bluuebunny/crossref_metadata_2025 huggingface dataset:
Perihilar clear cell cholangiocarcinoma: an often-diagnostic challenge
Authors: Marzouk Omar , Lakshmaiah Siddappa , Anjarwalla Salim
Published: December 2020

Cholangiocarcinomas are rare and often diagnosed late. Clear cell histology is a rare variant of such cancers. We report one such case of a man in his late 60s, with a history of excess alcohol intake, who was found to have deranged liver biochemical tests incidentally during an admission for an allergic reaction. Subsequent imaging to investigate this suggested a diagnosis of perihilar cholangiocarcinoma (ultrasound, CT, MRI, cholangiogram). Biopsy confirmed this to be of clear cell type on histology and immunohistochemistry. Diagnosis and further management of this rare entity was conducted in multidisciplinary meetings with the regional hepatobiliary centre. The patient was deemed unsuitable for surgical resection, underwent chemotherapy but died 1 year later.
First Danish case of infective endocarditis caused byEnterococcus hirae
Authors: Winther Mette , Dalager-Pedersen Michael , Tarpgaard Irene Harder , Nielsen Hans Linde
Published: December 2020

Enterococcus hirae, a member of theEnterococcusgenus, is known to cause infections, including infective endocarditis (IE), in animal species. In humans,E. hiraeis an uncommon pathogen, but has been associated with severe and recurrent disease. Here, we report the first Danish case ofE. hiraenative aortic valve IE in a 62-year-old woman with no history of heart disease. She presented to the hospital with symptoms of gastroenteritis but no signs of heart disease. Nevertheless, blood culture revealed growth ofE. hirae, and a transoesophageal echocardiography demonstrated a mobile mass adherent to the aortic valve, compatible with a vegetation. The patient was successfully treated forE. hiraenative aortic valve IE with 4 weeks of intravenous benzylpenicillin in combination with gentamicin for the initial 2 weeks. To the best of our knowledge, this is the first documented case ofE. hiraeIE in Denmark and the sixth documented case worldwide.
Reversal of vision loss after traumatic optic neuropathy
Authors: Mehta Aditi , Rathod Ramya , Virk Ramandeep S , Bashyal Byanjana
Published: December 2020

Traumatic optic neuropathy is sinister sequelae of craniofacial trauma leading to vision loss. The decision between early medical or surgical intervention is usually individualised. Visual evoked potentials may guide the treatment plan. We describe a young male presenting 5 days after a road traffic accident with no perception of light vision in the right eye. He was managed medically with high dose of intravenous steroids. At the 3-month follow-up, he reported a reversal of vision loss with return of visual acuity to 3/60, which improved to 6/36 at 5 months and remained stable at 8 months.
Overgrowth of soft tissues after transplantation of a connective tissue graft for the treatment of gingival recession
Authors: Ashurko Igor , Levonian Eduard , Dementev Ilia , Tarasenko Svetlana
Published: December 2020

The application of free connective tissue graft (CTG) is the gold standard in the treatment of gingival recession in the area of teeth and implants. The aim of this case report is to demonstrate a possible mucosal overgrowth complication in the soft tissue grafting area. A 24-year-old patient underwent the treatment of gingival recession in the tooth 2.3 region by an envelope technique using a free CTG from the hard palate region. Seven years after the surgery, a mucosal overgrowth was observed, which developed asymptomatically and did not cause any problems to the patient.
Spontaneous portomesenteric thrombosis in a non-cirrhotic patient with SARS-CoV-2 infection
Authors: Abeysekera Kushala WM , Karteszi Hedvig , Clark Amanda , Gordon Fiona H
Published: December 2020

Intra-abdominal thromboses are a poorly characterised thrombotic complication of COVID-19 and are illustrated in this case. A 42-year-old man with chronic hepatitis B (undetectable viral load, FibroScan 7.4 kPa) developed fever and cough in March 2020. 14 days later, he developed right upper quadrant pain. After being discharged with reassurance, he re-presented with worsening pain on symptom day 25. Subsequent abdominal ultrasound suggested portal vein thrombosis. CT of the abdomen confirmed portal and mid-superior mesenteric vein thromboses. Concurrent CT of the chest suggested COVID-19 infection. While reverse transcription PCR was negative, subsequent antibody serology was positive. Thrombophilia screen excluded inherited and acquired thrombophilia. Having been commenced on apixaban 5 mg two times per day, he is currently asymptomatic. This is the first case of COVID-19-related portomesenteric thrombosis described in the UK. A recent meta-analysis suggests 9.2% of COVID-19 cases develop abdominal pain. Threshold for performing abdominal imaging must be lower to avoid this reversible complication.
Subacute thyroiditis as a presenting manifestation of COVID-19: a report of an exceedingly rare clinical entity
Authors: Chakraborty Uddalak , Ghosh Shrestha , Chandra Atanu , Ray Aritra Kumar
Published: December 2020

The SARS-CoV-2 has wreaked havoc globally and has claimed innumerable lives all over the world. The symptoms of this disease may range from mild influenza-like symptoms to severe acute respiratory distress syndrome with high morbidity and mortality. With improved diagnostic techniques and better disease understanding, an increased number of cases are being reported with extrapulmonary manifestations of this disease ranging from renal and gastrointestinal to cardiac, hepatic, neurological and haematological dysfunction. Subacute thyroiditis is a self-limiting and painful thyroid gland inflammation most often secondary to viral infections. We report a case of subacute thyroiditis in a 58-year-old gentleman presenting with a painful swelling in the neck who was subsequently detected to be positive for SARS-CoV-2. We seek to highlight the broad clinical spectrum of the COVID-19 by reporting probably the first case of subacute thyroiditis possibly induced by SARS-CoV-2 infection from India.
Effects of BMI and LDL-cholesterol change pattern on cardiovascular disease in normal adults and diabetics
Authors: Youk Tae Mi , Kang Min Jin , Song Sun Ok , Park Eun-Cheol
Published: December 2020

Introduction

To examine how the risk of cardiovascular disease changes according to degree of change in body mass index (BMI) and low-density lipoprotein (LDL)-cholesterol in patients with diabetes using the health medical examination cohort database of the National Health Insurance Service in Korea. In comparison, the pattern in a non-diabetic control group was also examined.

Research design and methods

The study samples were 13 800 patients with type 2 diabetes and 185 898 non-diabetic controls, and their baseline characteristics and repeatedly measured BMI and LDL-cholesterol until occurrence of cardiovascular disease were collected in longitudinal data. We used the variability model that is joint of mixed effects and regression model, then estimated parameters about variability by Bayesian methods.

Results

The risk of cardiovascular disease was increased significantly with high average real variability (ARV) of BMI in the patients with diabetes, but the risk of cardiovascular disease was not increased according to degree of ARV in non-diabetic controls. The Bayesian variability model was used to analyze the effects of BMI and LDL-cholesterol change pattern on development of cardiovascular disease in diabetics, showing that variability did not have a statistically significant effect on cardiovascular disease. This shows the danger of the former simple method when interpreting only the mean of the absolute value of the variation.

Conclusions

The approach of simple SD in previous studies for estimation of individual variability does not consider the order of observation. However, the Bayesian method used in this study allows for flexible modeling by superimposing volatility assessments on multistage models.
Integrated digital system for community engagement and community-based surveillance during the 2014–2016 Ebola outbreak in Sierra Leone: lessons for future health emergencies
Authors: Jalloh Mohamed F , Sengeh Paul , James Nyuma , Bah Saiku , Jalloh Mohammad B , Owen Katharine , Pratt Samuel Abu , Oniba Allan , Sangarie Musa , Sesay Samuel , Bedson Jamie
Published: December 2020

Community engagement and community-based surveillance are essential components of responding to infectious disease outbreaks, but real-time data reporting remains a challenge. In the 2014–2016 Ebola outbreak in Sierra Leone, the Social Mobilisation Action Consortium was formed to scale-up structured, data-driven community engagement. The consortium became operational across all 14 districts and supported an expansive network of 2500 community mobilisers, 6000 faith leaders and 42 partner radio stations. The benefit of a more agile digital reporting system became apparent within few months of implementing paper-based reporting given the need to rapidly use the data to inform the fast-evolving epidemic. In this paper, we aim to document the design, deployment and implementation of a digital reporting system used in six high transmission districts. We highlight lessons learnt from our experience in scaling up the digital reporting system during an unprecedented public health crisis. The lessons learnt from our experience in Sierra Leone have important implications for designing and implementing similar digital reporting systems for community engagement and community-based surveillance during public health emergencies.
Individual interventions to improve adherence to pharmaceutical treatment, diet and physical activity among adults with primary hypertension. A systematic review protocol
Authors: Parra Dora Inés , Trapero Gimeno Isabel , Sánchez Rodríguez Javier Mauricio , Rodríguez Corredor Lizeth Catherine , Hernández Vargas Juliana Alexandra , López Romero Luis Alberto , García López Fernando J , Escudero-Gómez Cristina , Trujillo-Cáceres Silvia Juliana , Serrano-Gallardo Pilar , Vera-Cala Lina M
Published: December 2020

Introduction

Hypertension is a chronic disease with 31% worldwide prevalence in adults. It has been associated with non-adherence to therapeutic regime with a negative impact on the prognosis of the disease and healthcare-associated costs. So, it is necessary to identify effective interventions to improve adherence among the afflicted population. The objective of this protocol is to describe the methods for a systematic review that will evaluate the effect of individual interventions so as to improve adherence to the prescribed pharmacological treatment, as well as to prescribed diet and physical activity in adults with primary hypertension.

Methods and analysis

A systematic search of studies will be conducted in PubMed/MEDLINE, BVS, CINAHL, Embase, Cochrane and Scopus databases. Randomised and non-randomised clinical studies conducted in human beings, published from 1 January 2009 to 13 December 2019, are to be included, in any language. Adherence to pharmacological treatment, diet and physical activity, measured by direct and indirect methods, will be the primary outcome. Two independent reviewers will select relevant studies and will extract the data following the Cochrane’s Handbook for Systematic Reviews of Approach and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. Methodological quality will be evaluated using the risk-of-bias (RoB) 2 and Risk of Bias in Non-randomised Studies - of Interventions (ROBINS-I) tools. Risk of bias will also be evaluated, and if the criteria are met, a meta-analysis will be finally performed.

Ethics and dissemination

Information to be analysed is of a grouped nature, and given that its sources are published studies, no ethics committee approval is required. Results will be published in scientific journals, and in conferences, seminars and symposiums. Copyrights will be addressed by giving due credit through bibliographic references.

PROSPERO registration number

CRD42020147655
Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol
Authors: Taghavi Katayoun , Moono Misinzo , Mwanahamuntu Mulindi , Basu Partha , Limacher Andreas , Tembo Taniya , Kapesa Herbert , Hamusonde Kalongo , Asangbeh Serra , Sznitman Raphael , Low Nicola , Manasyan Albert , Bohlius Julia
Published: December 2020

Introduction

The simplest and cheapest method for cervical cancer screening is visual inspection after application of acetic acid (VIA). However, this method has limitations for correctly identifying precancerous cervical lesions (sensitivity) and women free from these lesions (specificity). We will assess alternative screening methods that could improve sensitivity and specificity in women living with humanimmunodeficiency virus (WLHIV) in Southern Africa.

Methods and analysis

We will conduct a paired, prospective, screening test accuracy study among consecutive, eligible women aged 18–65 years receiving treatment for HIV/AIDS at Kanyama Hospital, Lusaka, Zambia. We will assess a portable magnification device (Gynocular, Gynius Plus AB, Sweden) based on the Swede score assessment of the cervix, test for high-risk subtypes of human papillomavirus (HR-HPV, GeneXpert, Cepheid, USA) and VIA. All study participants will receive all three tests and the reference standard at baseline and at six-month follow-up. The reference standard is histological assessment of two to four biopsies of the transformation zone. The primary histological endpoint is cervical intraepithelial neoplasia grade two and above (CIN2+). Women who are VIA-positive or have histologically confirmed CIN2+ lesions will be treated as per national guidelines. We plan to enrol 450 women. Primary outcome measures for test accuracy include sensitivity and specificity of each stand-alone test. In the secondary analyses, we will evaluate the combination of tests. Pre-planned additional studies include use of cervigrams to test an automated visual assessment tool using image pattern recognition, cost-analysis and associations with trichomoniasis.

Ethics and dissemination

Ethical approval was obtained from the University of Zambia Biomedical Research Ethics Committee, Zambian National Health Regulatory Authority, Zambia Medicines Regulatory Authority, Swissethics and the International Agency for Research on Cancer Ethics Committee. Results of the study will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT03931083; Pre-results.
Comparison of cardiovascular disease risk factors, assessment and management in men and women, including consideration of absolute risk: a nationally representative cross-sectional study
Authors: Banks Emily , Welsh Jennifer , Joshy Grace , Martin Melonie , Paige Ellie , Korda Rosemary J
Published: December 2020

Objectives

Cardiovascular disease (CVD) is highly preventable and optimal treatments based on absolute risk can halve risk of future events. Compared with women, men have higher risks of developing CVD. However, women can experience suboptimal treatment. We aimed to quantify sex differences in CVD risk, assessment and treatment in Australian adults.

Design, participants, setting

Cross-sectional analysis of nationally representative data from interview, physical measures, medication review and blood and urine samples, from 2011 to 2012 Australian Health Survey participants aged 45–74 (n=11 518).

Outcome measures

CVD risk factors, absolute 5-year risk of a primary CVD event, blood pressure and cholesterol assessment in the previous 2 and 5 years and use of recommended CVD preventive medications were compared using Poisson regression to estimate age-adjusted male versus female prevalence ratios (PRs).

Results

Women had a generally more favourable CVD risk factor profile than men, including lower: current smoking prevalence (women=14.5%; men=18.4%, PR=0.78, 95% CI=0.70 to 0.88); body mass index (women (mean)=28.3 kg/m2; men (mean)=28.8 kg/m2, p<0.01); systolic and diastolic blood pressure (systolic: women (mean)=127.1 mm Hg; men (mean)=130.5 mm Hg, p<0.001); blood glucose (women (mean)=5.2 mmol/L; men (mean)=5.5 mmol/L); diabetes prevalence (women=6.8%; men=12.5%, PR=0.55, 95% CI=0.44 to 0.67); prior CVD (women=7.9%; men=11.3%) and absolute primary CVD risk (absolute 5-year CVD risk >15%: women=6.6%, 95% CI=5.4 to 7.8; men=15.4%, 95% CI=13.9% to 16.9%). Compared with men, women had higher low-density lipoprotein, high-density lipoprotein and total cholesterol and sedentary behaviour and lower physical activity. Blood pressure and cholesterol assessment were common in both sexes. Among those at high absolute risk, age-adjusted proportions receiving recommended CVD medications were low, without sex differences (women=21.3%; men=23.8%, PR=0.93, 95% CI=0.49 to 1.78). Fewer women than men with prior atherosclerotic CVD were receiving recommended treatment (women=21.8%, men=41.4%, PR=0.55, 95% CI=0.31 to 0.96).

Conclusion

Women have a more favourable CVD risk factor profile than men. Preventive treatment is uncommon and women with prior atherosclerotic CVD are around half as likely as men to be receiving recommended treatment.
Integrating care between an NHS hospital, a community provider and the role of commissioning: the experience of developing an integrated respiratory service
Authors: Banks Jonathan , Stone Tracey , Dodd James
Published: December 2020

Objectives

An integrated respiratory service was commissioned in 2016 in a UK region to support patients with chronic obstructive pulmonary disease. The service brought together the respiratory department of a National Health Service hospital and a not-for-profit community provider. This paper evaluates: (1) the perceived efficacy of integrated working between the organisations from the perspective of staff and (2) the relationship between commissioning and integration of the services.

Design

Semistructured interviews with staff from the three organisations involved in the integrated respiratory service. Staff were purposefully sampled. The interviews were audio recorded, transcribed and analysed thematically.

Setting

Secondary care respiratory unit; community provider of respiratory care; and a clinical commissioning group.

Participants

Nineteen interview participants: nine from the community provider; eight from the hospital and two from the clinical commissioning group.

Results

Staff identified lack of integration between the organisations characterised by: poor communication, lack of trust, absence of shared information technology and ineffective integrative initiatives. The commissioning process created barriers to integration including: contractual limitations which prevented pathway development, absence of agreed clinical governance arrangements and lack of recognition of community work undertaken by hospital staff. Positive working relationships were established over time as staff recognised the skills that each had to offer.

Conclusions

The commissioning process underpinned the relationship between the organisations and contributed to distrust and negative perceptions of the ‘other’. Commissioning an integrated service should incorporate dialogue with stakeholders as early as possible and before the contract is finalised to develop a bedrock of trust.
Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity
Authors: Tamura Kosuke , Vijayakumar Nithya P , Troendle James F , Curlin Kaveri , Neally Sam J , Mitchell Valerie M , Collins Billy S , Baumer Yvonne , Gutierrez-Huerta Cristhian A , Islam Rafique , Turner Briana S , Andrews Marcus R , Ceasar Joniqua N , Claudel Sophie E , Tippey Kathryn G , Giuliano Shayne , McCoy Regina , Zahurak Jessica , Lambert Sharon , Moore Philip J , Douglas-Brown Mary , Wallen Gwenyth R , Dodge Tonya , Powell-Wiley Tiffany M
Published: December 2020

Introduction

Although physical activity (PA) reduces cardiovascular disease (CVD) risk, physical inactivity remains a pressing public health concern, especially among African American (AA) women in the USA. PA interventions focused on AA women living in resource-limited communities with scarce PA infrastructure are needed. Mobile health (mHealth) technology can increase access to PA interventions. We describe the development of a clinical protocol for a multilevel, community-based, mHealth PA intervention for AA women.

Methods and analysis

An mHealth intervention targeting AA women living in resource-limited Washington, DC communities was developed based on the socioecological framework for PA. Over 6 months, we will use a Sequential Multi-Assignment, Randomized Trial approach to compare the effects on PA of location-based remote messaging (named ‘tailored-to-place’) to standard remote messaging in an mHealth intervention. Participants will be randomised to a remote messaging intervention for 3 months, at which point the intervention strategy will adapt based on individuals’ PA levels. Those who do not meet the PA goal will be rerandomised to more intensive treatment. Participants will be followed for another 3 months to determine the contribution of each mHealth intervention to PA level. This protocol will use novel statistical approaches to account for the adaptive strategy. Finally, effects of PA changes on CVD risk biomarkers will be characterised.

Ethics and dissemination

This protocol has been developed in partnership with a Washington, DC-area community advisory board to ensure feasibility and acceptability to community members. The National Institutes of Health Intramural IRB approved this research and the National Heart, Lung, and Blood Institute provided funding. Once published, results of this work will be disseminated to community members through presentations at community advisory board meetings and our quarterly newsletter.

Trial registration number

NCT03288207.
Relationship between primary school healthy eating and physical activity promoting environments and children’s dietary intake, physical activity and weight status: a longitudinal study in the West Midlands, UK
Authors: Garden Elizabeth Mairenn , Pallan Miranda , Clarke Joanne , Griffin Tania , Hurley Kiya , Lancashire Emma , Sitch Alice J , Passmore Sandra , Adab Peymane
Published: December 2020

Objective

We aimed to examine the association between food and physical activity environments in primary schools and child anthropometric, healthy eating and physical activity measures.

Design

Observational longitudinal study using data from a childhood obesity prevention trial.

Setting

State primary schools in the West Midlands region, UK.

Participants

1392 pupils who participated in the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) childhood obesity prevention trial (2011–2015).

Primary and secondary outcome measures

School environment (exposure) was categorised according to questionnaire responses indicating their support for healthy eating and/or physical activity. Child outcome measures, undertaken at three time points (ages 5–6, 7–8 and 8–9 years), included body mass index z-scores, dietary intake (using a 24-hour food ticklist) and physical activity (using an Actiheart monitor over 5 days). Associations between school food and physical activity environment categories and outcomes were explored through multilevel models.

Results

Data were available for 1304 children (94% of the study sample). At age 8–9 years, children in 10 schools with healthy eating and physical activity-supportive environments had a higher physical activity energy expenditure than those in 22 schools with less supportive healthy eating/physical activity environments (mean difference=5.3 kJ/kg body weight/24 hours; p=0.05). Children in schools with supportive physical activity environments (n=8) had a lower body mass index z-score than those in schools with less supportive healthy eating/physical activity environments (n=22; mean difference=−0.17, p=0.02). School food and physical activity promoting environments were not significantly associated with dietary outcomes.

Conclusions

School environments that support healthy food and physical activity behaviours may positively influence physical activity and childhood obesity.

Trial registration number

ISRCTN97000586.
Physical and mental health of women exposed to intimate partner violence in the 10 years after having their first child: an Australian prospective cohort study of first-time mothers
Authors: Brown Stephanie J , Conway Laura J , FitzPatrick Kelly M , Hegarty Kelsey , Mensah Fiona K , Papadopoullos Sandra , Woolhouse Hannah , Giallo Rebecca , Gartland Deirdre
Published: December 2020

Objective

To investigate mental and physical health of mothers exposed to recent and early postpartum intimate partner violence (IPV) in the 10 years after having their first child.

Design

Prospective pregnancy cohort study.

Setting

Women were recruited at six metropolitan public maternity hospitals in Melbourne, Australia and followed up at 1, 4 and 10 years post partum.

Study measures

Exposure to physical and/or emotional IPV was measured using the Composite Abuse Scale at 1, 4 and 10 years. At 10-year follow-up, mothers reported on physical and mental health, and functional health status.

Participants

1507 first-time mothers enrolled at mean of 15 weeks’ gestation.

Results

One in three women experienced IPV during the 10 years after having their first child. Women experiencing recent IPV (19.1%) reported worse physical and mental health than women not reporting IPV. Compared with women not reporting IPV, women experiencing recent IPV had higher odds of poor functional health status (Adj OR=4.5, 95% CI 3.2 to 6.3), back pain (Adj OR=2.0, 95% CI 1.4 to 2.9), incontinence (Adj OR=1.8, 95% CI 1.2 to 2.6), depressive symptoms (Adj OR=4.9, 95% CI 3.2 to 7.5), anxiety (Adj OR=5.1, 95% CI 3.0 to 8.6) and post-traumatic stress symptoms (Adj OR=7.2, 95% CI 4.6 to 11.1) at 10 years. Women with past IPV at 1 and/or 4 years (15.7% of the cohort) also had higher odds of physical and mental health problems. There was evidence of a gradient in health outcomes by recency of exposure to IPV.

Conclusions

Both recent and past exposure to IPV are associated with poor maternal physical and mental health 10 years after a first birth. Health services and advocacy organisations providing support to women need to be aware of the consistent relationship between IPV and a range of physical and mental health conditions, which may persist even after IPV appears to have ceased.
Prospective association between adherence to the Mediterranean diet and hepatic steatosis: the Swiss CoLaus cohort study
Authors: Khalatbari-Soltani Saman , Marques-Vidal Pedro , Imamura Fumiaki , Forouhi Nita G.
Published: December 2020

Objective

The Mediterranean diet has been promoted as a healthy dietary pattern, but whether the Mediterranean diet may help to prevent hepatic steatosis is not clear. This study aimed to evaluate the prospective association between adherence to the Mediterranean diet and risk of hepatic steatosis.

Design

Population-based prospective cohort study.

Setting

The Swiss CoLaus Study.

Participants

We evaluated 2288 adults (65.4% women, aged 55.8±10.0 years) without hepatic steatosis at first follow-up in 2009–2012. Adherence to the Mediterranean diet was scaled as the Mediterranean diet score (MDS) based on the Mediterranean diet pyramid ascertained with responses to Food Frequency Questionnaires.

Outcome measures

New onset of hepatic steatosis was ascertained by two indices separately: the Fatty Liver Index (FLI, ≥60 points) and the non-alcoholic fatty liver disease (NAFLD) score (≥−0.640 points). Prospective associations between adherence to the Mediterranean diet and risk of hepatic steatosis were quantified using Poisson regression.

Results

During a mean 5.3 years of follow-up, hepatic steatosis was ascertained in 153 (6.7%) participants by FLI criteria and in 208 (9.1%) by NAFLD score. After multivariable adjustment, higher adherence to MDS was associated with lower risk of hepatic steatosis based on FLI: risk ratio 0.84 (95% CI 0.73 to 0.96) per 1 SD of MDS; 0.85 (0.73 to 0.99) adjusted for BMI; and 0.85 (0.71 to 1.02) adjusted for both BMI and waist circumference. When using NAFLD score, no significant association was found between MDS and risk of hepatic steatosis (0.95 (0.83 to 1.09)).

Conclusion

A potential role of the Mediterranean diet in the prevention of hepatic steatosis is suggested by the inverse association observed between adherence to the Mediterranean diet and incidence of hepatic steatosis based on the FLI. The inconsistency of this association when hepatic steatosis was assessed by NAFLD score points to the need for accurate population-level assessment of fatty liver and its physiological markers.
What is the risk of prostate cancer mortality following negative systematic TRUS-guided biopsies? A systematic review
Authors: Kawa Sandra Miriam , Benzon Larsen Signe , Helgstrand John Thomas , Iversen Peter , Brasso Klaus , Røder Martin Andreas
Published: December 2020

Objective

To investigate the risk of prostate cancer-specific mortality (PCSM) following initial negative systematic transrectal ultrasound-guided (TRUS) prostate biopsies.

Design

Systematic review.

Data sources

PubMed and Embase were searched using a string combination with keywords/Medical Subject Headings terms and free text in the search builder. Date of search was 13 April 2020.

Study selection

Studies addressing PCSM following initial negative TRUS biopsies. Randomised controlled trials and population-based studies including men with initial negative TRUS biopsies reported in English from 1990 until present were included.

Data extraction

Data extraction was done using a predefined form by two authors independently and compared with confirm data; risk of bias was assessed using the Newcastle–Ottawa Scale for cohort studies when applicable.

Results

Four eligible studies were identified. Outcomes were reported differently in the studies as both cumulative incidence and Kaplan-Meier estimates have been used. Regardless of the study differences, all studies reported low estimated incidence of PCSM of 1.8%–5.2% in men with negative TRUS biopsies during the following 10–20 years. Main limitation in all studies was limited follow-up.

Conclusion

Only a few studies have investigated the risk of PCSM following initial negative biopsies and all studies included patients before the era of MRI of the prostate. However, the studies point to the fact that the risk of PCSM is low following initial negative TRUS biopsies, and that the level of prostate-specific antigen before biopsies holds prognostic information. This may be considered when advising patients about the need for further diagnostic evaluation.

PROSPERO registration number

CRD42019134548.
Antithrombotic management of patients with acute coronary syndrome and atrial fibrillation undergoing coronary stenting: a prospective, observational, nationwide study
Authors: De Luca Leonardo , Rubboli Andrea , Bolognese Leonardo , Gonzini Lucio , Urbinati Stefano , Murrone Adriano , Scotto di Uccio Fortunato , Ferrari Fabio , Lucà Fabiana , Caldarola Pasquale , Lucci Donata , Gabrielli Domenico , Di Lenarda Andrea , Gulizia Michele Massimo
Published: December 2020

Objective

The aim of the study was to assess current management of patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) undergoing coronary stenting.

Design

Non-interventional, prospective, nationwide study.

Setting

76 private or public cardiology centres in Italy.

Participants

Patients with ACS with concomitant AF undergoing percutaneous coronary intervention (PCI).

Primary and secondary outcome measures

To obtain accurate and up-to-date information on pharmacological management of patients with AF admitted for an ACS and undergoing PCI with stent implantation.

Results

Over a 12-month period, 598 consecutive patients were enrolled: 48.8% with AF at hospital admission and 51.2% developing AF during hospitalisation. At discharge, a triple antithrombotic therapy (TAT) was prescribed in 64.8%, dual antiplatelet therapy (DAPT) in 25.7% and dual antithrombotic therapy (DAT) in 8.8% of patients. Among patients with AF at admission, TAT and DAT were more frequently prescribed compared with patients with new-onset AF (76.3% vs 53.8% and 12.5% vs 5.3%, respectively; both p<0.0001), while a DAPT was less often used (11.2% vs 39.5%; p<0.0001). At multivariable analysis, a major bleeding event (OR: 5.40; 95% CI: 2.42 to 12.05; p<0.0001) and malignancy (OR: 5.11; 95% CI: 1.77 to 14.78; p=0.003) resulted the most important independent predictors of DAT prescription.

Conclusions

In this contemporary registry of patients with ACS with AF treated with coronary stents, TAT still resulted as the antithrombotic strategy of choice, DAT was reserved for high bleeding risk and DAPT was mainly prescribed in those developing AF during hospitalisation.

Trial registration number

NCT03656523.
Using qualitative and co-design methods to inform the development of an intervention to support and improve physical activity in childhood cancer survivors: a study protocol for BEing Active after ChildhOod caNcer (BEACON)
Authors: Brown Morven C , Araújo-Soares Vera , Skinner Roderick , Glaser Adam W , Sarwar Naseem , Saxton John M , Montague Kyle , Hall Jamie , Burns Olivia , Sharp Linda
Published: December 2020

Introduction

Childhood cancer survivors (CCSs) treated with cardiotoxic cancer treatments are at increased risk of developing cardiometabolic complications. This risk is further exacerbated by poor health behaviours. In particular, CCSs are less active than non-cancer comparators. Existing interventions aiming to improve physical activity (PA) levels in CCSs are methodologically weak. The aim of this study is to rigorously and systematically develop an evidence-based and theoretically-informed intervention to promote, support, improve and sustain PA levels in CCSs, with the long-term goal of reducing CCSs’ cardiovascular morbidity and mortality.

Methods and analysis

The BEing Active after ChildhOod caNcer (BEACON) study involves two workpackages at two National Health Service sites in England, UK.

Participants will be CCSs and their parents, and healthcare professionals (HCPs) involved in their care.

Workpackage one (WP1) will use qualitative methods to explore and understand the barriers and facilitators to PA in CCSs. Two sets of semistructured interviews will be conducted with (1) CCSs (aged 10–24 years) and (2) parents of CCSs. WP2 will use co-design methods to bring together stakeholders (CCSs; their parents; HCPs; researchers) to develop a prototype intervention. Where possible, all data will be audio recorded and transcribed.

Data from WP1 will be analysed using a thematic approach. Analysis of WP2 data will involve content analysis, and analysis of formative output and procedures.

Ethics and dissemination

The study was approved by North East-Tyne & Wear South Research Ethics Committee (REC ref: 18/NE/0274). Research findings will be disseminated primarily via national and international conferences and publication in peer-reviewed journals. Patient and public involvement will inform further dissemination activities.
Identifying the commonly used antibiotics for self-medication in urban Mozambique: a qualitative study
Authors: Torres Neusa F , Solomon Vernon P , Middleton Lyn E
Published: December 2020

Objectives

The study aimed at identifying the commonly used non-prescribed antibiotics (NPAs) and the main health conditions leading to the practices of self-medication with antibiotics (SMAs) in Maputo city, Mozambique.

Design

Cross-sectional qualitative study based on individual and group interviews.

Setting

The study was conducted in nine pharmacies of three socioeconomic areas of Maputo city, from October 2018 to March 2019.

Participants

The study included 32 pharmacy clients and 17 pharmacists. The pharmacy clients included men 10 (31%) and women 22 (69%) ranging from 19 to 67 years while the pharmacists included men 6 (35,3%) and women 11 (64,7%) with ages ranging from 24 to 47 years.

Findings

The majority of the pharmacy clients 30 (93.75%) admitted frequent use of NPAs, 15 (88.2%) out of the 17 pharmacists admitted dispensing NPAs. While the majority of the participants (16) mentioned the use of amoxicillin, also known as ‘two colours medicine’, 14 mentioned the use of cotrimoxazole and seven mentioned amoxicillin with clavulanic acid. Two to five participants also used tetracycline, ciprofloxacin, azithromycin, doxycycline, erythromycin, metronidazole and phenoxymethylpenicillin. The above mentioned NPAs were used to treat self-perceived sore throat, fever, pain, cough, vaginal discharge, eye problems, the common influenza, urinary infections, respiratory tract infections, wounds and toothaches.

Conclusions

Antibiotics are perceived as essential medical resources to manage health and illnesses. While taking an active role in their health-disease process, participants commonly used amoxicillin, ‘two colours’, cotrimoxazole and amoxicillin with clavulanic acid to manage their health and that of their families. In this sense, the practices of SMAs were perceived as part of the self-care process and not necessarily as misuse of antibiotics. A wideunderstanding of health-seeking beliefs and behaviours regarding the utilisation of antibiotics is needed to inform public health experts, health policymakers and other stake-holders in designing and implementing public health education and health promotion programsat all levels in Mozambique.
Transition from child to adult health services for young people with cerebral palsy in Ireland: a mixed-methods study protocol
Authors: Ryan Jennifer M , Fortune Jennifer , Walsh Aisling , Norris Meriel , Kerr C , Hensey Owen , Kroll Thilo , Lavelle Grace , Owens Mary , Byrne M , Walsh Michael
Published: December 2020

Introduction

The transition from child to adult health services is a challenging and complex process for young people with cerebral palsy (CP). Poorly managed transition is associated with deterioration in health, increased hospitalisations and reduced quality of life. While international research identifies key practices that can improve the experience and outcomes of transition, there is a paucity of data in the Irish context. This research study aims to gain an insight into the experience of transition for young people with CP in Ireland.

Methods and analysis

A convergent parallel mixed-methods design will be used to collect, analyse and interpret quantitative and qualitative data. Participants will be young people aged 16–22 years with CP, their parent(s)/carer(s) and service providers. Quantitative and qualitative data will be collected through questionnaires and interviews, respectively. Quantitative data will be reported using descriptive statistics. Where sufficient data are collected, we will examine associations between the experience of transition practices and sociodemographic and CP-related factors, respectively, using appropriate regression models. Associations between service provider characteristics and provision of key transition practices may also be explored using appropriate regression models. Qualitative data will be analysed using the Framework Method. A coding matrix based on key transitional practices identified from the literature will be used to identify convergence and divergence across study components at the integration stage.

Ethics and dissemination

The study has been approved by the RCSI University of Medicine and Health Sciences Research Ethics Committee (REC201911010). Results will be presented to non-academic stakeholders through a variety of knowledge translation activities. Results will be published in open access, peer-reviewed journals and presented at national and international scientific conferences.
TriMaster: randomised double-blind crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as second-line or third-line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on metformin treatment with or without a sulfonylurea—a MASTERMIND study protocol
Authors: Angwin Catherine , Jenkinson Caroline , Jones Angus , Jennison Christopher , Henley William , Farmer Andrew , Sattar Naveed , Holman Rury R , Pearson Ewan , Shields Beverley , Hattersley Andrew
Published: December 2020

Introduction

Pharmaceutical treatment options for patients with type 2 diabetes mellitus (T2DM) have increased to include multiple classes of oral glucose-lowering agents but without accompanying guidance on which of these may most benefit individual patients. Clinicians lack information for treatment intensification after first-line metformin therapy. Stratifying patients by simple clinical characteristics may improve care by targeting treatment options to those in whom they are most effective. This academically designed and run three-way crossover trial aims to test a stratification approach using three standard oral glucose-lowering agents.

Methods and analysis

TriMaster is a randomised, double-blind, crossover trial taking place at up to 25 clinical sites across England, Scotland and Wales. 520 patients with T2DM treated with either metformin alone, or metformin and a sulfonylurea who have glycated haemoglobin (HbA1c) >58 mmol/mol will be randomised to receive 16 weeks each of a dipeptidyl peptidase‐4 inhibitor, sodium-glucose co-transporter-2 inhibitor and thiazolidinedione in random order. Participants will be assessed at the end of each treatment period, providing clinical and biochemical data, and their experience of side effects. Participant preference will be assessed on completion of all three treatments. The primary endpoint is HbA1c after 4 months of therapy (allowing a range of 12–18 weeks for analysis). Secondary endpoints include participant-reported preference between the three treatments, tolerability and prevalence of side effects.

Ethical approval

This study was approved by National Health Service Health Research Authority Research Ethics Committee South Central—Oxford A, study 16/SC/0147. Written informed consent will be obtained from all participants. Results will be submitted to a peer-reviewed journal and presented at relevant scientific meetings. A lay summary of results will be made available to all participants.

Trial registration numbers

12039221; 2015-002790-38 and NCT02653209.
Duration of palliative care involvement and cancer care aggressiveness near the end of life
Authors: Monier Pierre Antoine , Chrusciel Jan , Ecarnot Fiona , Bruera Eduardo , Sanchez Stephane , Barbaret Cecile
Published: December 2020

Objectives

Previous studies have found an association between aggressive cancer care and lower quality end of life. Despite international recommendations, late or very late referral to palliative care seems frequent. This study aimed to evaluate the association between the duration of involvement of a palliative care team (PCT), and aggressive cancer care, and to identify factors associated with aggressive cancer care.

Methods

We performed an observational retrospective study in a single academic teaching hospital. In total, 561 inpatients with solid tumours or haematological malignancies were included. Patients followed by a PCT for at least 1 month before death were classified in the palliative care group. Aggressive cancer care was defined as: hospitalisations and/or a new line of chemotherapy within the last month of life, location of death, the use of chemotherapy in the last 2 weeks and hospice admissions within the last 3 days of life.

Results

Among the 561 patients, 241 (43%) were referred to the PCT; 89 (16%) were followed by the PCT for a month or more before death. In the last 2 weeks of life, 124 (22%) patients received chemotherapy, 110 (20%) died in an acute care unit. At least one criterion of aggressive cancer care was found in 395 patients overall (71%). Aggressive cancer care was significantly less frequent when the PCT referral occurred >1 month before death (p<0.0001).

Conclusion

More studies are needed to understand reasons for late referrals despite international recommendations encouraging integrative palliative care.

Ethics approval

The study was approved by the Grenoble Teaching Hospital ethics committee, and by the CNIL (French national commission for data privacy; Commission Nationale de l’Informatique et des Libertés) under the number 1987785 v 0. Due to ethical and legal restrictions, data are only available on request.
Dexmedetomidine withdrawal syndrome and opioid sensitivity
Authors: Ferguson Lana , Hooper Stacey
Published: December 2020

This case report describes the use of dexmedetomidine for refractory cancer pain management in a patient with significant pelvic disease due to metastatic urothelial cancer. Specifically, the management of increased opioid sensitivity secondary to dexmedetomidine is discussed. Further, the phenomenon of dexmedetomidine withdrawal syndrome and our management of this is addressed.
Systematic review to examine the methods used to adapt evidence-based psychological treatments for adults diagnosed with a mental illness
Authors: Harvey Allison G. , Lammers Hannah S. , Dolsen Emily A , Mullin Alice C. , Hilmoe Heather E. , Tran Melanie , Portnova Vera , Tuck Alison B. , Mallidi Ajitha , Fang Anya , Byrnes Caitlin , Kao Esther , Lee Colin
Published: December 2020

Question

The context for the implementation of evidence-based psychological treatments (EBPTs) often differs from the context in which the treatment was developed, which necessitates adaptations. In this systematic review we build on, and add to, prior approaches by examining the method used to guide such adaptations. In particular, we sought to elucidate the extent to which an empirical process is used.

Study selection and analysis

We focused on publications describing adaptations made to EBPTs for adults diagnosed with a mental illness. We searched PubMed, PsycINFO, Embase and Web of Science from database inception to July 2018. Two raters independently coded the articles for the method used to conduct the adaptation, the reason for and nature of the adaptation, and who made the adaptation.

Findings

The search produced 20 194 citations, which yielded 152 articles after screening. The most commonly used methods for planned adaptations were literature review (57.7%), clinical intuition (47.0%) and theory (38.9%). The use of data from stakeholder interviews ranked fourth (21.5%) and the use of other types of data (eg, pilot study, experiment, survey, interview) ranked last at fifth (12.1%). Few publications reporting ad hoc adaptations were identified (n=3).

Conclusions

This review highlights a need to (a) educate providers and researchers to carefully consider the methods used for the treatment adaptation process, and to use empirical methods where possible and where appropriate, (b) improve the quality of reporting of stakeholder interviews and (c) develop reporting standards that articulate optimal methods for conducting treatment adaptations.