Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient ...groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www.equator-network.org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports.
Objective To determine whether government efforts in reducing inequalities in health in European countries have actually made a difference to mortality inequalities by socioeconomic ...group.Design Register based study.Data source Mortality data by level of education and occupational class in the period 1990-2010, usually collected in a census linked longitudinal study design. We compared changes in mortality between the lowest and highest socioeconomic groups, and calculated their effect on absolute and relative inequalities in mortality (measured as rate differences and rate ratios, respectively).Setting All European countries for which data on socioeconomic inequalities in mortality were available for the approximate period between years 1990 and 2010. These included Finland, Norway, Sweden, Scotland, England and Wales (data applied to both together), France, Switzerland, Spain (Barcelona), Italy (Turin), Slovenia, and Lithuania.Results Substantial mortality declines occurred in lower socioeconomic groups in most European countries covered by this study. Relative inequalities in mortality widened almost universally, because percentage declines were usually smaller in lower socioeconomic groups. However, as absolute declines were often smaller in higher socioeconomic groups, absolute inequalities narrowed by up to 35%, particularly among men. Narrowing was partly driven by ischaemic heart disease, smoking related causes, and causes amenable to medical intervention. Progress in reducing absolute inequalities was greatest in Spain (Barcelona), Scotland, England and Wales, and Italy (Turin), and absent in Finland and Norway. More detailed studies preferably using individual level data are necessary to identify the causes of these variations.Conclusions Over the past two decades, trends in inequalities in mortality have been more favourable in most European countries than is commonly assumed. Absolute inequalities have decreased in several countries, probably more as a side effect of population wide behavioural changes and improvements in prevention and treatment, than as an effect of policies explicitly aimed at reducing health inequalities.
Objective To clarify and quantify the potential dose–response association between the intake of fruit and vegetables and risk of type 2 diabetes. Design Meta-analysis and systematic review of ...prospective cohort studies. Data source Studies published before February 2014 identified through electronic searches using PubMed and Embase. Eligibility criteria for selecting studies Prospective cohort studies with relative risks and 95% CIs for type 2 diabetes according to the intake of fruit, vegetables, or fruit and vegetables. Results A total of 10 articles including 13 comparisons with 24 013 cases of type 2 diabetes and 434 342 participants were included in the meta-analysis. Evidence of curve linear associations was seen between fruit and green leafy vegetables consumption and risk of type 2 diabetes (p=0.059 and p=0.036 for non-linearity, respectively). The summary relative risk of type 2 diabetes for an increase of 1 serving fruit consumed/day was 0.93 (95% CI 0.88 to 0.99) without heterogeneity among studies (p=0.477, I2=0%). For vegetables, the combined relative risk of type 2 diabetes for an increase of 1 serving consumed/day was 0.90 (95% CI 0.80 to 1.01) with moderate heterogeneity among studies (p=0.002, I2=66.5%). For green leafy vegetables, the summary relative risk of type 2 diabetes for an increase of 0.2 serving consumed/day was 0.87 (95% CI 0.81 to 0.93) without heterogeneity among studies (p=0.496, I2=0%). The combined estimates showed no significant benefits of increasing the consumption of fruit and vegetables combined. Conclusions Higher fruit or green leafy vegetables intake is associated with a significantly reduced risk of type 2 diabetes.
Objectives To summarise the evidence from studies of acute kidney injury (AKI) with regard to the effect of pre-AKI renal function and post-AKI renal function recovery on long-term mortality and ...renal outcomes, and to assess whether these factors should be taken into account in future prognostic studies. Design/Setting A systematic review of observational studies listed in Medline and EMBASE from 1990 to October 2012. Participants All AKI studies in adults with data on baseline kidney function to identify AKI; with outcomes either stratified by pre-AKI and/or post-AKI kidney function, or described by the timing of the outcomes. Outcomes Long-term mortality and worsening chronic kidney disease (CKD). Results Of 7385 citations, few studies met inclusion criteria, reported baseline kidney function and stratified by pre-AKI or post-AKI function. For mortality outcomes, three studies compared patients by pre-AKI renal function and six by post-AKI function. For CKD outcomes, two studies compared patients by pre-AKI function and two by post-AKI function. The presence of CKD pre-AKI (compared with AKI alone) was associated with doubling of mortality and a fourfold to fivefold increase in CKD outcomes. Non-recovery of kidney function was associated with greater mortality and CKD outcomes in some studies, but findings were inconsistent varying with study design. Two studies also reported that risk of poor outcome reduced over time post-AKI. Meta-analysis was precluded by variations in definitions for AKI, CKD and recovery. Conclusions The long-term prognosis after AKI varies depending on cause and clinical setting, but it may also, in part, be explained by underlying pre-AKI and post-AKI renal function rather than the AKI episode itself. While carefully considered in clinical practice, few studies address these factors and with inconsistent study design. Future AKI studies should report pre-AKI and post-AKI function consistently as additional factors that may modify AKI prognosis.
ObjectivesLocked-in syndrome (LIS) consists of anarthria and quadriplegia while consciousness is preserved. Classically, vertical eye movements or blinking allow coded communication. Given ...appropriate medical care, patients can survive for decades. We studied the self-reported quality of life in chronic LIS patients.Design168 LIS members of the French Association for LIS were invited to answer a questionnaire on medical history, current status and end-of-life issues. They self-assessed their global subjective well-being with the Anamnestic Comparative Self-Assessment (ACSA) scale, whose +5 and −5 anchors were their memories of the best period in their life before LIS and their worst period ever, respectively.Results91 patients (54%) responded and 26 were excluded because of missing data on quality of life. 47 patients professed happiness (median ACSA +3) and 18 unhappiness (median ACSA −4). Variables associated with unhappiness included anxiety and dissatisfaction with mobility in the community, recreational activities and recovery of speech production. A longer time in LIS was correlated with happiness. 58% declared they did not wish to be resuscitated in case of cardiac arrest and 7% expressed a wish for euthanasia.ConclusionsOur data stress the need for extra palliative efforts directed at mobility and recreational activities in LIS and the importance of anxiolytic therapy. Recently affected LIS patients who wish to die should be assured that there is a high chance they will regain a happy meaningful life. End-of-life decisions, including euthanasia, should not be avoided, but a moratorium to allow a steady state to be reached should be proposed.
ObjectiveThe aim of this study was to identify factors associated with mortality in children under 5 years of age using a nationally representative sample of singleton births for the period of ...2004–2011.Design, setting and participantsPooled 2004, 2007 and 2011 cross-sectional data sets of the Bangladesh Demographic and Health Surveys were analysed. The surveys used a stratified two-stage cluster sample of 16 722 singleton live-born infants of the most recent birth of a mother within a 3-year period.Main outcome measuresOutcome measures were neonatal mortality (0–30 days), postneonatal mortality (1–11 months), infant mortality (0–11 months), child mortality (1–4 years) and under-5 mortality (0–4 years).ResultsSurvival information for 16 722 singleton live-born infants and 522 deaths of children <5 years of age included: 310 neonatal deaths, 154 postneonatal deaths, 464 infant deaths, 58 child deaths and 522 under-5 deaths. Multiple variable analysis showed that, over a 7-year period, mortality reduced significantly by 48% for postneonatal deaths, 33% for infant deaths and 29% for under-5 deaths, but there was no significant reduction in neonatal deaths (adjusted OR (AOR)=0.79, 95% CI 0.59 to 1.06) or child deaths (AOR=1.00, 95% CI 0.51 to 1.94). The odds of neonatal, postneonatal, infant, child and under-5 deaths decreased significantly among mothers who used contraceptive and mothers who had other children aged 3 years or older. The risk of neonatal, postneonatal, infant, child and under-5 deaths was significantly higher in mothers who reported a previous death of a sibling.ConclusionsOur study suggests that family planning is needed to further reduce the overall rate of under-5 deaths in Bangladesh. To reduce childhood mortality, public health interventions that focus on child spacing and contraceptive use by mothers may be most effective.
Objectives To examine the association between body mass index (BMI) in young adulthood and cardiovascular risks, including venous thromboembolism, before 55 years of age. Design Cohort study using ...population-based medical databases. Setting Outcomes registered from all hospitals in Denmark from 1977 onwards. Participants 6502 men born in 1955 and eligible for conscription in Northern Denmark. Main outcome measures Follow-up began at participants’ 22nd birthday and continued until death, emigration or 55 years of age, whichever came first. Using regression analyses, we calculated the risks and HRs, adjusting for cognitive test score and years of education. Results 48% of all obese young men (BMI ≥30 kg/m2) were either diagnosed with type 2 diabetes, hypertension, myocardial infarction, stroke or venous thromboembolism or died before reaching 55 years of age. Comparing obese men with normal weight men (BMI 18.5 to <25.0 kg/m2), the risk difference for any outcome was 28% (95% CI 19% to 38%) and the HR was 3.0 (95% CI 2.3 to 4.0). Compared with normal weight, obesity was associated with an event rate that was increased more than eightfold for type 2 diabetes, fourfold for venous thromboembolism and twofold for hypertension, myocardial infarction and death. Conclusions In this cohort of young men, obesity was strongly associated with adverse cardiometabolic events before 55 years of age, including venous thromboembolism. Compared with those of normal weight, young obese men had an absolute risk increase for type 2 diabetes, cardiovascular morbidity or premature death of almost 30%.
ObjectiveTo study prepregnancy serum lipid levels and the association with the number of children.DesignProspective, population-based cohort.SettingLinked data from the Cohort of Norway and the ...Medical Birth Registry of Norway.Participants2645 women giving birth to their first child during 1994–2003 (488 one-child mothers and 2157 women with ≥2 births) and 1677 nulliparous women.Main outcome measuresORs for no and one lifetime pregnancy (relative to ≥2 pregnancies) obtained by multinomial logistic regression, adjusted for age at examination, education, body mass index (BMI), smoking, time since last meal and oral contraceptive use.ResultsAssessed in quintiles, higher prepregnant triglyceride (TG) and TG to high-density lipoprotein (TG:HDL-c) ratio levels were associated with increased risk of one lifetime pregnancy compared with having ≥2 children. Compared with the highest quintile, women in the lowest quintile of HDL cholesterol levels had an increased risk of one lifetime pregnancy (OR 1.7, 95% CI 1.2 to 2.4), as were women with the highest low-density lipoprotein (LDL) cholesterol, TG and TG:HDL-c ratio quintiles (compared with the lowest) (OR 1.2, 95% CI 0.8 to 1.7; OR 2.2, 95% CI 1.5 to 3.2; and OR 2.2, 95% CI 1.5 to 3.2, respectively). Similar effects were found in women with BMI≥25 and the highest LDL and total cholesterol levels in risk of lifetime nulliparity.ConclusionWomen with unfavourable prepregnant lipid profile had higher risk of having no or only one child. These findings substantiate an association between prepregnant serum lipid levels and number of children. Previously observed associations between low parity and increased cardiovascular mortality may in part be due to pre-existing cardiovascular disease lipid risk factors.
Objectives To provide information of semen quality among normal young Japanese men and indicate the frequency of reduced semen quality. Design Cross-sectional, coordinated studies of Japanese young ...men included from university areas. The men had to be 18–24 years, and both the man and his mother had to be born in Japan. Background information was obtained from questionnaires. Standardised and quality-controlled semen analyses were performed, reproductive hormones analysed centrally and results adjusted for confounding factors. Setting Four study centres in Japan (Kawasaki, Osaka, Kanazawa and Nagasaki). Participants 1559 men, median age 21.1 years, included during 1999–2003. Outcome measures Semen volume, sperm concentration, total sperm count, sperm motility, sperm morphology and reproductive hormone levels. Results Median sperm concentration was 59 (95% CI 52 to 68) million/ml, and 9% and 31.9% had less than 15 and 40 million/ml, respectively. Median percentage of morphologically normal spermatozoa was 9.6 (8.8 to 10.3)%. Small, but statistically significant, differences were detected for both semen and reproductive hormone variables between men from the four cities. Overall, the semen values were lower than those of a reference population of 792 fertile Japanese men. Conclusions Assuming that the investigated men were representative for young Japanese men, a significant proportion of the population had suboptimal semen quality with reduced fertility potential, and as a group they had lower semen quality than fertile men. However, the definitive role—if any—of low semen quality for subfertility and low fertility rates remain to be investigated.
ObjectiveWe aimed to epidemiologically assess rubella herd immunity as a function of time, age and gender in Japan, with reference to the recent 2012–2014 rubella epidemic.DesignThis study is a ...retrospective seroepidemiological analysis.Main outcome measuresThe susceptible fraction of the population was examined as a function of age and time. The age at infection was assessed using reported case data.ResultsWhereas 30 years ago rubella cases were seen only among children, the median (25–75th centiles) age of cases in 2014 was elevated to 32.0 (17.0–42.0) years among males and 27.0 (7.0–37.0) years among females. Susceptible pockets among male birth cohorts 1989–1993 and 1974–1978 were identified, with seropositive proportions of 70.0% and 68.0%, respectively. The majority of female age groups had greater seropositive proportions than the herd immunity threshold, with a minor susceptible pocket for those born from 1989 to 1993 (78.3% seropositive). The age-standardised seronegative proportion decreased to 18.3% (95% CI 16.8% to 19.8%) among males and 15.6% (95% CI 10.0% to 21.2%) among females in 2013, and the immune fraction was not sufficiently below the herd immunity threshold. While the number of live births born to susceptible mothers in 1983 was estimated at 171 876 across Japan, in 2013 it was reduced to 23 698.ConclusionsAn elevated age at rubella virus infection and the presence of susceptible pockets among adults were observed in Japan. Although, overall, the absolute number of rubella cases has steadily declined in Japan, the elevated age of rubella cases, along with increased numbers of susceptible adults, contributed to the observation of as many as 45 congenital rubella syndrome (CRS) cases, which calls for supplementary vaccination among susceptible adults. Assessing herd immunity is considered essential for routinely monitoring the risk of future rubella epidemics and CRS cases.
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