The 100 most-cited articles in BMJ Open, 2019

OBJECTIVE: To provide researchers with guidance on actions to take during intervention development. SUMMARY OF KEY POINTS: Based on a consensus exercise informed by reviews and qualitative interviews, we present key principles and actions for consideration when developing interventions to improve health. These include seeing intervention development as a dynamic iterative process, involving stakeholders, reviewing published research evidence, drawing on existing theories, articulating programme theory, undertaking primary data collection, understanding context, paying attention to future implementation in the real world and designing and refining an intervention using iterative cycles of development with stakeholder input throughout. CONCLUSION: Researchers should consider each action by addressing its relevance to a specific intervention in a specific context, both at the start and throughout the development process.

OBJECTIVES: To systematically examine the evidence of harms and benefits relating to time spent on screens for children and young people's (CYP) health and well-being, to inform policy. METHODS: Systematic review of reviews undertaken to answer the question 'What is the evidence for health and well-being effects of screentime in children and adolescents (CYP)?' Electronic databases were searched for systematic reviews in February 2018. Eligible reviews reported associations between time on screens (screentime; any type) and any health/well-being outcome in CYP. Quality of reviews was assessed and strength of evidence across reviews evaluated. RESULTS: 13 reviews were identified (1 high quality, 9 medium and 3 low quality). 6 addressed body composition; 3 diet/energy intake; 7 mental health; 4 cardiovascular risk; 4 for fitness; 3 for sleep; 1 pain; 1 asthma. We found moderately strong evidence for associations between screentime and greater obesity/adiposity and higher depressive symptoms; moderate evidence for an association between screentime and higher energy intake, less healthy…

Objectives To (1) provide an up-to-date overview of shared decision making (SDM)-models, (2) give insight in the prominence of components present in SDM-models, (3) describe who is identified as responsible within the components (patient, healthcare professional, both, none), (4) show the occurrence of SDM-components over time, and (5) present an SDM-map to identify SDM-components seen as key, per healthcare setting. Design Systematic review. Eligibility criteria Peer-reviewed articles in English presenting a new or adapted model of SDM. Information sources Academic Search Premier, Cochrane, Embase, Emcare, PsycINFO, PubMed, and Web of Science were systematically searched for articles published up to and including September 2, 2019. Results Forty articles were included, each describing a unique SDM-model. Twelve models were generic, the others were specific to a healthcare setting. Fourteen were based on empirical data, 26 primarily on analytical thinking. Fifty-three different elements were identified and clustered into 24 components. Overall , Describe treatment options was the…

OBJECTIVES: To investigate the relationship between teamwork and clinical performance and potential moderating variables of this relationship. DESIGN: Systematic review and meta-analysis. DATA SOURCE: PubMed was searched in June 2018 without a limit on the date of publication. Additional literature was selected through a manual backward search of relevant reviews, manual backward and forward search of studies included in the meta-analysis and contacting of selected authors via email. ELIGIBILITY CRITERIA: Studies were included if they reported a relationship between a teamwork process (eg, coordination, non-technical skills) and a performance measure (eg, checklist based expert rating, errors) in an acute care setting. DATA EXTRACTION AND SYNTHESIS: Moderator variables (ie, professional composition, team familiarity, average team size, task type, patient realism and type of performance measure) were coded and random-effect models were estimated. Two investigators independently extracted information on study characteristics in accordance with Preferred Reporting Items for Systematic…

OBJECTIVES: Inadequate postoperative pain control is common and is associated with poor clinical outcomes. This study aimed to identify preoperative predictors of poor postoperative pain control in adults undergoing inpatient surgery. DESIGN: Systematic review and meta-analysis DATA SOURCES: MEDLINE, Embase, CINAHL and PsycINFO were searched through October 2017. ELIGIBILITY CRITERIA: Studies in any language were included if they evaluated postoperative pain using a validated instrument in adults (≥18 years) and reported a measure of association between poor postoperative pain control (defined by study authors) and at least one preoperative predictor during the hospital stay. DATA EXTRACTION AND SYNTHESIS: Two reviewers screened articles, extracted data and assessed study quality. Measures of association for each preoperative predictor were pooled using random effects models. RESULTS: Thirty-three studies representing 53 362 patients were included in this review. Significant preoperative predictors of poor postoperative pain control included younger age (OR 1.18 [95% CI 1.05 to…

OBJECTIVES: To identify the determinants of antenatal care (ANC) utilisation in sub-Saharan Africa. DESIGN: Systematic review. DATA SOURCES: Databases searched were PubMed, OVID, EMBASE, CINAHL and Web of Science. ELIGIBILITY CRITERIA: Primary studies reporting on determinants of ANC utilisation following multivariate analysis, conducted in sub-Saharan Africa and published in English language between 2008 and 2018. DATA EXTRACTION AND SYNTHESIS: A data extraction form was used to extract the following information: name of first author, year of publication, study location, study design, study subjects, sample size and determinants. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist for reporting a systematic review or meta-analysis protocol was used to guide the screening and eligibility of the studies. The Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies was used to assess the quality of the studies while the Andersen framework was used to report findings. RESULTS: 74 studies that met the inclusion criteria were fully…

Objectives To assess the validity of the WHO concept of intrinsic capacity in a longitudinal study of ageing; to identify whether this overall measure disaggregated into biologically plausible and clinically useful subdomains; and to assess whether total capacity predicted subsequent care dependence. Design Structural equation modelling of biomarkers and self-reported measures in the English Longitudinal Study of Ageing including exploratory factor analysis, exploratory bi-factor analysis and confirmatory factor analysis. Longitudinal mediation and moderation analysis of incident care dependence. Settings Community, United Kingdom. Participants 2560 eligible participants aged over 60 years. Main outcome measures Activities of daily living (ADL) and instrumental activities of daily living (IADL). Results One general factor (intrinsic capacity) and five subfactors emerged: locomotor, cognitive; psychological; sensory; and ‘vitality’. This structure is consistent with biological theory and the model had a good fit for the data (χ2=71.2 (df=39)). The summary score of intrinsic capacity…

OBJECTIVES: Systematically review the qualitative literature on living with knee osteoarthritis from patient and carer perspectives. DESIGN: Systematic review of qualitative studies. Five electronic databases (CINAHL, Embase, MEDLINE, PsycINFO, SPORTDiscus) were searched from inception until October 2018. Data were synthesised using thematic and content analysis. PARTICIPANTS: Studies exploring the experiences of people living with knee osteoarthritis, and their carers were included. Studies exploring experiences of patients having participated in specific interventions, including surgery, or their attitudes about the decision to proceed to knee replacement were excluded. RESULTS: Twenty-six articles reporting data from 21 studies about the patient (n=665) and carer (n=28) experience of living with knee osteoarthritis were included. Seven themes emerged: (i) Perceived causes of knee osteoarthritis are multifactorial and lead to structural damage to the knee and deterioration over time (n=13 studies), (ii) Pain and how to manage it predominates the lived experience (n=19 studies),…

OBJECTIVE: Lack of access to mental health services during the perinatal period is a significant public health concern in the UK. Barriers to accessing services may occur at multiple points in the care pathway. However, no previous reviews have investigated multilevel system barriers or how they might interact to prevent women from accessing services. This review examines women, their family members' and healthcare providers' perspectives of barriers to accessing mental health services for women with perinatal mental illness in the UK. DESIGN: A systematic review and meta-synthesis of qualitative studies. DATA SOURCES: Qualitative studies, published between January 2007 and September 2018, were identified in MEDLINE, PsycINFO, EMBASE and CINAHL electronic databases, handsearching of reference lists and citation tracking of included studies. Papers eligible for inclusion were conducted in the UK, used qualitative methods and were focused on women, family or healthcare providers working with/or at risk of perinatal mental health conditions. Quality assessment was conducted using the…

OBJECTIVE: To assess and compare the performance of triage systems for identifying high and low-urgency patients in the emergency department (ED). DESIGN: Systematic review and meta-analysis. DATA SOURCES: EMBASE, Medline OvidSP, Cochrane central, Web of science and CINAHL databases from 1980 to 2016 with the final update in December 2018. ELIGIBILITY CRITERIA: Studies that evaluated an emergency medical triage system, assessed validity using any reference standard as proxy for true patient urgency and were written in English. Studies conducted in low(er) income countries, based on case scenarios or involving less than 100 patients were excluded. REVIEW METHODS: Reviewers identified studies, extracted data and assessed the quality of the evidence independently and in duplicate. The Quality Assessment of studies of Diagnostic Accuracy included in Systematic Reviews -2 checklist was used to assess risk of bias. Raw data were extracted to create 2×2 tables and calculate sensitivity and specificity. ED patient volume and casemix severity of illness were investigated as determinants of…

OBJECTIVES: Physicians often refer patients with musculoskeletal conditions to physical therapy. However, it is unclear to what extent physical therapists' treatment choices align with the evidence. The aim of this systematic review was to determine what percentage of physical therapy treatment choices for musculoskeletal conditions agree with management recommendations in evidence-based guidelines and systematic reviews. DESIGN: Systematic review. SETTING: We performed searches in Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine, Scopus and Web of Science combining terms synonymous with 'practice patterns' and 'physical therapy' from the earliest record to April 2018. PARTICIPANTS: Studies that quantified physical therapy treatment choices for musculoskeletal conditions through surveys of physical therapists, audits of clinical notes and other methods (eg, audits of billing codes, clinical observation) were eligible for inclusion. PRIMARY AND SECONDARY OUTCOMES: Using medians…

Objectives This review aims to: (1) explore the social support measures in studies examining the association between social support and depression among community-dwelling older adults in Asia and (2) the evidence of association. Design A systematic review was conducted using electronic databases of CINAHL, PubMed, PsychINFO, Psychology and Behavioural Sciences Collection, SocINDEX and Web of Science for articles published until the 11th of January 2018. Eligibility criteria All observational studies investigating the association between social support and depression among community-dwelling older adults in Asia were included. Participants Older adults aged 60 years and more who are living in the community. Exposure measures Social support. Outcome measures Depression. Results We retrieved16 356 records and screened 66 full-text articles. Twenty-four observational studies were included in the review. They consisted of five cohort studies and 19 cross-sectional studies. Social support was found to be measured by multiple components, most commonly through a combination of structural…

INTRODUCTION: Ductal carcinoma in situ (DCIS) is a non-invasive non-obligate precursor of invasive breast cancer. With guideline concordant care (GCC), DCIS outcomes are at least as favourable as some other early stage cancer types such as prostate cancer, for which active surveillance (AS) is a standard of care option. However, AS has not yet been tested in relation to DCIS. The goal of the COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial for low-risk DCIS is to gather evidence to help future patients consider the range of treatment choices for low-risk DCIS, from standard therapies to AS. The trial will determine whether there may be some women who do not substantially benefit from current GCC and who could thus be safely managed with AS. This protocol is version 5 (11 July 2018). Any future protocol amendments will be submitted to Quorum Centralised Institutional Review Board/local institutional review boards for approval via the sponsor of the study (Alliance Foundation Trials). METHODS AND ANALYSIS: COMET is a phase III, randomised controlled…

Objective To systematically review the effect of oral intake of bacterial probiotics on 15 variables related to obesity, diabetes and non-alcoholic fatty liver disease. Design Systematic review and meta-analysis. Data sources Medline, EMBASE and COCHRANE from 1990 to June 2018. Eligibility criteria Randomised controlled trials (≥14 days) excluding hypercholesterolaemia, alcoholic liver disease, polycystic ovary syndrome and children <3 years. Results One hundred and five articles met inclusion criteria, representing 6826 subjects. In overweight but not obese subjects, probiotics induced improvements in: body weight (k=25 trials, d=−0.94 kg mean difference, 95% CI −1.17 to −0.70, I²=0.0%), body mass index (k=32, d=−0.55 kg/m², 95% CI −0.86 to −0.23, I²=91.9%), waist circumference (k=13, d=−1.31 cm, 95% CI −1.79 to −0.83, I²=14.5%), body fat mass (k=11, d=−0.96 kg, 95% CI −1.21 to −0.71, I²=0.0%) and visceral adipose tissue mass (k=5, d=−6.30 cm², 95% CI −9.05 to −3.56, I²=0.0%). In type 2 diabetics, probiotics reduced fasting glucose (k=19, d=−0.66 mmol/L, 95% CI −1.00 to −0.31,…

OBJECTIVE: To evaluate age-dependent productivity loss caused by menstruation-related symptoms, measured in absenteeism (time away from work or school) and presenteeism (productivity loss while present at work or school). METHODS: Design/setting: internet-based, cross-sectional survey conducted in the Netherlands from July to October 2017. PARTICIPANTS: 32 748 women aged 15-45 years, recruited through social media. OUTCOME MEASURES: self-reported lost productivity in days, divided into absenteeism and presenteeism; impact of menstrual symptoms; reasons women give when calling in sick; and women's preferences regarding the implications of menstruation-related symptoms for schools and workplaces. RESULTS: A total of 13.8% (n=4514) of all women reported absenteeism during their menstrual periods with 3.4% (n=1108) reporting absenteeism every or almost every menstrual cycle. The mean absenteeism related to a woman's period was 1.3 days per year. A total of 80.7% (n=26 438) of the respondents reported presenteeism and decreased productivity a mean of 23.2 days per year. An average…

OBJECTIVES: Self-management is a concept frequently used within healthcare but lacks consensus. It is the aim of this study to clarify the concept. DESIGN: Concept analysis according to Walker and Avant, comprises eight steps: select concept, determine purpose, identify uses, determine defining attributes, identify model case, identify additional cases, identify antecedents and consequences and define empirical referents. SOURCES USED: PubMed, Scopus and Web of Science. RESULTS: Ten attributes delineating the concept have been identified and organised into three groups. Group (a): person-oriented attributes: the person must (1) actively take part in the care process, (2) take responsibility for the care process and (3) have a positive way of coping with adversity. Group (b): person-environment-oriented attributes: (4) the person must be informed about the condition, disease and treatment and self-management, (5) should be individualised, which entails expressing needs, values and priorities, (6) requires openness to ensure a reciprocal partnership with healthcare providers and (7)…

OBJECTIVES: To describe the epidemiology of diagnosed hypermobility spectrum disorder (HSD) and Ehlers-Danlos syndromes (EDS) using linked electronic medical records. To examine whether these conditions remain rare and primarily affect the musculoskeletal system. DESIGN: Nationwide linked electronic cohort and nested case-control study. SETTING: Routinely collected data from primary care and hospital admissions in Wales, UK. PARTICIPANTS: People within the primary care or hospital data systems with a coded diagnosis of EDS or joint hypermobility syndrome (JHS) between 1 July 1990 and 30 June 2017. MAIN OUTCOME MEASURES: Combined prevalence of JHS and EDS in Wales. Additional diagnosis and prescription data in those diagnosed with EDS or JHS compared with matched controls. RESULTS: We found 6021 individuals (men: 30%, women: 70%) with a diagnostic code of either EDS or JHS. This gives a diagnosed point prevalence of 194.2 per 100 000 in 2016/2017 or roughly 10 cases in a practice of 5000 patients. There was a pronounced gender difference of 8.5 years (95% CI: 7.70 to 9.22) in the…

OBJECTIVE: This study aimed to describe the consumption of ultra-processed foods in Australia and its association with the intake of nutrients linked to non-communicable diseases (NCDs). DESIGN: Cross-sectional study. SETTING: National Nutrition and Physical Activity Survey (2011-2012). PARTICIPANTS: 12,153 participants aged 2+ years. MAIN OUTCOME MEASURES: Average dietary content of nutrients linked to NCDs and the prevalence of intake outside levels recommended for the prevention of NCDs. DATA ANALYSIS: Food items were classified according to the NOVA system, a classification based on the nature, extent and purpose of industrial food processing. The contribution of each NOVA food group and their subgroups to total energy intake was calculated. Mean nutrient content of ultra-processed food and non-ultra-processed food fractions of the diet were compared. Across quintiles of the energy contribution of ultra-processed foods, differences in the intake of nutrients linked to NCDs as well as in the prevalence of intakes outside levels recommended for the prevention of NCDs were…

OBJECTIVES: To assess international trends and patterns of prenatal diagnosis of critical congenital heart defects (CCHDs) and their relation to total and live birth CCHD prevalence and mortality. SETTING: Fifteen birth defect surveillance programmes that participate in the International Clearinghouse for Birth Defects Surveillance and Research from 12 countries in Europe, North and South America and Asia. PARTICIPANTS: Live births, stillbirths and elective terminations of pregnancy for fetal anomaly diagnosed with 1 of 12 selected CCHD, ascertained by the 15 programmes for delivery years 2000 to 2014. RESULTS: 18 243 CCHD cases were reported among 8 847 081 births. The median total prevalence was 19.1 per 10 000 births but varied threefold between programmes from 10.1 to 31.0 per 10 000. CCHD were prenatally detected for at least 50% of the cases in one-third of the programmes. However, prenatal detection varied from 13% in Slovak Republic to 87% in some areas in France. Prenatal detection was consistently high for hypoplastic left heart syndrome (64% overall) and was lowest for…

OBJECTIVE: To systematically review the literature relating to the impact of multiple co-occurring modifiable risk factors for cognitive decline and dementia. DESIGN: A systematic review and meta-analysis of the literature relating to the impact of co-occurring key risk factors for incident cognitive decline and dementia. All abstracts and full text were screened independently by two reviewers and each article assessed for bias using a standard checklist. A fixed effects meta-analysis was undertaken. DATA SOURCES: Databases Medline, Embase and PsycINFO were searched from 1999 to 2017. ELIGIBILITY CRITERIA: For inclusion articles were required to report longitudinal data from participants free of cognitive decline at baseline, with formal assessment of cognitive function or dementia during follow-up, and an aim to examine the impact of additive or clustered comorbid risk factor burden in with two or more core modifiable risk factors. RESULTS: Seventy-nine full-text articles were examined. Twenty-two articles (18 studies) were included reporting data on >40 000 participants. Included…

Objective Inflammation has been implicated in the aetiology of mental illness. We conducted the first systematic review and meta-analysis of the association between peripheral markers of inflammation and generalised anxiety disorder (GAD). Design Systematic review and meta-analysis of studies measuring peripheral cytokine levels in people with GAD compared with controls. Data sources MEDLINE (1950–), EMBASE (1947–), PsycINFO (1872–) and Web of Science (1945–) databases up until January 2018. Eligibility criteria Primary, quantitative research studies of people with a diagnosis of GAD assessed using a standardised clinical interview that measured peripheral inflammatory markers. Data extraction and synthesis Two independent reviewers extracted data and assessed study quality. Meta-analysis using a random-effects model was conducted for individual cytokines where data from three or more studies were available. Results 14 of 1718 identified studies met the inclusion criteria, comprising 1188 patients with GAD and 10 623 controls. In total 16 cytokines were evaluated. Significantly…

OBJECTIVES: Children exposed to social adversity-hardship as a result of social circumstances such as poverty or intergenerational trauma-are at increased risk of poor outcomes across the life course. Understanding what promotes resilient outcomes is essential for the development of evidence informed intervention strategies. We conducted a systematic review to identify how child resilience is measured and what factors are associated with resilient outcomes. DESIGN: Systematic search conducted in CINAHL, MEDLINE and PsychInfo from January 2004 to October 2018 using the keywords 'resilien* and child* in the title or abstract. Eligible studies: (1) described children aged 5-12 years; (2) identified exposure to social adversity; (3) identified resilience; and (4) investigated factors associated with resilience. OUTCOME MEASURES: (1) approaches to identifying resilience and (2) factors associated with resilient outcomes. RESULTS: From 1979 studies retrieved, 30 studies met the inclusion criteria. Most studies were moderate to high quality, with low cultural competency. Social adversity…

OBJECTIVES: The evolution of multimorbidity describes the continuum from a healthy status to the development of a single disease and further progression to multimorbidity with additional diseases. We investigated the evolution of cardiometabolic multimorbidity and risk for mortality in a Chinese population. DESIGN: Longitudinal cohort study using data from the CHinese Electronic health Records Research in Yinzhou (CHERRY) study, with 5.43 million person-years follow-up (median 5.16 years). PARTICIPANTS: Data for 1 038 704 adults (total 22 750 deaths) were analysed. EXPOSURE: Cardiometabolic multimorbidity was defined as ever being diagnosed with two or more of three diseases: hypertension, diabetes and cardiovascular disease (CVD). PRIMARY AND SECONDARY OUTCOME MEASURES: Age-adjusted and sex-adjusted HRs were calculated for all-cause mortality. RESULTS: The cardiometabolic disease status of 105 209 (10.1%) individuals changed during the follow-up. The prevalence of cardiometabolic multimorbidity increased from 2.41% (95% CI: 2.38% to 2.44%) to 5.94% (95% CI: 5.90% to 5.99%).…

Objective To conduct a systematic review investigating the normal age-related changes in lung function in adults without known lung disease. Design Systematic review. Data sources MEDLINE, Embase and Cumulative Index to Nursing and Allied Health Literature (CINAHL) were searched for eligible studies from inception to February 12, 2019, supplemented by manual searches of reference lists and clinical trial registries. Eligibility criteria We planned to include prospective cohort studies and randomised controlled trials (control arms) that measured changes in lung function over time in asymptomatic adults without known respiratory disease. Data extraction and synthesis Two authors independently determined the eligibility of studies, extracted data and assessed the risk of bias of included studies using the modified Newcastle–Ottawa Scale. Results From 4385 records screened, we identified 16 cohort studies with 31 099 participants. All included studies demonstrated decline in lung function—forced expiratory volume in 1 s (FEV 1 ), forced vital capacity (FVC) and peak expiratory flow…

OBJECTIVES: To assess predictive factors for rheumatoid arthritis interstitial lung disease (RA-ILD) in two early rheumatoid arthritis (RA) inception cohorts with a focus on methotrexate (MTX) exposure. DESIGN: Multicentre prospective early RA inception cohort studies; the early RA study (ERAS) and the early RA network (ERAN). SETTING: Secondary care, ERAS nine centres, ERAN 23 centres in England, Wales and Ireland. PARTICIPANTS: Patients with new diagnosis of RA, n=2701. Standardised data including demographics, drug therapies and clinical outcomes including the presence of RA-ILD were collected at baseline, within 3-6 months, at 12 months and annually thereafter. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was the association of MTX exposure on RA-ILD diagnosis. Secondary outcomes were the association of demographic, comorbid and RA-specific factors on RA-ILD diagnosis and the association of MTX exposure on time to RA-ILD diagnosis. RESULTS: Of 92 eligible ILD cases, 39 occurred in 1578 (2.5%) MTX exposed and 53 in 1114 (4.8%) non-MTX exposed cases. The primary…

Objectives With the high and rising total cost of medical school, medical student debt is an increasing concern for medical students and graduates, with significant potential to impact the well-being of physicians and their patients. We hypothesised that medical student debt levels would be negatively correlated with mental health and academic performance, and would influence career direction (ie, medical specialty choice). Design We performed a systematic literature review to identify articles that assessed associations between medical student mental health, academic performance, specialty choice and debt. The databases PubMed, Medline, Embase, Scopus and PsycINFO were searched on 12 April 2017, for combinations of the medical subject headings Medical Student and Debt as search terms. Updates were incorporated on 24 April 2019. Results 678 articles were identified, of which 52 met the inclusion criteria after being reviewed in full text. The majority of studies were conducted in the USA with some from Canada, New Zealand, Scotland and Australia. The most heavily researched aspect…

Objective To characterise the contributing factors that affect medical students’ subspecialty choice and to estimate the extent of influence of individual factors on the students’ decision-making process. Design Systematic review and meta-analysis. Methods A systematic search of the Cochrane Library, ERIC, Web of Science, CNKI and PubMed databases was conducted for studies published between January 1977 and June 2018. Information concerning study characteristics, influential factors and the extent of their influence (EOI) was extracted independently by two trained investigators. EOI is the percentage level that describes how much each of the factors influenced students’ choice of subspecialty. The recruited medical students include students in medical school, internship, residency training and fellowship, who are about to or have just made a specialty choice. The estimates were pooled using a random-effects meta-analysis model due to the between-study heterogeneity. Results Data were extracted from 75 studies (882 209 individuals). Overall, the factors influencing medical students’…

OBJECTIVE: To ascertain contemporary approaches to the collection, reporting and analysis of adverse events (AEs) in randomised controlled trials (RCTs) with a primary efficacy outcome. DESIGN: A review of clinical trials of drug interventions from four high impact medical journals. DATA SOURCES: were searched for reports of original RCTs published between September 2015 and September 2016. METHODS: A prepiloted checklist was used and single data extraction was performed by three reviewers with independent check of a randomly sampled subset to verify quality. We extracted data on collection methods, assessment of severity and causality, reporting criteria, analysis methods and presentation of AE data. RESULTS: n=81). Sixty-two per cent reported some form of spontaneous AE collection but only 29% included details of specific prompts used to ascertain AE data. Numbers that withdrew from the trial were well reported (80%), however only 35% of these reported whether withdrawals were due to AEs. Results presented and analysis performed was predominantly on 'patients with at least one…

OBJECTIVES: To determine the effect of computerised cognitive training (CCT) on improving cognitive function for older adults with mild cognitive impairment (MCI). DESIGN: Systematic review and meta-analysis. DATA SOURCES: PubMed, Embase, Web of Science and the Cochrane Library were searched through January 2018. ELIGIBILITY CRITERIA: Randomised controlled trials comparing CCT with control conditions in those with MCI aged 55+ were included. DATA EXTRACTION AND SYNTHESIS: statistic. RESULTS: 18 studies met the inclusion criteria and were included in the analyses, involving 690 participants. Meta-analysis revealed small to moderate positive treatment effects compared with control interventions in four domains as follows: global cognitive function (g=0.23, 95% CI 0.03 to 0.44), memory (g=0.30, 95% CI 0.11 to 0.50), working memory (g=0.39, 95% CI 0.12 to 0.66) and executive function (g=0.20, 95% CI -0.03 to 0.43). Statistical significance was reached in all domains apart from executive function. CONCLUSIONS: This meta-analysis provides evidence that CCT improves cognitive function in…

OBJECTIVES: We conducted a Pakistan-wide community-based survey on the prevalence of type 2 diabetes using glycated haemoglobin (HbA1c) as the screening test. The aim was to estimate diabetes prevalence across different demographic groups as well as all regions of Pakistan. DESIGN, SETTINGS AND PARTICIPANTS: Multistaged stratified cluster sampling was used for the representative selection of people aged ≥20 years, residing in 378 sampled clusters of 16 randomly selected districts, in this cross-sectional study. Eligible participants had blood drawn for HbA1c analyses at field clinics near to their homes. The oral glucose tolerance test (OGTT) was conducted on a subsample of the participants. Overall and stratified prevalence of type 2 diabetes and its association with risk factors were estimated using logistic regression models. MAIN OUTCOME MEASURES: Prevalence of prediabetes and type 2 diabetes. RESULTS: Of 18 856 eligible participants the prevalence of prediabetes was 10.91% (95% CI 10.46 to 11.36, n=2057) and type 2 diabetes was 16.98% (95% CI 16.44 to 17.51, n=3201). Overall,…

Objective To estimate the association between the use of sodium glucose co-transporter-2 (SGLT2) inhibitors and postmarket harms as identified by drug regulatory agencies. Design We conducted a systematic review and meta-analysis of randomised controlled trials (RCT). Six large databases were searched from inception to May 2018. Random effects models were used to estimate pooled relative risks (RRs). Intervention SGLT2 inhibitors, compared with placebo or active comparators. Primary outcomes Acute kidney injury (AKI), diabetic ketoacidosis (DKA), urinary tract infections (UTI), bone fractures and lower limb amputations. Results We screened 2418 citations of which 109 were included. Most studies included one of four SGLT2 inhibitors, dapagliflozin, canagliflozin, empagliflozin and ipragliflozin. When compared with placebo, SGLT2 inhibitors were found to be significantly protective against AKI (RR=0.59; 95% CI 0.39 to 0.89; I2=0.0%), while no difference was found for DKA (RR 0.66; 95% CI 0.30 to 1.45, I2=0.0%), UTI (RR 1.02; 95% CI 0.95 to 1.09, I2=0.0%) or bone fracture (RR 0.87; 95%…

OBJECTIVES: This study examines associations between social media use and multiple sleep parameters in a large representative adolescent sample, controlling for a wide range of covariates. DESIGN: The authors used cross-sectional data from the Millennium Cohort Study, a large nationally representative UK birth cohort study. PARTICIPANTS: Data from 11 872 adolescents (aged 13-15 years) were used in analyses. METHODS: Six self-reported sleep parameters captured sleep timing and quality: sleep onset and wake times (on school days and free days), sleep onset latency (time taken to fall asleep) and trouble falling back asleep after nighttime awakening. Binomial logistic regressions investigated associations between daily social media use and each sleep parameter, controlling for a range of relevant covariates. RESULTS: Average social media use was 1 to <3 hours per day (31.6%, n=3720). 33.7% were classed as low users (<1 hour; n=3986); 13.9% were high users (3 to <5 hours; n=1602) and 20.8% were very high users (5+ hours; n=2203). Girls reported spending more time on social media than…

OBJECTIVES: In England, the NHS111 service provides assessment and triage by telephone for urgent health problems. A digital version of this service has recently been introduced. We aimed to systematically review the evidence on digital and online symptom checkers and similar services. DESIGN: Systematic review. DATA SOURCES: We searched Medline, Embase, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Health Management Information Consortium, Web of Science and ACM Digital Library up to April 2018, supplemented by phrase searches for known symptom checkers and citation searching of key studies. ELIGIBILITY CRITERIA: Studies of any design that evaluated a digital or online symptom checker or health assessment service for people seeking advice about an urgent health problem. DATA EXTRACTION AND SYNTHESIS: Data extraction and quality assessment (using the Cochrane Collaboration version of QUADAS for diagnostic accuracy studies and the National Heart, Lung and Blood Institute tool for observational studies) were done by one reviewer with a sample…

OBJECTIVE: Diabetes mellitus (DM) is associated with an increased fracture risk; however, the impact of DM and subsequent fracture at different sites and the associations according to patient characteristics remain unknown. DESIGN: Meta-analysis DATA SOURCES: The PubMed, EMBASE and Cochrane Library databases were searched from inception to March 2018. ELIGIBILITY CRITERIA: We included prospective and retrospective cohort studies on the associations of DM and subsequent fracture risk at different sites. DATA EXTRACTION AND SYNTHESIS: and Q statistics. RESULTS: Overall, DM was associated with an increased risk of total (RR: 1.32; 95% CI 1.17 to 1.48; p<0.001), hip (RR: 1.77; 95% CI 1.56 to 2.02; p<0.001), upper arm (RR: 1.47; 95% CI 1.02 to 2.10; p=0.037) and ankle fractures (RR: 1.24; 95% CI 1.10 to 1.40; p<0.001), whereas DM had no significant impact on the incidence of distal forearm (RR: 1.02; 95% CI 0.88 to 1.19; p=0.809) and vertebral fractures (RR: 1.56; 95% CI 0.78 to 3.12; p=0.209). RR ratios suggested that compared with patients with type 2 DM (T2DM), patients with type 1 DM…

MOTIVATION: Catheter-associated urinary tract infections (CAUTI) are a common and serious healthcare-associated infection. Despite many efforts to reduce the occurrence of CAUTI, there remains a gap in the literature about CAUTI risk factors, especially pertaining to the effect of catheter dwell-time on CAUTI development and patient comorbidities. OBJECTIVE: To examine how the risk for CAUTI changes over time. Additionally, to assess whether time from catheter insertion to CAUTI event varied according to risk factors such as age, sex, patient type (surgical vs medical) and comorbidities. DESIGN: Retrospective cohort study of all patients who were catheterised from 2012 to 2016, including those who did and did not develop CAUTIs. Both paediatric and adult patients were included. Indwelling urinary catheterisation is the exposure variable. The variable is interval, as all participants were exposed but for different lengths of time. SETTING: Urban academic health system of over 2500 beds. The system encompasses two large academic medical centres, two community hospitals and a…

BACKGROUND: Studies from different Western countries have reported a rapid increase in spinal surgery rates, an increase that exceeds by far the growing incidence rates of spinal disorders in the general population. There are few studies covering all lumbar spine surgery and no previous studies from Norway. OBJECTIVES: The purpose of this study was to investigate trends in all lumbar spine surgery in Norway over 15 years, including length of hospital stay, and rates of complications and reoperations. DESIGN: A longitudinal observational study over 15 years using hospital patient administrative data and sociodemographic data from the National Registry in Norway. SETTING AND PARTICIPANTS: Patients aged ≥18 years discharged from Norwegian public hospitals between 1999 and 2013. OUTCOME MEASURES: Annual rates of simple (microsurgical discectomy, decompression) and complex surgical procedures (fusion, disc prosthesis) in the lumbar spine. RESULTS: The rate of lumbar spine surgery increased by 54%, from 78 (95% CI (75 to 80)) to 120 (107 to 113) per 100 000, from 1999 to 2013. More men…

OBJECTIVE: To estimate the prevalence and incidence of placenta previa complicated by placenta accreta spectrum (PAS) and to examine the different criteria being used for the diagnosis. DESIGN: Systematic review and meta-analysis. DATA SOURCES: PubMed, Google Scholar, ClinicalTrials.gov and MEDLINE were searched between August 1982 and September 2018. ELIGIBILITY CRITERIA: Studies reporting on placenta previa complicated by PAS diagnosed in a defined obstetric population. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers performed the data extraction using a predefined protocol and assessed the risk of bias using the Newcastle-Ottawa scale for observational studies, with difference agreed by consensus. The primary outcomes were overall prevalence of placenta previa, incidence of PAS according to the type of placenta previa and the reported clinical outcomes, including the number of peripartum hysterectomies and direct maternal mortality. The secondary outcomes included the criteria used for the prenatal ultrasound diagnosis of placenta previa and the criteria used to diagnose…

The objective of this commentary is to develop a framework for assessing the rigour of qualitative approaches that identifies and distinguishes between the diverse objectives of qualitative health research, guided by a narrative review of the published literature on qualitative guidelines and standards from peer-reviewed journals and national funding organisations that support health services research, patient-centered outcomes research and other applied health research fields. In this framework, we identify and distinguish three objectives of qualitative studies in applied health research: exploratory, descriptive and comparative. For each objective, we propose methodological standards that may be used to assess and improve rigour across all study phases-from design to reporting. Similar to hierarchies of quality of evidence within quantitative studies, we argue that standards for qualitative rigour differ, appropriately, for studies with different objectives and should be evaluated as such. Distinguishing between different objectives of qualitative health research improves the…

Objectives To understand help-seeking by male victims of domestic violence and abuse (DVA) and their experiences of support services by systematically identifying qualitative and mixed-method studies and thematically synthesising their findings. Design Systematic review and qualitative evidence synthesis. Searches were conducted in 12 databases and the grey literature with no language or date restrictions. Quality appraisal of the studies was carried out using the Critical Appraisal Skills Programme tool. Reviewers extracted first and second order constructs related to help-seeking, identified themes and combined them by interpretative thematic synthesis. Setting DVA experienced by male victims and defined as any incident or pattern of incidents of controlling coercive or threatening behaviour, violence or abuse among people aged 18 or over who are or have been intimate partners or family members, regardless of gender or sexuality. Participants Male victims of DVA. Interventions Any intervention which provides practical and/or psychological support to male victims of DVA including…

OBJECTIVE: Although adaptive e-learning environments (AEEs) can provide personalised instruction to health professional and students, their efficacy remains unclear. Therefore, this review aimed to identify, appraise and synthesise the evidence regarding the efficacy of AEEs in improving knowledge, skills and clinical behaviour in health professionals and students. DESIGN: Systematic review and meta-analysis. DATA SOURCES: CINAHL, EMBASE, ERIC, PsycINFO, PubMed and Web of Science from the first year of records to February 2019. ELIGIBILITY CRITERIA: Controlled studies that evaluated the effect of an AEE on knowledge, skills or clinical behaviour in health professionals or students. SCREENING, DATA EXTRACTION AND SYNTHESIS: Two authors screened studies, extracted data, assessed risk of bias and coded quality of evidence independently. AEEs were reviewed with regard to their topic, theoretical framework and adaptivity process. Studies were included in the meta-analysis if they had a non-adaptive e-learning environment control group and had no missing data. Effect sizes (ES) were…

OBJECTIVES: Despite the publication of hundreds of trials on gout and hyperuricemia, management of these conditions remains suboptimal. We aimed to assess the quality and consistency of guidance documents for gout and hyperuricemia. DESIGN: Systematic review and quality assessment using the appraisal of guidelines for research and evaluation (AGREE) II methodology. DATA SOURCES: PubMed and EMBASE (27 October 2016), two Chinese academic databases, eight guideline databases, and Google and Google scholar (July 2017). ELIGIBILITY CRITERIA: We included the latest version of international and national/regional clinical practice guidelines and consensus statements for diagnosis and/or treatment of hyperuricemia and gout, published in English or Chinese. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently screened searched items and extracted data. Four reviewers independently scored documents using AGREE II. Recommendations from all documents were tabulated and visualised in a coloured grid. RESULTS: Twenty-four guidance documents (16 clinical practice guidelines and 8 consensus…

Objective To assess the magnitude of suicide rates in the first week and first month postdischarge following psychiatric hospitalisation. Design Meta-analysis of relevant English-language, peer-reviewed papers published in MEDLINE, PsycINFO or Embase between 01 January 1945 and 31 March 2017 and supplemented by hand searching and personal communication. A generalised linear effects model was fitted to the number of suicides, with a Poisson distribution, log link and log of person years as an offset. A random effects model was used to calculate the overall pooled rates and within subgroups in sensitivity analyses. Outcome measures Suicides per 100 000 person years in the first week and the first month after discharge from psychiatric hospitalisation. Results Thirty-four included papers comprised 29 studies that reported suicides in the first month postdischarge (3551 suicides during 222 546 patient years) and 24 studies that reported suicides in the first week postdischarge (1928 suicides during 60 880 patient years). The pooled estimate of the suicide rate in the first month…

Objectives Metered-dose inhalers (MDIs) contain propellants which are potent greenhouse gases. Many agencies propose a switch to alternative, low global warming potential (GWP) inhalers, such as dry powder inhalers (DPIs). We aimed to analyse the impact on greenhouse gas emissions and drug costs of making this switch. Setting We studied National Health Service prescription data from England in 2017 and collated carbon footprint data on inhalers commonly used in England. Design Inhalers were separated into different categories according to their mechanisms of action (eg, short-acting beta-agonist). Within each category we identified low and high GWP inhalers and calculated the cost and carbon impact of changing to low GWP inhalers. We modelled scenarios for swapping proportionally according to the current market share of each equivalent DPI (model 1) and switching to the lowest cost pharmaceutically equivalent DPI (model 2). We also reviewed available data on the carbon footprint of inhalers from scientific publications, independently certified reports and patents to provide more…

OBJECTIVE: The purpose was to analyse the effectiveness of high-fidelity patient simulation (HFPS) based on life-threatening clinical condition scenarios on undergraduate and postgraduate nursing students' learning outcomes. DESIGN: A systematic review and meta-analysis were conducted based on the Cochrane Handbook for Systematic Reviews of Interventions and its reporting was checked against the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. DATA SOURCES: PubMed, Scopus, CINAHL with Full Text, Wiley Online Library and Web of Science were searched until July 2017. Author contact, reference and citation lists were checked to obtain additional references. STUDY SELECTION: To be included, available full-texts had to be published in English, French, Spanish or Italian and (a) involved undergraduate or postgraduate nursing students performing HFPS based on life-threatening clinical condition scenarios, (b) contained control groups not tested on the HFPS before the intervention, (c) contained data measuring learning outcomes such as performance, knowledge,…

OBJECTIVES: The National Mental Health Survey (NMHS) of India was undertaken with the objectives of (1) estimating the prevalence and patterns of various mental disorders in representative Indian population and (2) identifying the treatment gap, healthcare utilisation, disabilities and impact of mental disorders. This paper highlights findings pertaining to depressive disorders (DD) from the NMHS. DESIGN: Multisite population-based cross-sectional study. Subjects were selected by multistage stratified random cluster sampling technique with random selection based on probability proportionate to size at each stage. SETTING: Conducted across 12 states in India (representing varied cultural and geographical diversity), employing uniform, standardised and robust methodology. PARTICIPANTS: 18 years) were interviewed. MAIN OUTCOME MEASURE: Prevalence of depressive disorders (ICD-10 DCR) diagnosed using Mini International Neuropsychiatric Interview V.6.0. RESULTS: The weighted prevalence of lifetime and current DD was 5.25% (95% CI: 5.21% to 5.29%, n=34 802) and 2.68% (95% CI: 2.65% to…

OBJECTIVES: Knowledge of how physical activity (PA) and sport participation are related to mental health throughout adolescence is scarce. Our objective was to describe PA levels and sport participation in a population-based sample of adolescents, and to explore how they relate to mental health in different age groups. DESIGN: A population-based cross-sectional study. SETTING AND PARTICIPANTS: The adolescent part of the Nord-Trøndelag Health Study, a Norwegian population-based health survey, conducted from 2006 to 2008. Of 10 464 invited participants (age 13-19 years), 7619 (73%) participated, of whom 3785 (50%) were boys. OUTCOME MEASURES: Mental health outcomes included psychological distress assessed using a short version of the Hopkins Symptom Check List Five items, self-esteem assessed using a short version of the Rosenberg Self-Esteem Scale and life satisfaction assessed with a single-item satisfaction with life measure. METHOD: Logistic regression models were used to estimate the likelihood of psychological distress, low self-esteem and low life satisfaction, according to…

OBJECTIVES: This study examined patient adherence and persistence to oral bisphosphonates for the treatment of osteoporosis in real-world settings. METHODS: A systematic review was completed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA) and National Health Service Economic Evaluation Database NHS EED) databases were searched for studies published in English language up to April 2018. Prospective and retrospective observational studies that used prescription claim databases or hospital medical records to examine patient adherence and persistence to oral bisphosphonate treatment among adults with osteoporosis were included. The Newcastle-Ottawa quality assessment scale (NOS) was used to assess the quality of included studies. RESULTS: The search yielded 540 published studies, of…

Introduction With increasing diabetes trends worldwide, morbidity, mortality and associated costs due to diabetes-related complications are a global public health concern. Diabetic retinopathy (DR) is among the leading causes of vision loss at the global level; accurate estimates of DR burden is of crucial importance for planning, implementing and evaluating DR prevention and care interventions. The available evidence on DR prevalence at the global level, dating back to 2008, only considered data from selected regions. Taking into account the rapidly changing patterns in DR epidemiology, the aim of the current study is to carry out a systematic review and meta-analysis to derive solid and updated estimates on global and setting-specific DR prevalence. Methods and analysis The systematic review methods have been defined following PRISMA guidelines. Studies published from 2008 through 2018 will be identified searching the electronic databases Embase, Medline, Cochrane, ISI Web of Knowledge, as well as through grey literature search. Retrieved records will be independently screened by…

OBJECTIVE: To analyse injuries related to manual and electric scooter use from January 2016 up to and including July 2019. SETTING: Electric scooter rental services were launched in Denmark in January 2019. The services were provided by private companies. Although rules for handling and riding scooters have been established, no reports either before or after introduction of electric scooters anticipated the full extent of use, and injuries to riders and pedestrians. PARTICIPANTS: All patient records mentioning manual or electric scooters. Records were reviewed, and data were stratified according to two groups: manual and electric scooters. INTERVENTIONS: A predefined survey was completed in all cases where 'scooter' was present. This contained variables such as type of scooter, type of participant, mechanism of injury, acuity, intoxication, referral to treatment facility. OUTCOME MEASURES: Among incidents involving scooters, summary statistics on continuous and categorical variables of interest were reported. RESULTS: 468 scooter-related injuries were recorded. We found that manual…

INTRODUCTION: On entry into the clinical environment, nursing students are confronted with many challenges. It is a common problem throughout the world, including Iran. Although many studies have been conducted on the problems of nursing students in the clinical environment, limited information is available on nursing students' experiences of the clinical learning environment and the way they respond to these experiences. Identifying nursing students' experiences is essential to develop interventions to reduce challenges. OBJECTIVE: This study aimed to explore nursing students' experiences in a clinical learning environment and the way they responded to these experiences. DESIGN: The present study was conducted based on the qualitative research design of the grounded theory methodology. SETTING: This study was conducted at schools of nursing in academic settings in Iran. PARTICIPANTS: The participants included 19 nursing students, 4 nursing instructors and 3 clinical nurses. METHODS: The data were collected using semistructured interviews, field notes and observation, and were…

Objective The role of platelet-to-lymphocyte ratio (PLR) as an indicator of inflammation has been the focus of research recently. We aimed to investigate theprognosticvalue of PLR for sepsis. Design A retrospective cohort study. Setting and participants Data were extracted from the Multiparameter Intelligent Monitoring in Intensive Care III database. Data on 5537 sepsis patients were analysed. Methods Logistic regression was used to explore the association between PLR and hospital mortality. Subgroup analyses were performed based on vasopressor use, acute kidney injury (AKI) and a Sequential Organ Failure Assessment (SOFA) score >10. Results In the logistic model with linear spline function, a PLR >200 was significantly (OR 1.0002; 95% CI 1.0001 to 1.0004) associated with mortality; the association wasnon-significantfor PLRs ≤200 (OR 0.997; 95% CI 1.19 to 1.67). In the logistic model using the PLR as a design variable, only high PLRs were significantly associated with mortality (OR 1.29; 95% CI 1.09 to 1.53); the association with low PLRs wasnon-significant(OR 1.15; 95% CI 0.96 to…

PURPOSE: To describe the rationale, methods and research potential of eye and vision measures available in UK Biobank. PARTICIPANTS: UK Biobank is a large, multisite, prospective cohort study. Extensive lifestyle and health questionnaires, a range of physical measures and collection of biological specimens are collected. The scope of UK Biobank was extended midway through data collection to include assessments of other measures of health, including eyes and vision. The eye assessment at baseline included questionnaires detailing past ophthalmic and family history, measurement of visual acuity, refractive error and keratometry, intraocular pressure (IOP), corneal biomechanics, spectral domain optical coherence tomography (OCT) of the macula and a disc-macula fundus photograph. Since recruitment, UK Biobank has collected accelerometer data and begun multimodal imaging data (including brain, heart and abdominal MRI) in 100 000 participants. Dense genotypic data and a panel of 20 biochemistry measures are available, and linkage to medical health records for the full cohort has begun.…

OBJECTIVE: To assess the efficacy and safety of intradialytic exercise for haemodialysis patients. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Databases, including PubMed, Embase, the Cochrane Library, China Biology Medicine and China National Knowledge Infrastructure, were screened from inception to March 2017. ELIGIBILITY CRITERIA: Randomised controlled trials (RCTs) aimed at comparing the efficacy and safety of intradialytic exercise versus no exercise in adult patients on haemodialysis for at least 3 months. A minimum exercise programme period of 8 weeks. DATA EXTRACTION: Study characteristics and study quality domains were reviewed. Studies were selected, and data extracted by two reviewers. DATA ANALYSIS: The pooled risk ratios and mean differences (MDs) with 95% CIs for dichotomous data and continuous data were calculated, respectively. RESULTS: A total of 27 RCTs involving 1215 subjects were analysed. Compared with no exercise, intradialytic exercise increased dialysis adequacy (Kt/V) (MD 0.07, 95% CI 0.01 to 0.12, p=0.02) and maximum volume of oxygen that the…

Objective Low neighbourhood socioeconomic status (NSES) has been linked to a higher risk of overweight/obesity, irrespective of the individual’s own socioeconomic status. No meta-analysis study has been done on the association. Thus, this study was done to synthesise the existing evidence on the association of NSES with overweight, obesity and body mass index (BMI). Design Systematic review and meta-analysis. Data sources PubMed, Embase, Scopus, Cochrane Library, Web of Sciences and Google Scholar databases were searched for articles published until 25 September 2019. Eligibility criteria Epidemiological studies, both longitudinal and cross-sectional ones, which examined the link of NSES to overweight, obesity or BMI, were included. Data extraction and synthesis Data extraction was done by two reviewers, working independently. The methodological quality of included studies was assessed using the Newcastle-Ottawa Scale for the observational studies. The summary estimates of the relationships of NSES with overweight, obesity and BMI statuses were calculated with random-effects…

OBJECTIVES: Low-level laser therapy (LLLT) is not recommended in major knee osteoarthritis (KOA) treatment guidelines. We investigated whether a LLLT dose-response relationship exists in KOA. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Eligible articles were identified through PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Physiotherapy Evidence Database and Cochrane Central Register of Controlled Trials on 18 February 2019, reference lists, a book, citations and experts in the field. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We solely included randomised placebo-controlled trials involving participants with KOA according to the American College of Rheumatology and/or Kellgren/Lawrence criteria, in which LLLT was applied to participants' knee(s). There were no language restrictions. DATA EXTRACTION AND SYNTHESIS: The included trials were synthesised with random effects meta-analyses and subgrouped by dose using the World Association for Laser Therapy treatment recommendations. Cochrane's risk-of-bias tool was used. RESULTS: 22 trials…

OBJECTIVES: To compare health-related quality of life and prevalence of chronic diseases in housed and homeless populations. DESIGN: Cross-sectional survey with an age-matched and sex-matched housed comparison group. SETTING: Hostels, day centres and soup runs in London and Birmingham, England. PARTICIPANTS: Homeless participants were either sleeping rough or living in hostels and had a history of sleeping rough. The comparison group was drawn from the Health Survey for England. The study included 1336 homeless and 13 360 housed participants. OUTCOME MEASURES: Chronic diseases were self-reported asthma, chronic obstructive pulmonary disease (COPD), epilepsy, heart problems, stroke and diabetes. Health-related quality of life was measured using EQ-5D-3L. RESULTS: Housed participants in more deprived neighbourhoods were more likely to report disease. Homeless participants were substantially more likely than housed participants in the most deprived quintile to report all diseases except diabetes (which had similar prevalence in homeless participants and the most deprived housed group).…

OBJECTIVES: This study aimed to assess the degree to which the 'social cure' model of psychosocial health captures the understandings and experiences of healthcare staff and patients in a social prescribing (SP) pathway and the degree to which these psychosocial processes predict the effect of the pathway on healthcare usage. DESIGN: Mixed-methods: Study 1: semistructured interviews; study 2: longitudinal survey. SETTING: An English SP pathway delivered between 2017 and 2019. PARTICIPANTS: Study 1: general practitioners (GPs) (n=7), healthcare providers (n=9) and service users (n=19). Study 2: 630 patients engaging with SP pathway at a 4-month follow-up after initial referral assessment. INTERVENTION: Chronically ill patients experiencing loneliness referred onto SP pathway and meeting with a health coach and/or link worker, with possible further referral to existing or newly created relevant third-sector groups. MAIN OUTCOME MEASURE: Study 1: health providers and users' qualitative perspectives on the experience of the pathway and social determinants of health. Study 2: patients'…

OBJECTIVES: To describe dietary sources of free sugars in different age groups of the UK population considering food groups classified according to the NOVA system and to estimate the proportion of excessive free sugars that could potentially be avoided by reducing consumption of their main sources. DESIGN AND SETTING: Cross-sectional data from the UK National Diet and Nutrition Survey (2008-2014) were analysed. Food items collected using a 4-day food diary were classified according to the NOVA system. PARTICIPANTS: 9364 individuals aged 1.5 years and above. MAIN OUTCOME MEASURES: Average dietary content of free sugars and proportion of individuals consuming more than 10% of total energy from free sugars. DATA ANALYSIS: Poisson regression was used to estimate the associations between each of the NOVA food group and intake of free sugars. We estimated the per cent reduction in prevalence of excessive free sugar intake from eliminating ultra-processed foods and table sugar. Analyses were stratified by age group and adjusted for age, sex, ethnicity, survey year, region and equivalised…

OBJECTIVES: To develop effective interventions to prevent publishing in presumed predatory journals (ie, journals that display deceptive characteristics, markers or data that cannot be verified), it is helpful to understand the motivations and experiences of those who have published in these journals. DESIGN: An online survey delivered to two sets of corresponding authors containing demographic information, and questions about researchers' perceptions of publishing in the presumed predatory journal, type of article processing fees paid and the quality of peer review received. The survey also asked six open-ended items about researchers' motivations and experiences. PARTICIPANTS: Using Beall's lists, we identified two groups of individuals who had published empirical articles in biomedical journals that were presumed to be predatory. RESULTS: Eighty-two authors partially responded (~14% response rate (11.4%[44/386] from the initial sample, 19.3%[38/197] from second sample) to our survey. The top three countries represented were India (n=21, 25.9%), USA (n=17, 21.0%) and Ethiopia…

OBJECTIVES: The goal of this study is to identify, analyse and classify interventions to improve adherence to reporting guidelines in order to obtain a wide picture of how the problem of enhancing the completeness of reporting of biomedical literature has been tackled so far. DESIGN: Scoping review. SEARCH STRATEGY: We searched the MEDLINE, EMBASE and Cochrane Library databases and conducted a grey literature search for (1) studies evaluating interventions to improve adherence to reporting guidelines in health research and (2) other types of references describing interventions that have been performed or suggested but never evaluated. The characteristics and effect of the evaluated interventions were analysed. Moreover, we explored the rationale of the interventions identified and determined the existing gaps in research on the evaluation of interventions to improve adherence to reporting guidelines. RESULTS: 109 references containing 31 interventions (11 evaluated) were included. These were grouped into five categories: (1) training on the use of reporting guidelines, (2) improving…

OBJECTIVE: To estimate the prevalence of non-communicable disease (NCD) risk factors in Kerala. DESIGN: A community-based, cross-sectional survey. PARTICIPANTS: In 2016-2017 a multistage, cluster sample of 12 012 (aged 18-69 years) participants from all 14 districts of Kerala were studied. MAIN OUTCOME MEASURES: NCD risk factors as stipulated in the WHO's approach to NCD risk factors surveillance were studied. Parameters that were studied included physical activity score, anthropometry, blood pressure (BP), and fasting blood glucose (FBG) and morning urine sample to estimate dietary intake of salt. RESULTS: The mean age was 42.5 years (SD=14.8). Abdominal obesity was higher in women (72.6%; 95% CI 70.7 to 74.5) compared with men (39.1%; 95% CI 36.6 to 41.7), and also higher among urban (67.4%; 95% CI 65.0 to 69.7) compared with rural (58.6%; 95% CI 56.6 to 60.5) residents. Current use of tobacco and alcohol in men was 20.3% (95% CI 18.6 to 22.1) and 28.9% (95% CI 26.5 to 31.4), respectively. The estimated daily salt intake was 6.7 g/day. The overall prevalence of raised BP was 30.4%…

Objectives To investigate whether the conclusion of a recent systematic review and network meta-analysis (Ciprianiet al) that antidepressants are more efficacious than placebo for adult depression was supported by the evidence. Design Reanalysis of a systematic review, with meta-analyses. Data sources 522 trials (116 477 participants) as reported in the systematic review by Ciprianiet aland clinical study reports for 19 of these trials. Analysis We used the Cochrane Handbook’s risk of bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to evaluate the risk of bias and the certainty of evidence, respectively. The impact of several study characteristics and publication status was estimated using pairwise subgroup meta-analyses. Results Several methodological limitations in the evidence base of antidepressants were either unrecognised or underestimated in the systematic review by Ciprianiet al. The effect size for antidepressants versus placebo on investigator-rated depression symptom scales was higher in trials with a ‘placebo run-in’…

OBJECTIVES: To develop an understanding of men's experiences of first-time fatherhood, their mental health and wellbeing needs. DESIGN: A qualitative study using semi-structured interviews. Data were analysed using framework analysis. SETTING: Two large National Health Service integrated care trusts covering four London (UK) local authority boroughs. PARTICIPANTS: First-time fathers with children under 12 months of age were included. Maximum variation sampling was used, with 21 fathers recruited. Ten of these men described their ethnic background as Indian, seven as White British, one as Spanish, one as Black African, one as Black Caribbean and one as Pakistani. Participants' ages ranged from 20 to over 60 years; completion of full-time education ranged from high school certificate to doctorate level; and annual income ranged from £15 000 to over £61 000. Non-English speaking fathers, those experiencing bereavement following neonatal death, stillbirth, pregnancy loss, sudden infant death, and fathers with existing severe mental illnesses were excluded. RESULTS: Nine major categories…

OBJECTIVES: To synthesise evidence on longer term unmet needs perceived by stroke survivors, and psychometric properties of the tools used to evaluate unmet care needs after stroke. DESIGN: Systematic review. SETTING: Community or patients' home. PARTICIPANTS: Stroke survivors. METHODS: We searched PubMed, PsycINFO, CINAHL, EMBASE from inception to 31 March 2018 to identify survey studies that evaluated unmet needs perceived by stroke survivors after hospital discharge. Reported unmet needs were categorised under three domains: body functioning, activity/participation and environmental factors. Ranges of prevalence rates of unmet needs reported in studies were presented. RESULTS: We included 19 eligible studies, with considerable heterogeneity in patients, survey methods and results. Psychometric properties of two stroke-specific tools were formally evaluated, indicating their moderate reliability and content/concurrent validity. The median number of reported unmet needs per stroke survivor was from two to five, and the proportion of stroke survivors with at least one unmet needs…

OBJECTIVES: Studies have found a 'healthy-migrant effect' (HME) among arriving migrants, that is, a better health status compared with others in the home country, but also in comparison with the population in the host country. The aims were to investigate whether the HME hypothesis is applicable to the Swedish context, that is, if health outcomes differed between a group of mainly labour migrants (Western migrants) and a group of mainly refugee/family reunion migrants (non-Western migrants) compared with the native Swedish population, and if there were any correlations between labour market attachment (LMA) and these health outcomes. DESIGN: Register-based, longitudinal cohort study. PARTICIPANTS: The cohort was defined on 31 December 1990 and consisted of all migrants aged 18-47 years who arrived in Sweden in 1985-1990 (n=74 954) and a reference population of native Swedes (n=1 405 047) in the same age span. They were followed for three consecutive 6-year periods (1991-1996, 1997-2002 and 2003-2008) and were assessed for five measures of health: hospitalisation for cardiovascular…

OBJECTIVE: Evaluate effectiveness, harms and burdens of faecal blood testing, sigmoidoscopy and colonoscopy screening for colorectal cancer over 15 years. DESIGN: We performed an update of a Cochrane systematic review, and performed network meta-analysis comparing randomised trials evaluating colorectal cancer screening with guaiac faecal occult blood test (gFOBT) (annual, biennial), faecal immunochemical test (FIT) (annual, biennial), sigmoidoscopy (once-only) or colonoscopy (once-only) in a healthy population, aged 50-79 years. We conducted subgroup analysis on sex. Follow-up >5 years was required for analysis of colorectal cancer incidence and mortality. RESULTS: 12 randomised trials proved eligible. Compared with no-screening, we found high certainty evidence for sigmoidoscopy screening slightly reducing colorectal cancer incidence (relative risk (RR) 0.76; 95% confidence interval (CI 0.70 to 0.83) and mortality (RR 0.74; 95% CI 0.69 to 0.80), while gFOBT screening had little or no difference on colorectal cancer incidence, but slightly reduced colorectal cancer mortality…

OBJECTIVE: To determine the magnitude of relationships of early life factors with child development in low/middle-income countries (LMICs). DESIGN: Meta-analyses of standardised mean differences (SMDs) estimated from published and unpublished data. DATA SOURCES: We searched Medline, bibliographies of key articles and reviews, and grey literature to identify studies from LMICs that collected data on early life exposures and child development. The most recent search was done on 4 November 2014. We then invited the first authors of the publications and investigators of unpublished studies to participate in the study. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Studies that assessed at least one domain of child development in at least 100 children under 7 years of age and collected at least one early life factor of interest were included in the study. ANALYSES: Linear regression models were used to assess SMDs in child development by parental and child factors within each study. We then produced pooled estimates across studies using random effects meta-analyses. RESULTS: We retrieved…

OBJECTIVE: This study aimed to evaluate the association between metformin treatment and the risk of neurodegenerative disease (ND) among elderly adults with type 2 diabetes mellitus (T2DM). DESIGN/SETTING/PARTICIPANTS: This retrospective longitudinal cohort study examined the effects of the length of metformin exposure on ND among elderly US veterans with T2DM and insulin treatment using the Veterans Affairs electronic medical record database. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary clinical outcome was defined as diagnosis of ND including dementia, Alzheimer's disease (AD), Parkinson's disease (PD), Huntington's disease (HD) and mild cognitive impairment during the follow-up period. The secondary clinical outcomes were separately measured by AD, PD, HD, dementia and mild cognitive impairment. RESULT: Adjusted by propensity score weight, a total of 5528 patients (mean age, 63.2±10.9 years; male, 98%; white, 60%) with a median follow-up of 5.2 years were selected. Those with ND or other mental disorders at baseline or who were on insulin for less than two-thirds of the…

INTRODUCTION: Individualising therapy is an important challenge for intensive care of patients with severe traumatic brain injury (TBI). Targeting a cerebral perfusion pressure (CPP) tailored to optimise cerebrovascular autoregulation has been suggested as an attractive strategy on the basis of a large body of retrospective observational data. The objective of this study is to prospectively assess the feasibility and safety of such a strategy compared with fixed thresholds which is the current standard of care from international consensus guidelines. METHODS AND ANALYSIS: CPPOpt Guided Therapy: Assessment of Target Effectiveness (COGiTATE) is a prospective, multicentre, non-blinded randomised, controlled trial coordinated from Maastricht University Medical Center, Maastricht (The Netherlands). The other original participating centres are Cambridge University NHS Foundation Trust, Cambridge (UK), and University Hospitals Leuven, Leuven (Belgium). Adult severe TBI patients requiring intracranial pressure monitoring are randomised within the first 24 hours of admission in neurocritical…

In an ambitious undertaking, Growing Up in Australia's Child Health CheckPoint streamlined and implemented wide-ranging population phenotypes and biosamples relevant to non-communicable diseases in nearly 1900 parent-child dyads throughout Australia at child aged 11-12 years. This BMJ Open Special Issue describes the methodology, epidemiology and parent-child concordance of 14 of these phenotypes, spanning cardiovascular, respiratory, bone, kidney, hearing and language, body composition, metabolic profiles, telomere length, sleep, physical activity, snack choice and health-related quality of life. The Special Issue also includes a cohort summary and study methodology paper.

OBJECTIVE: This study aims to estimate the technical efficiency of health systems in Asia. SETTINGS: The study was conducted in Asian countries. METHODS: We applied an output-oriented data envelopment analysis (DEA) approach to estimate the technical efficiency of the health systems in Asian countries. The DEA model used per-capita health expenditure (all healthcare resources as a proxy) as input variable and cross-country comparable health outcome indicators (eg, healthy life expectancy at birth and infant mortality per 1000 live births) as output variables. Censored Tobit regression and smoothed bootstrap models were used to observe the associated factors with the efficiency scores. A sensitivity analysis was performed to assess the consistency of these efficiency scores. RESULTS: The main findings of this paper demonstrate that about 91.3% (42 of 46 countries) of the studied Asian countries were inefficient with respect to using healthcare system resources. Most of the efficient countries belonged to the high-income group (Cyprus, Japan, and Singapore) and only one country…

INTRODUCTION: Occurrence of multiple brain metastases is a critical evolution of many cancers with significant neurological and overall survival consequences, despite new targeted therapy and standard whole brain radiotherapy (WBRT). A gadolinium-based nanoparticle, AGuIX, has recently demonstrated its effectiveness as theranostic and radiosensitiser agent in preclinical studies. The favourable toxicity profile in animals and its administration as a simple intravenous injection has motivated its use in patients with this first in human study. METHODS AND ANALYSIS: The NANO-RAD study is a phase I, first in human injection, monocentric, open-label, dose-escalation study to investigate the safety, the tolerability and the spectrum of side effects of AGuIX in combination with WBRT (30 Gy, 10 fractions of 3 Gy) for patients with multiple brain metastases. Five dose escalation cohorts are planned: 15, 30, 50, 75 and 100 mg/kg. A total of 15-18 patients will be recruited into this trial. The primary objective is to determine the maximum-tolerated dose of AGuIX nanoparticles combined with…

OBJECTIVE: This study examined the association of initial provider treatment with early and long-term opioid use in a national sample of patients with new-onset low back pain (LBP). DESIGN: A retrospective cohort study of patients with new-onset LBP from 2008 to 2013. SETTING: The study evaluated outpatient and inpatient claims from patient visits, pharmacy claims and inpatient and outpatient procedures with initial providers seen for new-onset LBP. PARTICIPANTS: 216 504 individuals aged 18 years or older across the USA who were diagnosed with new-onset LBP and were opioid-naïve were included. Participants had commercial or Medicare Advantage insurance. EXPOSURES: The primary independent variable is type of initial healthcare provider including physicians and conservative therapists (physical therapists, chiropractors, acupuncturists). MAIN OUTCOME MEASURES: Short-term opioid use (within 30 days of the index visit) following new LBP visit and long-term opioid use (starting within 60 days of the index date and either 120 or more days' supply of opioids over 12 months, or 90 days or…

OBJECTIVE: Companion robots, such as Paro, may reduce agitation and depression for older people with dementia. However, contradictory research outcomes suggest robot design is not always optimal. While many researchers suggest user-centred design is important, there is little evidence on the difference this might make. Here, we aimed to assess its importance by comparing companion robot design perceptions between older people (end users) and roboticists (developers). DESIGN: Older people and roboticists interacted with eight companion robots or alternatives at two separate events in groups of two to four people. Interactions were recorded, participants' comments and observations were transcribed, and content was analysed. Subsequently, each group participated in focus groups on perceptions of companion robot design. Discussions were recorded and transcribed, and content was analysed. PARTICIPANTS AND SETTINGS: Seventeen older people (5 male, 12 female, ages 60-99) at a supported living retirement complex, and 18 roboticists (10 male, 8 female, ages 24-37) at a research centre…

OBJECTIVES: Crew resource management (CRM) training formats have become a popular method to increase patient safety by consideration of the role that human factors play in healthcare delivery. The purposes of this review were to identify what is subsumed under the label of CRM in a healthcare context and to determine how such training is delivered and evaluated. DESIGN: Systematic review of published literature. DATA SOURCES: PubMed, PsycINFO and ERIC were searched through 8 October 2018. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Individually constructed interventions for healthcare staff that were labelled as CRM training, or described as based on CRM principles or on aviation-derived human factors training. Only studies reporting both an intervention and results were included. DATA EXTRACTION AND SYNTHESIS: The studies were examined and coded for relevant passages. Characteristics regarding intervention design, training conditions and evaluation methods were analysed and summarised both qualitatively and quantitatively. RESULTS: Sixty-one interventions were included. 48% did not…

OBJECTIVE: To determine the effect of occupational therapy provided at home on activities of daily living, behavioural and psychological symptoms of dementia (BPSD) and quality of life (QOL) for people with dementia, and the effect on family carer burden, depression and QOL. DESIGN: Systematic review and meta-analysis. METHODS: Eight databases were searched to February 2018. Randomised controlled trials of occupational therapy delivered at home for people with dementia and their family carers that measured ADL, and/or BPSD were included. Two independent reviewers determined eligibility, risk of bias and extracted data. RESULTS: Fifteen trials were included (n=2063). Occupational therapy comprised multiple components (median=8 sessions). Compared with usual care or attention control occupational therapy resulted in improvements in the following outcomes for people with dementia: overall ADL after intervention (standardised means difference (SMD) 0.61, 95% CI 0.16 to 1.05); instrumental ADL alone (SMD 0.22, 95% CI 0.07 to 0.37; moderate quality); number of behavioural and…

OBJECTIVES: To assess the effects of botulinum toxin for prevention of migraine in adults. DESIGN: Systematic review and meta-analysis. DATA SOURCES: CENTRAL, MEDLINE, Embase and trial registries. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) of botulinum toxin compared with placebo, active treatment or clinically relevant different dose for adults with chronic or episodic migraine, with or without the additional diagnosis of medication overuse headache. DATA EXTRACTION AND SYNTHESIS: Cochrane methods were used to review double-blind RCTs. Twelve week post-treatment time-point data was analysed. RESULTS: Twenty-eight trials (n=4190) were included. Trial quality was mixed. Botulinum toxin treatment resulted in reduced frequency of -2.0 migraine days/month (95% CI -2.8 to -1.1, n=1384) in chronic migraineurs compared with placebo. An improvement was seen in migraine severity, measured on a numerical rating scale 0 to 10 with 10 being maximal pain, of -2.70 cm (95% CI -3.31 to -2.09, n=75) and -4.9 cm (95% CI -6.56 to -3.24, n=32) for chronic and episodic…

OBJECTIVES: To examine the effect of cannabis policy liberalisation (decriminalisation and legalisation) levels of use in adolescents and young adults. DESIGN: Systematic review and meta-analysis. INCLUSION CRITERIA: Included studies were conducted among individuals younger than 25 years and quantitatively assessing consequences of cannabis policy change. We excluded articles: (A) exclusively based on participants older than 25 years; (B) only reporting changes in perceptions of cannabis use; (C) not including at least two measures of cannabis use; (D) not including quantitative data; and (E) reviews, letters, opinions and policy papers. PubMed, PsycINFO, Embase and Web of Science were searched through 1 March 2018. DATA EXTRACTION AND SYNTHESIS: Two independent readers reviewed the eligibility of titles and abstracts and read eligible articles, and four authors assessed the risk of bias (Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies). Extracted data were meta-analysed. The protocol was registered with PROSPERO. RESULTS: 3438 records were identified…

OBJECTIVE: Surgery remains an inherently male-dominated profession. The aim of this study was to survey women working within the discipline, to understand their current perceptions, providing insight into their practical day-to-day lives, supporting an action-oriented change. DESIGN AND SETTING: The link to a confidential, online survey was distributed through the Association of Surgeons of Great Britain and Ireland (ASGBI) social media platforms on Facebook and Twitter over a 2-week period in October 2017. PARTICIPANTS: Women working in surgical specialties and actively responding to the link shared through the ASGBI social media platforms. No patients were involved in the study. PRIMARY AND SECONDARY OUTCOME MEASURES: Data were analysed through a mixed-methods approach. The quantitative data were analysed through descriptive statistics and qualitative analysis was undertaken using a constant comparative analysis of the participants' comments, to identify salient patterns (themes). RESULTS: A total of 81 female participants replied (42% response rate based on the Facebook group…

INTRODUCTION: The environmental scan has been described as an important tool to inform decision-making on policy, planning and programme development in the healthcare sector. Despite the wide adoption of environmental scans, there is no consensus on a working definition within the health services delivery context and methodological guidance on the design and implementation of this approach is lacking in the literature. The objectives of this study are to map the extent, range and nature of evidence that describe the definitions, characteristics, conceptualisations, theoretical underpinnings, study limitations and other features of the environmental scan in the health services delivery literature and to propose a working definition specific to this context. METHODS AND ANALYSIS: This protocol describes a scoping review based on the methodology outlined by Khalil and colleagues. A comprehensive search strategy was developed by experienced health science librarians in consultation with the research team. A Peer Review of Electronic Search Strategies (PRESS) was completed. Two reviewers…

OBJECTIVE: To evaluate the diagnostic accuracy of keratoconus using deep learning of the colour-coded maps measured with the swept-source anterior segment optical coherence tomography (AS-OCT). DESIGN: A diagnostic accuracy study. SETTING: A single-centre study. PARTICIPANTS: A total of 304 keratoconic eyes (grade 1 (108 eyes), 2 (75 eyes), 3 (42 eyes) and 4 (79 eyes)) according to the Amsler-Krumeich classification, and 239 age-matched healthy eyes. MAIN OUTCOME MEASURES: The diagnostic accuracy of keratoconus using deep learning of six colour-coded maps (anterior elevation, anterior curvature, posterior elevation, posterior curvature, total refractive power and pachymetry map). RESULTS: Deep learning of the arithmetical mean output data of these six maps showed an accuracy of 0.991 in discriminating between normal and keratoconic eyes. For single map analysis, posterior elevation map (0.993) showed the highest accuracy, followed by posterior curvature map (0.991), anterior elevation map (0.983), corneal pachymetry map (0.982), total refractive power map (0.978) and anterior…

OBJECTIVES: High rates of healthcare worker (HCW) burn-out have led many to label it an 'epidemic' urgently requiring interventions. This prospective pilot study examined the efficacy, feasibility and evaluation of the 'Three Good Things' (3GT) intervention for HCWs, and added burn-out and work-life balance to the set of well-being metrics. METHODS: 228 HCWs participated in a prospective, repeated measures study of a web-based 15-day long 3GT intervention. Assessments were collected at baseline and 1, 6 and 12-month post-intervention. The primary measure of efficacy was a derivative of the emotional exhaustion subscale of the Maslach Burnout Inventory. The secondary measures were validated instruments assessing depression symptoms, subjective happiness, and work-life balance. Paired samples t-tests and Cohen's d effect sizes for correlated samples were used to examine the efficacy of the intervention. RESULTS: 3GT participants exhibited significant improvements from baseline in emotional exhaustion, depression symptoms and happiness at 1 month, 6 months and 12 months, and in…

OBJECTIVES: Rapid Recommendations addressing subacromial decompression surgery for shoulder pain. DESIGN: Systematic review. OUTCOME MEASURES: Rapid Recommendations panel as important for informing their recommendation (pain, function and health-related quality of life (HRQoL)). DATA SOURCES: MEDLINE, EMBASE and PsycINFO up to August 2018. STUDY SELECTION AND REVIEW METHODS: We included original studies of any intervention for shoulder conditions reporting estimates of anchor-based MIDs for relevant PROMs. Two reviewers independently evaluated potentially eligible studies according to predefined selection criteria. Six reviewers, working in pairs, independently extracted data from eligible studies using a predesigned, standardised, pilot-tested extraction form and independently assessed the credibility of included studies using an MID credibility tool. RESULTS: We identified 22 studies involving 5562 patients that reported 74 empirically estimated anchor-based MIDs for 10 candidate instruments to assess shoulder pain, function and HRQoL. We identified MIDs of high credibility for…

PURPOSE: The Early Life Exposure in Mexico to ENvironmental Toxicants (ELEMENT) Project is a mother-child pregnancy and birth cohort originally initiated in the mid-1990s to explore: (1) whether enhanced mobilisation of lead from maternal bone stores during pregnancy poses a risk to fetal and subsequent offspring neurodevelopment; and (2) whether maternal calcium supplementation during pregnancy and lactation can suppress bone lead mobilisation and mitigate the adverse effects of lead exposure on offspring health and development. Through utilisation of carefully archived biospecimens to measure other prenatal exposures, banking of DNA and rigorous measurement of a diverse array of outcomes, ELEMENT has since evolved into a major resource for research on early life exposures and developmental outcomes. PARTICIPANTS: n=1643 mother-child pairs sequentially recruited (between 1994 and 2003) during pregnancy or at delivery from maternity hospitals in Mexico City, Mexico. FINDINGS TO DATE: Maternal bone (eg, patella, tibia) is an endogenous source for fetal lead exposure due to…

OBJECTIVE: To assess the benefits and harms of pregabalin in the management of neuropathic pain. DESIGN: Rapid review and meta-analysis of phase III, randomised, placebo-controlled trials. PARTICIPANTS: Adults aged 18 years and above with neuropathic pain defined according to the International Association for the Study of Pain criteria. INTERVENTIONS: Pregabalin or placebo. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary outcomes were pain (as measured using validated scales) and adverse events. Our secondary outcomes were sleep disturbance, quality of life, Patient Global Impression of Change, Clinician Global Impression scale, anxiety and depression scores, overall discontinuations and discontinuations because of adverse events. RESULTS: We included 28 trials comprising 6087 participants. The neuropathic pain conditions studied were diabetic peripheral neuropathy, postherpetic neuralgia, herpes zoster, sciatica (radicular pain), poststroke pain and spinal cord injury-related pain. Patients who took pregabalin reported significant reductions in pain (numerical rating scale…

PURPOSE: The National Health Insurance Service (NHIS)-Senior was set up to provide high-quality longitudinal data that can be used to explore various aspects of changes in the socio-economical and health status of older adults, to predict risk factors and to investigate their health outcomes. PARTICIPANTS: The NHIS-Senior cohort, a Korean nationwide retrospective administrative data cohort, is composed of older adults aged 60 years and over in 2002. It consists of 558 147 people selected by 10% simple random sampling method from a total of 5.5 million subjects aged 60+ in the National Health Information Database. The cohort was followed up through 2015 for all subjects, except for those who were deceased. FINDINGS TO DATE: The healthcare utilisation and admission rates were the highest for acute upper respiratory infections and influenza (75.2%). The age-standardised (defined with reference to the world standard population) mortality rate for 10 years (through 2012) was 4333 per 100 000 person-years. Malignant neoplasms were the most common cause of death in both sexes (1032.1 per…

OBJECTIVES: Patients in inpatient mental health settings face similar risks (eg, medication errors) to those in other areas of healthcare. In addition, some unsafe behaviours associated with serious mental health problems (eg, self-harm), and the measures taken to address these (eg, restraint), may result in further risks to patient safety. The objective of this review is to identify and synthesise the literature on patient safety within inpatient mental health settings using robust systematic methodology. DESIGN: Systematic review and meta-synthesis. Embase, Cumulative Index to Nursing and Allied Health Literature, Health Management Information Consortium, MEDLINE, PsycINFO and Web of Science were systematically searched from 1999 to 2019. Search terms were related to 'mental health', 'patient safety', 'inpatient setting' and 'research'. Study quality was assessed using the Hawker checklist. Data were extracted and grouped based on study focus and outcome. Safety incidents were meta-analysed where possible using a random-effects model. RESULTS: Of the 57 637 article titles and…

Objectives The aim of this review was to explore the notion of alcohol-related presenteeism; that is, whether evidence in the research literature supports an association between employee alcohol consumption and impaired work performance. Design Systematic review of observational studies. Data sources MEDLINE, Web of Science, PsycINFO, CINAHL, AMED, Embase and Swemed+ were searched through October 2018. Reference lists in included studies were hand searched for potential relevant studies. Eligibility criteria We included observational studies, published 1990 or later as full-text empirical articles in peer-reviewed journals in English or a Scandinavian language, containing one or more statistical tests regarding a relationship between a measure of alcohol consumption and a measure of work performance. Data extraction and synthesis Two independent reviewers extracted data. Tested associations between alcohol consumption and work performance within the included studies were quality assessed and analysed with frequency tables, cross-tabulations and χ 2 tests of independence. Results…

INTRODUCTION: A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer. METHODS: We are conducting a large scale, multicentre pragmatic randomised clinical trial for patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. A total of 1278 patients with non-metastatic breast cancer will be randomly allocated to receive either photon or proton therapy. The primary outcomes are…

OBJECTIVES: Examination of the prevalence and patterns of multimorbidity among the elderly in China. DESIGN: Cross-sectional study. SETTING: More than 10 000 households in 28 of the 34 provinces of mainland China. PARTICIPANTS: 11 707 Chinese adults aged 60 and over. PRIMARY OUTCOME MEASURES: Prevalence and patterns of multimorbidity among the participants. Relative risks were calculated to estimate the probability of up to 14 chronic conditions coexisting with each other. Observed-to-expected (O/E) ratios were used to analyse the patterns of multimorbidity. RESULTS: Multimorbidity was present in 43.6% of respondents from the sample population, with women having the greater prevalence compared with men. There were 804 different comorbidity combinations identified, including 76 dyad combinations and 169 triad combinations. The top 10 morbidity dyads and triads accounted for 69.01% and 47.05% of the total dyad and triad combinations observed, respectively. Among the 14 chronic conditions included in the study, asthma, stroke, heart attack and six other chronic conditions were the main…

OBJECTIVE: The impact of severe mental illnesses (SMIs) is not limited to the person with the illness but extends to their family members and the community where the patient comes from. In this review, we systematically analyse the available evidence of impacts of SMI on family members, including parents, grandparents, siblings, spouses and children. DATA SOURCES: PubMed, PsycINFO, Embase and Global Index Medicus were searched from the inception of each database up to 9 November 2019. We also did manual searches of grey literature. ELIGIBILITY CRITERIA: We included studies that assessed the impacts of SMI on any family member. We excluded studies in admitted clinics and acute wards to rule out the acute effect of hospitalisation. DATA EXTRACTION: Two reviewers extracted data independently using the Cochrane handbook guideline for systematic reviews and agreed on the final inclusion of identified studies. RISK OF BIAS: The quality of the included studies was assessed using effective public health practice project quality assessment tool for quantitative studies.The review protocol…

OBJECTIVES: The aim of this study was to assess the prevalence and risk of pre-eclampsia and gestational hypertension in twin pregnancies compared with singleton pregnancies. DESIGN: Population-based cohort study. SETTING: Medical Birth Registry of Norway and Statistics Norway. PARTICIPANTS: 929 963 deliveries with 16 174 twin pregnancies in 1999-2014. METHODS: Pre-eclampsia prevalences in twin and singleton pregnancies were described in percentages. Multivariable regression analyses were performed to assess the risks of pre-eclampsia and gestational hypertension in twin pregnancies compared with those in singleton pregnancies, adjusted for previously known risk factors. PRIMARY AND SECONDARY OUTCOME MEASURES: Prevalence and risk of pre-eclampsia and gestational hypertension. RESULTS: The prevalence of pre-eclampsia in the study population was 3.7% (3.4% in singleton pregnancies, 11.8% in twin pregnancies (p=0.001)). The OR for pre-eclampsia in twin pregnancies was three to fourfold compared with singleton pregnancies (OR 3.78; 95% CI 3.59 to 3.96). After adjustment for known risk…

OBJECTIVES: We provide new estimates on size, composition and distribution of human resource for health in India and compare with the health workers population ratio as recommended by the WHO. We also estimate size of non-health workers engaged in health sector and the size of technically qualified health professionals who are not a part of the health workforce. DESIGN: Nationally representative cross-section household survey and review of published documents by the Central Bureau of Health Intelligence. SETTING: National. PARTICIPANTS: Head of household/key informant in a sample of 101 724 households. INTERVENTIONS: Not applicable. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the number and density of health workers,and the secondary outcome was the percentage of health workers who are technically qualified and the percentage of individuals technically qualified and not in workforce. RESULTS: The total size of health workforce estimated from the National Sample Survey (NSS) data is 3.8 million as of January 2016, which is about 1.2 million less than the total…

RATIONALE: Physical rehabilitation (encompassing early mobilisation) of the critically ill patient is recognised best practice; however, further work is needed to explore the patients' experience of rehabilitation qualitatively; a better understanding may facilitate implementation of early rehabilitation and elucidate the journey of survivorship. OBJECTIVES: To explore patient experience of physical rehabilitation from critical illness during and after a stay on intensive care unit (ICU). DESIGN: Exploratory grounded theory study using semistructured interviews. SETTING: Adult medical/surgical ICU of a London teaching hospital. PARTICIPANTS: A purposive sample of ICU survivors with intensive care unit acquired weakness (ICUAW) and an ICU length of stay of >72 hours. ANALYSIS: Data analysis followed a four-stage constant comparison technique: open coding, axial coding, selective coding and model development, with the aim of reaching thematic saturation. Peer debriefing and triangulation through a patient support group were carried out to ensure credibility. MAIN RESULTS: Fifteen…

One in four births in the UK is to foreign-born women. In 2016, the figure was 28.2%, the highest figure on record, with maternal and perinatal mortality also disproportionately higher for some immigrant women. Our objective was to examine issues of access and experience of maternity care by immigrant women based on a systematic review and narrative synthesis of empirical research. REVIEW METHODS: A research librarian designed the search strategies (retrieving literature published from 1990 to end June 2017). We retrieved 45 954 citations and used a screening tool to identify relevance. We searched for grey literature reported in databases/websites. We contacted stakeholders with expertise to identify additional research. RESULTS: We identified 40 studies for inclusion: 22 qualitative, 8 quantitative and 10 mixed methods. Immigrant women, particularly asylum-seekers, often booked and accessed antenatal care later than the recommended first 10 weeks. Primary factors included limited English language proficiency, lack of awareness of availability of the services, lack of understanding…

OBJECTIVE: To determine whether there were inequalities in the sustained rise in infant mortality in England in recent years and the contribution of rising child poverty to these trends. DESIGN: This is an analysis of trends in infant mortality in local authorities grouped into five categories (quintiles) based on their level of income deprivation. Fixed-effects regression models were used to quantify the association between regional changes in child poverty and regional changes in infant mortality. SETTING: 324 English local authorities in 9 English government office regions. PARTICIPANTS: Live-born children under 1 year of age. MAIN OUTCOME MEASURE: Infant mortality rate, defined as the number of deaths in children under 1 year of age per 100 000 live births in the same year. RESULTS: The sustained and unprecedented rise in infant mortality in England from 2014 to 2017 was not experienced evenly across the population. In the most deprived local authorities, the previously declining trend in infant mortality reversed and mortality rose, leading to an additional 24 infant deaths per…

INTRODUCTION AND OBJECTIVES: Surgical site infections (SSIs) represent a common and serious complication of all surgical interventions. Microorganisms are able to colonise sutures that are implanted in the skin, which is a causative factor of SSIs. Triclosan-coated sutures are antibacterial sutures aimed at reducing SSIs. Our objective is to update the existing literature by systematically reviewing available evidence to assess the effectiveness of triclosan-coated sutures in the prevention of SSIs. METHODS: A systematic review of EMBASE, MEDLINE, AMED (Allied and complementary medicine database) and CENTRAL was performed to identify full text randomised controlled trials (RCTs) on 31 May 2019. INTERVENTION: Triclosan-coated sutures versus non-triclosan-coated sutures. PRIMARY OUTCOME: Our primary outcome was the development of SSIs at 30 days postoperatively. A meta-analysis was performed using a fixed-effects model. RESULTS: Twenty-five RCTs were included involving 11 957 participants. Triclosan-coated sutures were used in 6008 participants and non triclosan-coated sutures were…

OBJECTIVES: As clinical practice guidelines vary widely in their search strategies and recommendations of complementary and alternative medicine (CAM) for depression, this overview aimed at systematically summarising the level 1 evidence on CAM for patients with a clinical diagnosis of depression. METHODS: PubMed, PsycInfo and Central were searched for meta-analyses of randomised controlled clinical trials (RCTs) until 30 June 2018. Outcomes included depression severity, response, remission, relapse and adverse events. The quality of evidence was assessed according to Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) considering the methodological quality of the RCTs and meta-analyses, inconsistency, indirectness, imprecision of the evidence and the potential risk of publication bias. RESULTS: The literature search revealed 26 meta-analyses conducted between 2002 and 2018 on 1-49 RCTs in major, minor and seasonal depression. In patients with mild to moderate major depression, moderate quality evidence suggested the efficacy of St. John's wort towards placebo…

OBJECTIVE: To assess (1) how well validated existing paediatric track and trigger tools (PTTT) are for predicting adverse outcomes in hospitalised children, and (2) how effective broader paediatric early warning systems are at reducing adverse outcomes in hospitalised children. DESIGN: Systematic review. DATA SOURCES: British Nursing Index, Cumulative Index of Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effectiveness, EMBASE, Health Management Information Centre, Medline, Medline in Process, Scopus and Web of Knowledge searched through May 2018. ELIGIBILITY CRITERIA: We included (1) papers reporting on the development or validation of a PTTT or (2) the implementation of a broader early warning system in paediatric units (age 0-18 years), where adverse outcome metrics were reported. Several study designs were considered. DATA EXTRACTION AND SYNTHESIS: Data extraction was conducted by two independent reviewers using template forms. Studies were quality assessed using a modified Downs and Black rating scale.…

OBJECTIVE: To assess the prevalence and factors associated with fatigue in the general population. DESIGN: Population-based, cross-sectional survey performed between May 2014 and April 2017. SETTING: General population of the city of Lausanne, Switzerland. PARTICIPANTS: 2848 participants (53.2% women, age range 45-86 years). PRIMARY OUTCOME MEASURE: Prevalence of fatigue the previous week, defined as a score of ≥4 using the Fatigue Severity Scale. RESULTS: The prevalence of fatigue was 21.9% (95% CI 20.4% to 23.4%) in the total sample. On bivariate analysis, participants with fatigue were younger, had a higher body mass index, a lower handgrip strength and lower ferritin levels. Participants with fatigue were more frequently women, had a lower educational level, presented more frequently with clinical insomnia, diabetes, anaemia, depression and low thyroid stimulating hormone (TSH) values, had a higher consumption of antihistamines, antidepressants and hypnotics, and rated more frequently their health as bad or very bad. Multivariable analysis showed that obesity (OR 1.40 (95% CI…