bluuebunny/crossref_metadata_2025 huggingface dataset:
Socioeconomic trajectories of body mass index and waist circumference: results from the English Longitudinal Study of Ageing
Authors: Zaninotto Paola , Lassale Camille
Published: April 2019

Objectives

To explore age trajectories of body mass index (BMI) and waist circumference (WC) and to examine whether these trajectories varied by wealth.

Design

Nationally representative prospective cohort study.

Setting

Observational study of people living in England.

Participants

7416 participants aged 52 and over of the English Longitudinal Study of Ageing (2004–2012).

Primary outcome measures

BMI and WC assessed objectively by a trained nurse.

Main exposure measure

Total non-pension household wealth quintiles defined as financial wealth, physical wealth (such as business wealth, land or jewels) and housing wealth (primary and secondary residential housing wealth), minus debts.

Results

Using latent growth curve models, we showed that BMI increased by 0.03 kg/m2(95% CI 0.02 to 0.04, p<0.001) per year and WC by 0.18 cm (95% CI 0.15 to 0.22, p<0.001). Age (linear and quadratic) showed a negative association with BMI and WC baseline and rates of change, indicating that older individuals had smaller body sizes and that the positive rates of change flattened to eventually become negative. The decline occurred around the age of 71 years for BMI and 80 years for WC. Poorest wealth was significantly related to higher baseline levels of BMI (1.97 kg/m295% CI 0.99 to 1.55, p<0.001) and WC (4.66 cm 95% CI 3.68 to 2.40, p<0.001). However, no significant difference was found in the rate of change of BMI and WC by wealth, meaning that the age trajectories of BMI and WC were parallel across wealth categories and that the socioeconomic gap did not close at older ages.

Conclusions

Older English adults showed an increase in BMI and WC over time but this trend reversed at older old age to display a sharp decrease. At any given age wealthier people had more favourable BMI and WC profile.
The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis
Authors: Collins Natalie J , Tan Jade M , Menz Hylton B , Russell Trevor G , Smith Anne J , Vicenzino Bill , Munteanu Shannon E , Hinman Rana S , Haines Terry P , Hart Harvi F , Patterson Brooke E , Cleary Gearoid , Donnar Joel W , Maclachlan Liam R , Crossley Kay M
Published: April 2019

Introduction

Patellofemoral (PF) osteoarthritis (OA) is a common and burdensome subgroup of knee OA, with very little evidence for effective treatments. Prefabricated foot orthoses are an affordable and accessible intervention that have been shown to reduce PF pain in younger adults. Similarities between PF pain and PFOA, as well as our pilot work, suggest that foot orthoses may also be an effective intervention for PFOA. The primary objective of this study is to compare the 3 month efficacy of prefabricated foot orthoses and flat shoe inserts in people with PFOA, on knee pain severity.

Methods and analysis

The FOOTPATH Study (FOot OrThoses for PAtellofemoral osteoarTHritis) is a multicentre, randomised, participant- and assessor-blinded superiority trial with two parallel groups, a 3 month observation period (pre-randomisation) and 12 month follow-up. 160 participants with a clinical diagnosis of PFOA will be recruited from three sites in Australia, and randomised to one of two groups (prefabricated foot orthoses or flat shoe inserts). The primary outcome is worst knee pain severity during a self-nominated aggravating activity in the previous week (100 mm visual analogue scale) at 3 months, with a secondary endpoint at 12 months. Secondary outcomes include global rating of change, symptoms, function, health-related quality of life, kinesiophobia, self-efficacy and use of co-interventions for knee pain. Blinded, intention-to-treat analyses of primary and secondary patient-reported outcomes will be performed, as well as economic analyses.

Ethics and dissemination

Ethical approval has been granted by La Trobe University’s Human Ethics Committee and The University of Queensland’s Medical Research Ethics Committee. Study outcomes will be disseminated via peer-reviewed journals, conference presentations targeting a range of healthcare disciplines and an open access website with clinician resources.

Trial registration number

ANZCTRN12617000385347; Pre-results.
Number of blood pressure measurements needed to estimate long-term visit-to-visit systolic blood pressure variability for predicting cardiovascular risk: a 10-year retrospective cohort study in a primary care clinic in Malaysia
Authors: Lim Hooi Min , Chia Yook Chin , Ching Siew Mooi , Chinna Karuthan
Published: April 2019

Objective

To determine the reproducibility of visit-to-visit blood pressure variability (BPV) in clinical practice. We also determined the minimum number of blood pressure (BP) measurements needed to estimate long-term visit-to-visit BPV for predicting 10-year cardiovascular (CV) risk.

Design

Retrospective study

Setting

A primary care clinic in a university hospital in Malaysia.

Participants

Random sampling of 1403 patients aged 30 years and above without any CV event at baseline.

Outcomes measures

The effect of the number of BP measurement for calculation of long-term visit-to-visit BPV in predicting 10-year CV risk. CV events were defined as fatal and non-fatal coronary heart disease, fatal and non-fatal stroke, heart failure and peripheral vascular disease.

Results

The mean 10-year SD of systolic blood pressure (SBP) for this cohort was 13.8±3.5 mm Hg. The intraclass correlation coefficient (ICC) for the SD of SBP based on the first eight and second eight measurements was 0.38 (p<0.001). In a primary care setting, visit-to-visit BPV (SD of SBP calculated from 20 BP measurements) was significantly associated with CV events (adjusted OR 1.07, 95% CI 1.02 to 1.13, p=0.009). Using SD of SBP from 20 measurement as reference, SD of SBP from 6 measurements (median time 1.75 years) has high reliability (ICC 0.74, p<0.001), with a mean difference of 0.6 mm Hg. Hence, a minimum of six BP measurements is needed for reliably estimating intraindividual BPV for CV outcome prediction.

Conclusion

Long-term visit-to-visit BPV is reproducible in clinical practice. We suggest a minimum of six BP measurements for calculation of intraindividual visit-to-visit BPV. The number and duration of BP readings to derive BPV should be taken into consideration in predicting long-term CV risk.
Patient expectations of a new treatment for eating disorders combining guided physical exercise and dietary therapy: an interview study of women participating in a randomised controlled trial at the Norwegian School of Sport Sciences
Authors: Pettersen Gunn , Rosenvinge Jan H , Skomakerstuen Tone , Sordal Solveig , Mathisen Therese Fostervold , Sundgot-Borgen Jorunn
Published: April 2019

Objectives

To study the expectations women with bulimia nervosa (BN) or binge eating disorder (BED) had to a new treatment programme based on guided physical exercise and dietary therapy.

Design and participants

Semistructured interviews were conducted with six women with BN and four women with BED following a group-based therapy programme. Transcribed interviews were analysed using a text-condensing analytic approach.

Results

The analysis resulted in three main categories, that is, expectations about (1) increased knowledge, (2) symptom changes and (3) therapeutic expertise. The women expected that learning more about nutrition and physical exercise would give them more energy, less fear of food, physical and mental symptoms and a negative body focus. They also expected therapists to be professional and competent, and able to take care of them.

Conclusion

The overall high and positive treatment expectation can, to some extent, reflect enthusiasm about a new and innovative approach to treatment. However, the results also reflect generic and highly adequate outcome expectations, which for the purpose of effectiveness should be incorporated into all treatment efforts at least for patients with eating disorders.

Trial registration number

NCT02079935; Results.
Communication skills training for the radiotherapy team to manage cancer patients’ emotional concerns: a systematic review
Authors: van Beusekom Mara Myrthe , Cameron Josie , Bedi Carolyn , Banks Elspeth , Humphris Gerald
Published: April 2019

Objectives

Many cancer patients experience high levels of anxiety and concern during radiotherapy, often with long-lasting effects on their well-being. This systematic review aims to describe and determine the effectiveness of communication skills training (CST) for the radiotherapy team (RT) to improve conversations in this setting and to support patients with emotional concerns.

Design

Systematic review.

Interventions

CST for RT members.

Data sources

On 17 April 2018, databases Medline, Embase, Scopus and PsycNET were searched.

Eligibility criteria, Population, Intervention, Comparison, Outcome(PICO)

Quantitative and/or qualitative articles were included that evaluate the effect of a CST for RT members (vs no CST) on communication behaviours and patients’ emotional concerns.

Data extraction and synthesis

Articles were appraised using the mixed-methods appraisal tool, and a narrative synthesis was performed.

Results

Of the nine included articles, five were randomised controlled trials, three were mixed-methods and one used repeated measurements. Four of the five different CST programmes managed to increase emotional communicative behaviour from the RT, and all studies measuring patient communicative behaviour found an improvement in at least one of the hypothesised outcomes. Two studies examining patient anxiety and concerns found a positive effect of the CST, although one found a negative effect; two other studies without a positive effect on mood made use of both empathic CST and tools.

Conclusions

There are promising indications that CST can be successfully introduced to improve emotional conversations between RT members and patients. With the right support, the RT can play an important role to help patients cope with their emotional concerns. Future work is necessary to confirm initial promising results and to ensure the learnt communication skills are sustained.
Multidimensional analysis of factors responsible for the low prevalence of ambulatory peritoneal dialysis in Germany (MAU-PD): a cross-sectional Mixed-Methods Study Protocol
Authors: Scholten Nadine , Ohnhaeuser Tim , Schellartz Isabell , von Gersdorff Gero , Hellmich Martin , Karbach Ute , Pfaff Holger , Samel Christina , Stock Stephanie , Rascher Katherine , Mettang Thomas
Published: April 2019

Introduction

Patients with end-stage kidney failure can be treated either by transplant or by dialysis, which can be administered as haemodialysis (HD) or peritoneal dialysis (PD). Although they are equivalent therapeutic options in terms of mortality, the percentage of patients in Germany treated with PD is currently very low (∼6%) compared with other countries. The aim of our study is to analyse the factors behind this percentage and their relevance to the choice of dialysis treatment in Germany. This includes analyses of regional disparities in the provision of care for dialysis patients as well as the evaluations of costs and the influence of reimbursement structures. This approach should provide further insights to explain the variation in the usage of PD and HD and will help to define starting points for future interventions.

Methods and analysis

A mixed-methods approach will be applied to several data sources, including administrative data (ambulatory physicians’ claim data, statutory health insurance claim data), quality assurance data from one of the largest German dialysis providers Kuratorium für Dialyse (KfH) and qualitative and quantitative survey data (patients, nephrologists and dialysis nurses). Qualitative data will be analysed content-analytically. Based on the quantitative data, multivariable analyses will be performed and, where possible, hierarchical models will be tested. This multidimensional approach will enable us to account for the different factors influencing the penetration of PD in Germany.

Ethics and dissemination

Ethics approval (17-299) has been obtained from the Ethics Committee of the Medical Faculty of the University of Cologne on 25 April 2018. National and international dissemination will be accomplished by informing healthcare practitioners, patients and professional organisations and other stakeholders via conferences, scientific and non-scientific publications and seminars.

Trial registration number

DRKS00012555; Pre-Results.
Genetic components of human pain sensitivity: a protocol for a genome-wide association study of experimental pain in healthy volunteers
Authors: Schmid Annina B , Adhikari Kaustubh , Ramirez-Aristeguieta Luis Miguel , Chacón-Duque Juan-Camilo , Poletti Giovanni , Gallo Carla , Rothhammer Francisco , Bedoya Gabriel , Ruiz-Linares Andres , Bennett David L
Published: April 2019

Introduction

Pain constitutes a major component of the global burden of diseases. Recent studies suggest a strong genetic contribution to pain susceptibility and severity. Whereas most of the available evidence relies on candidate gene association or linkage studies, research on the genetic basis of pain sensitivity using genome-wide association studies (GWAS) is still in its infancy. This protocol describes a proposed GWAS on genetic contributions to baseline pain sensitivity and nociceptive sensitisation in a sample of unrelated healthy individuals of mixed Latin American ancestry.

Methods and analysis

A GWAS on genetic contributions to pain sensitivity in the naïve state and following nociceptive sensitisation will be conducted in unrelated healthy individuals of mixed ancestry. Mechanical and thermal pain sensitivity will be evaluated with a battery of quantitative sensory tests evaluating pain thresholds. In addition, variation in mechanical and thermal sensitisation following topical application of mustard oil to the skin will be evaluated.

Ethics and dissemination

This study received ethical approval from the University College London research ethics committee (3352/001) and from the bioethics committee of the Odontology Faculty at the University of Antioquia (CONCEPTO 01–2013). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations at international conferences.
Protocol for a pilot randomised controlled trial of mindfulness-based cognitive therapy in youth with inflammatory bowel disease and depression
Authors: Ewais Tatjana , Begun Jake , Kenny Maura , Chuang Kai-Hsiang , Barclay Johanna , Hay Karen , Kisely Steve
Published: April 2019

Introduction

Inflammatory bowel disease (IBD) is a chronic autoinflammatory disease of the gastrointestinal tract with peak age of onset during adolescence and young adulthood. Adolescents and young adults (AYAs) with IBD experience higher depression rates compared with peers who are well or have other chronic conditions. Mindfulness-based interventions are of particular interest because of their potential to improve both the course of IBD and depression.

Methods and analysis

This study is a parallel design, single-blind, pilot randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) in AYAs with IBD and depression. The trial aims to recruit 64 participants who will be randomly allocated to MBCT or treatment as usual. The primary outcome measure is the depression subscale score from the Depression, Anxiety and Stress Scale. Secondary outcomes include anxiety, stress, post-traumatic growth, IBD-related quality of life, illness knowledge, medication adherence, mindfulness, IBD activity, inflammatory markers, microbiome and brain neuroconnectivity changes. All outcomes other than neuroimaging will be collected at three time points: at baseline, at therapy completion and at 20 weeks. Neuroimaging will be conducted at baseline and at therapy completion. Mixed-effects linear and logistic regression modelling will be used to analyse continuous and dichotomous outcomes, respectively. Participants’ experiences will be explored through focus groups, and thematic analysis will be used to generate relevant themes.

Ethics and dissemination

The protocol has been approved by the Mater Hospital Human Research Ethics Committee (HREC) and University of Queensland HREC. Trial findings will be published in peer-reviewed journals and will be presented at scientific conferences.

Trial registration number

ACTRN12617000876392, U1111-1197-7370; Pre-results.
Does the ‘Chinese New Year effect’ exist? Hospital mortality in patients admitted to internal medicine departments during official consecutive holidays: a nationwide population-based cohort study
Authors: Lin Shu-Man , Wang Jen-Hung , Huang Liang-Kai , Huang Huei-Kai
Published: April 2019

Objective

Our study aimed to compare the mortality risk among patients admitted to internal medicine departments during official consecutive holidays (using Chinese New Year holidays as an indicator) with that of weekend and weekday admissions.

Design

Nationwide population-based cohort study.

Setting

Taiwan’s National Health Insurance Research Database.

Patients

Patients admitted to internal medicine departments in acute care hospitals during January and February each year between 2001 and 2013 were identified. Admissions were categorised as: Chinese New Year holiday (n=10 779), weekend (n=35 870) or weekday admissions (n=143 529).

Outcome measures

ORs for in-hospital mortality and 30-day mortality were calculated using multivariate logistic regression with adjustment for confounders.

Results

Both in-hospital and 30-day mortality were significantly higher for patients admitted during the Chinese New Year holidays and on weekends compared with those admitted on weekdays. Chinese New Year holiday admissions had a 38% and 40% increased risk of in-hospital (OR=1.38, 95% CI 1.27 to 1.50, p<0.001) and 30-day (OR=1.40, 95% CI 1.31 to 1.50, p<0.001) mortality, respectively, compared with weekday admissions. Weekend admissions had a 17% and 19% increased risk of in-hospital (OR=1.17, 95% CI 1.10 to 1.23, p<0.001) and 30-day (OR=1.19, 95% CI 1.14 to 1.24, p<0.001) mortality, respectively, compared with weekday admissions. Analyses stratified by principal diagnosis revealed that the increase in in-hospital mortality risk was highest for patients admitted on Chinese New Year holidays with a diagnosis of ischaemic heart disease (OR=3.43, 95% CI 2.46 to 4.80, p<0.001).

Conclusions

The mortality risk was highest for patients admitted during Chinese New Year holidays, followed by weekend admissions, and then weekday admissions. Further studies are necessary to identify the underlying causes and develop strategies to improve outcomes for patients admitted during official consecutive holidays.
The utility of diagnostic selective nerve root blocks in the management of patients with lumbar radiculopathy: a systematic review
Authors: Beynon Rebecca , Elwenspoek Martha Maria Christine , Sheppard Athena , Higgins John Nicholas , Kolias Angelos G , Laing Rodney J , Whiting Penny , Hollingworth William
Published: April 2019

Objective

Lumbar radiculopathy (LR) often manifests as pain in the lower back radiating into one leg (sciatica). Unsuccessful back surgery is associated with significant healthcare costs and risks to patients. This review aims to examine the diagnostic accuracy of selective nerve root blocks (SNRBs) to identify patients most likely to benefit from lumbar decompression surgery.

Design

Systematic review of diagnostic test accuracy studies.

Eligibility criteria

Primary research articles using a patient population with low back pain and symptoms in the leg, SNRB administered under radiological guidance as index test, and any reported reference standard for the diagnosis of LR.

Information sources

MEDLINE (Ovid), MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Science Citation Index, Biosis, LILACS, Dissertation abstracts and National Technical Information Service from inception to 2018.

Methods

Risk of bias and applicability was assessed using the QUADAS-2 tool. We performed random-effects logistic regression to meta-analyse studies grouped by reference standard.

Results

6 studies (341 patients) were included in this review. All studies were judged at high risk of bias. There was substantial heterogeneity across studies in sensitivity (range 57%–100%) and specificity (10%–86%) estimates. Four studies were diagnostic cohort studies that used either intraoperative findings during surgery (pooled sensitivity: 93.5% [95% CI 84.0 to 97.6]; specificity: 50.0% [16.8 to 83.2]) or ‘outcome following surgery’ as the reference standard (pooled sensitivity: 90.9% [83.1 to 95.3]; specificity 22.0% [7.4 to 49.9]). Two studies had a within-patient case-control study design, but results were not pooled because different types of control injections were used.

Conclusions

We found limited evidence which was of low methodological quality indicating that the diagnostic accuracy of SNRB is uncertain and that specificity in particular may be low. SNRB is a safe test with a low risk of clinically significant complications, but it remains unclear whether the additional diagnostic information it provides justifies the cost of the test.
One-shot dilation versus serial dilation technique for access in percutaneous nephrolithotomy: a systematic review and meta-analysis
Authors: Peng Pan-xin , Lai Shi-cong , Ding Zhen-shan , He Yu-hui , Zhou Li-hua , Wang Xu-ming , Zhang Guan
Published: April 2019

Objective

The purpose of this study was to systematically review the outcomes of the use of one-shot dilation (OSD) and serial tract dilation for percutaneous nephrolithotomy (PCNL).

Methods

A systematic review and meta-analysis was conducted. The randomised controlled trials (RCTs) included in the study were identified from EMBASE, MEDLINE and the Cochrane Central Register of Controlled Trials. The last search was performed on 30 April 2018. Summary effects were calculated as risk ratios (RRs) with 95% CIs or mean differences (MDs) with 95% CIs. The endpoints included access time, fluoroscopy time, successful dilation rate, stone-free rate, postoperative decrease in haemoglobin levels, transfusion rate, complication rate and length of postoperative hospital stay.

Results

A total of seven RCTs were included in the study, with clinical data reported for 697 patients. The overall access time was approximately 110 s shorter in the OSD group than in the serial dilation group (MD, −110.14; 95% CI −161.99 to −58.30; p<0.0001). The fluoroscopy time was shorter with OSD in all RCTs. In addition, the decrease in postoperative haemoglobin levels was approximately 2.3g/L less in patients in the OSD group than in those in the serial dilation group (MD, −0.23; 95% CI−0.39 to −0.07; p=0.004). No relationship was found between the successful dilation rate, stone-free rate, transfusion rate, or complication rate and the method of tract dilation.

Conclusion

OSD is a safe and efficacious tract dilation technique that can reduce the access time, fluoroscopy time and postoperative decrease in haemoglobin level. No difference was found in the successful dilation rate, stone-free rate, transfusion rate or rate of complications between the OSD and serial dilation groups. The difference in the length of postoperative hospital stay was uncertain. OSD may be a better method of tract creation for PCNL.
Comparative evaluation of novel screening strategies for colorectal cancer screening in China (TARGET-C): a study protocol for a multicentre randomised controlled trial
Authors: Chen Hongda , Li Ni , Shi Jufang , Ren Jiansong , Liu Chengcheng , Zhang Yueming , Jiang Zheng , Zhang Zhihui , Dai Min
Published: April 2019

Introduction

Screening for colorectal cancer (CRC) is effective in reducing the disease burden. However, high-level evidence from randomised controlled trials on the effectiveness of CRC screening modalities is still lacking. We will conduct a large-scale multicentre randomised controlled trial in China to evaluate the effectiveness and cost-effectiveness of different CRC screening strategies.

Methods and analysis

20 000 eligible participants aged 50–74 years are enrolled in five provinces in China. After providing signed informed consent, the participants will be randomised into one of the three screening groups: (1) one-time colonoscopy (n=4000), (2) annual faecal immunochemical test (FIT) (n=8000) and (3) annual risk-adapted screening strategy (n=8000). The risk-adapted screening strategy will use an established CRC risk scoring system, the Asia-Pacific Colorectal Screening score. Participants at high risk of CRC will be referred for colonoscopy, while participants at low risk will be referred for an FIT. Information on clinical reports, epidemiological risk factors and health economic factors will be collected and stored in a web-based data management system. We will further request the participants to donate blood, faecal and saliva samples before conducting the colonoscopy. The primary outcome will be the detection rate of advanced colorectal neoplasia and the secondary outcomes will include the rates of CRC-related mortality, incidence of CRC, participation and complications. The study will last for at least 4 years and the cohort will be followed for 10 years to adequately answer the scientific questions.

Ethics and dissemination

This study was approved by the Ethics Committee of the National Cancer Center/Cancer Hospital, the Chinese Academy of Medical Sciences and Peking Union Medical College (18-013/1615). The results of the study will be submitted for publication in peer-reviewed journals and will be discussed by policy and decision makers.

Trial registration number

ChiCTR1800015506.
Plasma NT-proBNP levels associated with cardiac structural abnormalities in asymptomatic health examinees with preserved ejection fraction: a retrospective cross-sectional study
Authors: Nah Eun-Hee , Kim Seong Yoon , Cho Seon , Kim Suyoung , Cho Han-Ik
Published: April 2019

Objectives

Stage B heart failure (HF) is defined as an asymptomatic abnormality of the heart structure or function. The circulating level of N-terminal pro-B-type natriuretic peptide (NT-proBNP) is elevated in symptomatic patients with left ventricular (LV) dysfunction caused by a structural or functional abnormality. This study investigated the association of the NT-proBNP level with echocardiography-detected cardiac structural or diastolic abnormalities in asymptomatic subjects with preserved LV systolic function (ejection fraction >50%).

Methods

We retrospectively studied 652 health examinees who underwent echocardiography and an NT-proBNP test at a health-promotion centre in Seoul, between January 2016 and September 2018. The left ventricular mass index (LVMI) and the left atrial dimension (LAD) were used as markers for structural abnormalities, and the mean e’ velocity and mitral early flow velocity/early diastolic tissue velocity (E/e’) ratio were used as markers for diastolic dysfunction. The plasma NT-proBNP level was measured using electrochemiluminescence immunoassay (DPC Immulite 2000 XPi, Siemens Healthcare Diagnostics, Tarrytown, New York, USA).

Results

Subjects with preclinical structural abnormalities were older and had a higher body mass index (BMI), higher blood pressure, lower high-density lipoprotein cholesterol level, higher NT-proBNP level, and higher E/e’ (p<0.05). Multivariate regression analysis indicated that the factors associated with a higher NT-proBNP level were older age, female sex, lower BMI, higher creatinine level, higher LVMI and higher LAD (p<0.01).

Conclusion

Diastolic dysfunction is not associated with higher NT-proBNP levels, whereas preclinical cardiac structural abnormalities, as well as older age, female sex, lower BMI, and higher creatinine level, are associated with higher NT-proBNP levels.
Protocol for the Gut Bugs Trial: a randomised double-blind placebo-controlled trial of gut microbiome transfer for the treatment of obesity in adolescents
Authors: Leong Karen S W , Jayasinghe Thilini N , Derraik José G B , Albert Benjamin B , Chiavaroli Valentina , Svirskis Darren M , Beck Kathryn L , Conlon Cathryn A , Jiang Yannan , Schierding William , Vatanen Tommi , Holland David J , O’Sullivan Justin M , Cutfield Wayne S
Published: April 2019

Introduction

Animal studies showed that germ-free mice inoculated with normal mouse gut bacteria developed obesity, insulin resistance and higher triglyceride levels, despite similar food intake. In humans, an association has been found between obesity and gut microbiome dysbiosis. However, gut microbiome transfer has not been evaluated for the treatment of human obesity. We will examine the effectiveness of gut microbiome transfer using encapsulated material for the treatment of obesity in adolescents.

Methods and analysis

A two-arm, double-blind, placebo-controlled, randomised clinical trial of a single course of gut microbiome transfer will be conducted in 80 obese [body mass index (BMI) ≥30 kg/m2] adolescents (males and females, aged 14–18 years) in Auckland, New Zealand. Healthy lean donors (males and females, aged 18–28 years) will provide fresh stool samples from which bacteria will be isolated and double encapsulated. Participants (recipients) will be randomised at 1:1 to control (placebo) or treatment (gut microbiome transfer), stratified by sex. Recipients will receive 28 capsules over two consecutive mornings (~14 mL of frozen microbial suspension or saline). Clinical assessments will be performed at baseline, 6, 12 and 26 weeks, and will include: anthropometry, blood pressure, fasting metabolic markers, dietary intake, physical activity levels and health-related quality of life. Insulin sensitivity (Matsuda index), gut microbiota population structure characterised by 16S rRNA amplicon sequencing and body composition (using dual-energy X-ray absorptiometry) will be assessed at baseline, 6, 12 and 26 weeks. 24-hour ambulatory blood pressure monitoring will be performed at baseline and at 6 weeks. The primary outcome is BMI SD scores (SDS) at 6 weeks, with BMI SDS at 12 and 26 weeks as secondary outcomes. Other secondary outcomes include insulin sensitivity, adiposity (total body fat percentage) and gut microbial composition at 6, 12 and 26 weeks. Statistical analysis will be performed on the principle of intention to treat.

Ethics and dissemination

Ethics approval was provided by the Northern A Health and Disability Ethics Committee (Ministry of Health, New Zealand; 16/NTA/172). The trial results will be published in peer-reviewed journals and presented at international conferences.

Trial registration number

ACTRN12615001351505; Pre-results.
The effect of lowering the legal blood alcohol concentration limit on driving under the influence (DUI) in southern Taiwan: a cross-sectional retrospective analysis
Authors: Tsai Yu-Chin , Wu Shao-Chun , Huang Jin-Fu , Kuo Spencer C H , Rau Cheng-Shyuan , Chien Peng-Chen , Hsieh Hsiao-Yun , Hsieh Ching-Hua
Published: April 2019

Objectives

We aimed to profile the epidemiological changes of driving under the influence (DUI) in southern Taiwan after the legal blood alcohol concentration (BAC) limit was lowered from 50 to 30 mg/dL in 2013.

Setting

Level 1 trauma medical centre in southern Taiwan.

Participants

Data from 7447 patients (4375 males and 3072 females) were retrieved from the trauma registry system of a single trauma centre to examine patient characteristics (gender, age and BAC), clinical outcome variables (Abbreviated Injury Score, Injury Severity Score and mortality) and vehicular crash-related factors (vehicle type, airbag use in car crashes, helmet use in motorcycle crashes and time of crash) before and after the BAC limit change.

Results

Our results indicated that the percentage of DUI patients significantly declined from 10.99% (n=373) to 6.64% (n=269) after the BAC limit was lowered. Airbag use in car crashes (OR: 0.30, 95% CI 0.10 to 0.88, p=0.007) and helmet use in motorcycle crashes (OR: 0.20, 95% CI 0.15 to 0.26, p<0.001) was lower in DUI patients compared with non-DUI patients after the BAC limit change, with significant negative correlation. DUI behaviour increased crash mortality risk before the BAC limit change (OR: 4.33, 95% CI 2.20 to 8.54), and even more so after (OR: 5.60, 95% CI 3.16 to 9.93). The difference in ORs for mortality before and after the change in the BAC legal limit was not significant (p=0.568).

Conclusion

This study revealed that lowering the BAC limit to 30 mg/dL significantly reduced the number of DUI events, but failed to result in a significant reduction in mortality in these trauma patients.
International prospective observational study on intracranial pressure in intensive care (ICU): the SYNAPSE-ICU study protocol
Authors: Citerio Giuseppe , Prisco Lara , Oddo Mauro , Meyfroidt Geert , Helbok Raimund , Stocchetti Nino , Taccone Fabio , Vincent Jean-Louis , Robba Chiara , Elli Francesca , Sala Elisa , Vargiolu Alessia , Lingsma Hester
Published: April 2019

Introduction

Intracranial pressure (ICP) monitoring is commonly used in neurocritical care patients with acute brain injury (ABI). Practice about indications and use of ICP monitoring in patients with ABI remains, however, highly variable in high-income countries, while data on ICP monitoring in low and middle-income countries are scarce or inconsistent. The aim of the SYNAPSE-ICU study is to describe current practices of ICP monitoring using a worldwide sample and to quantify practice variations in ICP monitoring and management in neurocritical care ABI patients.

Methods and analysis

The SYNAPSE-ICU study is a large international, prospective, observational cohort study. From March 2018 to March 2019, all patients fulfilling the following inclusion criteria will be recruited: age >18 years; diagnosis of ABI due to primary haemorrhagic stroke (subarachnoid haemorrhage or intracranial haemorrhage) or traumatic brain injury; Glasgow Coma Score (GCS) with no eye opening (Eyes response=1) and Motor score ≤5 (not following commands) at ICU admission, or neuro-worsening within the first 48 hours with no eye opening and a Motor score decreased to ≤5. Data related to clinical examination (GCS, pupil size and reactivity, Richmond Agitation-Sedation Scale score, neuroimaging) and to ICP interventions (Therapy Intensity Levels) will be recorded on admission, and at day 1, 3 and 7. The Glasgow Outcome Scale Extended (GOSE) will be collected at discharge from ICU and from hospital and at 6-month follow-up. The impact of ICP monitoring and ICP-driven therapy on GOSE will be analysed at both patient and ICU level.

Ethics and dissemination

The study has been approved by the Ethics Committee ‘Brianza’ at the Azienda Socio Sanitaria Territoriale (ASST)-Monza (approval date: 21 November 2017). Each National Coordinator will notify the relevant ethics committee, in compliance with the local legislation and rules. Data will be made available to the scientific community by means of abstracts submitted to the European Society of Intensive Care Medicine annual conference and by scientific reports and original articles submitted to peer-reviewed journals.

Trial registration number

NCT03257904.
Accuracy of mortality statistics in Palestine: a retrospective cohort study
Authors: Massad Salwa , Dalloul Hadil , Ramlawi Asad , Rayyan Izzat , Salman Rand , Johansson Lars Age
Published: April 2019

Objective

To examine the accuracy of mortality statistics in Palestine, to identify gaps and to provide evidence-based recommendations to improve mortality statistics in Palestine.

Study design and setting

A retrospective death registry-based study that examined a stratified random sample of death notification forms (DNFs) of patients who died in hospitals in Palestine was reported in 2012. We randomly selected 600 deceased from the Cause of Death Registry: 400 from the West Bank and 200 from the Gaza Strip. Analysis was based on the randomly selected deaths that we were able to retrieve the medical records for; 371 deaths in the West Bank and 199 deaths in the Gaza Strip.

Results

Data in the Palestinian Health Information Centre (PHIC) registry had a low degree of accuracy: less than half of the underlying causes stated the correct cause of death. In general, deaths due to malignant neoplasms were more accurately reported on DNFs than other causes of death, and metabolic diseases (including diabetes) were the most problematic. Issues with coding and classification at the PHIC were most apparent for perinatal conditions and congenital anomalies.

Conclusion

Procedures for coding and classification at the PHIC deviate considerably from the international norms defined in the International Statistical Classification of Diseases and Related Health Problems (ICD) and account to a considerable extent for the discrepancies between the cause of death determined on the medical data on the death extracted from the deceased patient’s hospital records and the cause of death coded by the PHIC. We recommend the introduction of international coding software for coding and classification, and a review to improve data handling in hospitals, especially those with electronic patient records.
Oral anticoagulation therapy use in patients with atrial fibrillation after the introduction of non-vitamin K antagonist oral anticoagulants: findings from the French healthcare databases, 2011–2016
Authors: Maura Géric , Billionnet Cécile , Drouin Jérôme , Weill Alain , Neumann Anke , Pariente Antoine
Published: April 2019

Objectives

To describe (i) the trend in oral anticoagulant (OAC) use following the introduction of non-vitamin K antagonist oral anticoagulant (NOAC) therapy for stroke prevention in atrial fibrillation (AF) patients and (ii) the current patterns of use of NOAC therapy in new users with AF in France.

Design

(i) Repeated cross-sectional study and (ii) population-based cohort study.

Setting

French national healthcare databases (50 million beneficiaries).

Participants

(i) Patients with identified AF in 2011, 2013 and 2016 and (ii) patients with AF initiating OAC therapy in 2015–2016.

Primary and secondary outcome measures

(i) Trend in OAC therapy use in patients with AF and (ii) patterns of use of NOAC therapy in new users with AF.

Results

Between 2011 and 2016, use of OAC therapy moderately increased (+16%), while use of antiplatelet therapy decreased (−22%) among all patients with identified AF. In 2016, among the 1.1 million AF patients, 66% used OAC therapy and were more likely to be treated by vitamin K antagonist (VKA) than NOAC therapy, including patients at higher risk of stroke (63.5%), while 33% used antiplatelet therapy. Among 192 851 new users of OAC therapy in 2015–2016 with identified AF, NOAC therapy (66.3%) was initiated more frequently than VKA therapy, including in patients at higher risk of stroke (57.8%). Reduced doses were prescribed in 40% of NOAC new users. Several situations of inappropriate use at NOAC initiation were identified, including concomitant use of drugs increasing the risk of bleeding (one in three new users) and potential NOAC underdosing.

Conclusions

OAC therapy use in patients with AF remains suboptimal 4 years after the introduction of NOACs for stroke prevention in France and improvement in appropriate prescribing regarding NOAC initiation is needed. However, NOAC therapy is now the preferred drug class for initiation of OAC therapy in patients with AF, including in patients at higher risk of stroke.
Trends in occurrence and 30-day mortality of infective endocarditis in adults: population-based registry study in Finland
Authors: Ahtela Elina , Oksi Jarmo , Porela Pekka , Ekström Tommi , Rautava Paivi , Kytö Ville
Published: April 2019

Objectives

Infective endocarditis (IE) is a life-threatening disease associated with significant mortality. We studied recent temporal trends and age and sex differences in the occurrence and short-term mortality of IE.

Design

Population based retrospective cohort study.

Setting

Data of IE hospital admissions in patients aged ≥18 years in Finland during 2005–2014 and 30-day all-cause mortality data were retrospectively collected from mandatory nationwide registries from 38 hospitals.

Outcomes

Trends and age and sex differences in occurrence. Thirty-day mortality.

Results

There were 2611 cases of IE during the study period (68.2% men, mean age 60 years). Female patients were significantly older than males (62.0 vs 59.0 years, p=0.0004). Total standardised annual incidence rate of IE admission was 6.33/100 000 person-years. Men had significantly higher risk of IE compared with women (9.5 vs 3.7/100 000; incidence rate ratios [IRR] 2.49; p<0.0001) and difference was most prominent at age 40–59 years (IRR 4.49; p<0.0001). Incidence rate varied from 5.7/100 000 in 2005 to 7.1/100 000 in 2012 with estimated average 2.1% increase per year (p=0.036) and similar trends in both sexes. Significant increasing trend was observed in patients aged 18–29 years and 30–39 years (estimated annual increase 7.6% and 7.2%, p=0.002) and borderline in patients aged 40–49 years (annual increase 3.8%, p=0.08). In older population, IE incidence rate remained stable. The overall 30-day mortality after IE admission was 11.3%. Mortality was similar between sexes, increased with ageing, and remained similar during the study period.

Conclusions

Occurrence of IE is increasing in young adults in Finland. Men, especially middle-aged, are at higher risk for IE compared with women. Thirty-day mortality has remained stable at 11%, increased with ageing, and was similar between sexes.
Participatory governance over research in an academic research network: the case of Diabetes Action Canada
Authors: Willison Donald J , Trowbridge Joslyn , Greiver Michelle , Keshavjee Karim , Mumford Doug , Sullivan Frank
Published: April 2019

Digital data generated in the course of clinical care are increasingly being leveraged for a wide range of secondary purposes. Researchers need to develop governance policies that can assure the public that their information is being used responsibly. Our aim was to develop a generalisable model for governance of research emanating from health data repositories that will invoke the trust of the patients and the healthcare professionals whose data are being accessed for health research. We developed our governance principles and processes through literature review and iterative consultation with key actors in the research network including: a data governance working group, the lead investigators and patient advisors. We then recruited persons to participate in the governing and advisory bodies. Our governance process is informed by eight principles: (1) transparency; (2) accountability; (3) follow rule of law; (4) integrity; (5) participation and inclusiveness; (6) impartiality and independence; (7) effectiveness, efficiency and responsiveness and (8) reflexivity and continuous quality improvement. We describe the rationale for these principles, as well as their connections to the subsequent policies and procedures we developed. We then describe the function of the Research Governing Committee, the majority of whom are either persons living with diabetes or physicians whose data are being used, and the patient and data provider advisory groups with whom they consult and communicate. In conclusion, we have developed a values-based information governance framework and process for Diabetes Action Canada that adds value over-and-above existing scientific and ethics review processes by adding a strong patient perspective and contextual integrity. This model is adaptable to other secure data repositories.
Omega-3 polyunsaturated fatty acid intake norms and preterm birth rate: a cross-sectional analysis of 184 countries
Authors: Ciesielski Timothy H , Bartlett Jacquelaine , Williams Scott M
Published: April 2019

Background

The preponderance of evidence now indicates that elevated long-chain omega-3 polyunsaturated fatty acid (LC omega-3 PUFA) intake is often associated with reduced risk of preterm birth (PTB). This conclusion is based on recent meta-analyses that include several studies that reported null findings. We probed the reasons for this heterogeneity across studies and its implications for PTB prevention using country-level data.

Methods

We analysed the relationship between national PTB rates (<37 weeks of gestation) and omega-3 PUFA intake norms from 184 countries for the year 2010. To estimate the total LC omega-3 PUFA levels (eicosapentaenoic acid [EPA]/docosahexaenoic acid [DHA]) that these norms produce we utilised a metric that accounts for (1) seafood-based omega-3 intake (EPA/DHA) and (2) plant-based omega-3 intake (alpha-linolenic acid [ALA]), ~20% of which is converted to EPA/DHA in vivo. We then assessed the shape of the omega-3–PTB relationship with a penalised spline and conducted linear regression analyses within the linear sections of the relationship.

Results

Penalised spline analyses indicated that PTB rates decrease linearly with increasing omega-3 levels up to ~600 mg/day. Income-adjusted linear regression analysis among the countries in this exposure range indicated that the number of PTBs per 100 live births decreases by 1.5 (95% CI 2.8 to 0.3) for each 1 SD increase in omega-3 intake norms (383 mg/day).

Conclusions

Taken with prior evidence for a causal association on the individual level, our findings indicate that omega-3 PUFA deficiency may be a widespread contributing factor in PTB risk. Consideration of baseline omega-3 PUFA levels is critical in the design of future interventions.
Longitudinal access and exposure to green-blue spaces and individual-level mental health and well-being: protocol for a longitudinal, population-wide record-linked natural experiment
Authors: Mizen Amy , Song Jiao , Fry Richard , Akbari Ashley , Berridge Damon , Parker Sarah C , Johnson Rhodri , Lovell Rebecca , Lyons Ronan A , Nieuwenhuijsen Mark , Stratton Gareth , Wheeler Benedict W , White James , White Mathew , Rodgers Sarah E
Published: April 2019

Introduction

Studies suggest that access and exposure to green-blue spaces (GBS) have beneficial impacts on mental health. However, the evidence base is limited with respect to longitudinal studies. The main aim of this longitudinal, population-wide, record-linked natural experiment, is to model the daily lived experience by linking GBS accessibility indices, residential GBS exposure and health data; to enable quantification of the impact of GBS on well-being and common mental health disorders, for a national population.

Methods and analysis

This research will estimate the impact of neighbourhood GBS access, GBS exposure and visits to GBS on the risk of common mental health conditions and the opportunity for promoting subjective well-being (SWB); both key priorities for public health. We will use a Geographic Information System (GIS) to create quarterly household GBS accessibility indices and GBS exposure using digital map and satellite data for 1.4 million homes in Wales, UK (2008–2018). We will link the GBS accessibility indices and GBS exposures to individual-level mental health outcomes for 1.7 million people with general practitioner (GP) data and data from the National Survey for Wales (n=~12 000) on well-being in the Secure Anonymised Information Linkage (SAIL) Databank. We will examine if these associations are modified by multiple sociophysical variables, migration and socioeconomic disadvantage. Subgroup analyses will examine associations by different types of GBS. This longitudinal study will be augmented by cross-sectional research using survey data on self-reported visits to GBS and SWB.

Ethics and dissemination

All data will be anonymised and linked within the privacy protecting SAIL Databank. We will be using anonymised data and therefore we are exempt from National Research Ethics Committee (NREC). An Information Governance Review Panel (IGRP) application (Project ID: 0562) to link these data has been approved.

The research programme will be undertaken in close collaboration with public/patient involvement groups. A multistrategy programme of dissemination is planned with the academic community, policy-makers, practitioners and the public.