bluuebunny/crossref_metadata_2025_split huggingface dataset:
Accuracy and reliability of the sensory test performed using the laryngopharyngeal endoscopic esthesiometer and rangefinder in patients with suspected obstructive sleep apnoea hypopnoea: protocol for a prospective double-blinded, randomised, exploratory study
Authors: Giraldo-Cadavid Luis Fernando , Bastidas Alirio Rodrigo , Padilla-Ortiz Diana Marcela , Concha-Galan Diana Carolina , Bazurto María Angelica , Vargas Leslie 
Published: August 2017

IntroductionPatients with obstructive sleep apnoea hypopnoea syndrome (OSA) might have varying degrees of laryngopharyngeal mechanical hyposensitivity that might impair the brain’s capacity to prevent airway collapse during sleep. However, this knowledge about sensory compromises in OSA comes from studies performed using methods with little evidence of their validity. Hence, the purpose of this study is to assess the reliability and accuracy of the measurement of laryngopharyngeal mechanosensitivity in patients with OSA using a recently developed laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER).Methods and analysisThe study will be prospective and double blinded, with a randomised crossover assignment of raters performing the sensory tests. Subjects will be recruited from patients with suspected OSA referred for baseline polysomnography to a university hospital sleep laboratory. Intra-rater and inter-rater reliability will be evaluated using the Bland–Altman’s limits of agreement plot, the intraclass correlation coefficient, and the Pearson or Spearman correlation coefficient, depending on the distribution of the variables. Diagnostic accuracy will be evaluated plotting ROC curves using standard baseline polysomnography as a reference. The sensory threshold values ​​for patients with mild, moderate and severe OSA will be determined and compared using ANOVA or the Kruskal–Wallis test, depending on the distribution of the variables. The LPEER could be a new tool for evaluating and monitoring laryngopharyngeal sensory impairment in patients with OSA. If it is shown to be valid, it could help to increase our understanding of the pathophysiological mechanisms of this condition and potentially help in finding new therapeutic interventions for OSA.Ethics and disseminationThe protocol has been approved by the Institutional Review Board of Fundacion Neumologica Colombiana. The results will be disseminated through conference presentations and peer-reviewed publication.Trial registrationThis trial was registered at Clinical Trials Accuracy of the sensory test using the lLaryngopharyngeal endoscopic esthesiometer in obstructive sleep apnea. Protocol ID: 201611-22405. ClinicalTrials.gov ID:NCT03109171.
Making a balanced plate for pregnant women to improve birthweight of infants: a study protocol for a cluster randomised controlled trial in rural Bangladesh
Authors: Chowdhury Morseda , Raynes-Greenow Camille , Alam Ashraful , Dibley Michael J 
Published: August 2017

ObjectivesLow birthweight significantly contributes to neonatal mortality, morbidities and psychosocial debilities throughout the course of life. A large proportion of infants (36–55%) in Bangladesh is born with low birthweight. Nutritional status of women during pregnancy is critical for optimal growth and development of the fetus. Nutrition education has been found to improve maternal nutritional status. Our study aims to determine whether nutrition education with a practical demonstration during pregnancy is an effective intervention for improving the birthweight of infants compared with standard nutrition education only.Methods and analysisWe will conduct a community-based cluster randomised controlled trial in one rural district of Bangladesh. Treatments will be allocated evenly between the study clusters (n=36). Participants in the intervention clusters receive ‘balanced plate nutrition education’ with a practical demonstration from community health workers 4–7 times throughout their entire pregnancy, starting from the first trimester. The control clusters will receive standard nutrition education delivered by public and other healthcare providers as per ongoing antenatal care protocol. Our sample size would be 900 pregnant women to determine 100 g differences in mean birthweight, considering 5% type 1 error, 80% power and an intra-cluster correlation coefficient of 0.03. The primary outcome of the trial is birthweight of the infants and the secondary outcomes include daily caloric intake and dietary diversity score among the pregnant women. Outcomes will be measured at enrolment, third to ninth month of gestation (monthly) and at delivery. Community health workers blinded to the study hypothesis will collect all data.Ethics and disseminationThe study was approved by the James P Grant School of Public Health, BRAC University Ethical Review Committee, Dhaka, Bangladesh. We will communicate the final results to relevant research and public health groups and publish research papers in peer-reviewed journals.Trial registration numberACTRN12616000080426.
Validation of newly developed and redesigned key indicator methods for assessment of different working conditions with physical workloads based on mixed-methods design: a study protocol
Authors: Klussmann Andre , Liebers Falk , Brandstädt Felix , Schust Marianne , Serafin Patrick , Schäfer Andreas , Gebhardt Hansjürgen , Hartmann Bernd , Steinberg Ulf 
Published: August 2017

IntroductionThe impact of work-related musculoskeletal disorders is considerable. The assessment of work tasks with physical workloads is crucial to estimate the work-related health risks of exposed employees. Three key indicator methods are available for risk assessment regarding manual lifting, holding and carrying of loads; manual pulling and pushing of loads; and manual handling operations. Three further KIMs for risk assessment regarding whole-body forces, awkward body postures and body movement have been developed de novo. In addition, the development of a newly drafted combined method for mixed exposures is planned. All methods will be validated regarding face validity, reliability, convergent validity, criterion validity and further aspects of utility under practical conditions.Methods and analysisAs part of the joint project MEGAPHYS (multilevel risk assessment of physical workloads), a mixed-methods study is being designed for the validation of KIMs and conducted in companies of different sizes and branches in Germany. Workplaces are documented and analysed by observations, applying KIMs, interviews and assessment of environmental conditions. Furthermore, a survey among the employees at the respective workplaces takes place with standardised questionnaires, interviews and physical examinations. It is intended to include 1200 employees at 120 different workplaces. For analysis of the quality criteria, recommendations of the COSMIN checklist (COnsensus-based Standards for the selection of health Measurement INstruments) will be taken into account.Ethics and disseminationThe study was planned and conducted in accordance with the German Medical Professional Code and the Declaration of Helsinki as well as the German Federal Data Protection Act. The design of the study was approved by ethics committees. We intend to publish the validated KIMs in 2018. Results will be published in peer-reviewed journals, presented at international meetings and disseminated to actual users for practical application.
Testing the effectivity of the mixed virtual reality training Into D’mentia for informal caregivers of people with dementia: protocol for a longitudinal, quasi-experimental study
Authors: Jütten Linda Helena , Mark Ruth Elaine , Maria Janssen Ben Wilhelmus Jacobus , Rietsema Jan , Dröes Rose-Marie , Sitskoorn Margriet Maria 
Published: August 2017

IntroductionInformal caregivers for people with dementia (hereafter: caregivers) often feel (over)burdened by the care for a loved one with dementia, and this can have various deleterious effects on both caregivers and patients. Support for caregivers is urgently needed, and for this reason, a dementia simulator (Into D’mentia) was developed in which caregivers experience what it is like to have dementia. The simulator attempts to heighten caregivers’ empathy and understanding for the patient and, in turn, diminish their own caregiver burden. The current study evaluates whether the simulator is effective on a number of outcomes.Methods and analysisA longitudinal, quasi-experimental study is ongoing in the Netherlands. We aim to recruit 142 caregivers in total divided over two groups: 71 caregivers in the intervention group and 71 caregivers in the control group. All participants will complete interviews and questionnaires at four time points: at baseline, 1 week, 2.5 months and 15 months after the training. The primary outcomes include empathy, caregiver burden, caregiver’s sense of competence, social reliance, anxiety, depression and caregivers’ subjective and objective health.Ethics and disseminationThis study is being carried out in agreement with the Declaration of Helsinki, and the protocol has been approved by the local ethics committees.Registration detailsThis study is registered with The Netherlands National Trial Register (NNTR5856).
The relationship between ambulatory blood pressure variability and enlarged perivascular spaces: a cross-sectional study
Authors: Yang Shuna , Qin Wei , Yang Lei , Fan Huimin , Li Yue , Yin Jiangmei , Hu Wenli 
Published: August 2017

ObjectivesRecent studies reported that 24-hour ambulatory blood pressure variability (ABPV) was associated with lacunar infarction and white matter hyperintensities (WMH). However, the relationship between ABPV and enlarged perivascular spaces (EPVS) has not been investigated. Thus, our study aimed to investigate whether ABPV is associated with EPVS by 24-hour ambulatory blood pressure monitoring (ABPM).DesignWe conducted this study as a cross-sectional study.SettingsThe study was based on patients who presented for physical examinations in our hospital from May 2013 to June 2016.ParticipantsPatients with both brain MRI scans and 24-hour ABPM were included and patients with acute stroke, a history of severe stroke and some other severe diseases were excluded. A total of 573 Chinese patients were prospectively enrolled in this study.Primary and secondary outcome measuresEPVS in basal ganglia (BG) and white matter (WM) were identified on MRI and classified into three categories by the severity. WMH were scored by the Fazekas scale. Coefficient of variation (CV) and SD were considered as metrics of ABPV. Spearman correlation analysis and ordinal logistic regression analysis were used to assess the relationship between ABPV and EPVS.ResultsThere were statistical differences among the subgroups stratified by the severity of EPVS in BG in the following ABPV metrics: SD and CV of systolic blood pressure (SBP), CV of diastolic blood pressure (DBP) in 24 hours, daytime and nighttime and SD of DBP in nighttime. The above ABPV metrics were positively associated with the degree of EPVS. The association was unchanged after adjusting for confounders. Spearman correlation analysis showed ABPV was not related to the degree of EPVS in the WM.ConclusionABPV was independently associated with EPVS in BG after controlling for blood pressure, but not in the WM. Pathogenesis of EPVS in BG and WM might be different.
Comparing provision and appropriateness of health care between immigrants and non-immigrants in Germany using the example of neuraxial anaesthesia during labour: cross-sectional study
Authors: Razum Oliver , Reiss Katharina , Breckenkamp Jürgen , Kaufner Lutz , Brenne Silke , Bozorgmehr Kayvan , Borde Theda , David Matthias 
Published: August 2017

ObjectiveResearch on health services for immigrants has mostly been concerned with access barriers but rarely with appropriateness and responsiveness of care. We assessed whether appropriateness and responsiveness of care depend on migration status, using provision of neuraxial anaesthesia (NA) during labour as indicator. In relation to their migration status, we analysed whether (1) women undergoing elective or secondary/urgent secondary caesarean sections (ESCS) appropriately receive NA (instead of general anaesthesia), (2) women delivering vaginally appropriately receive NA and (3) women objecting to NA, for example, for religious reasons, may deliver vaginally without receiving NA (provider responsiveness).DesignCross-sectional study.SettingThree obstetric hospitals in Berlin, Germany.MethodsQuestionnaire survey covering 6391 women with migration history (first and second generations) and non-immigrant women giving birth; data linkage with routine obstetric data. We assessed the effects of migrant status, German language proficiency, religion and education on the provision of NA (primary outcome) after adjusting for other maternal and obstetric parameters.ResultsThe chance of receiving NA for elective/ESCS was independent of migrant status after controlling for confounding variables (adjusted OR (aOR) 0.93, 95% CI 0.65 to 1.33). In vaginal deliveries, first (but not second) generation women (aOR 0.79, 95% CI 0.65 to 0.95), women with low German language skills (aOR 0.77, 95% CI 0.58 to 0.99) and women with low educational attainment (aOR 0.62, 95% CI 0.47 to 0.82) had lower chances of receiving NA; there was no evidence of overprovision among women with strong affinity to Islam (aOR 0.77, 95% CI 0.63 to 0.94).ConclusionsWe found evidence for underprovision of care among first-generation immigrants, among women with low German language proficiency and particularly among all women with low educational attainment, irrespective of migration status. There was no evidence for overprovision of care to immigrant women, either inappropriately (general anaesthesia for ESCS) or because of low provider responsiveness (no opt-out for NA in vaginal delivery).
Comparing perceived clarity of information on overdiagnosis used for breast and prostate cancer screening in England: an experimental survey
Authors: Ghanouni Alex , Renzi Cristina , McBride Emily , Waller Jo 
Published: August 2017

Objectives‘Overdiagnosis’, detection of disease that would never have caused symptoms or death, is a public health concern due to possible psychological and physical harm but little is known about how best to explain it. This study evaluated public perceptions of widely used information on the concept to identify scope for improving communication methods.DesignExperimental survey carried out by a market research company via face-to-face computer-assisted interviews.SettingInterviews took place in participants’ homes.Participants2111 members of the general public in England aged 18–70 years began the survey; 1616 were eligible for analysis. National representativeness was sought via demographic quota sampling.InterventionsParticipants were allocated at random to receive a brief description of overdiagnosis derived from written information used by either the NHS Breast Screening Programme or the prostate cancer screening equivalent.Primary and secondary outcome measuresThe primary outcome was how clear the information was perceived to be (extremely/very clear vs less clear). Other measures included previous exposure to screening information, decision-making styles and demographic characteristics (eg, education). Binary logistic regression was used to assess predictors of perceived clarity.ResultsOverdiagnosis information from the BSP was more likely to be rated as more clear compared with the prostate screening equivalent (adjusted OR: 1.43, 95% CI 1.17 to 1.75; p=0.001). Participants were more likely to perceive the information as more clear if they had previously encountered similar information (OR: 1.77, 1.40 to 2.23; p<0.0005) or a screening leaflet (OR: 1.35, 1.04 to 1.74; p=0.024) or had a more ‘rational’ decision-making style (OR: 1.06, 1.02 to 1.11; p=0.009).ConclusionsOverdiagnosis information from breast screening may be a useful template for communicating the concept more generally (eg, via organised campaigns). However, this information may be less well-suited to individuals who are less inclined to consider risks and benefits during decision-making.
The impact of chronic hepatitis B infection on major adverse cardiovascular events and all-cause mortality in patients with diabetes: a nationwide population-based study from Taiwan
Authors: Kuo Chin-Sung , Chen Yung-Tai , Hsu Chien-Yi , Chang Chun-Chin , Chou Ruey-Hsing , Li Szu-Yuan , Kuo Shu-Chen , Huang Po-Hsun , Chen Jaw-Wen , Lin Shing-Jong 
Published: August 2017

ObjectivesThe association between hepatitis B virus (HBV) infection and cardiovascular disease remains uncertain. This study explored long-term hard endpoints (ie, myocardial infarction and ischaemic stroke) and all-cause mortality in diabetic patients with chronic HBV infection in Taiwan from 2000 to 2013.DesignThis study was retrospective, longitudinal and propensity score-matched.Setting Nationwide claims data for the period 2000–2013 were retrieved from Taiwan’s National Health Insurance Research Database.ParticipantsThe study included 40 162 diabetic patients with chronic HBV infection (HBV cohort) and 40 162 propensity score-matched diabetic patients without HBV infection (control cohort). Chronic HBV infection was identified based on three or more outpatient clinic visits or one hospital admission with a diagnosis of HBV infection.Main outcome measuresPrimary outcomes were major adverse cardiovascular events (MACE, including myocardial infarction and ischaemic stroke), heart failure and all-cause mortality.ResultsDuring the median follow-up period of 5.3±3.4 years, the HBV cohort had significantly lower risks of myocardial infarction (adjusted HR (aHR)=0.49; 95% CI 0.42 to 0.56), ischaemic stroke (aHR=0.61; 95% CI 0.56 to 0.67), heart failure (aHR=0.50; 95% CI 0.43 to 0.59) and all-cause mortality (aHR=0.72; 95% CI 0.70 to 0.75) compared with the control cohort. The impact of HBV infection on the sequential risk of MACE was greater in patients with fewer diabetic complications.ConclusionsChronic HBV infection was associated with decreased risk of MACE, heart failure and all-cause mortality in patients with diabetes. Further research is needed to investigate the mechanism underlying these findings.
Safety of ceftriaxone in paediatrics: a systematic review protocol
Authors: Zeng Linan , Choonara Imti , Zhang Lingli , Xue Song , Chen Zhe , He Miaomiao 
Published: August 2017

IntroductionCeftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups.Methods and analysisMEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case–control studies, cross-sectional studies, case series and case reports evaluating the safety of ceftriaxone in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools developed by the National Institutes of Health will be used for quality assessment. Meta-analysis of the incidence of ADRs from RCTs and prospective studies will be done. Subgroup analyses will be performed for age and dosage regimen.Ethics and disseminationFormal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings.PROSPERO registration numberCRD42017055428.
Psychometric properties of the Chinese version of the WHOQOL-HIV BREF to assess quality of life among people living with HIV/AIDS: a cross-sectional study
Authors: Zhu Yaxin , Liu Jie , Qu Bo 
Published: August 2017

ObjectivesThis study aims to assess the psychometric properties of the Chinese version of the WHOQOL-HIV BREF.DesignCross-sectional study.SettingCenters for Disease Control and Prevention and infectious disease hospitals in three Chinese provinces.ParticipantsSample of 1100 people living with HIV/AIDS (PLWHA).InterventionsWe recruited 1100 PLWHA to evaluate their quality of life (QOL) using the WHOQOL-HIV BREF. Of these participants, 57 were randomly selected to repeat the QOL evaluation 2 weeks later.Main outcome measuresThe reliability of the WHOQOL-HIV BREF was assessed in terms of its internal consistency and test–retest reliability. The construct, concurrent, convergent, discriminant and known-group validity were also analysed. In addition, the factorial invariance across genders was assessed.ResultsCronbach’s α coefficient for the overall scale was 0.93. Except for the spirituality domain, which had an α below 0.70 (0.66), the other five domains showed adequate internal consistency. The test–retest reliability revealed a statistically significant intraclass correlation coefficient of 0.72–0.82 (p<0.001). Confirmatory factor analysis found that the six-domain structure produced an acceptable fit to the data. The instrument showed factorial invariance across gender groups. All domains were significantly correlated with the general items and the SF-36 (p<0.01). The correlation coefficients were >0.40 (r=0.40–0.67), except for the association between the spirituality domain and two general items (QOL: r=0.33; health status: r=0.36). Subjects with lower CD4 counts had lower scores for all domains (p<0.05). Symptomatic participants had significantly lower scores than asymptomatic participants on the physical, psychological and independence domains (p<0.05).ConclusionsThe WHOQOL-HIV BREF revealed good psychometric characteristics among Chinese PLWHA. These findings offer promising support for the use of the WHOQOL-HIV BREF as a measure of QOL among Chinese PLWHA and in cross-cultural comparative studies on QOL.
Distinguishing variation in referral accuracy from referral threshold: analysis of a national dataset of referrals for suspected cancer
Authors: Burton Christopher D , McLernon David J , Lee Amanda J , Murchie Peter 
Published: August 2017

ObjectivesTo distinguish between variation in referral threshold and variation in accurate selection of patients for referral in fast-track referrals for possible cancer. To examine factors associated with threshold and accuracy and model the effects of changing thresholds.DesignAnalysis of national data on cancer referrals from general practices in England over a 5-year period. We developed a new method to estimate specificity of referral to complement existing sensitivity. We used bivariate meta-analysis to produce summary measures and described practices in relation to these.Setting5479 general practitioner (GP) practices with data relating to more than 50 cancer cases diagnosed over the 5 years.OutcomesNumber of practices whose 95% confidence regions for sensitivity and specificity indicated that they were outliers in terms of either referral threshold or decision accuracy.Results2019 practices (36.8%) were outliers in relation to referral threshold compared with 1205 practices (22%) in relation to decision accuracy. Practice age profile, cancer incidence and deprivation showed a modest association with decision accuracy but not with thresholds. If all practices shared the referral behaviour of those in the highest quintile of age-standardised referral rate, there would be a 3.3% increase in cancers detected through fast-track pathways at the cost of a 36.9% increase in urgent referrals.ConclusionThis new method permits variation in referral to be described more precisely and quality improvement activities to be targeted. Changing referral thresholds without increasing accuracy will result in modest effects on detection rates and a large increase in demand on diagnostic services.