prevalence, for example, children and young people aged 5-19 years. DATA SELECTION: 2 reviewers independently assessed the studies for eligibility, extracted data and assessed study consistency. Owing to the heterogeneity in the methodologies among the reported studies, only narrative synthesis of the results was carried out. RESULTS: Having identified 1032 publications, 131 articles were selected and 25 articles met the inclusion criteria and had…

OBJECTIVES: To identify studies of existing instruments available for clinicians to record overall patient preferences and priorities for care, suitable for use in routine primary care practice in patients with multimorbidity. To examine the data for all identified tools with respect to validity, acceptability and effect on health outcomes. DESIGN: Systematic Review. DATA SOURCES: MEDLINE, EMBASE and Cochrane databases, each with a predefined search strategy. ELIGIBILITY CRITERIA: Citations were included if they reported a tool used to record patient priorities or preferences for treatment, and quantitative or qualitative results following administration of the tool. RESULTS: Our search identified 189 potential studies of which 6 original studies and 2 discussion papers were included after screening for relevance. 5 of 6 studies (83%) were of cross-sectional design and of moderate quality. All studies reported on the usability of a tool in order to elicit patient preferences. No studies reported on changes to patient-specific healthcare outcomes as a consequence of recording…

OBJECTIVE: The aim of this meta-analysis was to determine the psychological impact associated with motor vehicle crash (MVC)-related physical injuries. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Multiple search engines included MEDLINE (via OVID), PsycINFO and Embase, and studies were sourced from scientific journals, conference papers and doctoral theses. STUDY SELECTION: A high-yield search strategy was employed. Terms like 'psychological distress', 'depression', 'PTSD' and 'motor vehicle accident' were employed. These key words were run primarily and secondary searches were then conducted in association with the major injury types. Studies needed to compare psychological distress in people injured in an MVC with uninjured controls who had not recently experienced an MVC. DATA EXTRACTION: Searches resulted in the identification of 2537 articles, and after eliminating duplicates and studies not meeting inclusion criteria, 24 studies were selected involving 4502 injured participants. These studies were entered into separate meta-analyses for mild to moderate…

OBJECTIVES: To compare the food, nutrient and 'family meal' intakes of infants following baby-led weaning (BLW) with those of infants following a more traditional spoon-feeding (TSF) approach to complementary feeding. STUDY DESIGN AND PARTICIPANTS: Cross-sectional study of dietary intake and feeding behaviours in 51 age-matched and sex-matched infants (n=25 BLW, 26 TSF) 6-8 months of age. METHODS: Parents completed a questionnaire, and weighed diet records (WDRs) on 1-3 non-consecutive days, to investigate food and nutrient intakes, the extent to which infants were self-fed or parent-fed, and infant involvement in 'family meals'. RESULTS: BLW infants were more likely than TSF infants to have fed themselves all or most of their food when starting complementary feeding (67% vs 8%, p<0.001). Although there was no statistically significant difference in the large number of infants consuming foods thought to pose a choking risk during the WDR (78% vs 58%, p=0.172), the CI was wide, so we cannot rule out increased odds with BLW (OR, 95% CI: 2.57, 0.63 to 10.44). No difference was observed…