bluuebunny/crossref_metadata_2025_split huggingface dataset:
Stakeholder views on the acceptability of Human Infection Studies in Malawi
Authors: Kapumba Blessings M. , Jambo Kondwani , Rylance Jamie , Gmeiner Markus , Sambakunsi Rodrick , Parker Michael , Gordon Stephen B. , Gooding Kate 
Published: December 2019

Abstract
Background: Human infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMIC) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMIC.
Methods: We conducted 6 deliberative focus groups and 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members and district health government officials.
Findings: Stakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example balancing equity, safety and relevance in inclusion criteria.
Conclusions: Our findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out.
Key words: Human Infection Studies, pneumococcal, Malawi, acceptability, ethics
Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)
Authors: Hurley Deirdre , Jeffares Isabelle , Hall Amanda M , Keogh Alison , Toomey Elaine , McArdle Danielle , McDonough Suzanne M , Guerin Suzanne , Segurado Ricardo , Matthews James 
Published: December 2019

Abstract
Background The Self-management of Osteoarthritis (OA) and Low back pain (LBP) through Activity and Skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results 14 clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (Intervention: mean (SD) =4.92 (1.31), range 2-7; UP: mean (SD) =5.08 (2.43), range 1-9). 120 participants (83.3% of n=144 expected) were recruited (Intervention n=59; UP n=61), with follow up data obtained from 80.8% (n=97) at 6 weeks, 84.2% (n=101) at 2 months and 71.7% (n=86) at 6 months. Most participants received treatment as allocated (Intervention n=49; UP n=54). The qualitative interviews (12 participants; 10 PTs) found the Intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between group effects. Conclusions While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. Trial Registration: ISRCTN Registry, ISRCTN49875385, Registered 26 March 2014. https://doi.org/10.1186/ISRCTN49875385
Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management. - The CIPIC Rehab study: study protocol for a randomised controlled trial
Authors: Siercke Maj , Jørgensen Lise Pyndt , Missel Malene , Thygesen Lau Caspar , Blach Pernille Peppercorn , Sillesesn Henrik , Berg Selina Kikkenborg 
Published: December 2019

Abstract
Introduction: Intermittent claudication (IC) caused by Peripheral Artery Disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced health-related quality of life. The disease leads to social isolation, the risk of cardiovascular morbidity, and mortality. Non-operative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised training, yet many patients with IC lack motivation for changes in health behavior. No studies investigating the effects of existing cardiac rehabilitation targeted patients with IC have been published. The aim of this paper is to present the rationale and design of the CIPIC Rehab Study, which examines the effect of a cross-sectoral rehabilitation programme versus usual care for patients in non-operative management for IC. Methods and analysis: A randomised clinical trial aims to investigate whether cardiac rehabilitation for patients with IC in non-operative management versus usual care is superior to treatment as usual. The trial will allocate 118 patients, 1:1 individual randomisation to either the intervention or control group. The primary outcome is maximal walking distance measured by the standardised treadmill walking test. The secondary outcome is pain-free walking distance measured by the standardised treadmill walking test, healthy diet measured by a fat-fish-fruit-green score, and level of physical activity measured by activity score within official recommendations. Statistical analyses will be blinded. Several exploratory analyses will be performed. A mixed-method design is used to evaluate qualitative and quantitative findings. A qualitative and a survey-based complementary study will be undertaken to investigate patients’ post-discharge experiences. A qualitative post-intervention study will explore experiences of participation in rehabilitation. Discussion: The study is the first to assess the effect of a cardiac rehabilitation programme designed for patients with intermittent claudication. The study will describe how to monitor and improve rehabilitations programme for patients with intermittent claudication in a real-world setting. Mixed method strategies can allow for both exploration and generalization in the same study, but the research design is a complex intervention and any effects found can not be awarded a specific component.
Hepatic resection versus TILA-TACE in the treatment of Resectable Hepatocellular Carcinoma: study protocol for a randomized controlled trial
Authors: Feng Yangyang , Jin Yun , Jin Kai , Yu Yuanquan , Zhou Donger , Wu Jianjun , Li Bin , Zhang Guangqiang , Peng Shuyou , Qi Xiaogang , Geng Hao , Guo Yinghao , Chao Ming , Li Jiangtao 
Published: December 2019

Abstract
Background: Hepatic resection and transcatheter arterial chemoembolization (TACE) are common treatments for hepatocellular carcinoma (HCC). Targeting intratumoral lactic acidosis TACE (TILA-TACE) is a new therapeutic approach developed by our team that has superior response rate and effective rate than conventional TACE (cTACE). In this randomized-controlled trial, we will compare the efficacy of hepatic resection and TILA-TACE in patients clinically diagnosed with HCC to provide reliable clinical data for the subsequent effective treatment of HCC patients. Methods: A total of 230 resectable HCC patients will be given hepatic resection or TILA-TACE using a parallel-controlled approach, and the efficacy of the treatments Page 4 of 24 will be compared. The primary endpoint is the post-treatment progression-free survival (PFS) of the patients, and the secondary endpoints are the post-treatment overall survival (OS), 1-year, 3-year and 5-year survival, and the quality of life of the patients at each corresponding stage. Discussion: The aim of this study is to compare the efficacy of hepatic resection and TILA-TACE in the treatment of resectable HCC. Trial registration: ClinicalTrials.gov,NCT03314532.Registered on 19 October 2017. Keywords: Hepatocellular carcinoma, Hepatic resection, TACE, TILA-TACE, Randomized-controlled study.
Strong Families: A new family skills training programme for challenged and humanitarian settings: a single-arm intervention tested in Afghanistan
Authors: Haar Karin , El-Khani Aala , Molgaard Virginia , Maalouf Wadih 
Published: December 2019

Abstract
Background
Children living in challenged humanitarian settings (rural/underserved areas, displaced, refugees, conflict/post conflict) are at greater risk of mental health difficulties or behavioural problems, with caregivers acting as their main protective factors. While many family skills programmes exist, very few were developed for, or piloted in, low resource settings (settings with limited infrastructure). We designed the brief and light Strong Families (SF) programme, consisting of 5 hours contact time over 3 weeks. We conducted a pilot study aiming to test the feasibility of implementation, and preliminary effectiveness of SF, in improving child behaviour and family functioning in Afghanistan.

Methods
We recruited female caregivers and children aged 8-12 years through schools and drug treatment centres and enrolled them in the SF programme. Demographic data, emotional and behavioural difficulties of children and parental skills and family adjustment measures were collected from caregivers before, 2 and 6 weeks after the intervention. Outcome was assessed through the SDQ (Strengths and Difficulties Questionnaire), assessing children’s behavioural, emotional, and social issues, and PAFAS (Parenting and Family Adjustment Scales), measuring parenting practices and family functioning.

Results
We enrolled 72 families in the programme with a 93.1% retention rate (n=67) for data collection 6 weeks post intervention. Mean age of caregivers was 36.1 years, they had 3.8 children on average and 91.7% of them had experienced war/armed conflict in their past. The average total difficulty score of the SDQ (ranging from 0 to 40, with scores above 16 being indicative of high problems) of the 72 children reduced significantly, from 17.8 at pre-test to 12.9 at post-test and 10.6 at second follow-up, with no difference in gender and most noticeably amongst those with the highest scores at baseline. Likewise, PAFAS scores decreased significantly after the programme, again with caregivers with the highest scores at baseline improving most.

Conclusions
The implementation of a brief family skills programme was seemingly effective and feasible in a resource-limited setting and positively improved child mental health and parenting practices and family adjustment skills. These results suggest the value of such a programme and call for validation through further impact assessment and outcome evaluation.
CAPAbility: Comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial.
Authors: Clarke Celia , Pomeroy Valerie , Clark Allan , Creelman Graham , Hancock Nicola , Horton Simon , Killett Anne , Mann Charles , Payerne Estelle , Toms Andoni , Roberts Gareth , Smith Toby , Swart Ann Marie , McNamara Iain 
Published: December 2019

Abstract
Background: Osteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% of patients report poor functional outcomes following surgery. This study will investigate the functional outcome of two TKR; the JOURNEY II Bi Cruciate Stabilised knee, a newer prosthesis designed to provide guided motion and improve knee kinematics by more closely approximating a normal knee and the GENESIS II, a proven existing design. Aim: To compare the change in patient reported outcome scores of the JOURNEY II BCS and the GENESIS II from pre-operation to six months post-operation. Methods : CAPAbility is a pragmatic, blinded, two-arm parallel, randomised controlled trial recruiting patients with primary osteoarthritis due to have unilateral TKR surgery across two UK hospitals. Eligible participants (n=80) will be randomly allocated to receive either the JOURNEY II or the GENESIS II BCS knee prosthesis. Baseline measures will be taken prior to surgery. Patients will be followed at one week, six to eight weeks and six months post-operatively. Primary outcome is the Oxford Knee Score (OKS) at six months post-operatively. Secondary outcomes include: other patient-reported outcome measures (PROMs), biomechanical, radiological (computerised tomography, (CT)), clinical efficacy and safety outcomes. An embedded qualitative study will also investigate patients’ perspectives via interview pre- and post-surgery on variables known to affect the outcome of TKR surgery. A sub-sample (n=30) will have additional in-depth interviews to explore themes identified. The surgeons’ perspectives on the operation will be investigated by a group interview after all participants have undergone surgery. Discussion : This trial will evaluate two generations of TKR using PROMS, kinematic and radiological analyses and qualitative outcomes from the patient perspective.
A Qualitative Study of Physician Perspectives on Adaptation to Electronic Health Records
Authors: Sieck Cynthia Judine , Pearl Nicole , Bright Tiffani J. , Yen Po-Yin 
Published: December 2019

Abstract
Background Electronic Health Records (EHRs) have the potential to improve many aspects of care and their use has increased in the last decade. Because of this, acceptance and adoption of EHRs is less of a concern than adaptation to use. To understand this issue more deeply, we conducted a qualitative study of physician perspectives on EHR use to identify factors that facilitate adaptation.Methods We conducted semi-structured interviews with 9 physicians across a range of inpatient disciplines at a large Academic Medical Center. Interviews were conducted by phone, lasting approximately 30 minutes, and were transcribed verbatim for analysis. We utilized inductive and deductive methods in our analysis.Results We identified 4 major themes related to EHR adapation: impact of EHR changes on physicians, how physicians managed these changes, factors that facilitated adapation to using the EHR and adapting to using the EHR in the patient encounter. Within these themes, physicians felt that a positive mindset toward change, providing upgrade training that was tailored to their role, and the opportunity to learn from colleagues were important facilitators of adaption.Conclusions As EHR use moves beyond implementation, physicians continue to be required to adapt to the technology and to its frequent changes. Our study provides actionable findings that allow healthcare systems to focus on factors that facilitate the adaptation process for physicians.
Co-infection with Campylobacter and rotavirus in less than 5 year old children with acute gastroenteritis in Nepal during 2017-2018
Authors: Bhattarai Vishnu , Sharma Saroj , Author) Komal Raj Rijal(Former Corresponding , Author) Megha Raj Banjara(New Corresponding 
Published: December 2019

Abstract
Background: Diarrhoea, although easily curable, is a global cause of death for a half million children every year. Rotavirus and Campylobacter are the most common etiological agents of diarrhoea in children less than 5 years of age. However, in Nepal, these causative agents are not routinely examined for the diagnosis and treatment. The main objective of this study was to determine Campylobacter co-infection associated with rotavirus diarrhoea in children less than 5 years of age. Methods: A cross-sectional study was conducted at Kanti Children's Hospital (KCH), Kathmandu, Nepal from November 2017 to April 2018. A total of 303 stool specimens from children affected with diarrhoea were processed to detect rotavirus using a rapid rotavirus antigen detection test kit, and Campylobacter by microscopy, culture and biochemical tests. Antibiotic susceptibility tests of Campylobacter isolates were performed according to European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidelines 2015. Results: Of 303 samples, 91 (30.0%) were positive for co-infection with rotavirus and Campylobacter. Rotavirus mono-infection was detected in 61 (20.1%), and Campylobacter mono-infection was detected in 81 (26.7%) samples. Patient’s age, month of infection, untreated water and frequent soil contact were the major risk factors for infections. Clinical features such as >9 loose motions per day, fever, vomiting, mild to moderate dehydration, diarrhea persisting 6-9 days and presence of mucus in stool were significant (p<0.05) clinical features, and were more severe in coinfection compared to mono-infections in multivariate analysis. Conclusion: The study shows a high rate of rotavirus and Campylobacter coinfection in children with diarrhoea. Diagnosis based management of diarrhoeal cases can guide the specific treatment. Keywords: Campylobacter, rotavirus, co-infection, diarrhoea, children
The Oral Microbiome and Salivary Proteins Influence Caries in Preschool Children
Authors: Chen Wang , Jiang Qian , Yan GuoWei , Yang DeQin 
Published: December 2019

Abstract
Background Oral microbiome and salivary proteins play a critical role in the occurrence and development of caries. In this study, we used metagenomic and metaproteomic analyses to explore the microbiological and proteinic biomarkers and investigate the etiology of caries in preschool children. Our study aims to offer a better comprehension of these factors and the relationship with caries, and these findings might facilitate caries risk assessment and provide a basis for future prevention strategies.Methods Children six to eight years old living in rural isolated areas with or without caries were recruited. Supragingival plaque and unstimulated saliva were collected for 16S rDNA pyrosequencing and isobaric tags for relative and absolute quantitation (iTRAQ)technique coupled with quantitative nano-flow liquid chromatography-tandem mass spectrometry(LC-MS/MS), respectively.Results We found the six most abundant phyla (Firmicutes, Bacteroidetes, Fusobacteria, Proteobacteria, Actinobacteria, and Candidate division TM7). The Alpha diversity analysis demonstrated that the richness and diversity of the bacterial communities were similar between children with caries-free and caries-active groups; LEfSe detected differences in the bacterial community including Dialister, Selenomonas, Actinomyces, and Mogibacterium in the caries-active group (P<0.05) and Capnocytophaga, Fusobacterium, Desulfuromonadales, Haemophilus, and Porphyromonas in the caries-free group(P<0.05). The core microbiome was defined as 18 predominant genera in preschool children with caries. The results of the salivary proteome identified 9135 unique peptides and 1662 proteins group from 20 salivary samples. Two hundred fifty-eight proteins were differentially expressed between the caries-free and caries-active groups.Conclusions The diversity of the microbial community has little effect on caries but some bacteria with different relative abundance between the caries-active and caries-free group could be considered as potential biomarkers for preschool children with caries. In addition, as a critical host factor of caries, the salivary proteins are different in caries-free and caries-active groups.
Progression of the smoking epidemic in high-income regions and its effects on male-female survival differences: a cohort-by-age analysis of 17 countries.
Authors: Wensink Maarten , Álvarez Jesús-Adrián , Rizzi Silvia , Janssen Fanny , Lindahl-Jacobsen Rune 
Published: December 2019

Abstract
Background Of all lifestyle behaviours, smoking caused the most deaths in the last century. Because of the time lag between the act of smoking and dying from smoking, and because males generally take up smoking before females do, male and female smoking epidemiology often follows a typical double wave pattern dubbed the ‘smoking epidemic’. How are male and female deaths from this epidemic differentially progressing in high-income regions on a cohort-by-age basis? How have they affected male-female survival differences? MethodsWe used data for the period 1950-2015 from the WHO Mortality Database and the Human Mortality Database on three geographic regions that have progressed most into the smoking epidemic: high-income North America, high-income Europe and high-income Oceania. We examined changes in smoking-attributable mortality fractions as estimated by the Preston-Glei-Wilmoth method by age (ages 50-85) across birth cohorts 1870-1965. We used these to trace sex differences with and without smoking-attributable mortality in period life expectancy between ages 50 and 85. ResultsIn all three high-income regions, smoking explained up to 50% of sex differences in period life expectancy between ages 50 and 85 over the study period. These sex differences have declined since at least 1980, driven by smoking-attributable mortality, which tended to decline in males and increase in females overall. Thus, there was a convergence between sexes across recent cohorts. While smoking-attributable mortality was still increasing for older female cohorts, it was declining for females in the more recent cohorts in the US and Europe, as well as for males in all three regions.ConclusionsThe smoking epidemic contributed substantially to the male-female survival gap and to the recent narrowing of that gap in high-income North America, high-income Europe and high-income Oceania. The precipitous decline in smoking-attributable mortality in recent cohorts bodes somewhat hopeful. Yet, smoking-attributable mortality remains high, and therefore cause for concern.